Gilead's ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

US anti-virals major Gilead Sciences (Nasdaq: GILD) has released strong top-line results from a Phase III clinical trial (GS-US-337-0113) in Japan evaluating the investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg, with and without ribavirin (RBV), for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection.

Among patients receiving 12 weeks of LDV/SOF without RBV, 100% (n=83/83) of treatment-naive and 100% (n=88/88) of treatment-experienced patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Among patients receiving LDV/SOF plus RBV, 96% (n=80/83) of treatment-naive and 100% of treatment-experienced patients (n=87/87) achieved SVR12. Across all arms, patients with cirrhosis achieved a 99% (n=75/76) SVR12. The study met its primary endpoint of superiority versus a predefined historical SVR12 rate. Patients who achieve SVR12 are considered cured of HCV infection.

Genotype 1 is the most common strain of HCV in Japan, accounting for around 70% of the more than one million people chronically infected with the disease. The majority of these infections are due to HCV genotype 1b. Current treatment options for genotype 1 HCV infection involve up to 48 weeks of therapy with pegylated interferon injections, RBV tablets and other oral medicines, which may not be suitable for certain patients.