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Gilead Announces New Data from Viral Hepatitis Research Programs at The Liver Meeting® 2019
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Download the PDF here
-- Data Demonstrate Reductions in Hepatocellular Carcinoma in Hepatitis B (HBV) Patients Treated with Vemlidy
-- Improved Markers of Bone and Renal Safety Also Seen with Vemlidy in Separate Analysis of HBV Patients with Hepatic or Renal Impairment
-- Data on Investigational TLR8 Agonist GS-9688 Support Continued Advancement of the Company's HBV Cure Research Program
November 08, 2019
This is abbreviated press release. Pdf of full press release attached and contains full safety discussion.
BOSTON--(BUSINESS WIRE)--Nov. 8, 2019-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data on Vemlidy® (tenofovir alafenamide 25 mg, TAF) that continue to support an improved safety profile compared with tenofovir disoproxil fumarate (TDF) in patients with chronic hepatitis B (HBV) infection. These results, along with new data from Gilead's HBV cure and hepatitis C (HCV) research programs, are being presented at The Liver Meeting® 2019 in Boston this week.
Chronic HBV infection is a leading risk factor for the development of hepatocellular carcinoma (HCC) globally. The impact of HBV treatment on HCC incidence was evaluated in a long-term analysis of two Phase 3 studies of Vemlidy (Oral 0194), in which 1,632 HBV patients were randomized to receive either Vemlidy or TDF once daily in two cohorts. Through three or five years of follow-up, dependent on cohort, HCC was observed in 21 patients (1.0 percent in the TAF group; 1.9 percent in the TDF group), with a median time to onset of 104 weeks. The HCC incidence observed in this study was significantly lower than the predicted incidence using the REACH-B model, particularly for patients without cirrhosis. Additional follow-up is needed to further characterize the impact of longer-term treatment on HCC risk reduction.
In the United States, Vemlidy is indicated for the treatment of chronic HBV infection in adults with compensated liver disease. The U.S. product label for Vemlidy contains a BOXED WARNING for the risk of severe post-treatment acute exacerbation of HBV. See below for U.S. Important Safety Information.
"Chronic infection with hepatitis B virus can lead to an increased risk of developing serious and life-threatening liver damage," said Young-Suk Lim, M.D., Ph.D., lead study author and professor, Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. "This analysis suggests that sustained viral suppression from treatment with Vemlidy may reduce the risk of hepatocellular carcinoma in chronic hepatitis B patients, which is the most common type of liver cancer in adults."
Markers of Bone and Renal Safety with Vemlidy
Data from multiple studies presented at AASLD demonstrate continued viral suppression (HBV DNA <20 IU/mL) and improvements in bone and renal markers with Vemlidy in patients with chronic HBV and also in high-risk HBV patients with hepatic or renal impairment.
In an analysis from a Phase 3 study evaluating virally suppressed chronic HBV patients (Poster 0455), 243 patients who had previously been treated with TDF for a median of four years were switched to Vemlidy for 48 weeks. Switching from TDF to Vemlidy resulted in improvement in certain bone and renal markers regardless of the duration (<4 years vs ≥ 4 years) of prior TDF use.
In an open-label Phase 2 study (Poster 0483), 93 HBV patients with moderate to severe renal impairment and those with end-stage renal disease (ESRD) on chronic hemodialysis (HD) who were virally suppressed taking TDF and/or other antivirals for at least 48 weeks, were switched to Vemlidy for 96 weeks. At week 24, all patients with ESRD and 97 percent of patients with moderate or severe renal impairment met the primary endpoint of maintaining viral load suppression.
In renally-impaired HBV patients, switching to Vemlidy from TDF resulted in increases in hip and spine bone mineral density and decreases in most bone turnover markers including in ESRD patients on HD, as well as decreases in renal tubular markers and increases in glomerular filtration rate (eGFRCG). Similar results were achieved in a Phase 2 open-label study of 31 virally suppressed HBV patients with moderate or severe hepatic impairment (Child-Turcotte-Pugh Class B or C) who were switched to Vemlidy and treated for 24 weeks (Poster 0501).
The use of Vemlidy in chronic HBV patients with moderate or severe hepatic impairment is investigational; its safety and efficacy have not been established.
HBV Functional Cure Research
GS-9688 is an investigational oral selective small molecule agonist of toll-like receptor 8 (TLR8). In a Phase 2 multicenter, randomized, double-blind study of 48 virally suppressed chronic HBV patients (Poster 0697), GS-9688, taken in combination with oral antivirals, was well-tolerated over an extended dosing period and demonstrated dose-dependent pharmacodynamic activity. Clinical activity was also evaluated; five percent of patients receiving GS-9688 achieved a ≥ 1 log10 IU/mL decline in hepatitis B surface antigen (HBsAg) levels or hepatitis B e-antigen (HBeAg) loss at 24 weeks. These data support ongoing studies of GS-9688 as well as novel combinations aimed at achieving a functional cure of HBV.
The safety and efficacy of GS-9688 have not been established. GS-9688 is an investigational compound and is not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority.
HCV Treatment in Pediatric Patients
There are limited approved HCV treatment options for children younger than 12 years old, particularly those with HCV genotypes 2 and 3. In an open-label study of patients 6 to <18 years of age with HCV genotypes 1, 2, 3, 4 and 6 (Poster 0748), 12 weeks of treatment with Epclusa® (sofosbuvir/velpatasvir) resulted in a cure rate (SVR12) of 95 percent (97/102) in patients 12 to <18 years old and 92 percent (67/73) in those 6 to <12 years old. Most AEs were mild or moderate in severity; four patients experienced a serious AE, one which was attributed to treatment. The most common AEs (>15 percent of patients) were headache, fatigue and nausea in adolescents, and vomiting, cough and headache in patients 6 to <12 years old. The study is ongoing in children ages 3 to <6 years old.
The use of Epclusa in the aforementioned patient population is investigational; its safety and efficacy have not been established. Epclusa is indicated in the United States for the treatment of adults with chronic HCV genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis. The U.S. product label for Epclusa contains a BOXED WARNING for the risk of hepatitis B reactivation in HCV/HBV co-infected patients. See below for U.S. Important Safety Information.
This is abbreviated press release. Pdf of full press release attached and contains full safety discussion.
U.S. full Prescribing Information for Epclusa and Vemlidy, including BOXED WARNINGS, is available at www.gilead.com.
Epclusa and Vemlidy 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.
Source: Gilead Sciences, Inc.
Greg Mann
(424) 322-1795
Sonia Choi, Media
(650) 425-5483
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