Safety and efficacy of sofosbuvir plus velpatasvir with or without ribavirin for chronic hepatitis C virus infection: A systematic review and meta-analysis

Abstract

Velpatasvir is a newly FDA-approved inhibitor of hepatitis C virus (HCV) NS5A protein. We performed this systematic review and meta-analysis to investigate the safety and efficacy of velpatasvir plus sofosbuvir in the treatment of chronic HCV infection. A computerized literature search of PubMed, SCOPUS, EMBASE, EBSCO, Web of science, and Cochrane CENTRAL was conducted using relevant keywords. Data from eligible studies were pooled in a fixed effect meta-analysis model, using OpenMeta[Analyst] software. Pooled data from six randomized trials (n=1427 patients) showed that velpatasvir plus sofosbuvir achieved sustained virological response (SVR12) rates of 98.2% in genotype-1, 99.4% in genotype-2, 94.7% in genotype-3, 99.6% in genotype-4, 97.1% in genotype-5, and 98.8% in genotype-6 patients. The addition of ribavirin did not significantly increase the SVR12 (RR=0.95, 95%CI [0.88, 1.02]) or decrease relapse rates (RR=2.52, 95% CI [0.49, 12.87]) in HCV genotype-1 patients. However, adding ribavirin significantly increased SVR12 (RR=89.5, 95% CI [80.4, 99.5]) in genotype-3 patients. In conclusion, the 12-week regimen of sofosbuvir plus velpatasvir was highly effective in HCV patients, including those with cirrhosis and former treatment experience. Except for genotype-3, adding ribavirin was not associated with significant improvements in SVR12 rates. Further studies should investigate the effect of adding ribavirin to this regimen, especially in HCV genotype-3 patients.

Hematological Changes in HCV Patients Treated with Different Sofosbuvir-Based Regimens

“…This is near to what we found in ALLY-3 trial, where 152 treatment-naive and treatment-experienced subjects with HCV genotype 3 infection were treated with dclatasvir in combination with sofosbuvir [12]. The safety and beneficial effects of sofosbuvir not only confined to the combinations we used as with what reported with daclatasvir [13], but also reported in other combinations as with velpatasvir [14], and moreover this safety and beneficial effects have been found in special difficult to treat cases [15] . For patients suffering compensated chronic hepatitis C virus infection and received treatment by regimens containing sofosbuvir combined with interferon or ribavirin or both together, there was a significant decrease in the levels of hemoglobin, total leucocytic count and platelet count before and after treatment.…”

Treatment of hepatitis C: Results in real life

“…Sofosbuvir plus velpatasvir has been shown to be very effective in clinical trials with SVR12 rates of 99.4% in genotype 2 infection . Although no real‐world studies are yet available for this combination and the role of ribavirin remains unclear, a 12‐week regimen is the first line treatment, whatever the stage of fibrosis, for both treatment‐naïve and treatment‐experienced patients with genotype 2 infection.…”

Sofosbuvir: Treatment of Chronic Hepatitis C and the Main Trends in Patent Protection

“…It has showed that the 12-week regimen of -analysis of six randomized trials (n=1427 patients) sofosbuvir plus velpatasvir was highly effective in HCV patients, including those with cirrhosis and former treatment experience. Except for genotype-3, adding ribavirin was not associated with significant improvements in SVR12 rates [39].…”