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
. 2023 Feb 28;11(1):144-155.
doi: 10.14218/JCTH.2022.00006. Epub 2022 Jun 28.

Efficacy and Safety of Sofosbuvir-based Regimens in Hepatitis C Patients With Decompensated Cirrhosis: A Systematic Review and Meta-analysis

Wenyan Zhang  1 , Jing Zhang  1 , Shan Tang  1 , Yali Liu  1 , Xiaofei Du  1 , Lixia Qiu  1 , Menglu Liu  1 , Haibin Yu  1 , Calvin Q Pan  2
Affiliations

Efficacy and Safety of Sofosbuvir-based Regimens in Hepatitis C Patients With Decompensated Cirrhosis: A Systematic Review and Meta-analysis

Wenyan Zhang et al. J Clin Transl Hepatol. .

Abstract

Background and aims: Decompensated cirrhotic patients with hepatitis C (HCV) are often under-represented in clinical trials. We aimed to evaluate pooled data on the efficacy and safety of sofosbuvir (SOF)-based regimens in these patients.

Methods: We conducted a systemic review and meta-analysis by searching multiple databases for studies published from October 2010 to October 2020. Outcomes of interest were sustained virologic response (SVR) and safety of SOF-based regimens in decompensated HCV patients. Two reviewers independently performed the study selection and data extraction.

Results: We included 33 studies that enrolled 5,302 HCV patients. The pooled SVR rate in decompensated patients with SOF-based regimens was 85.1% (95% CI: 82.8-87.3). Patients on SOF/velpatasvir±ribavirin achieved a significantly higher SVR (91.0%, 95% CI: 87.7-93.9) than that of SOF/ledipasvir±ribavirin [(86.3%, 95% CI: 84.6-87.8); p=0.004)], or on SOF/daclatasvir±ribavirin (82.4%, 95% CI: 78.2-86.2%; p<0.001). Adding ribavirin to SOF-based regimens (pooled SVR 84.9%, 95% CI: 81.7-87.9) did not significantly increase the SVR [(83.8% (95% CI: 76.8-89.8%; p=0.76)] in decompensated patients, which was also true in subgroup analyses for each regimen within the same treatment duration. However, adding ribavirin significantly increased the frequency of adverse events from 52.9% (95% CI: 28.0-77.1) to 89.2% (95% CI: 68.1-99.9) and frequency of severe events. The pooled incidence of hepatocellular carcinoma and case-fatality of decompensated patients were 3.1% (95% CI: 1.5-5.0) and 4.6% (95% CI: 3.1-6.3), respectively. The overall heterogeneity was high. There was no publication bias.

Conclusions: The analysis found that 12 weeks of SOF/velpatasvir without ribavirin is the preferred therapy, with a significantly higher SVR compared with other SOF-based regimens in decompensated HCV patients.

Keywords: Direct-acting antiviral; HCV liver failure; Ribavirin; Sustained virologic response.

PubMed Disclaimer

Conflict of interest statement

CQP is a speaker and consultant for Gilead Sciences. He also received a research grant from Gilead Sciences and Assembly Biosciences. The other authors have no conflict of interests related to this publication.

Figures

Fig. 1
Fig. 1. Flow diagram of study selection.
Fig. 2
Fig. 2. Forest plots of SVR12 rates of all hepatitis C patients with cirrhosis.
The dotted vertical line and the diamond show the summary effect (random-effect model); outer edges show the 95% confidence intervals (CIs). SVR, sustained virologic response.
Fig. 3
Fig. 3. Treatment outcomes of patients with compensated versus decompensated cirrhosis.
Horizontal bars are 95% confidence intervals (CIs) The box size indicates relative sample size. Two-tailed p-values <0.05 are significant (meta-regression).
Fig. 4
Fig. 4. SVR12 rates of patients with decompensated cirrhosis on different regimens.
Horizontal bars are 95% confidence intervals (CIs); box size indicates relative sample size. (n=36). Two-tailed p-values <0.05 are significant (meta-regression).
Fig. 5
Fig. 5. Outcomes of decompensated patients treated with and without RBV.
Horizontal bars are 95% confidence intervals (CIs); box size indicates relative sample size. (n=36). Two-tailed p-values <0.05 are significant (meta-regression).
Fig. 6
Fig. 6. Pooled safety results of patients with decompensated cirrhosis.
Dotted vertical line and diamond show the summary effect (random-effect model); outer edge shows 95% confidence intervals (CIs). AEs, adverse reactions; SAEs, serious adverse reactions; HCC, hepatocellular carcinoma.
Fig. 7
Fig. 7. Safety profiles for decompensated patients treated with and without RBV.
Horizontal bars are 95% confidence intervals (CIs); box size indicates relative sample size. (n=36). Two-tailed p-values <0.05 are significant (meta-regression).
Fig. 8
Fig. 8. Safety profiles for decompensated and compensated patients treated with and without RBV.
Horizontal bars are 95% confidence intervals (CIs); box size indicates relative sample size. (n=36). Two-tailed p-values <0.05 are significant (meta-regression).
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Polaris Observatory HCV Collaborators Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2(3):161–176. doi: 10.1016/S2468-1253(16)30181-9. - DOI - PubMed
    1. Messina JP, Humphreys I, Flaxman A, Brown A, Cooke GS, Pybus OG, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61(1):77–87. doi: 10.1002/hep.27259. - DOI - PMC - PubMed
    1. de Oliveria Andrade LJ, D’Oliveira A, Melo RC, De Souza EC, Costa Silva CA, Paraná R. Association between hepatitis C and hepatocellular carcinoma. J Glob Infect Dis. 2009;1(1):33–37. doi: 10.4103/0974-777X.52979. - DOI - PMC - PubMed
    1. Wang X, Fan X, Deng H, Zhang X, Zhang K, Li N, et al. Efficacy and safety of glecaprevir/pibrentasvir for chronic hepatitis C virus genotypes 1-6 infection: A systematic review and meta-analysis. Int J Antimicrob Agents. 2019;54(6):780–789. doi: 10.1016/j.ijantimicag.2019.07.005. - DOI - PubMed
    1. Kamal-Yanni M. Hepatitis C drug affordability. Lancet Glob Health. 2015;3(2):e73–e74. doi: 10.1016/S2214-109X(14)70365-1. - DOI - PubMed