Gilead Sciences Announces Subanalyses of Safety and Efficacy Data from a Phase 2 Study of Chronic Hepatitis B Patients with Renal or Hepatic Impairment Switching to Vemlidy(r)

Gilead Sciences, Inc. today announced new sub-analysis data from a Phase 2 open-label study (GS-US-320-4035; NCT03180619), evaluating the safety and efficacy of switching to Vemlidy®# (tenofovir alafenamide 25 mg, TAF) from tenofovir disoproxil fumarate (TDF) and/or other oral antiviral treatment (OAV) among virally suppressed hepatitis B patients with renal or hepatic impairment. The data presented at the Global Hepatitis Summit (GHS) 2021 (18-20 June) demonstrate Vemlidy provides high rates of viral suppression and stable or improved markers of renal and bone safety in a subset analysis of patients from Taiwan, China Region of China who were enrolled in GS-US-320-4035.

A total of 124 patients recruited for the study were given TAF 25mg once daily for 96 weeks. Patients who were previously either on TDF or other OAVs were enrolled in one of two groups: Part A (renal impairment) or Part B (hepatic impairment). Among the 124 patients, 33 patients were from Taiwan, China (22 patients in Part A and 11 patients in Part B). Sub-analyses of the data from the Taiwan, China patients showed that the majority maintained viral suppression and had stable or slightly improved bone and renal parameters after 96 weeks of TAF treatment. No patients from Taiwan, China discontinued treatment due to an adverse event. Results of this study will be presented at GHS [Poster #310 (part A) & Poster #315 (part B)].

"These latest sub-analyses reinforce the role of Vemlidy in the treatment of chronic hepatitis B infection. With the additional data, healthcare providers can be confident that Vemlidy is an effective and durable option even for patients with other conditions such as hepatic or renal impairment," said Betty Chiang, Vice President of Medical Affairs, International, Gilead Sciences.

In addition to the Phase 2 switch study, Gilead will also be presenting a poster at GHS, titled Gilead Sciences' Commitment to Global Elimination of Hepatitis C [Poster #135], on its strategy and initiatives, including educational programs, investigator-sponsored research projects, program grants, and technology transfer and voluntary licensing for hepatitis C elimination. 

Gilead supports the efforts of governments and partners with professional and community-based organizations, healthcare providers, and payers to accelerate progress toward the WHO's 2030 hepatitis B and C elimination goals.[1]

[1] WHO | Combating hepatitis B and C to reach elimination by 2030
#Vemlidy is only recommended in patients with moderate or severe hepatic impairment in certain countries in Asia. For more information, please check local product label.

About Study 4305 (NCT03180619)

The primary objective of this study is to evaluate the safety and tolerability of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment. This study consists of 2 Parts. Ninety-three renally-impaired participants were enrolled in Part A and 31 hepatically impaired participants were enrolled in Part B from multiple countries.

Safety parameters, including serial determinations of renal function (eGFRCG), quantitative markers of tubular proteinuria and changes in hip and spine bone mineral density (BMD) and serum markers of bone turnover (C-type collagen sequence [CTX]; procollagen type 1 N-terminal propeptide [P1NP]) were measured. Efficacy outcomes, including viral suppression (HBV DNA <20 IU/mL) and biochemical response (% with normal ALT) through 96 weeks, were also assessed.

About Vemlidy®

Vemlidy® (tenofovir alafenamide 25 mg, TAF) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor currently approved in China (Mainland of Chian, Taiwan, China Region), India, Indonesia, Japan, Malaysia, Pakistan, Philippines, Singapore, South Korea, Thailand and Vietnam for the treatment of chronic hepatitis B virus infection in adults.

* For product indication details, please consult local labeling in individual countries.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.