Clinical Trials

Date: 2016-04-16

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at The International Liver CongressTM 2016 in Barcelona, Spain

Company: Gilead Sciences (USA - CA)

Product: sofosbuvir, velpatasvir (GS-5816) and voxilaprevir (GS-9857)

Action mechanism: direct-acting antiviral agent/RNA polymerase (NS5B) inhibitor/ nonstructural protein 5A (NS5A) inhibitor/ NS3/4A protease inhibitor. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. This direct-acting agent interferes directly with the HCV life cycle by suppressing viral replication. GS-9857 is an investigational NS3/4A protease inhibitor.  Velpatasvir (GS-5816) is a second-generation investigational NS5A inhibitor.

Disease: chronic hepatitis C virus infection

Therapeutic area: Infectious diseases

Country:

Trial details:

Latest news:

• • On April 16, 2016, Gilead Sciences announced results from several Phase 2 and Phase 3 studies evaluating its fixed-dose combination therapy SOF/VEL plus GS-9857 for the treatment of chronic hepatitis C virus (HCV) infection. Data were presented this week at The International Liver Congress 2016 in Barcelona, Spain .Data from three Phase 2 trials evaluating SOF/VEL plus GS-9857, a pangenotypic protease inhibitor.
• 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. 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.
• 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 FDA for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.

Is general: Yes