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Cited by 688

The DOI matches its Crossref record; 45 of the 45 references it cites were found in a registry or an index.

Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review

Open access
Falade-Nwulia, Oluwaseun, Suarez-Cuervo, Catalina, Nelson, David R., Fried, Michael W., Segal, Jodi B., Sulkowski, Mark S.·2017·Annals of Internal Medicine
DOI 10.7326/m16-2575
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Abstract

BACKGROUND: Rapid improvements in hepatitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chronic HCV infection. PURPOSE: To summarize published literature on the efficacy and safety of oral DAAs for treatment of persons with chronic HCV infection. DATA SOURCES: MEDLINE and EMBASE from inception through 1 November 2016. STUDY SELECTION: 42 English-language studies from controlled and single-group registered clinical trials of adults with HCV infection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included at least 2 DAAs. DATA EXTRACTION: Two investigators abstracted data on study design, patient characteristics, and virologic and safety outcomes sequentially and assessed quality independently. DATA SYNTHESIS: Six DAA regimens showed high sustained virologic response (SVR) rates (>95%) in patients with HCV genotype 1 infection without cirrhosis, including those with HIV co-infection. Effective treatments for HCV genotype 3 infection are limited (2 DAA regimens). Patients with hepatic decompensation, particularly those with Child-Turcotte-Pugh class C disease, had lower SVR rates (78% to 87%) than other populations. The addition of ribavirin was associated with increased SVR rates for certain DAA regimens and patient groups. Overall rates of serious adverse events and treatment discontinuation were low (<10% in the general population); regimens that included ribavirin had more mild or moderate adverse events than those without. LIMITATIONS: Twenty-three studies had moderate risk of bias (10 were open-label single-group trials, 11 had limited information on concealment of the allocation scheme, and 5 had selective outcome reporting). All but 1 of the studies were industry-funded. Heterogeneity of interventions precluded pooling. CONCLUSION: Multiple oral DAA regimens show high rates of safety, tolerability, and efficacy for treatment of HCV genotype 1 infection, particularly among persons without cirrhosis. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42014009711).

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Metadata

Authors
Falade-Nwulia, O., Suarez-Cuervo, C., Nelson, D. R., Fried, M. W., Segal, J. B., & Sulkowski, M. S.
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2017-05-02
Volume
166
Issue
9
Pages
637-648
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/m16-2575
OpenAlex
W2602169852
Cited by
688
References
45
FWCI
48.05
Type
journal article
Language
en
Open access
green

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