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Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead's viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results from two Phase 3 studies demonstrating improved long-term bone and renal safety in HBV-infected patients one year after switching from Viread® (tenofovir disoproxil fumarate 300mg) to Vemlidy® (tenofovir alafenamide 25mg) will be presented on October 21. "Gilead continues to study the effectiveness of our once-daily sofosbuvir-based single tablet regimens in diverse chronic HCV-infected patient populations to provide the opportunity for cure for all patient populations, including those most difficult to cure," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. "We are also committed to advancing the long-term care of patients with chronic HBV infection, and are pleased to share multiple new data presentations demonstrating the ongoing improvements in bone and renal safety observed when patients switch from Viread to Vemlidy." Harvoni, Epclusa and Vosevi have Boxed Warnings in their product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV coinfected patients, and Vemlidy has a Boxed Warning regarding the risk of post-treatment severe acute exacerbation of hepatitis B. See below for important safety information for all products. Harvoni in Renally Impaired Patients (Poster #1587) In an open-label Phase 2 study evaluating once-daily Harvoni for 12 weeks among HCV genotype 1 patients with severe renal impairment (creatinine clearance = 30 mL/min), 100 percent (18/18) of patients achieved SVR12, including patients with compensated cirrhosis (n=2) and those who had failed prior treatment (n=4). Safety events were consistent with those expected for the patient population. The most common adverse events (AEs) (>15 percent) were fatigue (22 percent), headache (22 percent) and hyperkalemia (17 percent). Four patients (22 percent) reported serious AEs, none of which was related to study drug. There were no deaths and no patients discontinued treatment in the study. Harvoni is approved for adults with chronic HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis, adults with genotype 1 infection with decompensated cirrhosis in combination with ribavirin (RBV), and adults with genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with RBV. The safety and efficacy of Harvoni have not been established in patients with severe renal impairment. Epclusa in Liver Transplant Patients (Poster #1069) In an open-label Phase 2 study evaluating once-daily Epclusa for 12 weeks among 79 liver transplant patients with genotype 1-4 chronic HCV infection, treatment with Epclusa resulted in an overall SVR12 rate of 96 percent, including patients with cirrhosis and prior treatment failure, and was well tolerated.
Baseline resistance mutations did not impact SVR rates. Two patients relapsed in this study - one treatment-naïve non-cirrhotic patient with HCV genotype 1a and one treatment-experienced non-cirrhotic patient with HCV genotype 3. Common adverse effects (AEs) (>10 percent) were headache (24 percent), fatigue (20 percent) and cough (10 percent). Three patients (4 percent) experienced serious AEs; none was related to study drug. One patient discontinued treatment after one week due to hyperglycemia. There were no deaths, graft loss or episodes of acute liver transplant rejection. Epclusa is approved for patients with genotype 1-6 without cirrhosis or with compensated cirrhosis, and in combination with RBV for patients with decompensated cirrhosis. The safety and efficacy of Epclusa in liver transplant recipients has not been established. Vosevi in NS5A Treatment-Experienced Patients (Poster #1178) A deferred treatment cohort of the POLARIS-1 Phase 3 study confirmed previously reported results demonstrating the effectiveness of 12 weeks of Vosevi as salvage therapy for treatment-experienced patients. The study evaluated once-daily Vosevi in NS5A-inhibitor experienced patients with chronic HCV who were initially randomized to receive placebo in POLARIS-1. Vosevi treatment was associated with an overall SVR12 rate of 97 percent (143/147), with 97 percent (141/145) of genotype 1 patients achieving SVR12 and 100 percent (2/2) of genotype 6 patients achieving SVR12. Four patients experienced virologic relapse after completing treatment. The most common adverse effects (>10 percent) were fatigue (21 percent), headache (20 percent), diarrhea (19 percent) and nausea (14 percent). Six patients (4 percent) experienced serious AEs unrelated to study drug, and there were no discontinuations due to AEs. Vosevi is approved for patients without cirrhosis or with compensated cirrhosis who have HCV genotype 1, 2, 3, 4, 5 or 6 and have been previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. Vemlidy in Patients Switching from Viread (Poster #904) and Two Year Resistance Analysis (Oral #26) A post-hoc analysis of a subgroup of the 1,298 treatment-naïve and treatment-experienced patients with chronic HBV infection from two Phase 3 studies (Studies 108 and 110, Poster #904) demonstrated that patients who were switched after 96 weeks of treatment with Viread to Vemlidy experienced improvements in renal function, bone mineral density (BMD) and serum alanine aminotransferase (ALT) normalization while maintaining viral suppression, after 48 weeks of treatment with Vemlidy. In patients initially randomized to Viread, high rates of virologic control (HBV DNA <29 IU/mL) were maintained after switching from Viread to Vemlidy. When assessed at Week 96 (pre-switch), 88 percent of Viread patients (156/177) had achieved virologic suppression. When these patients were switched to Vemlidy, 89 percent (149/167) had achieved virologic suppression at Week 144. Median creatinine clearance (CrCL) increased among switch patients by 3.6 (-3.6, +9.0) ml/min (p<0.001). Mean hip BMD (n=180) increased by 0.96 percent (2.41) (p<0.001) and spine BMD (n=181) increased by 1.83 percent (3.20) (p<0.001). In addition, rates of serum ALT normalization (by the AASLD criteria) increased from 47 percent of patients pre-switch at Week 96 to 65 percent after 48 weeks of Vemlidy (p<0.001). A prespecified analysis that will be presented during an oral session (Oral #26) evaluated virologic resistance after 96 weeks of treatment with Vemlidy or Viread. Of the 1,242 patients who entered year two of treatment, similar percentages of patients treated with Vemlidy (10.5 percent; 87/828) or Viread (10.9 percent; 45/414) qualified for evaluation. Using genotypic and phenotypic analyses, no resistance to either Vemlidy or Viread was detected in any patients at 96 weeks. Vemlidy is approved for the treatment of chronic HBV infection in adults with compensated liver disease. The safety and efficacy of switching virologically suppressed patients onto Vemlidy have not been established. Important Safety Information About Harvoni, Epclusa and Vosevi BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions (News - Alert)
Consult the full Prescribing Information for Harvoni, Epclusa, and Vosevi for more information on potentially significant drug interactions, including clinical comments. Important Safety Information About Vemlidy BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Warnings and Precautions
Adverse Reactions Most common adverse reactions (incidence =5%; all grades) through Week 48 were headache, abdominal pain, fatigue, cough, nausea and back pain. Drug Interactions
Consult the full prescribing information for Vemlidy for more information on potentially significant drug interactions, including clinical comments.
Dosage and Administration 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. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statement 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 risk that Gilead may observe unfavorable results from additional clinical trials involving Harvoni, Epclusa, Vosevi and Vemlidy in certain difficult-to-treat patient populations. 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 June 30, 2017, 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. U.S. Full Prescribing Information for Harvoni, Epclusa, Vosevi, Vemlidy and Viread including BOXED WARNING, is available at www.gilead.com. Harvoni, Epclusa, Vosevi, Vemlidy and Viread 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 (News - Alert) (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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