GILEAD ANNOUNCES HARVONI® (LEDIPASVIR/SOFOSBUVIR) STUDY RESULTS IN CHRONIC HEPATITIS C PATIENTS WITH ADVANCED LIVER DISEASE AND THOSE WHO FAILED PRIOR TREATMENT
– High Cure Rates in Nearly 800 Hepatitis C Virus (HCV Patients with Advanced Liver Disease) –
Boston, November 11, 2014 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options, including patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant and patients who failed previous treatment with other direct acting antivirals. These data will be presented this week at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2014) in Boston.
"Chronic hepatitis C patients with advanced liver disease are among the most difficult to cure and traditionally have had limited or no treatment options," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. "The data presented this week demonstrate that provides high cure rates for patients with advanced liver disease, as well as for those who failed prior treatment with other antivirals, including sofosbuvir-based regimens."
Ledipasvir/sofosbuvir was approved by the U.S. Food and Drug Administration on October 10, 20141 and Health Canada on October 16, 2014 under the trade name Harvoni and is the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Applications are pending in the European Union, Japan and Switzerland.
Advanced Liver Disease
In a pooled analysis of Phase 2 and Phase 3 open-label studies (Oral #82) in more than 500 genotype 1 HCV infected patients with compensated cirrhosis who received ledipasvir/sofosbuvir alone or with ribavirin (RBV) for 12 or 24 weeks, 96 percent of patients achieved sustained virologic response (SVR12). Patients who achieve SVR12 are considered cured of HCV infection.2
Two prospective analyses from a Phase 2 open-label study (Study GS-US-337-0123) evaluating patients with decompensated cirrhosis and those with HCV recurrence following liver transplantation also are being presented. In the first subgroup (Oral #239), 108 genotype 1 and 4 infected patients with decompensated cirrhosis, including those with moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Class B) and severe hepatic impairment (CPT Class C), received ledipasvir/sofosbuvir plus RBV for 12 or 24 weeks.3 Overall, SVR12 rates were 87 percent (n=45/52) in the 12-week arm and 89 percent (n=42/47) in the 24-week arm.
The second subgroup (Oral #8) evaluated 12 or 24 weeks of ledipasvir/sofosbuvir plus RBV among 223 genotype 1 and 4 patients who developed HCV recurrence following liver transplantation.4 Among non-cirrhotic patients, SVR12 rates were 96 percent (n=53/55) and 98 percent (n=55/56) following 12 and 24 weeks of treatment, respectively. For patients with compensated cirrhosis, SVR12 rates were 96 percent for both 12 weeks (n=25/26) and 24 weeks (n=24/25) of therapy. SVR12 rates among patients with decompensated cirrhosis were 81 percent for both 12 weeks (n=25/31) and 24 weeks (n=17/21) of therapy.
Retreatment of Patients Who Failed Prior Therapy
Study GS-US-337-0121 (Late Breaker Oral #LB-6) evaluated 155 genotype 1 patients with compensated cirrhosis who had failed prior treatment with pegylated interferon (PegIFN)/RBV and subsequently PegIFN/RBV plus a protease inhibitor. In this study, patients were randomized (1:1) to receive ledipasvir/sofosbuvir plus RBV for 12 weeks or ledipasvir/sofosbuvir alone for 24 weeks. Ninety six percent (n=74/77) of those receiving ledipasvir/sofosbuvir plus RBV for 12 weeks and 97 percent (n=75/77) of those receiving ledipasvir/sofosbuvir for 24 weeks achieved SVR12.5
In a second study (Oral #235), 51 genotype 1 patients who previously failed SOF/PegIFN/RBV, SOF/RBV or a SOF placebo/PegIFN/RBV treatment regimen received ledipasvir/sofosbuvir plus RBV for 12 weeks. Twenty nine percent (n=15/51) had cirrhosis.6 Ninety eight percent (n=50/51) achieved SVR12 following 12 weeks of treatment with ledipasvir/sofosbuvir plus RBV.
In all of these studies, ledipasvir/sofosbuvir was well tolerated and its safety profile was generally consistent with that observed in clinical trials of ledipasvir/sofosbuvir. Adverse events included fatigue, headache, nausea and anemia, which was more common among patients taking RBV. Grade 3/4 laboratory abnormalities were infrequent and included decreases in hemoglobin, which is consistent with RBV-associated anemia.
The safety and efficacy of ledipasvir/sofosbuvir have not been established for the investigational uses described above.
Additional information about these studies can be found at www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
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 longer-term results from these studies and other ongoing and subsequent clinical trials involving Harvoni, alone or in combination with other products, for the treatment of HCV in other patient populations. As Harvoni is used over longer periods of time, Gilead may find new issues such as safety or drug resistance, which may require it to provide additional warnings or contraindications in the label, which could reduce the market acceptance of Harvoni. 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, 2014, 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.
Harvoni is a registered trademark of Gilead Sciences, Inc.
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.