April 16, 2016
Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies
– Studies Highlight Progress with Approved Therapies and Investigational Pangenotypic Regimens, Including Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 –
“The data presented this week continue to underscore the high cure rates
and safety of our sofosbuvir-based HCV therapies, and support their
utility across all patient HCV genotypes and disease stages,” said
Results from the open-label, Phase 3 ASTRAL-5 study (PS104), led by
SOF/VEL is currently being evaluated by regulatory agencies in
Sofosbuvir/Velpatasvir (SOF/VEL) Plus GS-9857
Data from three Phase 2 trials evaluating SOF/VEL plus GS-9857, a pangenotypic protease inhibitor, (Studies GS-US-367-1168 and GS-US-367-1169 and TRILOGY-3) also were selected for presentation.
Studies 1168 and 1169
Studies 1168 and 1169 evaluated 6 and 8 weeks of SOF/VEL plus GS-9857, with or without ribavirin (RBV), among treatment-naïve patients and 12 weeks of SOF/VEL plus GS-9857 among patients who failed prior treatment including those previously exposed to a direct acting antiviral (DAA) regimen. Study 1168 evaluated 197 genotype 1 patients and Study 1169 evaluated 128 genotype 2-6 patients.
Treatment-naïve patients: Poster SAT-138 highlighted combined safety and efficacy results from Studies 1168 and 1169 evaluating SOF/VEL plus GS-9857, with or without ribavirin, in genotype 1-6, treatment-naïve patients, with and without cirrhosis. SVR12 rates were:
|SOF/VEL plus GS-9857||SOF/VEL plus GS-9857 with RBV|
|6 weeks||8 weeks||8 weeks|
|SVR12||79% (n=53/67)||96% (n=95/99)||81% (n=25/31)|
The most common adverse events (>10 percent) across the three study arms were headache, nausea, fatigue, diarrhea and anemia.
Treatment-experienced patients: Oral presentation PS008 highlighted combined safety and efficacy results from Studies 1168 and 1169 evaluating 12 weeks of SOF/VEL plus GS-9857 in genotype 1-6, treatment-experienced patients. Twenty-seven percent of patients were NS5A inhibitor-experienced, 52 percent were non-NS5A inhibitor, DAA-experienced and 21 percent failed interferon-based treatment without a DAA. Overall, the SVR12 rate was 99 percent (n=127/128). One genotype 3 patient with cirrhosis who had failed prior treatment with sofosbuvir plus pegylated interferon/ribavirin relapsed. Frequently reported adverse events (>10 percent) were headache, fatigue, diarrhea and nausea.
Studies 1168 and 1169 were led by
A late-breaker oral presentation (PS021) featuring data from a Phase 2 trial, led by Dr. Lawitz, evaluated 12 weeks of a fixed-dose combination of SOF/VEL/GS-9857, with or without RBV, among genotype 1, DAA-experienced, HCV-infected patients, including patients with cirrhosis. One hundred percent (n=24/24) of patients receiving 12 weeks of therapy with SOF/VEL/GS-9857 and 96 percent (n=24/25) of patients receiving SOF/VEL/GS-9857 plus RBV achieved SVR12. Among the 49 patients in this trial, 41 percent had prior exposure to an NS5A inhibitor and 47 percent previously received at least two classes of DAA. The most common adverse events (>10 percent) across both treatment arms were fatigue and anemia.
Based on these data a fixed-dose combination of SOF/VEL/GS-9857 is being
evaluated in four Phase 3 studies (POLARIS-1, POLARIS-2, POLARIS-3 and
POLARIS-4). SOF/VEL/GS-9857 has been granted a Breakthrough Therapy
designation by the
Harvoni is the first single tablet HCV regimen approved in
Data from an evaluation of Harvoni in genotype 1 HCV-infected
adolescents aged 12 to 17 have been selected for presentation in a late
breaker oral session (LB-4597). Presented by
Further information about the clinical studies described above can be found at www.clinicaltrials.gov.
Uses for Harvoni in certain HCV patient populations highlighted above 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 for Harvoni
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).
Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.
In addition to rifampin and St. John’s wort, co-administration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such co-administration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Co-administration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Co-administration 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.
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 SOF/VEL, SOF/VEL/GS-9857 and Harvoni in certain patient
populations, including adolescents aged 12 to 18. In addition, the
regulatory filings for SOF/VEL and SOF/VEL/GS-9857 may not be approved
by regulatory agencies, and marketing approvals, if granted, may have
significant limitations on their use. 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 Annual Report on Form 10-K for the
U.S. full Prescribing Information for Harvoni is available at www.gilead.com.
Harvoni is a registered trademark of
For more information on
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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Cara Miller, 650-522-1616