Product information and disease descriptionPlace of product in therapyDisease descriptionEpidemiology
Prevalence of Refractory mucocutaneous herpes simplex virus infection in immunocompromised adults
43 evidence topics · 33 sources
Resistance rates by population in the consensus review
| Population | Reported rate |
|---|---|
| Immunocompetent patients | “very low (<1%)” |
| Hematopoietic cell transplant recipients | “often ranging from 0% to 14% in hematopoietic cell transplant (HCT) recipients” |
| Solid organ transplant recipients | “0%–3% of solid-organ transplant (SOT) recipients” |
| Advanced HIV disease | “with prevalence rates of 3%–7%” |
| People with HIV receiving effective antiretroviral treatment | “they are much less common in patients receiving effective antiretroviral treatment” |
Prevalence by population in a review of resistance to nucleoside analogues
| Population | Reported prevalence |
|---|---|
| Immunocompetent patients, United Kingdom and United States surveys | “A low prevalence of HSV resistance to ACV was reported in immunocompetent patients during extensive screening surveys in the United Kingdom (0.7%) and the United States (0.3%) between 1980 and 1992” |
| Immunocompromised patients overall | “The prevalence of HSV infections with reduced susceptibility to ACV in immunocompromised patients is higher and varies from 3.5% to 10%” |
| HIV-positive patients | “The prevalence of ACV resistance has ranged from 3.5% to 7% in HIV-positive patients” |
| Solid organ transplant recipients | “from 2.5% to 10% in solid organ transplant recipients” |
| Hematopoietic stem cell recipients | “However, the highest prevalence rates have been reported in recipients of hematopoietic stem cells, with a range of 4.1% to 10.9%” |
| Hematopoietic stem cell recipients, highest single report | “An even higher frequency (36%) of ACV resistance in that population has also been reported” |
Systematic review of prevalence: immunocompetent and immunocompromised populations
Hematopoietic cell transplant recipients: range of prevalence of refractory and resistant infection in a narrative review
Stability of prevalence over two decades: resistance among isolates by immune status
Reported cases of clinical resistance by underlying condition
French surveillance network of 15 laboratories: patients excreting acyclovir-resistant strains by immune status
French surveillance network: bone marrow transplant recipients excreting acyclovir-resistant strains
French surveillance network: patients with hematologic disease excreting acyclovir-resistant strains
French surveillance network: patients with HIV infection excreting acyclovir-resistant strains
French surveillance network: solid organ transplant recipients excreting acyclovir-resistant strains
French surveillance network: other immunocompromised groups
French surveillance network: foscarnet resistance and clinical resistance among patients with acyclovir-resistant strains
Survey in northwest England: resistance among isolates by immune status
Survey in northwest England: patients treated for cancer shedding resistant virus
Survey in northwest England: heart or lung transplant recipients shedding resistant virus
Survey in northwest England: HIV-infected patients shedding resistant virus
Survey in the Netherlands: patients with resistant isolates by immune status and transplant status
Ten-year French survey: change in prevalence among immunocompromised patients and allogeneic transplant recipients
Four-year French laboratory survey: resistance among samples referred for suspected resistance
United States tertiary care center: patients with resistant isolates by immune status
United States sexually transmitted disease and HIV clinics: acyclovir-resistant genital isolates by HIV status
People with HIV in a French hospital cohort: patients with confirmed acyclovir-resistant infection over 10 years
People with HIV: resistance among genital isolates as stated in guidelines
Allogeneic transplant recipients with HSV-1 infection in a United Kingdom center: share with acyclovir resistance
Hematopoietic cell transplant recipients with refractory infection at 7 United States centers: laboratory-confirmed resistance among those tested
Immunocompromised adults treated with foscarnet at 5 United States sites: resistant and refractory episodes
Pivotal trial population: share with laboratory-confirmed acyclovir resistance at enrollment
Allogeneic transplant recipients with resistant infection at one United States center: dual resistance to foscarnet and acyclovir
Solid organ transplant recipients: susceptibility of isolates after prophylaxis
Solid organ transplant recipients: guideline statement on relative frequency
Patients with a positive HSV polymerase chain reaction at a French center: confirmed genotypic resistance over 8 years
German laboratory collection of HSV-1 strains over four decades: acyclovir-resistant strains and trend
United States patient-count estimate stated by the company
United States patient-count estimates by line of treatment in the company briefing
| Measure | Value on the slide |
|---|---|
| Slide title | “Pritelivir: Potential Market in the U.S. and Clinical Positioning” |
| Quantity estimated | “Estimated number of patients in the U.S.” |
| First-line treatment | “≈180,000” |
| Share that proceeds to second-line treatment | “5-20%”; “(Depending on the underlying disease)” |
| Second-line treatment | “≈15,000” |
| Criterion for second-line treatment | “When symptoms fail to improve and acyclovir resistance is suspected, 2nd line treatment is initiated” |
| Basis of the estimates | “Based on internal investigation” |
United States claims and health record analysis: data source and cohort definitions
United States claims and health record analysis: diagnosed HSV cases and immunocompromised subgroups
United States claims and health record analysis: treatment-modification patterns used as proxies for refractory infection
United States claims and health record analysis: modification patterns among immunocompromised patients with any pattern, by subgroup
| Pattern | Hematopoietic cell transplant | Solid organ transplant | People living with HIV | Immunocompromising therapy |
|---|---|---|---|---|
| Upward titration | “42.0% (n=58)” | “43.8% (n=57)” | “36.8% (n=225)” | “43.5% (n=535)” |
| Switch within first-line therapy | “72.5% (n=100)” | “54.6% (n=71)” | “51.3% (n=314)” | “58.9% (n=725)” |
| Route of administration change | “18.1% (n=25)” | “26.2% (n=34)” | “29.9% (n=183)” | “30.3% (n=373)” |
| Switch from first-line to second-line therapy | “13.8% (n=19)” | “11.5% (n=15)” | “17.2% (n=105)” | “8.2% (n=101)” |
| Second-line therapy without a first-line switch | “1.4% (n=2)” | “6.2% (n=8)” | “5.6% (n=34)” | “2.8% (n=34)” |