Gilead Sciences, Inc. (NASDAQ:GILD) announced that the FDA has approved updated labeling for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV. Epclusa received regulatory approval for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin, in the United States on June 28, 2016.
Epclusa has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV co-infected patients. See below for important safety information.
“HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded use, Epclusa provides co-infected patients with a much needed one-pill-a-day regimen that works across all HCV genotypes and is compatible with widely-used antiretroviral regimens,” said David Wyles, M.D., Chief, Division of Infectious Disease, Denver Health Medical Center; Associate Professor of Medicine, University of Colorado School of Medicine. “With Epclusa, physicians have an important new treatment option for their HCV/HIV co-infected patients.”
The supplemental new drug application (sNDA) was supported by data from the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of treatment with Epclusa in 106 subjects with genotype 1-4 HCV infection who were co-infected with HIV and on stable antiretroviral therapy. In the study, 95 percent (101/106) of patients achieved the primary endpoint of SVR12, defined as an undetectable viral load 12 weeks after completing therapy.
The safety profile of Epclusa in HCV/HIV co-infected patients was similar to that observed in HCV mono-infected patients. The most common adverse events (in at least 10 percent of subjects) were fatigue (22 percent) and headache (10 percent).
“Epclusa has already helped further simplify HCV treatment among mono-infected patients, and we are pleased that HCV/HIV co-infected patients can benefit from this pan-genotypic single tablet regimen,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “This approval advances the commitment we’ve made to the HCV and HIV communities to deliver innovative new treatments that address their unmet medical needs.”
Shares of Gilead Sciences closed today at $75.70, down $0.39 or -0.51%. GILD has a 1-year high of $82.10 and a 1-year low of $63.76. The stock’s 50-day moving average is $70.31 and its 200-day moving average is $68.57.
On the ratings front, GILD has been the subject of a number of recent research reports. In a report issued on July 27, BMO analyst Ian Somaiya reiterated a Hold rating on GILD, with a price target of $82, which represents a potential upside of 7% from where the stock is currently trading. Separately, on the same day, Maxim’s Gabrielle Zhou reiterated a Hold rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ian Somaiya and Gabrielle Zhou have a yearly average return of 12.8% and a loss of 0.6% respectively. Somaiya has a success rate of 61% and is ranked #259 out of 4627 analysts, while Zhou has a success rate of 43% and is ranked #3446.
Sentiment on the street is mostly bullish on GILD stock. Out of 14 analysts who cover the stock, 11 suggest a Buy rating and 3 recommend to Hold the stock. The 12-month average price target assigned to the stock is $85.29, which represents a potential upside of 12% from where the stock is currently trading.
Gilead Sciences, Inc. is a biopharmaceutical company, which discovers, develops and commercializes therapeutics for unmet medical need. It focuses on human immunodeficiency virus and liver diseases, such as chronic hepatitis C virus infection & chronic hepatitis B virus infection, hematology & oncology, and cardiovascular & inflammation as well as respiratory diseases. The company’s products include Descovy, Odefsey, Genvoya, Stribild, Complera, Atripla, Truvada, Viread, Emtriva, Tybost, Vitekta, Vemlidy, Epclusa, Harvoni, Sovaldi, Viread, Hepsera, Zydelig, Letairis, Ranexa, Lexiscan, Cayston, Tamiflu, AmBisome and Macugen.