Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis

Abstract

Background and aims Limited data is available on the efficacy of direct acting anti-viral drugs on hepatitis C in drug users. The aim of this meta-analysis was to comprehensively analyze the efficacy and safety of LDV/SOF in drug users infected with the hepatitis C virus (HCV). Methods The PubMed, Cochrane library, Embase and Web of Science databases were searched for articles published till April 2021 on HCV-positive drug users who were treated with ledipasvir/sofosbuvir (LDV/SOF). The primary endpoint was pooled sustained virological response at 12 weeks (SVR12) with 95% confidence interval (95% CI). Funnel plots and Egger’s test were used to assess the publication bias. Results A total of 12 studies and 711 subjects treated with LDV/SOF-based regimen for HCV were included, and the pooled SVR12 rate was 89.8% (95% CI 85.9–92.7). The pooled SVR12 rate of genotype 1 drug users was 92.4% (95% CI 88.6–95.0). Subgroup analysis showed that pooled SVR12 rates of patients treated with LDV/SOF and LDV/SOF ± RBV were 89.2% (95% CI 83.4–93.1), 90.4% (95% CI 83.6–94.5) respectively. In addition, the SVR12 rates were 88% (95% CI 70.7–95.7) for 8 weeks, 89.9% (95% CI 81.0–94.9) for 12 weeks and 82.2% (95% CI 24.9–98.5) for 24 weeks of treatment. Conclusion LDV/SOF is a safe and relatively effective treatment for hepatitis C in drug users.

Excellent hepatitis C virus cure rates despite increasing complexity of people who use drugs: Integrated‐Test‐stage Treat study final outcomes

“…Despite the cohort becoming increasingly complex over the last 8 years, our SVR12 rates (86%) and treatment adherence (91%) are consistent with two recent meta‐analyses 5,25 . As previously reported in PWUD, 25 there were very few true virological failures (26% of all non‐SVRs) in our study.…”

“…Those currently undiagnosed are likely to represent the hardest to reach PWUD, necessitating innovative strategies for linkage to care. The importance of developing decentralised models of care for PWUD cannot be overemphasised, especially since excellent HCV cure rates can be achieved (~90%) 5 with an ~80% reduction in all-cause, liver and drug-related mortality. 6 Though the advent of direct-acting antivirals (DAA) 7 has revolutionised HCV management and led to the WHO mandate to eliminate HCV by 2030, 8 this will not be possible without moving away from the traditional hospital-based delivery of HCV care.…”

“…Those currently undiagnosed are likely to represent the hardest to reach PWUD, necessitating innovative strategies for linkage to care. The importance of developing decentralised models of care for PWUD cannot be overemphasised, especially since excellent HCV cure rates can be achieved (~90%) 5 with an ~80% reduction in all‐cause, liver and drug‐related mortality 6 …”

Towards hepatitis C elimination in France: Scanvir, an effective model to test and treat drug users on dedicated days

“…Pangenotypic regimens, sofosbuvir/velpatasvir or glecaprevir/ pibrentasvir, led to a new paradigm ('treat to screen') in the management of difficult-to-treat populations such as PWIDs. These treatments require minimal data before their initiation, have an excellent tolerance, a response rate greater than 95% 11,[25][26][27][28][29] and very few drug-to-drug interactions including OSTs. 30,31 All our PWIDs who began a brief treatment course of 8-12 weeks remained compliant especially thanks to the work of the addictology nurses.…”

Hepatitis C virus micro‐elimination in people who inject drugs: Challenges and chance in Taiwan and worldwide

“…28,29 A meta-analysis including a total of 12 studies and 711 PWID treated with a ledipasvir/sofosbuvir (LDV/SOF)-based regimen reported that the pooled SVR rate was 89.8%. 30 The safety and efficacy of GLE/PIB in PWID receiving OST are shown in pooled data from eight trials. No significant difference was found in the SVR rate between patients receiving OST (96.2%, 151/157) and those not receiving OST (97.9%, 2055/2099).…”