-- Full Results from Four Phase 3 ASTRAL Studies of Sofosbuvir/Velpatasvir to be Presented --
SAN FRANCISCO--(BUSINESS WIRE)--Nov. 14, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced it will present 32 scientific presentations related to its approved medicines and investigational therapies for the treatment of chronic hepatitis C virus (HCV) infection at The Liver Meeting 2015 in San Francisco. Data include results from studies of Harvoni® (ledipasvir/sofosbuvir) and Sovaldi® (sofosbuvir) that advance the understanding of the profiles of these drugs in several patient populations. Detailed results from the four Phase 3 ASTRAL studies evaluating the company’s next potential single tablet regimen – a once-daily combination of velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, with sofosbuvir (SOF) – also will be presented.
“We continue to advance our understanding of the safety and efficacy of Sovaldi and Harvoni in diverse groups of HCV patients, including several special patient populations that historically have not been studied,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are also pleased to share data evaluating our next-generation investigational sofosbuvir-based therapies SOF/VEL and SOF/VEL plus GS-9857. In total, the data highlighted this week demonstrate the strength of sofosbuvir as the backbone of multiple hepatitis C treatment regimens in numerous hepatitis C-infected patient populations.”
Harvoni
Harvoni is the first single tablet regimen for the treatment of chronic HCV genotype 1. Following the U.S. Food and Drug Administration’s approval of Gilead’s supplemental new drug application on November 12, 2015, Harvoni is now also indicated for genotypes 4, 5 and 6. Data presented this week demonstrate the efficacy and safety profile of Harvoni in populations with unmet medical needs including pre- and post-liver transplant patients with decompensated cirrhosis (Posters #1130, #1045, #1049). In addition, Oral #96 describes a review of safety data from the SOLAR-1 and SOLAR-2 studies that suggest a new algorithm for the detection of potential drug-induced liver injury in patients with decompensated cirrhosis receiving direct acting antiviral-based regimens. A new analysis and an additional study describe the efficacy and safety of Harvoni in Asian patients (Poster #1105) and in patients with hereditary bleeding disorders (Poster #1034).
Sovaldi
Results and new analyses from several studies highlighting the utility of Sovaldi in combination with other agents in several diverse and newly-studied populations, including Asian patients (Poster #1080) and those with severe renal impairment (Poster #1128) also will be presented this week. Sovaldi is approved in combination with other agents for the treatment of genotypes 1-4 chronic HCV infection.
Hepatitis C Pipeline
Detailed results from Gilead’s four Phase 3 ASTRAL studies of SOF/VEL in patients with genotype 1-6 chronic HCV infection, ASTRAL-1 (Oral LB-2), ASTRAL-2 (Oral #205), ASTRAL-3 (Oral #249) and ASTRAL-4 (Poster LB-13), will be presented at various times throughout The Liver Meeting 2015. Based on these data, Gilead submitted a new drug application (NDA) for SOF/VEL to the FDA on October 28, 2015. The company plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year. If approved, SOF/VEL would be Gilead’s third HCV medication and the first all-oral, pan-genotypic, single tablet HCV regimen.
Gilead also will present new data from a study evaluating the safety and efficacy of the combination of SOF/VEL with GS-9857, an investigational pangenotypic NS3/4A protease inhibitor, in patients with HCV genotype 1 and 3 infection (Oral #38). Based on these data, SOF, VEL and GS-9857 co-formulated into a fixed-dose combination will be advanced into Phase 3 studies.
Abstracts for Gilead’s presentations can be accessed at http://www.aasld.org/sites/default/files/2015SupplementFULLTEXT.pdf. Further information about the clinical studies described above can be found at www.clinicaltrials.gov.
Uses in certain HCV patient populations highlighted above for Harvoni and Sovaldi are investigational and have not been determined to be safe or efficacious. SOF/VEL and SOF/VEL/GS-9857 are investigational products and have not been determined to be safe or efficacious.
Important Safety Information About Harvoni
Contraindications
If Harvoni is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
Important Safety Information About Sovaldi
Contraindications
Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone is not recommended for use with Sovaldi in combination with another DAA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect of Sovaldi Due to Use with P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Sovaldi as they may significantly decrease sofosbuvir plasma concentrations.
Risk Associated with Combination Treatment: Because Sovaldi is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
Related Products Not Recommended: Sovaldi is not recommended for use with other products containing sofosbuvir.
Adverse Reactions
Most common (≥20%, all grades) adverse reactions for:
Sovaldi + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
Sovaldi + ribavirin combination therapy were fatigue and headache
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Sovaldi is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.
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 possibility of unfavorable results from these studies and other ongoing and subsequent clinical trials involving Harvoni, Sovaldi, SOF/VEL and SOF/VEL with GS-9857. The FDA may not approve the SOF/VEL fixed-dose combination, and any marketing approvals, if granted, may have significant limitations on its use. In addition, Gilead may be unable to file for regulatory approval of SOF/VEL in other geographies in the currently anticipated timelines. As a result, Gilead may not be able to successfully commercialize SOF/VEL. 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, 2015, 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 Sovaldi and Harvoni is available at www.gilead.com.
Sovaldi and Harvoni 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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