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Clin Infect Dis. 2016 Jun 15;62(12):1497-1504. doi: 10.1093/cid/ciw119. Epub 2016 Mar 1.

Real-World Sustained Virologic Response Rates of Sofosbuvir-Containing Regimens in Patients Coinfected With Hepatitis C and HIV.

Author information

1
Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai.
2
Department of Pharmacotherapy, Brooklyn Hospital Center.
3
Division of Liver Diseases.
4
Department of Medicine, Icahn School of Medicine at Mount Sinai.
5
Faculty Practice Associates, Mount Sinai Hospital.
6
Division of Infectious Diseases, Brooklyn Hospital Center.
7
Division of Liver Diseases, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York City, New York.

Abstract

BACKGROUND:

Patients with hepatitis C virus (HCV) with or without human immunodeficiency virus (HIV) achieve high sustained virological response (SVR) rates on sofosbuvir (SOF)-containing regimens in clinical trials. Real world data on patients coinfected with HCV and HIV treated with SOF-based regimens are lacking.

METHODS:

This observational cohort study included HIV/HCV-coinfected adults with genotype 1 HCV who initiated treatment with a SOF-containing regimen between December 2013 and December 2014 (n = 89) at the Mount Sinai Hospital or the Brooklyn Hospital Center. The primary outcome was SVR at 12 weeks after the end of treatment. The secondary outcomes were risk factors for treatment failure, serious adverse events, and side effects. A post hoc per protocol analysis of SVR was performed on patients who completed treatment and follow-up.

RESULTS:

In an intention-to-treat analysis, SVR rates were 76% (31/41) for simeprevir (SMV)/SOF, 94% (16/17) for SMV/SOF/ribavirin (RBV), and 52% (16/31) for SOF/RBV. The SVR rates of SMV/SOF/RBV and SMV/SOF did not differ significantly in this small study (P = .15). However the SVR rate of SMV/SOF/RBV was higher than that of SOF/RBV (P < .01). In a per protocol analysis, SMV/SOF/RBV had a higher SVR rate than SOF/RBV: 100% (16/16) vs 57% (16/28) (P < .01). The most commonly reported adverse effects were rash, pruritus, fatigue, and insomnia. One patient who had decompensated cirrhosis prior to treatment initiation died after receiving SMV/SOF.

CONCLUSIONS:

SMV/SOF ± RBV is an effective option with minimal adverse effects for most HIV-positive patients with genotype 1 HCV. SMV should be used with caution in patients with decompensated cirrhosis.

KEYWORDS:

HIV; hepatitis C; simeprevir; sofosbuvir

PMID:
26936665
PMCID:
PMC4885645
DOI:
10.1093/cid/ciw119
[Indexed for MEDLINE]
Free PMC Article

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