Safety and efficacy of sofosbuvir plus ledipasvir with and without ribavirin for chronic HCV genotype-1 infection: a systematic review and meta-analysis.

BACKGROUND:

Ledipasvir and sofosbuvir are new direct-acting antiviral for patients with hepatitis C virus (HCV) infection. Ledipasvir inhibits the hepatitis C virus non-structural 5A protein, while sofosbuvir is a nucleotide polymerase inhibitor. Many studies evaluated the safety and efficacy of ledipasvir and sofosbuvir combination with and without Ribavirin for patients with chronic HCV genotype 1.

METHODS:

A computer literature search of PubMed, SCOPUS, Web of knowledge, and Cochrane CENTRAL has been conducted. Studies were screened for eligibility and data were extracted. Sustained Virologic Response (SVR) rate and commonly reported adverse events were pooled as risk ratio (RR) using Review Manager Version 5.3 for windows and OpenMeta [Analyst] software.

RESULTS:

Eight randomized controlled trials (n=1892) were pooled in the final analysis. Twelve week ledipasvir and sofosbuvir regimen achieved SVR of 97.5% and 89% in non-cirrhotic and cirrhotic patients respectively. Twenty-four week ledipasvir and sofosbuvir regimen achieved SVR of 99.6% and 92.6% in non-cirrhotic and cirrhotic patients respectively. When Ribavirin was added to the treatment regiment, the SVR did not differ significantly in either of the treatment regiments (12 week

SVR:

93.9% vs. 96.7%, RR=0.97, P=0.19, and 24 week

SVR:

94.8% vs. 97.2%, RR= 0.98, P=0.24).

CONCLUSIONS:

The combination of Sofosbuvir and Ledipasvir achieved high SVR (>90%) in both cirrhotic and non-cirrhotic patients with HCV genotype 1. The addition of Ribavirin to this regimen did not significantly increase the SVR.