Format

Send to

Choose Destination
Clin Infect Dis. 2014 Dec 1;59(11):1579-87. doi: 10.1093/cid/ciu675. Epub 2014 Sep 5.

Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study.

Author information

1
Icahn School of Medicine at Mount Sinai, New York, New York.
2
Medizinische Universitätsklinik I-Immunologische Ambulanz, Bonn, Germany.
3
Royal London Hospital, United Kingdom.
4
Hospital General de Elche and Universidad Miguel Hernández, Alicante, Spain.
5
McGill University Health Centre, Montreal, Canada.
6
Centre Hospitalier Universitaire Gui De Chauliac, Montpellier, France.
7
Janssen Global Services, Titusville.
8
Janssen Research and Development, Raritan, New Jersey.
9
Janssen Infectious Diseases BVBA.
10
Janssen Research and Development, Beerse, Belgium.

Abstract

BACKGROUND:

Simeprevir is an oral, once-daily, hepatitis C virus (HCV) NS3/4A protease inhibitor for the treatment of chronic HCV genotype 1 infection. Human immunodeficiency virus (HIV) coinfection accelerates progression of liver disease. This uncontrolled, open-label trial explored the safety and efficacy of simeprevir in patients with HCV genotype 1/HIV type 1 (HIV-1) coinfection.

METHODS:

Patients received simeprevir (150 mg once daily) with pegylated interferon alfa-2a/ribavirin (peg-IFN/RBV) for 12 weeks. Noncirrhotic HCV treatment-naive patients and prior relapsers received response-guided therapy (RGT) with peg-IFN/RBV for 24 or 48 weeks. Prior null responders, prior partial responders, and patients with cirrhosis received peg-IFN/RBV for 48 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12).

RESULTS:

One hundred and six patients (93 on antiretroviral therapy) were enrolled and treated. SVR12 rates were 79.2% in HCV treatment-naive patients, 57.1% in prior null responders, 86.7% in prior relapsers, and 70.0% in prior partial responders. Fifty-four of 61 eligible patients (88.5%) met RGT criteria for 24 weeks of peg-IFN/RBV, of whom 87.0% (47/54) achieved SVR12. SVR12 rates were 80.0% (36/45) and 63.6% (14/22) for patients with METAVIR scores of F0-F2 and F3-F4, respectively. Common adverse event (AE) rates were consistent with peg-IFN/RBV therapy (fatigue, headache, nausea, neutropenia). Most AEs were grade 1/2; serious AEs occurred in 5.7% of patients, none of which were fatal.

CONCLUSIONS:

Simeprevir was generally well tolerated with safety similar to that observed in HCV-monoinfected patients and high SVR12 rates in HCV treatment-naive patients, prior relapsers, prior partial responders, and prior null responders with HIV-1 coinfection.

CLINICAL TRIALS REGISTRATION:

NCT01479868.

KEYWORDS:

coinfection; hepatitis C virus; human immunodeficiency virus type 1; simeprevir

PMID:
25192745
DOI:
10.1093/cid/ciu675
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center