Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2022 Oct 21;101(42):e31183.
doi: 10.1097/MD.0000000000031183.

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis

Affiliations
Meta-Analysis

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis

Xiao-Dan Ren et al. Medicine (Baltimore). .

Abstract

Introduction: The sofosbuvir-velpatasvir single-tablet regimen (Epclusa) is a newly FDA-approved inhibitor of hepatitis C virus (HCV). This meta-analysis aimed to investigate the safety and efficacy of velpatasvir-sofosbuvir in the treatment of chronic HCV infection.

Methods: A comprehensive literature search of PubMed, Cochrane CENTRAL, EMBASE and Web of Science was conducted. Data from eligible studies were pooled in a fixed-effect meta-analysis model, using Open-Meta and RevMan software's.

Results: Pooled data showed that velpatasvir-sofosbuvir achieved sustained virological response (SVR12) rates of 94.2% (95% CI 90.7-97.7%, P < .001) in 1277 patients. The addition of ribavirin did not significantly increase the SVR12 (RR = 1.03, 95%CI [0.95, 1.11]) in HCV genotype-1 patients and the SVR12 (RR = 1.09, 95%CI [0.86, 1.38]) in HCV genotype-2 patients. However, adding ribavirin significantly increased SVR12 (RR = 1.13, 95% CI [1.04, 1.23]) in genotype-3 patients.

Conclusion: In conclusion, the 12-week regimen of sofosbuvir-velpatasvir was highly effective in HCV patients. Except for genotype-3, adding ribavirin was not associated with significant improvements in SVR12 rates.

PubMed Disclaimer

Conflict of interest statement

The authors have no funding and conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
The PRISMA flow diagram of studies’ screening and selection.
Figure 2.
Figure 2.
Risk of bias summary according to Cochrane risk of the bias assessment tool.
Figure 3.
Figure 3.
Forest plots of pooled proportions of SRV rates for sofosbuvir-velpatasvir in HCV patients.
Figure 4.
Figure 4.
Forest plots of pooled risk ratio comparing sofosbuvir plus velpatasvir with the sofosbuvir-velpatasvir and RBV in terms of SVR 12 rates in different GTs.
Figure 5.
Figure 5.
Forest plots of pooled risk ratio comparing sofosbuvir-velpatasvir with the sofosbuvir-velpatasvir and RBV in terms of virologic failure rates with 95% CI. CI = confidence interval, RBV = ribavirin, RR = risk ratio.
Figure 6.
Figure 6.
Forest plots of pooled risk ratio comparing sofosbuvir plus velpatasvir with the sofosbuvir-velpatasvir and RBV in terms of serious adverse event rates in HCV patients.
Figure 7.
Figure 7.
The distribution of common adverse events of sofosbuvir-velpatasvir in HCV patients.

References

    1. WHO. Progress Report on HIV, Viral Hepatitis and Sexually Transmitted Infections 2019. Accountability for the Global Health Sector Strategies, 2016-2021[R]. Geneva: World Health Organization. 2021.
    1. Saito Y, Imamura M, Uchida T, et al. Ribavirin induces hepatitis C virus genome mutations in chronic hepatitis patients who failed to respond to prior daclatasvir plus asunaprevir therapy. J Med Virol. 2020;92:210–8. - PubMed
    1. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2:161–76. - PubMed
    1. Xu F, Moorman AC, Tong X, et al. All-cause mortality and progression risks to hepatic decompensation and hepatocellular carcinoma in patients infected with hepatitis C virus. Clin Infect Dis. 2016;62:289–97. - PubMed
    1. Bhatia HK, Singh H, Grewal N, et al. Sofosbuvir: a novel treatment option for chronic hepatitis C infection. J Pharmacol Pharmacother. 2014;5:278–84. - PMC - PubMed

Publication types