Similar Sustained Virologic Response in Real-World and Clinical Trial Studies of Hepatitis C/Human Immunodeficiency Virus Coinfection
Clinical trials evaluating efficacy of direct-acting antiviral (DAA) therapies demonstrate sustained virologic response (SVR) rates greater than 90% in patients infected with hepatitis C (HCV) and human immunodeficiency virus (HIV). However, generalizability of this data to real-world coinfected populations is unknown.
We aim to compare efficacy data from clinical trials to effectiveness data of real-world observational studies that evaluate oral interferon-free HCV treatment regimens in patients infected with HIV and HCV.
We included English-language studies on PubMed and MEDLINE databases from inception until October 2017. Eight clinical trials and 11 observational studies reporting on efficacy data and effectiveness data, respectively, of interferon-free oral DAA regimens in HCV/HIV coinfected patients, were included.
Of patients in the eight clinical trials evaluated, 93.1% (1218/1308) achieved SVR12; of the 11 real-world observational studies, 90.8% (2269/2499) achieved SVR12. Relative risk between those treated in clinical trials versus observational studies was 0.98. Patients with genotype 1 infection, African-American patients, cirrhotic patients, and patients with prior HCV treatment experience had similar rates of SVR in real-world and clinical trial cohorts.
SVR among real-world HCV/HIV coinfected populations treated with DAA regimens is similar to SVR of patients studied in clinical trials. Historically negative predictors of achieving SVR during the era of interferon-based treatments, such as those with cirrhosis, prior HCV treatment failure, GT1 infection, and African-American race, are not associated with a significantly lower SVR in real-world populations treated with various DAA regimens.
KeywordsHepatitis C HIV Coinfection Sustained virologic response
Study concept and design (CS, SS); acquisition of data (CS, LN); analysis and interpretation of data (CS); drafting of the manuscript (CS, LN); critical revision of the manuscript for important intellectual content (SS); statistical analysis (not applicable; administrative, technical, or material support; study supervision (SS).
Compliance with ethical standards
Conflict of interest
The authors of this manuscript have no conflicts of interest to disclose.
- 12.Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. London The Cochrane Collaboration 2011.Google Scholar
- 13.Sterne J, Higgins JPT, Reeves B. Development Group for ROBINS-I. A tool for assessing Risk of Bias in Non-randomized Studies of Interventions. Version 5. 2016. www.riskofbias.info. Accessed August 3, 2016.
- 17.Sulkowski M, Hezode C, Gerstoft J, et al. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/ hepatitis C virus co-infection (C-WORTHY): a randomized, open label phase 2 trial. Lancet. 2015;385:1087–1097.CrossRefGoogle Scholar
- 24.Falade-Nwulia O, Sutcliffe C, Moon J, Chander G, Wansom T, Keruly J, et al. High hepatitis C cure rates among black and nonblack human immunodeficiency virus-infected adults in an urban center. High hepatitis C cure rates among black and nonblack human immunodeficiency virus-infected adults in an urban center. Hepatology. 2017 Jun 13. https://doi.org/10.1002/hep.29308. (Epub ahead of print).CrossRefGoogle Scholar