ILC2016 Sofosbuvir/velpatasvir and experimental compound GS-9857 shows promise in Hepatitis C infected patients whose previous treatment has failed

New triple drug combination shows promise in Hepatitis C infected patients whose previous treatment has failed
April 14, 2016
Press Releases

High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfuly treated with direct-acting antivirals

The study showed that 99% of patients with HCV genotype 1, 2, 3, 4 and 6 who had previously received treatment, achieved SVR 12 weeks after treatment using this triple combination.

April 14, 2016, Barcelona, Spain: New data presented today at The International Liver Congress™ 2016 in Barcelona, Spain, demonstrates a high sustained virologic response (SVR) at 12 weeks from the all-oral combination of sofosbuvir/velpatasvir and experimental compound GS-9857 in patients with the Hepatitis C virus (HCV). This triple combination treatment was generally safe and effective, even in patients who had been unsuccessfully treated with direct acting antivirals (DAAs, medicines which have been used to treat and cure almost all patients with HCV). The study showed that 99% of patients with HCV genotype 1, 2, 3, 4 and 6 who had previously received treatment, achieved SVR 12 weeks after treatment using this triple combination.

Hepatitis C is a virus carried via the blood, which infects and damages the liver.1 HCV infects liver cells, resulting in inflammation and fibrosis.1 In chronic HCV cases, such symptoms may continue to increase and result in liver cirrhosis, scarring of the liver.1 Despite the high overall SVR rate achieved with currently approved DAA therapies, approximately 5% of patients treated with DAAs will not be cured.2 According to the study authors, for this small proportion of patients who are not cured, retreatment options are significantly limited.

“Our study demonstrates that for HCV patients whose prior treatment has failed with the use of DAAs, this triple combination provides a high rate of sustained virologic response across HCV genotypes,” said Dr Eric Lawitz, Clinical Professor of Medicine at the University of Texas Health Science Center, San Antonio and lead author of the study. “Furthermore, the study indicates that the treatment combination is generally safe and well tolerated by patients, providing a promising alternative for HCV sufferers who have limited re-treatment options.”

Two global, open-label Phase 2 studies were conducted among chronic HCV-infected patients that had failed prior HCV treatment. Genotype 1 HCV-infected patients enrolled in the study had previously been treated with an NS5A-inhibitor or multiple classes of DAAs, and genotype 2-6 HCV-infected patients had previously been treated with pegylated-interferon (Peg-IFN) plus ribavarin and/or any DAA. All patients received the triple combination of sofosbuvir/velpatasvir plus GS-9857 for 12 weeks. Frequently reported adverse events (AEs) were headache, fatigue, diarrhea and nausea; most were mild or moderate in severity.

“Having offered promising results, this three drug combination is being further evaluated in Phase 3 trials as a single tablet regimen in DAA-experienced patients,” said Professor Laurent Castera, EASL Secretary General.

Study demonstrates the potential for a new triple combination treatment for hepatitis C patients whose prior treatment with direct-acting antivirals failed
April 14, 2016
Press Releases

The combination of sofosbuvir, velpatasvir, and GS-9857 demonstrates safety and efficacy in patients with genotype 1 hepatitis C

April 14, 2016, Barcelona, Spain: A new combination treatment for hepatitis C has potential for patients who were not cured by current treatment options. The study, presented at The International Liver CongressTM in Barcelona, Spain, demonstrated that the combination of sofosbuvir, velpatasvir and the investigational drug GS-9857 with or without ribavirin resulted in high rates of sustained virologic response 12 weeks after treatment (SVR12) in genotype 1 HCV patients who had previously received and failed treatment with direct-acting antivirals (DAAs). Overall, 98% of patients in the study achieved SVR12 with this three-drug combination in a single tablet with or without ribavirin.

Between 130 and 150 million people globally have chronic Hepatitis C virus (HCV) infection.1 It is estimated that 15 million people in the World Health Organization’s EU Region are living with Hepatitis C, representing 2% of adults.2 Worldwide, genotype 1 HCV is the most common, accounting for approximately half of all hepatitis C infections.3

“Our study set out to evaluate the safety and efficacy of this investigational combination for hard-to-treat patients with genotype 1 hepatitis C,” said Dr Eric Lawitz, Clinical Professor of Medicine at the Texas Liver Institute, University of Texas Health Science Centre, San Antonio and lead author of the study. “With the triple combination of three potent drugs, sofosbuvir, velpatasvir and GS-9857, we demonstrated that high SVR12 results were achieved with or without ribavirin.”

Patients previously treated with DAAs were randomised to receive the combination treatment with or without ribavirin for 12 weeks. The primary endpoint of the study was SVR12. SVR12 was achieved in 100% of patients who took sofosbuvir, velpatasvir and GS-9857 without ribavirin and in 96% of patients who additionally took ribavirin.

A total of 49 patients were randomised and treated in the American study. The majority were male (65%), and had HCV genotype 1a (88%). Overall, 41% of patients had previously received an NS5A inhibitor, and 47% of patients had previously received at least two classes of DAA. The triple combination of sofosbuvir, velpatasvir and GS-9857, with or without ribavirin was generally safe and well tolerated. There was one serious adverse event and two patients discontinued treatment with ribavirin due to adverse events. Most frequent adverse events were fatigue and anaemia, which were only observed in patients that received ribavirin.

“This new combination of treatments could add to our arsenal of therapies for patients with Hepatitis C, a disease which could eventually be eradicated. In the hard-to-treat patient population who had previously failed on existing treatment regimens, the combination with GS-9857 could provide these people with another hope,” said Professor Tom Hemming Karlsen, EASL Vice-Secretary.