Extended therapy with pegylated interferon and weight-based ribavirin for HCV-HIV coinfected patients.

TitleExtended therapy with pegylated interferon and weight-based ribavirin for HCV-HIV coinfected patients.
Publication TypeJournal Article
Year of Publication2012
AuthorsChung RT, Umbleja T, Chen JY, Andersen JW, Butt AA, Sherman KE
Corporate AuthorsActg A5178 Study Team
JournalHIV Clin Trials
Volume13
Issue2
Pagination70-82
Date Published2012 Mar-Apr
ISSN1528-4336
KeywordsAdult, Body Weight, Coinfection, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Hepatitis C, HIV Infections, Humans, Interferon-alpha, Male, Middle Aged, Polyethylene Glycols, Ribavirin, Risk Factors
Abstract

BACKGROUND: It is unknown whether extended treatment with pegylated interferon (PEG) and weight-based ribavirin (WBR) results in higher rates of sustained viro-logic response (SVR) among HCV-HIV coinfected patients compared with standard duration therapy.

OBJECTIVE: The study aimed to measure rates of SVR among coinfected patients who received extended therapy with PEG plus WBR.

METHODS: HCVHIV coinfected subjects were treated with PEG and WBR, and those who achieved early virologic response (EVR; ≥ 2 log decrease in HCV RNA from baseline or HCV RNA<600 IU/mL) at week 12 were eligible to continue treatment for 72 weeks. SVR (HCV RNA<60 IU/mL) was measured 24 weeks after treatment discontinuation. Predictors of SVR were assessed in simple and multivariate logistic regression.

RESULTS: A total of 329 subjects enrolled at 36 sites. Of 184 subjects who achieved EVR, 169 entered Step 3: 89% male, 52% White, 29% Black, and 71% HCV treatment naïve. The overall SVR rate was 27% (95% CI, 22%-32%) among all subjects, and 33% (95% CI, 27%-40%) among the 223 who were HCV treatment naïve. In exploratory analyses, among 120 treatment-naïve subjects who entered Step 3, the SVR rate was 62% (95% CI, 52%-70%). In this subgroup, predictors of SVR were HCV genotype 2 or 3 (P = .03), HCV RNA <800,000 IU/mL at study entry (P = .05), and achievement of complete EVR (HCV RNA<600 IU/mL at week 12;P < .0001).

CONCLUSION: Among all subjects, we observed a comparable overall SVR rate to prior studies of subjects treated for 48 weeks. Extended treatment with PEG and WBR may be beneficial to subsets of coinfected patients, specifically those who are treatment naïve and achieve complete EVR.

DOI10.1310/hct1302-70
Alternate JournalHIV Clin Trials
PubMed ID22510354
PubMed Central IDPMC3367320
Grant ListK24 DK070528 / DK / NIDDK NIH HHS / United States
K24 DK070528 / DK / NIDDK NIH HHS / United States
K24 DK078772 / DK / NIDDK NIH HHS / United States
K24 DK078772 / DK / NIDDK NIH HHS / United States
P30 AI050410 / AI / NIAID NIH HHS / United States
T32 DK007191 / DK / NIDDK NIH HHS / United States
U01 AI038858 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
U01 AI38858 / AI / NIAID NIH HHS / United States