SINGAPORE, Feb. 4, 2021 /PRNewswire/ -- Gilead Sciences announced today at the 2021 Asian Pacific Association for the Study of the Liver Conference (APASL), findings from two sub-analyses that demonstrated the continued efficacy and improved safety of Vemlidy® (tenofovir alafenamide 25 mg, TAF) compared with tenofovir disoproxil fumarate (TDF) in Asian patients with chronic hepatitis B virus (HBV).
The first sub-analysis in Asia demonstrated that Vemlidy provides durable virologic suppression in HBV and an improved renal and bone safety profile when compared with TDF. The sub-analysis examined the clinical outcomes of East Asian patients who participated in two randomized Phase 3 studies. Of the 1,298 patients with chronic hepatitis B (CHB) in both studies, 591 (45.5%) were East Asian patients, of which 401 received TAF, while 84 received TDF followed by open-label (OL)-TAF for 3 years and 106 received TDF followed by OL-TAF for 2 years.
East Asian CHB patients who received 240 weeks of therapy showed high rates of viral suppression and ALT normalization. HBeAg loss and seroconversion were observed at similar rates in all groups, and HBsAg loss rates were low. Data showed that TAF was well-tolerated across all groups. Over 240 weeks, patients in the TAF group had lower median declines in kidney function as measured by Cockcroft-Gault estimated glomerular filtration rate (eGFRCG) compared with those in the TDF treated groups. Increases in bone mineral density were observed after switching from TDF to TAF, accompanied with a decrease and stabilization in bone turnover markers.
Another sub-analysis was conducted among patients of Asian ethnicity using 96-week clinical data from a randomized Phase 3 study in 488 virologically-suppressed adults with CHB. In this group, 400 (82%) were of Asian ethnicity and received either TAF or TDF treatment for 48 weeks in a double-blind fashion, followed by all patients receiving open-label TAF for an additional 48 weeks. Results showed that in virologically-suppressed patients of Asian ethnicity with CHB on long-term TDF, switching to Vemlidy demonstrated maintenance of a high rate of viral suppression in 94% (n=376) of patients, along with continued high rates of normal ALT and improved markers of renal and bone health.
"These results are extremely encouraging for those seeking HBV treatment options in Asia. Healthcare providers can be confident that Vemlidy is an effective and durable option for people living with HBV who are looking to replace their current regimen," said Betty Chiang, Vice President of Medical Affairs, International, Gilead Sciences.
The World Health Organization estimated that in 2015, 257 million people were living with chronic HBV infection, which resulted in approximately 887,000 deaths, mostly from cirrhosis of the liver and hepatocellular carcinoma (i.e. primary liver cancer).[1] The Asia-Pacific region[2], which includes the Southeast Asia and Western Pacific regions, has among the highest historical prevalence of HBV infection, estimated at 3.5% and 5.7% respectively.[3] Over the last five years Gilead has supported more than 130 clinical trials, investigator-sponsored research and collaborative studies in liver disease in the Asia-Pacific region.
About Vemlidy®
Vemlidy® (tenofovir alafenamide 25 mg, TAF) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor currently approved in China, Hong Kong, India, Indonesia, Japan, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, 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 research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from other ongoing and additional clinical trials involving Vemlidy. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Vemlidy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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[1] https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
[2] Asia Pacific Region, in this particular case, refers to the Southeast Asia and Western Pacific Regions and the countries within; as defined by the WHO.
[3] Razavi-Shearer, Devin ; Razavi, Homie and Gamkrelidze Ivane. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol 2018; 3: 383–403. Published Online March 26, 2018 http://dx.doi.org/10.1016/ S2468-1253(18)30056-6.