Simeprevir plus pegylated interferon and ribavirin was associated with an 80% sustained virologic response rate at 12 weeks among previously untreated patients with hepatitis C virus (HCV) and HIV coinfection, results from the phase 3, open-label, single-arm, international study indicate.
Douglas Dieterich, MD, of Mount Sinai Medical Center in New York, presented the data during the 2014 Conference on Retroviruses and Opportunistic Infections.
The study cohort included 106 patients without liver cirrhosis, who had HCV genotype 1a (n=88) or 1b (n=18) infection. Patients were categorized according to previous treatment history. Fifty-three patients were treatment-naïve; 28 patients were nullresponders; disease relapsed in 15 patients; and 15 were partial responders.
Patients who were treatment-naive and those who previously relapsed were assigned to 12 weeks of treatment with simeprevir (Olysio, Janssen), and 24 or 48 weeks of pegylated interferon and ribavirin. Partial, null responders and those with cirrhosis were assigned to 48 weeks of interferon treatment.
The primary outcome measure was the proportion of patients who achieved a sustained virological response 12 weeks after completing treatment (SVR12) vs. data from a historical control group pooled from the APRICOT study of pegylated interferon and ribavirin treatment in people with HIV and HCV co-infection.
The overall SVR12 rate in the current study was 74%. Compared with 29% of treatment-naïve controls treated with pegylated interferon and ribavirin in the APRICOT study, 79% of treatment-naïve patients in the current study achieved SVR12 (P<0.001).
When compared with only 5% of null-responders in the control group, SVR12 was achieved in 87% of those who relapsed, in 70% of partial responders and 57% of null responders.
Results from a set of sub-analyses indicated 89% of patients with genotype 1b infection achieved SVR12 vs. 71% of those with genotype 1a. No significant difference in treatment response was observed among those with genotype 1a, as according to Q80K mutation presence (67% with mutation vs. 72% without mutation).
“One of things we found in several analyses we have done is that being HIV-positive seems to be a positive predictive value for success in treatment,” Dieterich said. “Despite the negative demographics, the only thing we could conclude was that HIV-positive patients take their medications and this may be an adherence issue — although I certainly don’t know for sure,” Dieterich said.
Disclosure: Dieterich reports no disclosures.