Ledipasvir/Sofosbuvir: 99% SVR in Asian Patients With HCV GT1

SAN FRACISCO, CA—Ledipasvir/sofosbuvir given once daily for 12 weeks was highly effective in Asian patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, including those with compensated cirrhosis, a study concluded at The Liver Meeting® 2015.

The sustained virologic response at 12 weeks (SVR12) rate was 99% and, among patients who had failed prior NS3/4A protease-inhibitor-containing regimens, SVR12 was 100%, reported Masashi Mizokami, MD, PhD, from the National Center for Global Health and Medicine, Tokyo, Japan, and colleagues.

Although the majority of patients across the US, Europe, Japan, Korea, and Taiwan with HCV are infected with GT1, "important differences in host and viral characteristics exist between Asian- and Western-infected populations, including mean age, body mass index (BMI), interleukin-28B (IL-28B) genotype, and HCV GT1 subtype," they noted.

Dr. Mizokami and colleagues conducted an analysis to evaluate the safety and efficacy of ledipasvir/sofosbuvir single tablet in a large cohort of Asian patients with chronic HCV GT1 infection. Patient data from two Phase 3 trials (GS-US337-0113 [Japan], GS-US-337-0131 [Korea and Taiwan]) looked at treatment with ledipasvir/sofosbuvir (90mg/400mg) for 12 weeks in treatment-naïve (n=171) and treatment-experienced (n=178) adults.

A total of 13% of the treatment-naïve patients had cirrhosis, as did 25% of those who were treatment-experienced. The majority of patients were GT1b-infected (95% and 93%), and IL-28B CC genotype (74% and 50%), respectively. Researchers also assessed HCV RNA; the presence of NS5A and NS5B resistance-associated variants (RAV) was evaluated by deep sequencing (cutoff of 1%).

The primary efficacy endpoint, SVR12, was seen in all but 3 patients (99%; n=346/349). At 24 weeks, 4 patients failed to achieve SVR: 2 patients relapsed at post-treatment Week 4; 1 patients with HCV GT1b was newly infected after achieving SVR12 with GT2a infection; and 1 patient withdrew consent on Day 2 of treatment, for an overall relapse rate of 0.6%.

Study authors reported all treatment-experienced patients with cirrhosis achieved SVR12. NS5A RAVs were detected at the time of relapse but no NS5B RAVs were detected.

Among the 31 patients who had failed prior NS3/4A protease inhibitors—boceprevir (n=12), telaprevir (n=4), simeprevir (n=7), vaniprevir (n=6), and faldaprevir (n=2)—all achieved SVR12 after treatment with ledipasvir/sofosbuvir for 12 weeks.

Overall, single-tablet ledipasvir/sofosbuvir led to high efficacy rates and was well tolerated in Asian patients with chronic HCV GT1 infection, Dr. Mizokami concluded, adding, "including those with cirrhosis or who had failed prior NS3/4A protease inhibitor-containing regimens.” 

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