The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis

Abstract

Background. The recommended therapy for patients with chronic hepatitis C (CHC), genotype 1, who have cirrhosis and have failed prior therapy is 12 weeks of sofosbuvir (SOF), ledipasvir (LDV), and ribavirin (RBV). This recommendation is based on expert opinion, and the efficacy of 12 weeks of SOF/LDV compared to SOF/LDV/RBV in this patient population has not yet been established. Methods. We conducted a systematic review and meta-analysis. Two investigators independently searched electronic databases and relevant conference proceedings for randomized controlled trials comparing rates of sustained virologic response 12 weeks after therapy (SVR12) when using 12 weeks of SOF/LDV versus 12 weeks of SOF/LDV/RBV in patients with CHC, genotype 1, who have cirrhosis and failed previous therapy. Results. Our search strategy yielded 596 studies of which four met criteria for inclusion. The pooled RR of not achieving SVR12 with SOF/LDV versus SOF/LDV/RBV was 1.21 (95% CI: 0.42–3.48). Adverse events were lower in the SOF/LDV compared to the SOF/LDV/RBV arms (pooled RR: 0.11, 95% CI: 0.04–0.29). Conclusions. Our findings suggest that 12 weeks of SOF/LDV cannot be considered noninferior to 12 weeks of SOF/LDV/RBV to achieve SVR12 in patients with CHC who have cirrhosis and failed prior therapy.

Sofosbuvir/Velpatasvir - A Promising Treatment for Chronic Hepatitis C Virus Infection

“…Patients who got SOF/LDV/RBV experienced considerably more adverse events than those who only received SOF/LDV [28]. When comparing LDV/SOF vs. LDV/SOF/RBV, the pooled relative risk of any adverse event (AE) was 0.11 (95% CI: 0.04-0.29) [28]. There were differences in adverse effects linked with ribavirin, such as fatigue/asthenia, rash, irritability, cough/bronchitis, and anemia [28].…”

“…Stokes et al conducted a systemic review and meta-analysis studying the side effects of sofosbuvir/ledipasvir/ribavirin (SOF/LDV/RBV) and sofosbuvir/ledipasvir (SOF/LDV) in 1179 patients with chronic HCV genotype 1 (GT1) [28]. Patients who got SOF/LDV/RBV experienced considerably more adverse events than those who only received SOF/LDV [28]. When comparing LDV/SOF vs. LDV/SOF/RBV, the pooled relative risk of any adverse event (AE) was 0.11 (95% CI: 0.04-0.29) [28].…”

“…When comparing LDV/SOF vs. LDV/SOF/RBV, the pooled relative risk of any adverse event (AE) was 0.11 (95% CI: 0.04-0.29) [28]. There were differences in adverse effects linked with ribavirin, such as fatigue/asthenia, rash, irritability, cough/bronchitis, and anemia [28]. There were four serious adverse events linked to study therapy, all of which occurred in the SOF/LDV/RBV groups.…”

“…There were four serious adverse events linked to study therapy, all of which occurred in the SOF/LDV/RBV groups. Hemolytic anemia, nonfatal myocardial infarction, morbilliform rash, and cardiac arrest were among the complications [28].…”

Consensus on management of hepatitis C virus infection in resource-limited Ukraine and Commonwealth of Independent States regions

“…The use of a ribavirin-free sofosbuvir and ledipasvir combination regimen has been found to be associated with a significant improvement in the quality of life in HCV GT1-infected patients, regardless of the treatment history or the presence of cirrhosis or HIV co-infection[75-78]. An increase in toxicity has been noted with the inclusion of ribavirin in the treatment regimen[75,79].…”