Evicenter
MarkdownP&T meetings
Hibsago (bepirovirsen)

Chronic hepatitis B virus infection in adults without cirrhosis

Also known as GSK3228836
Manufacturer
GSK
Last updated
190 sources

Product information and disease descriptionProduct descriptionProduct information

Access and distribution

5 evidence topics · 5 sources

Access and patient support programs named at approval

“The company will also be leveraging access and patient support programs to assist with Hibsago’s U.S. rollout.” (opens the source at this quote in a new tab)

Specialty pharmacy or distribution network

No evidence found.

Company contact and product website named in the labeling

“To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” (opens the prescribing information at this quote)

“For more information about HIBSAGO, call 1-888-825-5249 or visit our website at www.hibsago.com.” (opens the prescribing information at this quote)

Care setting: laboratory monitoring and first dose under healthcare provider supervision

“HIBSAGO therapy should be prescribed only when appropriate laboratory monitoring can be performed to manage the treatment regimen.” (opens the prescribing information at this quote)

“HIBSAGO must be administered under the guidance and supervision of a healthcare provider for the initial dose to ensure proper injection technique.” (opens the prescribing information at this quote)

“Patients or caregivers may administer HIBSAGO after their healthcare provider determines that it is appropriate and with medical follow-up, including laboratory testing.” (opens the prescribing information at this quote)

“Six-month treatment with option of self-administration after first dose” (opens the source at this quote in a new tab)

Companion diagnostic for patient selection

“The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic device to aid in the selection of patients with chronic HBV infection for treatment with antiviral therapy in accordance with the FDA approved drug labeling and to assist in monitoring patients throughout the course of treatment.” (opens the source at this quote in a new tab)

“Quantitative surface antigen testing will support the diagnosis and identification of patients suitable for treatment with bepirovirsen who have baseline HBsAg levels ≤3000 IU/ml. Several tests are available, including a recently authorised FDA test.” (opens the source at this quote in a new tab)

Distribution in mainland China: collaboration with SBP Group

“GSK plc (LSE/NYSE: GSK) today announced that it has entered into an exclusive strategic collaboration with Sino Biopharmaceutical, (SBP Group), through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), to accelerate bepirovirsen in mainland China at launch.” (opens the source at this quote in a new tab)

“Under the agreement, CTTQ will be responsible for importation, distribution, hospital access, and promotional and non-promotional activities for bepirovirsen in mainland China. GSK will remain the marketing authorisation holder and retain responsibility for regulatory, quality, pharmacovigilance and global medical strategy.” (opens the source at this quote in a new tab)

“Under the terms of the agreement, CTTQ will purchase bepirovirsen from GSK under agreed supply terms for an initial term of 5.5 years.” (opens the source at this quote in a new tab)

“Collaboration provides scaled access to over 5,000 medical centres in China at launch” (opens the source at this quote in a new tab)