Study aim stated in the first congress presentation of Part C

“Study Aim: To evaluate the efficacy and safety of pritelivir compared with investigator's choice (ICT)” (opens the source at this quote in a new tab)

Objective stated in the congress abstract

“PRIOH-1 evaluated the safety and efficacy of pritelivir vs. investigator’s choice therapy (ICT) in immunocompromised (IC) patients with refractory herpes simplex virus (HSV) infection, with or without resistance (R±R).” (opens the source at this quote in a new tab)

Part C: superiority objective in the ClinicalTrials.gov record

“This trial part is designed to show superiority of pritelivir against Investigator's Choice in obtaining clinical cure, ie, number of subjects with all lesions healed within 28 days.” (opens the source at this quote in a new tab)

Main objectives of Parts C, D, and F in the EU Clinical Trials Register record

“Part C: to investigate the efficacy of oral pritelivir 100 mg once a day in immunocompromised subjects with acyclovir (ACV)-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infections for a treatment period of 28 days as a maximum in comparison to "Investigator's Choice" treatment for a maximum treatment duration of 28 days” (opens the source at this quote in a new tab)
“Part D (complete): to investigate the efficacy of oral pritelivir 100 mg once a day in immunocompromised subjects with ACV-R and foscarnet-R/intolerant mucocutaneous HSV infections for a treatment period of 28 days as a maximum” (opens the source at this quote in a new tab)
“Part F: investigate the safety and tolerability of oral pritelivir 100 mg once a day in IS with ACV-R and foscarnet-R/intolerant mucocutaneous HSV infections for a treatment period of 28 days as a max after completion of enrollment in Part D.” (opens the source at this quote in a new tab)

Secondary objectives of Parts C, D, and F in the EU Clinical Trials Register record

“Part C: to investigate the efficacy of oral pritelivir 100 mg once a day in immunocompromised subjects with ACV-R mucocutaneous HSV infections for a treatment period of 42 days as a maximum in comparison to "Investigator's Choice" treatment for a maximum treatment duration of 42 days” (opens the source at this quote in a new tab)
“Part D (complete): to investigate the efficacy of oral pritelivir 100 mg once a day in immunocompromised subjects with ACV-R and foscarnet-R/intolerant mucocutaneous HSV infections for a treatment period of 42 days as a maximum” (opens the source at this quote in a new tab)
“Part F: to investigate the efficacy of oral pritelivir 100 mg once a day in immunocompromised subjects with ACV-R and foscarnet-R/intolerant mucocutaneous HSV infections for a treatment period of 28 days as a maximum” (opens the source at this quote in a new tab)

Part E: main objective in the EU Clinical Trials Information System record

“Part E: to investigate the safety and tolerability of oral pritelivir 100 mg once a day in immunocompromised subjects with ACV-S mucocutaneous HSV infections for a treatment period of 28 days as a maximum.” (opens the source at this quote in a new tab)

Parts D and F: purpose stated in the prescribing information

“The efficacy of HOVILPRI was further evaluated in Parts D and F of Trial PRIOH-1, which had a non-randomized, open-label, single-arm design to assess the efficacy and safety of HOVILPRI (400 mg loading dose on Day 1 followed by 100 mg once daily).” (opens the prescribing information at this quote)

Aim stated in the company release of topline results

“The aim of the trial was to evaluate the efficacy and safety of pritelivir compared to SoC (investigator’s choice of foscarnet, cidofovir, compounded topical cidofovir or imiquimod) in treating immunocompromised patients with refractory HSV infection, with or without resistance (R±R).” (opens the source at this quote in a new tab)

Aim stated in the company release on completion of enrollment

“The study (2023-510088-37-00) aims to demonstrate superior efficacy and safety of pritelivir vs. investigator’s choice for refractory HSV infections in immunocompromised patients.” (opens the source at this quote in a new tab)

Study dates and status in the ClinicalTrials.gov record

Field	Registry value
Study start (actual)	“2017-05-08”
Primary completion (actual)	“2025-08-15”
Study completion (actual)	“2025-11-11”
First posted	“2017-03-08”
Last update posted	“2026-06-12”
Status	“Completed”
Results	“No Results Posted”

Start of the phase 3 part

“WUPPERTAL, GERMANY / ACCESSWIRE / July 8, 2021 / AiCuris Anti-infective Cures AG, a leading company in the discovery and development of drugs against infectious diseases, today announced the start of pivotal phase 3 development with its proprietary lead compound pritelivir, a novel helicase-primase inhibitor, following encouraging phase 2 interim results achieved in the phase 2 part of its clinical phase 2/3 trial, PRIOH-1.” (opens the source at this quote in a new tab)
“First clinical sites are already initiated.” (opens the source at this quote in a new tab)

Closure of Part D

“Part D has been closed in June 2022.” (opens the source at this quote in a new tab)

Completion of enrollment

“Wuppertal, Germany, July 24, 2025 – Aicuris Anti-infective Cures AG today announced the completion of patient enrollment in its pivotal Phase 3 trial, PRIOH-1, evaluating pritelivir for the treatment of refractory and/or treatment resistant herpes simplex virus (HSV) infections in immunocompromised patients.” (opens the source at this quote in a new tab)

Number of locations in the ClinicalTrials.gov record

“This study has 70 locations” (opens the source at this quote in a new tab)

Study locations in the ClinicalTrials.gov record

Location	Facility
Birmingham, Alabama, United States	“University of Alabama at Birmingham”
Huntsville, Alabama, United States	“Metro Infectious Disease Consultants, LLC - Huntsville”
Mobile, Alabama, United States	“University of South Alabama”
Tucson, Arizona, United States	“University Arizona - Department of Medicine Arizona Health Sciences Center”
Duarte, California, United States	“City of Hope”
Los Angeles, California, United States	“Cedars-Sinai Medical Center”
Sacramento, California, United States	“University of California, Division of Infectious Diseases”
DeLand, Florida, United States	“Midland Florida Clinical Research Center, LLC”
Ft. Pierce, Florida, United States	“Midway Immunology and Research Center (MIRC)”
Gainesville, Florida, United States	“University of Florida (UF) - Division of Infectious Disease”
Miami, Florida, United States	“Links Clinical Trials”
Tampa, Florida, United States	“University of South Florida”
Atlanta, Georgia, United States	“Emory Hospital Midtown Infectious Disease Clinic”
Decatur, Georgia, United States	“Metro Infectious Disease Consultants - Atlanta”
Burr Ridge, Illinois, United States	“Metro Infectious Disease Consultants, LLC”
Chicago, Illinois, United States	“Department of Medicine J. H. Stroger Hospital of Cook County”
Baton Rouge, Louisiana, United States	“LSU Health Baton Rouge Pulmonary Clinic”
New Orleans, Louisiana, United States	“Tulane University - School of Medicine”
Baltimore, Maryland, United States	“Johns Hopkins University School of Medicine”
Boston, Massachusetts, United States	“Brigham and Women's Hospital”
Minneapolis, Minnesota, United States	“University of Minnesota”
Lee's Summit, Missouri, United States	“Lee's Summit MO United States 64086”
Omaha, Nebraska, United States	“University of Nebraska Medical Center”
New Brunswick, New Jersey, United States	“Rutgers Robert Wood Johnson Medical School”
Brooklyn, New York, United States	“Kings Country Hospital Center”
New York, New York, United States	“David H. Koch Center at Memorial Sloan Kettering Cancer Center”
Durham, North Carolina, United States	“Duke University Medical Center - Division of Infectious Diseases”
Winston-Salem, North Carolina, United States	“Atrium Health Wake Forest Baptist”
Cincinnati, Ohio, United States	“Cincinnati Children's Hospital Medical Center”
Hershey, Pennsylvania, United States	“Penn State Health Milton S. Hershey Medical Center”
Pittsburgh, Pennsylvania, United States	“University of Pittsburgh Medical Center”
Houston, Texas, United States	“MD Anderson Cancer Center”
Seattle, Washington, United States	“Fred Hutchinson Cancer Research Center”
Córdoba, Argentina	“Hospital Rawson”
Córdoba, Argentina	“Sanatorio Mayo Privado S.A.”
La Plata, Argentina	“Instituto FIDES”
Parkville, Australia	“Melbourne Health - Royal Melbourne Hospital”
Westmead, Australia	“Westmead Hospital, Centre for Infectious Disease and Microbiology”
Bruges, Belgium	“AZ Sint-Jan Brugge”
Brussels, Belgium	“Centre Hospitalier Universitaire Saint Pierre”
Roeselare, Belgium	“AZ Delta”
Edmonton, Alberta, Canada	“Alberta Health Services Cross Cancer Institute at the University of Alberta”
Limoges, France	“CHU Limoges - Centre national de reference des Herpes virus”
Nantes, France	“CHU de Nantes”
Paris, France	“Hôpital Saint Louis - AP-HP”
Paris, France	“AP-HP Hopital Necker-Enfants Malades”
Paris, France	“AP-HP Hopital Bichat - Claude Bernard”
Tbilisi, Georgia	“LLC Diakor”
Tbilisi, Georgia	“Multiprofile Clinic Consilium Medulla LTD”
Cologne, Germany	“Universitätsklinikum Köln”
Essen, Germany	“Universitätsklinikum Essen”
Würzburg, Germany	“Universitätsklinikum Würzburg”
Athens, Greece	“General Hospital of Athens - Laiko”
Heraklion, Greece	“Regional University General Hospital of Heraklion”
Tel Litwinsky, Israel	“Chaim Sheba Medical Center”
Calabria, Italy	“Grande Ospedale Metropolitano”
Milan, Italy	“Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano”
Pavia, Italy	“Fondazione IRCCS Policlinico San Matteo”
Chihuahua City, Mexico	“Unidad de Investigacion CIMA SC”
Distrito Federal, Mexico	“Centro de Investigacion Clinica GRAMEL S.C.”
Durango, Mexico	“Instituto de Investigaciones Aplicadas a la Neurociencia A.C”
Guadalajara, Mexico	“Centro de Investigacion Farmaceutica Especializado de Occidente S.C.”
Veracruz, Mexico	“Arke SMO S.A. de C.V.”
Basel, Switzerland	“Universitaetsspital Basel”
Geneva, Switzerland	“Hopitaux universitaires de Geneve”
Zurich, Switzerland	“Universitaetsspital Zuerich”
Kyiv, Ukraine	“ARENSIA Exploratory Medicine LLC”
Edinburgh, United Kingdom	“Nhs Lothian”
London, United Kingdom	“Research Department of Haematology, UCL Cancer Institute”
Newcastle upon Tyne, United Kingdom	“Freeman Hospital”

Countries and number of participants as reported in the release on completion of enrollment

“The study recruited 157 participants across 12 countries in Europe, North America and Australia.” (opens the source at this quote in a new tab)

Countries and number of participants as reported in the release of topline results

“The open-label, comparative trial (NCT03073967 / Eudra-CT 2023-510088-37-00) was conducted in centers across 15 countries and enrolled 158 immunocompromised participants.” (opens the source at this quote in a new tab)

Sites and countries as reported on the trial-in-progress congress poster

“Global study with 66 active sites in 14 countries” (opens the source at this quote in a new tab)

Sites and countries as reported in the company corporate presentation

“Randomized, open-label, pivotal phase 3 trial with 60 sites in 14 countries” (opens the source at this quote in a new tab)

Sites and regions planned at the start of the phase 3 part

“The phase 3 part of the trial with a study design based on the phase 2 part will compare lesion healing in a given time frame and is conducted worldwide at up to 70 sites in the US, South America, Europe, and China and plans to enroll 128 patients.” (opens the source at this quote in a new tab)

European Union member states, trial dates, and recruitment dates

Member state	Trial start	Trial end	Recruitment start	Recruitment end
France	“07/04/2022”	“06/06/2025”	“03/11/2022”	“12/02/2025”
Belgium	“15/03/2022”	“11/06/2025”	“04/04/2022”	“21/05/2025”
Germany	“06/05/2022”	“30/10/2025”	“17/02/2023”	“22/07/2025”
Italy	“01/06/2022”	“26/10/2023”	“29/12/2022”	“15/06/2023”
Greece	“01/06/2022”	“11/01/2025”	“15/09/2022”	“03/10/2024”

Overall trial dates in the EU Clinical Trials Information System record

Field	Registry value
Locations	“Greece, Belgium, Italy, Germany, France”
Start of trial	“15/03/2022”
End of trial	“30/10/2025”
Global end of trial	“11/11/2025”
Estimated recruitment start date in the EU and EEA	“18/06/2021”

Planned sites and regions in the EU Clinical Trials Register record

Field	Registry value
Date the record was first entered in the EudraCT database	“2021-06-14”
Date of competent authority decision, Germany	“2022-01-06”
Number of sites anticipated in Germany	“E.8.4.1 Number of sites anticipated in Member State concerned 2”
Number of sites anticipated in the EEA	“E.8.5.1 Number of sites anticipated in the EEA 14”
Regions in which trial sites are planned	“Argentina Switzerland Australia Canada Georgia Israel Mexico United Kingdom United States Belgium France Germany Greece Italy”

Prescribing information: design of Part C

“The efficacy of HOVILPRI was evaluated in a randomized, open-label, comparator-controlled, superiority trial (PRIOH-1 Phase 3 Trial, Part C; NCT 03073967) in immunocompromised participants with mucocutaneous (mucosal and/or cutaneous lesions) HSV infection that was refractory (with or without documented resistance) to treatment with acyclovir, valacyclovir, or famciclovir.” (opens the prescribing information at this quote)
“A total of 101 participants (≥18 years) were randomized 1:1 and treated with HOVILPRI (N = 51) or Investigator’s Choice (N =50).” (opens the prescribing information at this quote)

Prescribing information: design of Parts D and F

“The efficacy of HOVILPRI was further evaluated in Parts D and F of Trial PRIOH-1, which had a non-randomized, open-label, single-arm design to assess the efficacy and safety of HOVILPRI (400 mg loading dose on Day 1 followed by 100 mg once daily).” (opens the prescribing information at this quote)
“Enrolled participants were immunocompromised and had acyclovir/foscarnet (ACV/FOS) refractory HSV infection or were FOS intolerant (N=35).” (opens the prescribing information at this quote)

FDA approval announcement: design of Part C

“The efficacy of Hovilpri was evaluated in a randomized, open-label, comparator-controlled, superiority trial (PRIOH-1 Phase 3 Trial, Part C; NCT 03073967) in immunocompromised participants with mucocutaneous HSV infection who did not respond to treatment with acyclovir, valacyclovir, or famciclovir.” (opens the source at this quote in a new tab)
“Participants received Hovilpri or the trial investigator’s choice of available treatments for up to 28 days until all mucocutaneous lesions healed, which was extended up to 42 days if lesions were improving but not completely healed after 28 days.” (opens the source at this quote in a new tab)

Parts of the trial in the ClinicalTrials.gov record

“The trial comprises 5 Parts, Part A, B, C, D, E and F. Part A and Part B (Phase 2) have been finalised.” (opens the source at this quote in a new tab)
“Parts C, D, E and F (Phase 3).” (opens the source at this quote in a new tab)

Part C: randomized comparison in the ClinicalTrials.gov record

“Part C is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety of oral pritelivir in subjects with acyclovir resistent (ACV-R) mucocutaneous HSV episodes. Subjects with ACV-R mucocutaneous HSV infection will be randomized 1:1 to receive either oral pritelivir or Investigator's Choice.” (opens the source at this quote in a new tab)

Part D: design in the ClinicalTrials.gov record

“Part D is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either: present with iv foscarnet resistance/intolerance already at Screening for inclusion, or developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment).” (opens the source at this quote in a new tab)

Part E: design in the ClinicalTrials.gov record

“Part E is an open-label, multi-center design to assess the safety and efficacy of pritelivir in subjects with acyclovir susceptible (ACV-S) mucocutaneous HSV episodes, (Part E is not being conducted in Germany).” (opens the source at this quote in a new tab)

Part F: design in the ClinicalTrials.gov record

“Part F is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either: present with iv foscarnet resistance/intolerance already at Screening for inclusion, or developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment).” (opens the source at this quote in a new tab)

Design details in the ClinicalTrials.gov record

Field	Registry value
Phase	“Phase 3”
Allocation	“Randomized”
Interventional model	“Parallel Assignment”
Masking	“None (Open Label)”
Primary purpose	“Treatment”
Sponsor	“AiCuris Anti-infective Cures AG”
Collaborator	“Medpace, Inc.”

Arms in the ClinicalTrials.gov record

Arm	Registry description
Part C, pritelivir	“Experimental: Part C, Pritelivir Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days”
Part C, investigator's choice	“Active Comparator: Part C, Investigator's Choice: Foscarnet iv, 40 mg/kg tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg body weight given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, topically applied 3 times per week, for up to 28 days and potential prolongation for up to additional 14 days.”
Parts D and F, pritelivir	“Experimental: Part D+F, Pritelivir Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days”
Part E, pritelivir	“Experimental: Part E, Pritelivir Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days”

Phase 3 design and planned arm sizes on the trial-in-progress congress poster

Element	Poster text
Design	“Randomized, open-label, multi-center trial in immunocompromised acyclovir refractory/resistant HSV patients”
Planned total	“N=153”
Part C population	“Acyclovir-refractory/resistant”
Part C allocation	“1:1”
Part C experimental arm	“Experimental arm N=49”
Part C comparator arm	“Comparator arm N=49”
Part C treatment duration	“Treatment up to 28 days”
Part C extension	“Prolongation up to 42 days”
Part C follow-up	“Follow-up of 28 days”
Parts D and F population	“Acyclovir refractory/resistant and foscarnet-resistant or intolerant”
Parts D and F size	“Pritelivir only N=35”
Part E population	“Acyclovir-susceptible”
Part E size	“Pritelivir only N=20”

Design fields in the EU Clinical Trials Register record

Field	Registry value
Controlled	“E.8.1 Controlled Yes”
Randomised	“E.8.1.1 Randomised Yes”
Open	“E.8.1.2 Open Yes”
Double blind	“E.8.1.4 Double blind No”
Parallel group	“E.8.1.5 Parallel group Yes”
Placebo comparator	“E.8.2.2 Placebo No”
Number of treatment arms	“E.8.2.4 Number of treatment arms in the trial 2”
Data monitoring committee	“E.8.7 Trial has a data monitoring committee Yes”
Condition is a rare disease	“E.1.3 Condition being studied is a rare disease Yes”
End of trial	“The end of the trial is defined as the last subject’s last visit/call.”

Assessment of lesion healing by the investigator

“Lesion healing was investigator assessed and was defined as all lesions having completely epithelised” (opens the source at this quote in a new tab)

Addition of the phase 3 part to the phase 2 trial by amendment

“Following the strong results achieved in phase 2, AiCuris directly amended this trial with a pivotal phase 3 part as a basis for NDA submission.” (opens the source at this quote in a new tab)

Change in the control arm design between protocol versions

“The stratified Cochran-Mantel-Haenszel test was used to compare treatment groups, adjusting for protocol versions that reflected change in the control arm design.” (opens the prescribing information at this quote)

“Stratified Cochran Mantel Haensel test adjusted for protocol versions (4.0 and earlier, 5.0 and later).” (opens the source at this quote in a new tab)

Follow-up visits and telephone contacts in the ClinicalTrials.gov record

“Recurrence rate at 2 months following PoTV assessed by telephone, defined as number of subjects with a recurrence as assessed by the Investigator following 2/3 months after PoTV relative to the total number of subjects assessed for recurrence at the respective telephone call per treatment.” (opens the source at this quote in a new tab)
“At 3 months following post treatment visit, from randomization up to a maximum of 139 days” (opens the source at this quote in a new tab)
“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days” (opens the source at this quote in a new tab)

Sponsorship and medical writing support

“This trial was sponsored by AiCuris Anti-infective Cures AG Medical writing support provided by Medicomm Partners Ltd., UK.” (opens the source at this quote in a new tab)

Prescribing information: population, definition of refractory infection, and excluded disease forms

“Refractory HSV infection (clinical failure) was defined as no clinical improvement after at least 7 days of standard-of-care nucleoside analogue treatment [acyclovir (ACV), valacyclovir (VACV) or famciclovir (FCV)], with or without laboratory confirmed genotypic/phenotypic resistance for the current HSV outbreak.” (opens the prescribing information at this quote)
“Participants with ocular, CNS, or disseminated HSV disease were not enrolled.” (opens the prescribing information at this quote)

Part C inclusion criteria in the ClinicalTrials.gov record

“Immunocompromised men and women of any ethnic group aged ≥16 years. In Canada, Germany, Belgium: Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic cell or solid organ transplantation, and chronic use of immunosuppressive treatment) men and women of any ethnic group aged >18 years.” (opens the source at this quote in a new tab)
“ACV-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic ACV resistance testing for current lesion. Clinical failure is defined as no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high oral doses of acyclovir, valacyclovir or famciclovir.” (opens the source at this quote in a new tab)
“Lesions accessible for visual inspection to allow assessment of lesion healing including visualization by endoscopy.” (opens the source at this quote in a new tab)
“Willingness to use highly effective birth control.” (opens the source at this quote in a new tab)
“Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test at Day 1.” (opens the source at this quote in a new tab)

Age eligibility as stated in each source

“Ages Eligible for Study 16 Years and older” (opens the source at this quote in a new tab)

“In this randomized (1:1), controlled, open label trial, 101 IC patients (≥16 years) with R±R HSV mucocutaneous infection received oral pritelivir (100 mg daily; 400 mg loading dose) or ICT (IV foscarnet, IV/topical cidofovir, or topical imiquimod) for up to 28 days, extendable to 42 days.” (opens the source at this quote in a new tab)

“In this randomized (1:1), controlled, open label trial, 101 IC patients (≥18 years) with R±R HSV mucocutaneous infection received oral pritelivir (100 mg daily; 400 mg loading dose) or ICT (IV foscarnet, IV/topical cidofovir, or topical imiquimod) for up to 28 days, extended up to 42 days, if lesions were improving.” (opens the source at this quote in a new tab)

“Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic cell or solid organ transplantation, and chronic use of immunosuppressive treatment) men and women of any ethnic group aged > 18 years.” (opens the source at this quote in a new tab)

Eligible immunocompromising conditions in the congress abstract

“Eligibility criteria included hematopoietic cell transplant, solid organ transplant, HIV, malignancy, or chronic use of immunosuppressive treatment with refractory/clinical failure (defined as no clinical improvement of lesions after ≥7 days of standard of care nucleoside analogue therapy or confirmed acyclovir resistance).” (opens the source at this quote in a new tab)

Key inclusion criteria in the congress presentation

“Key inclusion criteria: Immunocompromised adults, ACV refractory ± resistant mucocutaneous HSV infection based on:” (opens the source at this quote in a new tab)
“Refractory/Clinical Failure; No clinical improvement of HSV lesion(s) after ≥ 7 days with therapeutic doses of a NUC OR” (opens the source at this quote in a new tab)
“Resistance; Laboratory confirmed genotypic/phenotypic ACV resistance for current lesion” (opens the source at this quote in a new tab)
“NUC, nucleoside analogue (acyclovir, valacyclovir or famciclovir); R±R or refractory ± resistant HSV, refractory with or without resistant HSV infection.” (opens the source at this quote in a new tab)

Definitions of refractory and resistant infection shown in the congress presentation

“No clinical improvement of HSV lesion(s) or new lesions after at least 7 days of standard-of-care HSV nucleoside analogue” (opens the source at this quote in a new tab)
“treatment (excluding prophylaxis and suppressive therapy)” (opens the source at this quote in a new tab)
“A refractory HSV infection with laboratory-confirmed genotypic/phenotypic” (opens the source at this quote in a new tab)
“resistance for the current HSV outbreak” (opens the source at this quote in a new tab)
“Therapeutic doses of nucleoside analogues include acyclovir (ACV), valacyclovir (VACV) or famciclovir (FCV).” (opens the source at this quote in a new tab)
“Genotypic: viral genetic alteration(s) that decreases susceptibility and/or phenotypic assay demonstrating increased IC50 above the assay cutoff to one or more antiviral drug(s).” (opens the source at this quote in a new tab)
“These definitions were developed for use in clinical trials of new therapies, but can provide guidance for clinical practice” (opens the source at this quote in a new tab)

Resistance testing by the local laboratory

“Resistance; Local laboratory confirmed genotypic/phenotypic ACV resistance testing for current lesion” (opens the source at this quote in a new tab)

Part C exclusion criteria in the ClinicalTrials.gov record

“Known resistance/intolerance to pritelivir or any of the excipients.” (opens the source at this quote in a new tab)
“Previous treatment in PRIOH-1.” (opens the source at this quote in a new tab)
“Baseline safety laboratory abnormalities.” (opens the source at this quote in a new tab)
“History or current evidence of gastrointestinal malabsorption which, in the opinion of the Investigator, may affect the extent of absorption of pritelivir.” (opens the source at this quote in a new tab)
“Hemodialysis for any indication and ESRD (eGFR <15 mL/min; stage 5 CKD)” (opens the source at this quote in a new tab)
“History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other relevant diseases.” (opens the source at this quote in a new tab)
“Pregnant and/or breastfeeding women.” (opens the source at this quote in a new tab)

Part C exclusion criteria: laboratory thresholds in the EU Clinical Trials Register record

Laboratory variable	Exclusion threshold
Absolute neutrophil count	“ANC <1000 cells/mm3”
Platelets	“platelet count <25,000 cells/mm3”
Hemoglobin	“hemoglobin <8.0 g/dL”
Aminotransferases	“AST or ALT >5 x ULN”
Bilirubin	“bilirubin >2.5 x ULN”

Part C exclusion criteria: other conditions in the EU Clinical Trials Register record

“Abnormalities in hematological, clinical chemical or any other laboratory variables at Screening measured by the central or local laboratory regarded as clinically relevant by the Investigator unless they are due to underlying disease or condition.” (opens the source at this quote in a new tab)
“Any other local condition including bacterial superinfection which in the opinion of the Investigator would interfere with the efficacy evaluation.” (opens the source at this quote in a new tab)
“Having received an investigational drug in an investigational drug trial within 7 half-lives after the last administration of this drug before initiating trial medication. Current participation in a clinical trial without receiving other investigational drugs (eg, follow-up phase of a trial, observational study) is permitted. Other investigational drugs are also not permitted during participation in this trial.” (opens the source at this quote in a new tab)

Parts D and F: inclusion criterion replacing the Part C resistance criterion

“ACV-R and foscarnet-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic resistance testing for current lesion or documented intolerance to iv foscarnet requiring cessation of foscarnet treatment or precluding foscarnet treatment.” (opens the source at this quote in a new tab)
“Subjects will be able to enter Part F only after closure of enrollment in Part D.” (opens the source at this quote in a new tab)

Parts D and F: definitions of foscarnet failure and foscarnet intolerance

“Clinical failure of foscarnet treatment is defined as no improvement after at least 7 days of foscarnet iv therapy. For subjects coming from Part C due to clinical failure of foscarnet, clinical failure is defined as discontinuation and/or replacement of foscarnet after at least 7 days of treatment due to worsening of lesion(s) and/or appearance of new lesion(s).” (opens the source at this quote in a new tab)
“Manifestations of foscarnet intolerance may include, impairment of renal function, seizures, genital irritation and/or ulcerations, extremity paresthesia, nausea, granulocytopenia, anemia, leukopenia, thrombopenia, hypokalemia, hypocalcemia, hypomagnesemia, diabetes insipidus, injection site reactions, psychiatric disorders, including but not limited to anxiety and aggression.” (opens the source at this quote in a new tab)

Parts D and F: exclusion criteria

“All exclusion criteria as for Part C, except for exclusion criteria 1 and 12 which are replaced by: 1. Known intolerance to pritelivir or any of the excipients and 12. Having received an investigational drug in an investigational drug trial within 7 half-lives after the last administration of this drug before initiating trial medication, except for subjects entering Part D who have previously received foscarnet treatment in Part C of this trial.” (opens the source at this quote in a new tab)

Part E: inclusion and exclusion criteria in the ClinicalTrials.gov record

“All inclusion criteria as for Part C, except for inclusion criterion 2, which is replaced by: 2. Recurrent mucocutaneous HSV infection considered ACV-S.” (opens the source at this quote in a new tab)
“All exclusion criteria in Part E are identical to those in Part C with the addition of: 13. Having used acyclovir, valacyclovir, or famciclovir within 3 days prior to starting pritelivir.” (opens the source at this quote in a new tab)

Prescribing information: regimens and treatment duration in Part C

“Participants received HOVILPRI (400 mg loading dose on Day 1 followed by 100 mg once daily) or Investigator’s Choice treatment (IV foscarnet, IV/topical cidofovir, or 5% topical imiquimod) for up to 28 days until all mucocutaneous lesions healed, extended up to 42 days total if lesions were improving but not completely healed after 28 days.” (opens the prescribing information at this quote)

Pritelivir dose and rationale for the loading dose in the ClinicalTrials.gov record

“Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).” (opens the source at this quote in a new tab)

Comparator options and doses in the ClinicalTrials.gov record

“Comparator per investigator's choice (provided the drug listed below is nationally approved): Foscarnet intermittent infusions of 40 mg/kg every 8 hours or 60 mg/kg every 12 hours (to be adjusted in case of renal impairment) for a minimum of 1 hour duration, or Cidofovir iv infusion of 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical treatment, applied 2 to 4 times daily, or Imiquimod 5% topical treatment, 3 times per week.” (opens the source at this quote in a new tab)

Treatment duration and extension in the ClinicalTrials.gov record

“Duration of treatment: Until all mucocutaneous HSV lesions are healed or up to 28 days, whichever is earlier. A prolongation up to a maximum of 42 days may be possible depending on the clinical progress.” (opens the source at this quote in a new tab)

Comparator described in the release of topline results

“SoC (investigator’s choice of foscarnet, cidofovir, compounded topical cidofovir or imiquimod)” (opens the source at this quote in a new tab)
“All pritelivir-treated patients received a loading dose of 400 mg of pritelivir on the first day of treatment followed by 100 mg each subsequent day until all lesions were healed.” (opens the source at this quote in a new tab)

Prescribing information: treatments received in the investigator's choice arm

“Investigator’s Choice arm was IV foscarnet (70%), followed by topical 5% imiquimod (14%), IV cidofovir (12%), and topical cidofovir (4%).” (opens the prescribing information at this quote)

Treatments received in the investigator's choice arm, full analysis population

Investigator's choice treatment	ICT, N = 50, n (%)
Foscarnet IV	“35 (70)”
Imiquimod topical	“7 (14)”
Cidofovir IV	“6 (12)”
Cidofovir topical	“2 (4)”

Extent of exposure in days by treatment received, full analysis population

Statistic	Pritelivir, N = 51	Foscarnet IV, N = 35	Cidofovir IV, N = 6	Cidofovir topical, N = 2	Imiquimod topical, N = 7
Mean (SD)	“27.1 (10.88)”	“18.2 (11.79)”	“14.7 (10.39)”	“34.5 (10.61)”	“34.7 (12.13)”
Median	“27.0”	“16.0”	“13.0”	“34.5”	“43.0”
Q1, Q3	“19.0, 41.0”	“8.0, 28.0”	“7.0, 13.0”	“27.0, 42.0”	“21.0, 45.0”
Minimum, maximum	“6, 43”	“1, 43”	“7, 35”	“27, 42”	“17, 45”

Prescribing information: duration of pritelivir treatment and share with extended treatment

“Across the 51 participants treated with HOVILPRI, the mean duration of treatment was 27.1 days (range 6–43).” (opens the prescribing information at this quote)
“33 % of participant in the HOVILPRI arm extended treatment up to 42 days, whose lesions were improving by Day 28.” (opens the prescribing information at this quote)

Treatments received in the investigator's choice arm, HIV subgroup

Investigator's choice treatment	HIV subgroup, N = 15, n (%)
Foscarnet IV	“7 (47%)”
Imiquimod topical	“6 (40%)”
Cidofovir IV	“0 (0%)”
Cidofovir topical	“2 (13%)”

Antiretroviral therapy in the HIV subgroup

“All patients in the HIV subgroup were on ARV therapy at baseline.” (opens the source at this quote in a new tab)

Protocol specification for acid-reducing agents

“Concomitant use of proton pump inhibitors, antacids and H2-receptor antagonists (H2 blockers) may reduce the systemic bioavailability of pritelivir” (opens the source at this quote in a new tab)
“Protocol specification; Avoid concomitant use with esomeprazole and rabeprazole. Avoid concomitant use with omeprazole and lansoprazole at daily doses above 20 mg and with pantoprazole daily doses above 80 mg.” (opens the source at this quote in a new tab)

Parts D and F: pritelivir regimen and washout after foscarnet

“Subjects entering Part D after cessation of foscarnet treatment in Part C will require a washout period of at least 3 days prior to starting pritelivir.” (opens the source at this quote in a new tab)

“Pritelivir 100 mg QD, following 400 mg loading dose” (opens the source at this quote in a new tab)

Part E: pritelivir regimen in the ClinicalTrials.gov record

“Experimental: Part E, Pritelivir Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days” (opens the source at this quote in a new tab)

Non-randomized parts: regimen described in a company release

“An additional 56 patients were treated with oral pritelivir (100 mg daily, 400 mg loading dose on the first day of therapy) in non-randomized parts of the trial.” (opens the source at this quote in a new tab)

Prescribing information: primary efficacy endpoint

“The primary efficacy endpoint was the proportion of participants with all lesions healed with complete epithelization, as assessed by the Investigator, (response rate) during the treatment period up to 28 days.” (opens the prescribing information at this quote)
“Response rate defined as all mucocutaneous HSV lesions healed by complete epithelization within the treatment period and no appearance of new lesions post-end of treatment, as assessed by the Investigator.” (opens the prescribing information at this quote)

Prescribing information: treatment is not curative

“Because HSV establishes lifelong latent infection, treatment is not curative.” (opens the prescribing information at this quote)

Primary outcome measure in the ClinicalTrials.gov record

Field	Registry value
Outcome measure	“Efficacy measured by cure rate”
Measure description	“Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 28 days relative to the total number of subjects treated with trial medication in the respective treatment group.”
Time frame	“Up to a maximum of 28 days”

Primary endpoint in the EU Clinical Trials Register record: cure, failure, and indeterminate response

“Endpoints will be evaluated separately in Part C, Part D and Part F.” (opens the source at this quote in a new tab)
“Cure rate: number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 28 days relative to the total number of subjects treated with trial medication in the respective treatment group.” (opens the source at this quote in a new tab)
“Failure is defined as meeting at least one of the following criteria at the end of treatment within the treatment period of up to 28 days: a) not all lesions have healed, b) discontinuation and/or replacement of trial medication after at least 7 days of treatment due to worsening of lesion(s) and/or appearance of new lesion(s), c) discontinuation of trial medication due to trial medication related adverse event or intolerance to trial medication before lesion healing, or d) discontinuation due to resistance to trial medication.” (opens the source at this quote in a new tab)
“Indeterminate: Circumstances preclude where it is not possible to attribute either cure or failure, for example due to: a) lost during treatment period, b) subject treated with trial medication needed concomitant CMV treatment or treatment for other infection with medications that were also active against HSV, c) subject refuses endoscopy for non-cutaneous lesions at the end of treatment when the Investigator considers the lesions have healed in the absence of any clinical signs and symptoms.” (opens the source at this quote in a new tab)

Primary endpoint as worded in the congress presentations

“Primary endpoint: % of subjects with compete lesion healed up to 28 days of treatment” (opens the source at this quote in a new tab)

“Primary endpoint: % of patients with complete lesion healing (cure rate) up to 28 days of treatment” (opens the source at this quote in a new tab)

“The primary endpoint was complete lesion healing within 28 days. Secondary endpoints included safety and tolerability.” (opens the source at this quote in a new tab)

Lesion healing as the endpoint carried over from the phase 2 part

“The phase 3 part of the trial with a study design based on the phase 2 part will compare lesion healing in a given time frame” (opens the source at this quote in a new tab)

Prescribing information: secondary endpoint

“The secondary endpoint was the response rate up to 42 days.” (opens the prescribing information at this quote)

Secondary efficacy outcome measures in the ClinicalTrials.gov record

Outcome measure	Measure description	Time frame
Cure rate up to 42 days	“Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 42 days relative to the total number of subjects treated with trial medication in the respective treatment group.”	“Up to a maximum of 42 days”
Time to lesion healing	“Time to lesion healing, defined as complete epithelization of the mucocutaneous HSV lesion(s) within the treatment period and no appearance of new lesions, as assessed by the Investigator.”	“Up to a maximum of 42 days”
Recurrence rate at 2 months	“Recurrence rate at 2 months following PoTV assessed by telephone, defined as number of subjects with a recurrence as assessed by the Investigator following 2/3 months after PoTV relative to the total number of subjects assessed for recurrence at the respective telephone call per treatment.”	“At 2 months following post treatment visit, from randomization up to a maximum of 108 days”
Recurrence rate at 3 months	“Recurrence rate at 3 months following PoTV assessed by telephone, defined as number of subjects with a recurrence as assessed by the Investigator following 2/3 months after PoTV relative to the total number of subjects assessed for recurrence at the respective telephone call per treatment.”	“At 3 months following post treatment visit, from randomization up to a maximum of 139 days”
Pain rate	“Number of days with pain at lesion site relative to the total number of days with analyzable pain data through daily subject self-reporting”	“Up to a maximum of 42 days”
Time to pain cessation at site of lesion	“Starting at first dose of trial medication until pain is no longer reported by the subject (date and time)”	“Up to a maximum of 42 days”
Average pain score	“Using a single-dimensional scale assessing pain intensity through daily subject self-reporting”	“Up to a maximum of 42 days”
Clinical shedding rate	“Number of HSV positive swabs per subject relative to the total number of swabs collected per subject from lesion swabs taken from HSV lesion(s)”	“From date of randomization until the date of first documented healing, assessed up to a maximum of 42 days”
Time to cessation of shedding	“Number of days until swabs taken are negative”	“Up to a maximum of 42 days”
Mean log number of HSV DNA copies	“Mean log number of HSV DNA copies on HSV DNA positive swabs from lesion(s) as detected by quantitative real-time PCR (polymerase chain reaction).”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Resistance to trial medication	“Resistance to trial medication for lesions not healed within the treatment period or newly appeared lesions under treatment before or at the PoTV.”	“From date of randomization until the date of post treatment visit, assessed up to a maximum of 73 days”

Secondary endpoints of Part C in the EU Clinical Trials Register record: recurrence, pain scale, and resistance

“Recurrence rate at 1, 2 and 3 months following PoTV, defined as number of subjects with a recurrence as assessed by the Investigator following 1/2/3 months after PoTV relative to the total number of subjects assessed for recurrence.” (opens the source at this quote in a new tab)
“Average pain score using a single-dimensional scale assessing pain intensity (NUMERIC RATING SCALE [NRS]), 11 intensities: no pain to worst pain imaginable) through daily subject self-reporting.” (opens the source at this quote in a new tab)
“Clinical shedding rate (number of positive HSV PCR swabs per subject relative to the total number of swabs collected per subject) from HSV PCR swabs taken from HSV lesion(s) until healing.” (opens the source at this quote in a new tab)
“Resistance to trial medication for lesions not healed within the treatment period or newly appeared lesions under treatment before or at the PoTV. Only applicable for trial medication comprising pritelivir, foscarnet, or cidofovir.” (opens the source at this quote in a new tab)

Secondary endpoints as listed in the congress presentations

“Secondary endpoints: % of patients with complete lesion healing up to 42 days of treatment; pre-defined subgroup analyses of % of patients with complete lesion healing up to 28 and 42 days of treatment” (opens the source at this quote in a new tab)

“Secondary endpoints: % of patients with complete lesion healing up to 42 days of treatment; median time to undetectable HSV DNA; mean rate of detectable HSV DNA; and safety & tolerability” (opens the source at this quote in a new tab)

Endpoints as listed on the trial-in-progress congress poster

“Primary Endpoint: healing rate (Day 28)” (opens the source at this quote in a new tab)
“Efficacy endpoints includes healing rate (Day 42), time to lesion healing and cessation of shedding, pain scores, shedding rate, therapy failure rate, and resistance rate” (opens the source at this quote in a new tab)
“Safety/tolerability endpoints includes AEs, SAEs, discontinuation, AEs of special interest, labs, ECGs, vital signs, discontinuation rates” (opens the source at this quote in a new tab)
“PK and Quality of Life” (opens the source at this quote in a new tab)

Secondary safety outcome measures in the ClinicalTrials.gov record

Outcome measure	Measure description	Time frame
Chronic kidney disease, number of subjects	“Safety measured by number of subjects developing chronic kidney disease”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Chronic kidney disease, percentage of subjects	“Safety measured by percentage of subjects developing chronic kidney disease”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Acute kidney injury	“Acute Kidney Injury (AKI) stage >1 of KDIGO (Kidney Disease: Improving Global Outcome) criteria (increase in serum creatinine by 2.0 to 2.9 times compared to baseline or urine output <0.5 mL/kg/h for >12 hours)”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Renal impairment	“Safety measured by percentage of subjects developing renal impairment”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Electrolyte abnormality	“Safety measured by percentage of subjects developing electrolyte abnormality All abnormal values”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Seizures	“Safety measured by percentage of subjects developing seizures All seizures”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Anemia	“Safety measured by percentage of subjects developing anemia Haemoglobin measurement”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Adverse events	“Incidence of Adverse Events”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Hematology	“Incidence of abnormal hematologic laboratory test results”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Lymphadenopathy	“Incidence of lymphadenopathy measured by physical examination”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
C-reactive protein	“Incidence of CRP increase”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Cutaneous adverse events	“Incidence of cutaneous adverse events by physical examination”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Partial thromboplastin time	“Incidence of (a)PTT increase”	“From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days”
Discontinuation rate	“Number of subjects discontinuing pritelivir or 'Inverstigator's Choice' due to AE(s) or intolerance relative to the total number of subjects treated with pritelivir or foscarnet, respectively”	“Up to a maximum of 42 days”

Viral DNA endpoints: detection limit and definition of the detection rate

“HSV DNA limit of detection ≥150 copies/mL.” (opens the source at this quote in a new tab)
“HSV detection rate is the number of positive swabs divided by the total number of swabs taken for a given patient (presented as a percentage). The mean HSV detection rate per treatment group is the mean (average) of the HSV detection rates within a treatment group.” (opens the source at this quote in a new tab)

Sample size calculation for Part C

“The sample size was calculated assuming a cure rate of 85% for pritelivir and a response rate of 60% for foscarnet. The 1:1 randomisation of the study (based on a total sample size of 98 subjects) achieves a power of at least 80% based on exact unconditional Barnard test for 2x2 contingency tables for a 2-sided alpha level of 5%.” (opens the source at this quote in a new tab)

Planned number of participants by part on the trial-in-progress congress poster

Part	Planned number
All phase 3 parts	“N=153”
Part C, pritelivir	“Experimental arm N=49”
Part C, investigator's choice	“Comparator arm N=49”
Parts D and F	“Pritelivir only N=35”
Part E	“Pritelivir only N=20”

Planned number of participants in the EU Clinical Trials Register record

Field	Registry value
Planned number in the whole clinical trial	“F.4.2.2 In the whole clinical trial 153”
Planned number in the EEA	“F.4.2.1 In the EEA 40”
Adults aged 18 to 64 years	“F.1.2.1 Number of subjects for this age range: 130”
Adults aged 65 years or older	“F.1.3.1 Number of subjects for this age range: 8”

Planned enrollment announced at the start of the phase 3 part

“plans to enroll 128 patients” (opens the source at this quote in a new tab)

Planned enrollment in the company corporate presentation

“Study recruits a total of 153 into 3 cohorts, 2 of 3 cohorts are fully enrolled” (opens the source at this quote in a new tab)

Enrollment as reported on the trial-in-progress congress poster

“Randomized, open-label, multi-center trial enrolling 153, mostly acyclovir-refractory immunocompromised patients” (opens the source at this quote in a new tab)
“PRITELIVIR PHASE 3 TRIAL HAS COMPLETED ENROLLMENT” (opens the source at this quote in a new tab)

Enrollment as reported in the release on completion of enrollment

“The study recruited 157 participants across 12 countries in Europe, North America and Australia.” (opens the source at this quote in a new tab)

Enrollment as reported in the release of topline results

“The open-label, comparative trial (NCT03073967 / Eudra-CT 2023-510088-37-00) was conducted in centers across 15 countries and enrolled 158 immunocompromised participants.” (opens the source at this quote in a new tab)
“102 R±R HSV patients were randomized 1:1 and treated with pritelivir or investigator´s choice to demonstrate superior efficacy (percentage of fully healed lesions) and evaluate the safety profile of pritelivir. In addition, HSV patients were treated with pritelivir in two additional non-randomized cohorts: one study-arm included 35 patients who were R±R to acyclovir and foscarnet or intolerant to foscarnet, the second study-arm included 21 acyclovir-sensitive patients.” (opens the source at this quote in a new tab)

Enrollment as reported on the registry

“Enrollment (Actual) 158” (opens the source at this quote in a new tab)

Randomized and non-randomized participants as reported in later company releases

“The global, controlled, open-label comparative trial (PRIOH-1, NCT03073967 / Eudra-CT 2023-510088-37-00) included 101 randomized patients and 56 non-randomized patients with R±R HSV infection, including patients living with HIV, hematopoietic stem-cell and solid organ transplant patients, and patients with malignancies, autoimmune or inflammatory disorders.” (opens the source at this quote in a new tab)

“The global, controlled, open-label comparative trial (NCT03073967 / Eudra-CT 2023-510088-37-00) randomized and treated a total of 101 immunocompromised patients with R±R HSV infection, including transplant recipients (hematopoietic stem-cell and solid organ), patients with malignancies, autoimmune or inflammatory disorders, and patients with an HIV infection. An additional 56 patients were treated in the non-randomized part of the trial.” (opens the source at this quote in a new tab)

Participants randomized, treated, and analyzed in Part C

Group	Congress presentation value
Enrolled and randomized	“Enrolled & Randomized N=102”
Randomized to each arm	“Pritelivir N=51 Investigator’s Choice N=51”
Treated with pritelivir	“Pritelivir Treated N=51”
Treated with investigator's choice	“Investigator’s Choice Treated N=50”
Randomized and not treated	“Not Treated (N=1)”

Prescribing information: participants randomized and treated in Part C and enrolled in Parts D and F

“A total of 101 participants (≥18 years) were randomized 1:1 and treated with HOVILPRI (N = 51) or Investigator’s Choice (N =50).” (opens the prescribing information at this quote)
“Enrolled participants were immunocompromised and had acyclovir/foscarnet (ACV/FOS) refractory HSV infection or were FOS intolerant (N=35).” (opens the prescribing information at this quote)

Prescribing information: size of the pritelivir safety database

“The safety of HOVILPRI was evaluated in 206 adults treated with HOVILPRI and an additional 100 healthy adult participants exposed to HOVILPRI in clinical trials.” (opens the prescribing information at this quote)

Analysis population of the primary efficacy result in the prescribing information

“n=number of participants with healed lesions within the respective treatment arm; N=number of participants in the respective arm” (opens the prescribing information at this quote)
“Full Analysis Set.” (opens the prescribing information at this quote)

Definition of the overall population in the congress presentation

“Overall population is defined as all patients that were randomized and treated, and patients may have more than one underlying condition; each subject is counted once under each applicable ‘Underlying Disease’ category.” (opens the source at this quote in a new tab)

Analysis sets and handling of indeterminate responses in the EU Clinical Trials Register record

“Indeterminate responses will be considered as failures in the Full Analysis Set (FAS) and the modified FAS (mFAS) and will be excluded from the denominator (major protocol violation) for the calculation of cure rates in PP1 and PP2 sets.” (opens the source at this quote in a new tab)

Denominator of the cure rate in the ClinicalTrials.gov record

“relative to the total number of subjects treated with trial medication in the respective treatment group” (opens the source at this quote in a new tab)

Primary analysis: stratified test and confidence interval method

“The stratified Cochran-Mantel-Haenszel test was used to compare treatment groups, adjusting for protocol versions that reflected change in the control arm design.” (opens the prescribing information at this quote)
“Confidence Intervals are based on the stratified Sato method and the p-value from the stratified CMH test.” (opens the prescribing information at this quote)

Stratification factor of the primary analysis in the congress presentations

“Stratified Cochran Mantel Haensel test adjusted for protocol versions (4.0 and earlier, 5.0 and later).” (opens the source at this quote in a new tab)

Significance level and power of the planned comparison

“achieves a power of at least 80% based on exact unconditional Barnard test for 2x2 contingency tables for a 2-sided alpha level of 5%” (opens the source at this quote in a new tab)

Subgroup analyses: unadjusted difference, exact confidence interval, and minimum subgroup size

“The treatment difference is calculated as cure rate in the pritelivir treatment group minus the cure rate in the investigator’s choice treatment group. Comparisons are only populated for subgroup categories with at least 5 patients in both treatment groups. The 95% exact CI is based on the score statistic (Chan and Zhang, 1999). m, number of patients cured; M, total number of patients in the category.” (opens the source at this quote in a new tab)

Subgroup analyses described as pre-defined

“pre-defined subgroup analyses of % of patients with complete lesion healing up to 28 and 42 days of treatment” (opens the source at this quote in a new tab)

HIV subgroup analysis described as post hoc

“HIV (post-hoc analysis)” (opens the source at this quote in a new tab)
“Total HIV subgroup of patients.” (opens the source at this quote in a new tab)

Classification of participants by underlying disease and by immunosuppressive condition

“Subjects may have more than one underlying condition, each subject is counted once under each applicable ‘Underlying Disease’ category.” (opens the source at this quote in a new tab)
“A subject is only counted under one ‘Immunosuppressive Condition’ category based on the hierarchy; Transplant; Oncology/autoimmune/inflammatory disorders; HIV Infection.” (opens the source at this quote in a new tab)

Definition of baseline and of laboratory-confirmed acyclovir resistance

“Baseline is defined as the last valid measurement prior to the first dose of the study medication. Local lab ACV-R test results - local lab Positive genotypic/phenotypic ACV resistance testing for current lesion.” (opens the source at this quote in a new tab)

Viral DNA analyses: population, censoring, and models

“Analysis performed on subgroup of patients who had a positive HSV DNA PCR result at baseline. Patients who had positive HSV DNA PCR result at the post-treatment visit were censored at that visit. Patients who had no post-baseline HSV DNA PCR evaluation were censored at the date of first dose.” (opens the source at this quote in a new tab)
“The risk ratio, 95% CI and p-value are generated using a Poisson regression model, with the number of HSV positive swabs as the response variable, and treatment groups as an explanatory variable. The log of the number of swabs collected per patient is included in the model as an offset variable. Patients with no detectable HSV DNA at baseline have been excluded from the analysis.” (opens the source at this quote in a new tab)
“For post-hoc comparison of the percentage of patients with cessation of DNA detection, the p-value was generated from a Barnard's test; the 95% exact CI was calculated based on score statistic (Chan and Zhang, 1999).” (opens the source at this quote in a new tab)

Resistance analyses: participants tested

“Resistance investigated in treatment failures with detectable HSV DNA at post-treatment visit” (opens the source at this quote in a new tab)
“Sanger sequencing or next-generation sequencing (NGS), directly conducted from lesion swabs.” (opens the source at this quote in a new tab)

“In the PRIOH-1 Phase 3 trial (NCT 03073967) in immunocompromised participants, viral sequence analysis was performed on samples obtained from pritelivir-treated participants who did not heal on pritelivir treatment and for whom on-treatment samples were available for analysis.” (opens the prescribing information at this quote)

Safety analysis population

“Safety Population Pritelivir (n=51) n (%) ICT (n=50) n (%)” (opens the source at this quote in a new tab)

Part C: disposition by arm

Disposition	Pritelivir	Investigator's choice
Treated	“Pritelivir Treated N=51”	“Investigator’s Choice Treated N=50”
Completed treatment	“Completed Pritelivir N=48 (94.1%)”	“Completed Investigator’s Choice N=27 (54%)”
Did not complete treatment	“Withdrawn N=3 (5.9%)”	“Withdrawn N=23 (46%)”
Adverse event	“Adverse events: n=3 (5.9%)”	“Adverse event: n=1 (2%)”

Part C: other reasons for not completing treatment in the investigator's choice arm

Reason	Investigator's choice
Death	“Death: n=3 (6%)”
Foscarnet intolerance	“FOS intolerance: n=9 (18%)”
Treatment failure or new lesions	“Failure/new lesions: n=5 (10%)”
Physician decision, withdrawal by the participant, or other	“Physician decision/subject withdrawal/other: n=5 (10%)”

Part C: participants randomized and participant not treated

“Enrolled & Randomized N=102” (opens the source at this quote in a new tab)
“Not Treated (N=1)” (opens the source at this quote in a new tab)

Part C: completion of treatment as summarized in the congress presentation

“PRIOH-1 patient disposition: 94% patients completed pritelivir vs. 54% with investigator’s choice treatment” (opens the source at this quote in a new tab)

Prescribing information: participants randomized and treated

“A total of 101 participants were randomized 1:1 and treated with either HOVILPRI or the Investigator’s Choice.” (opens the prescribing information at this quote)

Prescribing information: participants with treatment extended beyond day 28

“33 % of participant in the HOVILPRI arm extended treatment up to 42 days, whose lesions were improving by Day 28.” (opens the prescribing information at this quote)

HIV subgroup: disposition by arm

Disposition	Pritelivir	Investigator's choice
Treated	“Pritelivir Treated N=23”	“Investigator’s Choice Treated N=15”
Completed treatment	“Completed Pritelivir N=22 (95.7%)”	“Completed Investigator’s Choice N=9 (60%)”
Did not complete treatment	“Withdrawn n=1 (4.3%)”	“Withdrawn N=6 (40%)”
Adverse event	“Adverse events: n=1 (4.3%)”	“Adverse event: n=1 (2%)”

HIV subgroup: other reasons for not completing treatment in the investigator's choice arm

Reason	Investigator's choice
Foscarnet intolerance	“FOS intolerance: n=2(13%)”
Treatment failure or new lesions	“Failure/new lesions: n=1 (6.7%)”
Physician decision, withdrawal by the participant, or other	“Physician decision/subject withdrawal/other: n=3 (20%)”

HIV subgroup: completion of treatment as reported in the company release

“The majority (96%) of people living with HIV completed pritelivir treatment compared with 60% in the investigator’s choice treatment group.” (opens the source at this quote in a new tab)

Parts D, E, and F: participants treated

“In addition, HSV patients were treated with pritelivir in two additional non-randomized cohorts: one study-arm included 35 patients who were R±R to acyclovir and foscarnet or intolerant to foscarnet, the second study-arm included 21 acyclovir-sensitive patients.” (opens the source at this quote in a new tab)

Parts D, E, and F: completion and discontinuation

No evidence found.

Prescribing information: age, sex, race, and ethnicity

“The mean age of participants was 53 years (range 19-84 years), 53% were male. Race and ethnicity were as follows: 49% White, 23% Black/African American, 16% American Indian/Alaska native, 10% other, and 3% Asian; 26 % were of Hispanic/Latino ethnicity.” (opens the prescribing information at this quote)

Prescribing information: refractory infection, laboratory-confirmed resistance, and underlying conditions

“At enrollment, the majority of participants, 71%, had refractory HSV infection and 29% had laboratory confirmed ACV resistance.” (opens the prescribing information at this quote)
“Participants represented a wide range of immunosuppressive clinical conditions, including one or more of the following underlying conditions: hematologic malignancy/disorder (47%), hematopoietic stem-cell transplantation (40%), HIV infection (38%), autoimmune/inflammatory diseases (29%), non-hematologic malignancies (26%) or solid-organ transplantation (4%).” (opens the prescribing information at this quote)

Demographics and baseline characteristics by arm, full analysis population

Characteristic	Pritelivir, n = 51, n (%)	ICT, n = 50, n (%)	Total, n = 101, n (%)
Mean age, years (SD)	“49.2 (14.9)”	“56.0 (14.6)”	“52.6 (15.1)”
Male	“32 (62.7)”	“21 (42.0)”	“53 (52.5)”
Female	“19 (37.3)”	“29 (58.0)”	“48 (47.5)”
Reason for treatment start: refractory HSV (clinical failure)	“39 (76.5)”	“33 (66.0)”	“72 (71.3)”
Reason for treatment start: laboratory-confirmed acyclovir resistance	“12 (23.5)”	“17 (34.0)”	“29 (28.7)”
American Indian or Alaskan Native	“11 (21.6)”	“5 (10.0)”	“16 (15.8)”
Asian	“1 (2.0)”	“2 (4.0)”	“3 (3.0)”
Black or African American	“14 (27.5)”	“9 (18.0)”	“23 (22.8)”
Native Hawaiian or Other Pacific Islander	“0”	“0”	“0”
White	“20 (39.2)”	“29 (58.0)”	“49 (48.5)”
Other race	“5 (9.8)”	“5 (10.0)”	“10 (9.9)”
Maximum length of index lesion, participants with a measurement	“47”	“42”	“89”
Maximum length of index lesion (mm), mean (SD)	“31.2 (28.3)”	“37.3 (41.7)”	“34.1 (35.2)”

Underlying disease by arm, with participants counted under each applicable condition

Underlying disease	Pritelivir, n = 51, n (%)	ICT, n = 50, n (%)	Total, n = 101, n (%)
Stem cell transplant	“14 (27.5)”	“26 (52.0)”	“40 (39.6)”
Solid organ transplant	“2 (3.9)”	“2 (4.0)”	“4 (4.0)”
Hematological cancer or disorder	“18 (35.3)”	“29 (58.0)”	“47 (46.5)”
Non-hematologic malignancy	“10 (19.6)”	“16 (32.0)”	“26 (25.7)”
Autoimmune or inflammatory disease	“19 (37.3)”	“10 (20.0)”	“29 (28.7)”
HIV infection	“23 (45.1)”	“15 (30.0)”	“38 (37.6)”

Immunosuppressive condition by arm, with each participant counted once by hierarchy

Immunosuppressive condition	Pritelivir, n = 51, n (%)	ICT, n = 50, n (%)	Total, n = 101, n (%)
Transplant	“16 (31.4)”	“28 (56.0)”	“44 (43.6)”
Oncology, autoimmune, or inflammatory disorders	“19 (37.3)”	“15 (30.0)”	“34 (33.7)”
HIV infection	“16 (31.4)”	“7 (14.0)”	“23 (22.8)”

HSV type at baseline

“HSV-1 and HSV-2 were identified in 31.7% and 45.5% of patients, respectively; HSV was unspecified/not detected at baseline in 22.8% of patients.” (opens the source at this quote in a new tab)

Share of participants living with HIV as reported in the conference abstract

“A broad range of immunocompromised conditions were included, among them 22.8% (23/101) PLHIV with a mean CD4 cell count of 350 cells/mm3; other conditions included transplant (hematopoietic stem-cell and solid organ) (43.5%), malignancy or autoimmune or inflammatory disorders (33.7%).” (opens the source at this quote in a new tab)

Share of participants living with HIV as reported in the company release

“In the subgroup, people living with HIV represented 37.6% (38/101) of all immunocompromised patients enrolled in the PRIOH-1 Phase 3 trial and had a mean CD4 cell count of 334.8 cells/mm³. Among these patients, 81.6% (31/38) had refractory HSV (no clinical improvement in HSV lesions after ≥ 7 days of treatment), and 18.4% (7/38) had laboratory-confirmed acyclovir resistance. 40% of the study cohort had another underlying immunosuppressive condition.” (opens the source at this quote in a new tab)

Immunocompromising conditions as reported in the journal abstract

“The mean age of patients was 52.6 years (range 19-84 years) and 52.5% were male. Refractory HSV was diagnosed in 71.3%, and acyclovir resistant infection in 28.7%. HSV-1 and HSV-2 were identified in 31.7% and 45.5% of patients, respectively. Immunocompromised conditions included transplant (43.6%), oncology and other indications (including autoimmune, primary immunodeficiency disorders, and use of chronic immunosuppressive agents) (33.7%), and HIV infection (22.8%).” (opens the source at this quote in a new tab)

HIV subgroup: demographics and baseline characteristics by arm

Characteristic	Pritelivir, N = 23, n (%)	ICT, N = 15, n (%)	Total, N = 38, n (%)
Mean age, years (SD)	“48.5 (12.9)”	“50.0 (15.6)”	“49.1 (13.9)”
Male	“20 (87.0)”	“9 (60.0)”	“29 (76.3)”
Female	“3 (13.0)”	“6 (40.0)”	“9 (23.7)”
Reason for treatment start: refractory HSV (clinical failure)	“20 (87.0)”	“11 (73.3)”	“31 (81.6)”
Reason for treatment start: laboratory-confirmed acyclovir resistance	“3 (13.0)”	“4 (26.7)”	“7 (18.4)”
American Indian or Alaskan Native	“7 (30.4)”	“3 (20.0)”	“10 (26.3)”
Asian	“1 (4.3)”	“0”	“1 (2.6)”
Black or African American	“11 (47.8)”	“8 (53.3)”	“19 (50.0)”
White	“1 (4.3)”	“4 (26.7)”	“5 (13.2)”
Other race	“3 (13.0)”	“0”	“3 (7.9)”
Maximum length of index lesion, participants with a measurement	“23”	“13”	“36”
Maximum length of index lesion (mm), mean (SD)	“35.6 (33.8)”	“38.7 (29.3)”	“36.7 (31.9)”
CD4 count, participants with a measurement	“21”	“15”	“36”
CD4 count (cells/mm3), mean (SD)	“349.0 (242.9)”	“314.8 (226.9)”	“334.8 (233.6)”
CD4 count (cells/mm3), Q1, Q3	“137.0, 541.0”	“149.0, 473.0”	“143.0, 514.5”

HIV subgroup: participants with a CD4 count below 200 cells/mm3

Measure	Pritelivir, N = 23	ICT, N = 15	Total, N = 38
CD4 count below 200 cells/mm3, n (%)	“7 (33.3)”	“7 (46.7)”	“14 (36.8)”

HIV subgroup: other underlying conditions

Underlying disease	HIV subgroup, N = 38, n (%)
HIV infection only	“23 (60%)”
HIV infection and non-hematologic malignancy	“11 (29%)”
HIV infection and hematological cancer or disorder	“2 (5%)”
HIV infection and transplant	“1 (3%)”
HIV infection, hematological cancer or disorder, and non-hematologic malignancy	“1 (3%)”

Lesion site at baseline

No evidence found.

Parts D and F: underlying immunosuppressive conditions

“Underlying immunosuppressive conditions included hematologic malignancy/disorder, hematopoietic stem-cell transplantation, non-hematologic malignancies, HIV infection, autoimmune/inflammatory diseases and solid-organ transplantation.” (opens the prescribing information at this quote)

Part E: baseline characteristics

No evidence found.

Primary endpoint: all lesions healed up to day 28, prescribing information

Measure	HOVILPRI, n/N (%)	Investigator's Choice, n/N (%)	Adjusted treatment difference (95% CI)	p-value
Response rate: proportion of participants with lesions healed up to Day 28	“32/51 (63%)”	“17/50 (34%)”	“28.4 (9.6, 47.3)”	“0.0047”

“The primary efficacy result from PRIOH-1 is displayed in Table 8.” (opens the prescribing information at this quote)
“Table 6: Primary Efficacy Result in PRIOH-1, Part C” (opens the prescribing information at this quote)

Primary endpoint as reported in the FDA approval announcement

“By 28 days, all lesions were healed in 63% of patients receiving Hovilpri, compared with 34% of patients receiving one of the other medications.” (opens the source at this quote in a new tab)

Primary endpoint as reported in the congress presentation

“Pritelivir achieved superior lesion healing of 62.7% vs. 34% for ICT, up to day 28 of treatment” (opens the source at this quote in a new tab)
“With an adjusted treatment difference of 28.4%, p=0.0047 (95% CI: 9.6-47.3)” (opens the source at this quote in a new tab)

Primary endpoint as reported in the journal abstract

“Pritelivir demonstrated superior lesion healing of 62.7% vs. 34.0% for ICT up to 28 days, resulting in an adjusted treatment difference of 28.4%, p=0.0047 [95% CI: 9.6, 47.3] (Fig.1).” (opens the source at this quote in a new tab)

Secondary endpoint: all lesions healed up to day 42, prescribing information

“The observed response rates were 82% treated with HOVILPRI vs. 42% with Investigator’s Choice, with an adjusted treatment difference of 40% (95% CI: 22.7, 57.7).” (opens the prescribing information at this quote)

Lesion healing up to day 28 and up to day 42, congress presentation

Measure	Pritelivir	Investigator's choice	Adjusted treatment difference	P value
Complete lesion healing up to day 28	“n= 32/51”	“n= 17/50”	“28.4% (95% CI, 9.6- 47.3)”	“p=0.0047”
Complete lesion healing up to day 42	“n= 42/51”	“n= 21/50”	“40.2% (95% CI, 22.7-57.7)”	“p<0.0001”

“Pritelivir achieved a statistically significant higher rate of complete lesion healing (62.7%) vs ICT (34%), up to 28 days of treatment; adjusted treatment difference 28.4% (95% CI, 9.6- 47.3); p=0.0047” (opens the source at this quote in a new tab)
“82.4% of pritelivir treated patients achieved complete lesion healing vs 42% with ICT; adjusted treatment difference 40.2% (95% CI, 22.7-57.7); p<0.0001” (opens the source at this quote in a new tab)

Lesion healing up to day 42 as reported in the company releases

“Treatment effect and response rates increased with extended treatment up to 42 days; among patients who continued therapy, 82.4% of those treated with pritelivir achieved complete lesion healing compared with 42.0% with investigator’s choice therapy (ICT), resulting in an adjusted treatment difference of 40.2% (p < 0.0001)” (opens the source at this quote in a new tab)

“Up to day 42, the observed response rates were 82% for HOVILPRI and 42% for Investigator’s Choice treatment, corresponding to an adjusted treatment difference of 40.0% (95% CI: 22.7, 57.7).” (opens the source at this quote in a new tab)

“Statistical superiority in lesion healing further increased in patients receiving up to 42 days of treatment (p<0.0001).” (opens the source at this quote in a new tab)

Unadjusted treatment difference in the full analysis set

Time point	Pritelivir, m/M (%)	Investigator's choice, m/M (%)	Treatment difference, % (95% CI)
Up to 28 days of treatment	“32/51 (62.7)”	“17/50 (34.0)”	“28.7 (8.0, 47.1)”
Up to 42 days of treatment	“42/51 (82.4)”	“21/50 (42.0)”	“40.4 (20.7, 56.8)”

Subgroups by region, sex, age, and race: lesion healing up to day 28

Subgroup	Pritelivir, m/M (%)	Investigator's choice, m/M (%)	Treatment difference, % (95% CI)
United States	“14/27 (51.9)”	“7/28 (25.0)”	“26.9 (0.1, 50.6)”
Outside the United States	“18/24 (75.0)”	“10/22 (45.5)”	“29.5 (-0.1, 55.3)”
Male	“21/32 (65.6)”	“9/21 (42.9)”	“22.8 (-5.3, 48.6)”
Female	“11/19 (57.9)”	“8/29 (27.6)”	“30.3 (0.5, 56.6)”
Age 18 to 44 years	“16/21 (76.2)”	“4/11 (36.4)”	“39.8 (1.1, 69.6)”
Age 45 to 64 years	“12/20 (60.0)”	“8/23 (34.8)”	“25.2 (-5.7, 52.9)”
Age 65 years or older	“4/10 (40.0)”	“5/16 (31.3)”	“8.8 (-29.0, 47.5)”
American Indian or Alaska Native	“9/11 (81.8)”	“3/5 (60.0)”	“21.8 (-26.1, 71.6)”
Asian	“1/1 (100)”	“0/2 (0.0)”	“NC”
Black or African American	“6/14 (42.9)”	“1/9 (11.1)”	“31.7 (-11.2, 63.5)”
White	“13/20 (65.0)”	“12/29 (41.4)”	“23.6 (-5.7, 49.6)”
Other race	“3/5 (60.0)”	“1/5 (20.0)”	“40.0 (-30.5, 86.7)”

Subgroups by region, sex, age, and race: lesion healing up to day 42

Subgroup	Pritelivir, m/M (%)	Investigator's choice, m/M (%)	Treatment difference, % (95% CI)
United States	“21/27 (77.8)”	“10/28 (35.7)”	“42.1 (15.0, 64.4)”
Outside the United States	“21/24 (87.5)”	“11/22 (50.0)”	“37.5 (9.2, 61.2)”
Male	“27/32 (84.4)”	“11/21 (52.4)”	“32.0 (4.0, 57.0)”
Female	“15/19 (78.9)”	“10/29 (34.5)”	“44.5 (12.1, 67.5)”
Age 18 to 44 years	“17/21 (81.0)”	“4/11 (36.4)”	“44.6 (7.9, 73.4)”
Age 45 to 64 years	“16/20 (80.0)”	“10/23 (43.5)”	“36.5 (5.9, 62.0)”
Age 65 years or older	“9/10 (90.0)”	“7/16 (43.8)”	“46.3 (6.4, 73.8)”
American Indian or Alaska Native	“11/11 (100)”	“3/5 (60.0)”	“40.0 (-1.2, 85.3)”
Asian	“1/1 (100)”	“0/2 (0.0)”	“NC”
Black or African American	“10/14 (71.4)”	“2/9 (22.2)”	“49.2 (2.8, 78.9)”
White	“17/20 (85.0)”	“14/29 (48.3)”	“36.7 (7.5, 59.2)”
Other race	“3/5 (60.0)”	“2/5 (40.0)”	“20.0 (-47.5, 75.7)”

Subgroups by immunocompromised condition: lesion healing up to day 28

Immunocompromised condition	Pritelivir, m/M (%)	Investigator's choice, m/M (%)	Treatment difference, % (95% CI)
Transplant	“8/16 (50.0)”	“11/28 (39.3)”	“10.7 (-20.3, 40.4)”
Oncology and other (non-transplant)	“13/19 (68.4)”	“4/15 (26.7)”	“41.8 (6.7, 69.0)”
HIV infection	“11/16 (68.8)”	“2/7 (28.6)”	“40.2 (-7.5, 73.7)”

Subgroups by immunocompromised condition: lesion healing up to day 42

Immunocompromised condition	Pritelivir, m/M (%)	Investigator's choice, m/M (%)	Treatment difference, % (95% CI)
Transplant	“12/16 (75.0)”	“14/28 (50.0)”	“25.0 (-6.6, 51.0)”
Oncology and other (non-transplant)	“17/19 (89.5)”	“5/15 (33.3)”	“56.1 (20.3, 80.0)”
HIV infection	“13/16 (81.3)”	“2/7 (28.6)”	“52.7 (6.4, 83.1)”

Pritelivir against each investigator's choice treatment: lesion healing up to day 28

Comparator received	Investigator's choice, m/M (%)	Treatment difference against pritelivir (32/51), % (95% CI)
Foscarnet IV	“12/35 (34.3)”	“28.5 (4.1, 48.0)”
Cidofovir IV	“3/6 (50.0)”	“12.7 (-26.3, 51.6)”
Cidofovir topical	“0/2 (0.0)”	“NC”
Imiquimod 5% topical	“2/7 (28.6)”	“34.2 (-10.4, 62.2)”

Pritelivir against each investigator's choice treatment: lesion healing up to day 42

Comparator received	Investigator's choice, m/M (%)	Treatment difference against pritelivir (42/51), % (95% CI)
Foscarnet IV	“14/35 (40.0)”	“42.4 (19.1, 60.7)”
Cidofovir IV	“4/6 (66.7)”	“15.7 (-15.3, 59.1)”
Cidofovir topical	“1/2 (50.0)”	“NC”
Imiquimod 5% topical	“2/7 (28.6)”	“53.8 (3.7, 80.6)”

Subgroups by laboratory-confirmed acyclovir resistance: lesion healing up to day 28 and up to day 42

Subgroup and time point	Pritelivir, n/N (%)	ICT, n/N (%)	Treatment difference, % (95% CI)
Laboratory-confirmed acyclovir resistance, up to day 28	“11/22 (50.0)”	“10/34 (29.4)”	“20.6 (-6.9, 45.7)”
Acyclovir resistance not detected or not evaluable, up to day 28	“21/29 (72.4)”	“7/16 (43.8)”	“28.7 (-2.2, 56.2)”
Laboratory-confirmed acyclovir resistance, up to day 42	“17/22 (77.3)”	“14/34 (41.2)”	“36.1 (7.0,58.2)”
Acyclovir resistance not detected or not evaluable, up to day 42	“25/29 (86.2)”	“7/16 (43.8)”	“42.5 (10.7,68.0)”

“Treatment effect favors pritelivir whether laboratory confirmed ACV resistance (ACV R) is present or not up to 28 days, with further improvement up to 42 days of treatment” (opens the source at this quote in a new tab)

HIV subgroup, all participants living with HIV: lesion healing up to day 28 and up to day 42

Time point	Pritelivir, healed	Pritelivir, %	Investigator's choice, healed	Investigator's choice, %	Difference	P value
Up to day 28	“n= 14/23”	“61%”	“n= 3/15”	“20%”	“37%”	“p=0.0265”
Up to day 42	“n= 18/23”	“78%”	“n= 4/15”	“27%”	“46%”	“p=0.0046”

HIV subgroup, all participants living with HIV: result and confidence interval in the company release

“Similar to other subgroups, pritelivir achieved superior lesion healing of 61% (14/23) within up to 28 days of treatment, compared with 20% (3/15) for ICT, with an adjusted treatment difference of 37%, p = 0.027 [95%CI 7.6, 66.8] (post-hoc analysis).” (opens the source at this quote in a new tab)

HIV subgroup, participants classified under HIV infection by hierarchy: result in the conference abstract

“In a subgroup analysis, 68.8% of the PLHIV in the pritelivir arm vs. 28.6% in the ICT arm had lesion healing with a treatment difference of 40.2% [95% CI: -7.5, 73.7], consistent with the overall positive treatment effect of pritelivir (Figure 1).” (opens the source at this quote in a new tab)

Time to lesion healing, recurrence, and treatment failure rate

No evidence found.

Viral DNA: time to undetectable HSV DNA in lesion swabs

“MEDIAN TIME TO UNDETECTABLE HSV DNA IN THE MUCOCUTANEOUS LESIONS WAS SHORTER ON PRITELIVIR: 9 DAYS VS ICT 21 DAYS” (opens the source at this quote in a new tab)
“Hazard ratio 1.76 (HR >1 favors pritelivir); 95% CI, 0.98-3.16; p = 0.0581” (opens the source at this quote in a new tab)

“Pritelivir treatment significantly reduced viral replication and viral burden, shortening the median time to undetectable HSV in lesions to 9 days compared with 21 days with ICT (p = 0.0581)” (opens the source at this quote in a new tab)

Viral DNA: participants at risk in the analysis of time to undetectable HSV DNA

Time (days)	Pritelivir	Investigator's choice
0	“38”	“39”
7	“37”	“33”
14	“17”	“21”
21	“8”	“14”
28	“3”	“11”
35	“3”	“6”
42	“1”	“4”
49	“0”	“0”

“Number at Risk Pritelivir 38 37 17 8 3 3 1 0 Investigator’s choice 39 33 21 14 11 6 4 0” (opens the source at this quote in a new tab)

Viral DNA: mean detection rate in lesion swabs and cessation of detection

Measure	Pritelivir	Investigator's choice	Comparison
Mean HSV DNA detection rate in lesion swabs	“26,4%”	“54,1%”	“Risk Ratio = 0.37 95% CI, 0.23-0.59 p<0.0001”
Participants with cessation of HSV DNA detection, post hoc analysis	“73.7%”	“48.7%”	“Difference: 25.0% 95% CI, 2.7-45.5 p=0.025”

Measure	Pritelivir	Investigator's choice
Participants with cessation of HSV DNA detection, count	“n = 28/38”	“n = 19/39”

Resistance outcomes: prescribing information

“Paired baseline and on-treatment/end-of-treatment sequences were obtained for 8.3% (4/48) of pritelivir-treated participants who experienced treatment failure (lesions not healed by Day 28).” (opens the prescribing information at this quote)
“The pUL5 K356N (>1,000-fold reduction in susceptibility in cell culture) substitution was detected in 1 participant infected with HSV-1. The pUL5 K355R (50-fold reduction, 2 participants) and pUL5 N341K, pUL5 G351R (distinct viral subpopulations, 33-fold reduction, 1 participant) substitutions were detected in participants infected with HSV-2.” (opens the prescribing information at this quote)

Resistance outcomes: congress presentation

“One person with pritelivir resistance in an HCT patient with HSV-2” (opens the source at this quote in a new tab)
“Only 1 participant on pritelivir with failure (lesions improving but not completely healed) with detectable HSV DNA at post-treatment visit (after 42 days of treatment)” (opens the source at this quote in a new tab)
“Two pritelivir resistance-associated substitutions (UL5 N341K and G351R) detected” (opens the source at this quote in a new tab)
“Phenotypic test result: EC50 of 0.126 μM (<5x EC50 of the control of 0.129 μM)” (opens the source at this quote in a new tab)
“Both substitutions were not present at baseline and emerged on treatment day 36” (opens the source at this quote in a new tab)
“Foscarnet-resistant mutations detected in a PLHIV with HSV-2” (opens the source at this quote in a new tab)
“Resistance-associated substitutions and substitutions of unknown significance detected in UL30 by NGS, all at low allele frequency (11-16%)” (opens the source at this quote in a new tab)

Parts D and F: lesion healing up to day 28 and up to day 42

“Treatment with HOVILPRI resulted in lesion healing in 40% (95% CI: 23.9, 57.9) of participants during the treatment period up to 28 days and 66% (95% CI: 47.8, 80.9) of participants up to 42 days.” (opens the prescribing information at this quote)

Part E: efficacy results

No evidence found.

Patient-reported pain endpoints specified for Part C

“Pain rate: number of days with pain at lesion site relative to the total number of days with analyzable pain data through daily subject self-reporting.” (opens the source at this quote in a new tab)
“Time to pain cessation at site of lesion starting at first dose of trial medication until pain is no longer reported by the subject (date and time).” (opens the source at this quote in a new tab)
“Average pain score using a single-dimensional scale assessing pain intensity (NUMERIC RATING SCALE [NRS]), 11 intensities: no pain to worst pain imaginable) through daily subject self-reporting.” (opens the source at this quote in a new tab)

Quality of life listed among the trial assessments

“PK and Quality of Life” (opens the source at this quote in a new tab)

Results for pain and quality-of-life endpoints

No evidence found.

Prescribing information: adverse reactions and discontinuations in Part C

“The adverse reaction (all grades) occurring in more than 5% of participants receiving HOVILPRI was headache, which occurred in 6% and 4% of the HOVILPRI and Investigator’s choice participants, respectively.” (opens the prescribing information at this quote)
“Adverse reactions were reported in 22% of HOVILPRI-treated participants, compared with 54% of participants in the Investigator’s Choice treatment arm. Discontinuations due to adverse drug reactions occurred in 2% and 20% of participants, respectively.” (opens the prescribing information at this quote)

Prescribing information: hepatic laboratory abnormalities in Part C

“Hepatic laboratory abnormalities were observed in both treatment groups in PRIOH-1, Part C. ALT elevations ≥2.5 × upper limit of normal (ULN) were reported in 4/51 (8%) participants receiving HOVILPRI and 1/50 (2%) receiving Investigator’s Choice, while AST elevations ≥2.5 × ULN were reported in 3/51 (6%) and 2/50 (4%) participants, respectively. One participant discontinued HOVILPRI due to elevated liver enzymes.” (opens the prescribing information at this quote)

Prescribing information: duration of exposure in Part C

“Across the 51 participants treated with HOVILPRI, the mean duration of treatment was 27.1 days (range 6–43).” (opens the prescribing information at this quote)

Overview of adverse events by arm, safety population

Category	Pritelivir, n = 51, n (%)	ICT, n = 50, n (%)
Patients with any AE	“41 (80.4)”	“45 (90.0)”
Exposure-adjusted event rate per patient year	“42.8”	“102.0”
Drug-related TEAEs	“11 (21.6)”	“27 (54.0)”
Treatment-emergent serious adverse events	“10 (19.6)”	“15 (30.0)”
Treatment discontinuation due to any TEAE	“2 (3.9)”	“11 (22.0)”
Treatment discontinuation due to drug-related TEAEs	“1 (2.0)”	“10 (20.0)”

Adverse events of special interest by arm, including renal and electrolyte events

Category	Pritelivir, n = 51, n (%)	ICT, n = 50, n (%)
Patients with any TEAEs of special interest	“13 (25.5)”	“27 (54.0)”
Skin disorders	“5 (9.8)”	“8 (16.0)”
Hematological AE	“5 (9.8)”	“14 (28.0)”
Renal or urinary disorders	“3 (5.9)”	“13 (26.0)”
Electrolyte abnormalities	“1 (2.0)”	“8 (16.0)”

Treatment-emergent adverse events with an incidence of 5% or more, by preferred term

MedDRA preferred term	Pritelivir, n = 51, n (%)	ICT, n = 50, n (%)
Patients with any TEAE	“40 (78.4)”	“44 (88.0)”
Nausea	“4 (7.8)”	“12 (24.0)”
Diarrhea	“6 (11.8)”	“7 (14.0)”
Headache	“7 (13.7)”	“6 (12.0)”
Vomiting	“3 (5.9)”	“5 (10.0)”
Dizziness	“3 (5.9)”	“4 (8.0)”
Hypokalemia	“0”	“7 (14.0)”
Hypomagnesemia	“1 (2.0)”	“6 (12.0)”
Thrombocytopenia	“1 (2.0)”	“6 (12.0)”
Anemia	“1 (2.0)”	“4 (8.0)”
Cough	“2 (3.9)”	“3 (6.0)”
Decreased appetite	“4 (7.8)”	“1 (2.0)”

“Incidence of TEAEs ≥5%” (opens the source at this quote in a new tab)

Adverse events among reasons for not completing treatment, by arm

Reason	Pritelivir	Investigator's choice
Adverse event	“Adverse events: n=3 (5.9%)”	“Adverse event: n=1 (2%)”

Deaths and foscarnet intolerance among reasons for not completing treatment in the investigator's choice arm

“Death: n=3 (6%)” (opens the source at this quote in a new tab)
“FOS intolerance: n=9 (18%)” (opens the source at this quote in a new tab)

Safety summary in the journal abstract

“The most common TEAEs are presented in Table 1. The majority of events are lower for pritelivir vs. ICT. Pritelivir was associated with fewer renal, electrolyte events and drug-related TEAE discontinuations (2.0%) compared with ICT (20.0%).” (opens the source at this quote in a new tab)

Most common adverse events with pritelivir as reported in the company release

“Pritelivir demonstrated a favorable safety and tolerability profile. It was associated with fewer renal, electrolyte events and drug-related TEAE discontinuations (2.0%) compared with ICT (20.0%). The most common TEAEs that occurred while receiving pritelivir were headache (13.7%), diarrhea (11.8%), nausea (7.8%), decreased appetite (7.8%), vomiting (5.9%) and dizziness (5.9%).” (opens the source at this quote in a new tab)

Safety as summarized in the FDA approval announcement

“The most common adverse reaction was headache.” (opens the source at this quote in a new tab)

Parts D and F: safety in the prescribing information

“The safety of HOVILPRI was also evaluated in a non-randomized, open-label, multicenter, single-arm Phase 3 trial, PRIOH-1 (Parts D and F) in immunocompromised adults with acyclovir/foscarnet (ACV/FOS) refractory HSV infection or who were FOS intolerant (N=35).” (opens the prescribing information at this quote)
“populations was consistent with that observed in Part C, with no new or unexpected adverse drug reactions identified.” (opens the prescribing information at this quote)

Part E: safety results

No evidence found.

Summary

Part C was open-label, and the investigator assessed lesion healing. The comparator was the investigator's choice among four regimens; 35 of 50 comparator participants (70%) received intravenous foscarnet, and the control arm design changed between protocol versions. The trial randomized 102 participants and analyzed 101; confidence intervals for several subgroups include zero, and the analysis of all 38 participants with HIV was post hoc. In the comparator arm, 23 of 50 participants (46%) did not complete treatment. Parts D and F were single-arm with 35 participants, and no result for Part E was located. As of October 2026, Part C results come from the prescribing information, congress presentations and abstracts, and company releases; no full peer-reviewed publication was found, and the ClinicalTrials.gov record has no posted results. Sources differ on total enrollment (153, 157, or 158). The share of participants with HIV is 37.6% (38 of 101) when each participant is counted under every underlying disease and 22.8% (23 of 101) when each is counted once by hierarchy.

Open-label design and investigator assessment of the primary endpoint

“randomized, open-label, comparator-controlled, superiority trial” (opens the prescribing information at this quote)
“as assessed by the Investigator” (opens the prescribing information at this quote)

Comparison of adverse reaction rates across trials

“Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.” (opens the prescribing information at this quote)

Disease forms excluded from enrollment

“Participants with ocular, CNS, or disseminated HSV disease were not enrolled.” (opens the prescribing information at this quote)

Subgroup comparisons limited by subgroup size

“Comparisons are only populated for subgroup categories with at least 5 patients in both treatment groups.” (opens the source at this quote in a new tab)

Paired sequences available for resistance analysis

“Paired baseline and on-treatment/end-of-treatment sequences were obtained for 8.3% (4/48) of pritelivir-treated participants who experienced treatment failure (lesions not healed by Day 28).” (opens the prescribing information at this quote)

Results posting on the registry

“No Results Posted” (opens the source at this quote in a new tab)