Wire News

New data on antiviral treatments for Hepatitis B and C

A HOLD FreeRelease 8

Gilead Sciences today announced data from multiple studies highlighting the clinical benefit and differentiation of its hepatitis treatments, as well as Gilead’s ongoing commitment to liver research to advance the elimination of viral hepatitis in Asia. The data are being presented at the 31st Conference of the Asian Pacific Association for the Study of the Liver (APASL 2022), March 30 – April 3, 2022 in Seoul, South Korea.    

“The clinical data from our studies reinforce the well-established efficacy and safety profiles of our treatments and the potential clinical benefit to people living with hepatitis B and C. These encouraging data can further support healthcare providers in making the appropriate treatment choice for hepatitis patients in Asia.” said Betty Chiang, Vice President of Medical Affairs, International, Gilead Sciences.

Data from three tenofovir (TFV)-based studies for the treatment of hepatitis B (HBV) presented at the conference showed that at treatment initiation few patients at low risk of hepatocellular carcinoma (HCC) progressed to higher risk, while many medium- or high-risk patients improved to lower risk of HCC after long-term TFV treatment.  

Data from a Phase 2 study of TFV disoproxil fumarate (TDF) vs. TDF/emtricitabine (FTC) in immune-tolerant (IT) patients and two Phase 3 studies, comparing tenofovir alafenamide (TAF) vs. TDF in immune-active (IA) patients were used to generate HCC risk scores by using Modified PAGE-B (mPAGE-B), a tool to predict 5-year HCC risk (low-risk [0-≤8], medium-risk [9-12], and high-risk [≥13]). 

Of 126 IT patients, 106 (84%), 19 (15%) and 1 (0.8%) were low , medium , or high risk, respectively at baseline. At Week 192, the majority remained categorically unchanged or improved. No IT patients developed HCC. Of 1,631 IA patients (1,092 TAF; 539 TDF->TAF), 901 (55%), 588 (36%), and 142 (9%) were low-, medium-, or high-risk, respectively at baseline. At Week 240, the majority remained unchanged or improved; only 22 (2%) patients shifted to higher risk. Overall, 22 HCC cases developed (0.2%, 1.2%, and 9.2% in the low-, medium-, and high-risk groups at baseline).

Additional data presented at the conference provides an assessment of the bone and renal safety profile of TAF across Gilead’s TAF HBV clinical development program. Data from 1,911 patients treated with TAF or TDF were analysed and across multiple HBV patient types, including those at higher risk of TDF-associated bone and/or renal toxicity. Stable or improved bone and renal parameters were observed with TAF treatment compared to TDF treatment.

In hepatitis C, a Phase 3b study looking at treatment-naïve and treatment-experienced chronic hepatitis C (CHC) patients in Korea showed that treatment with sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir achieved high sustained virological response with no on-treatment virologic failure or treatment-related serious adverse events. In another study evaluating potential drug-drug interactions (DDIs) in Korean CHC patients using widely available direct acting antivirals, sofosbuvir/velpatasvir showed a favourable DDI profile despite the high rates of comorbidity and comedications among the aging trend of the CHC population in Korea.

Leave a Comment