Telaprevir for chronic Hepatitis C virus genotype 1 infection in patients with HIV

Telaprevir for chronic Hepatitis C virus genotype 1 infection in patients with HIV

The latest issue of the Annals of Internal Medicine evaluates combination therapy with telaprevir for chronic Hepatitis C virus genotype 1 infection in patients with HIV.

Telaprevir plus peginterferon-α2a (PEG-IFN-α2a) and ribavirin substantially increases treatment efficacy for genotype 1 chronic hepatitis C virus (HCV) infection versus PEG-IFN-α2a–ribavirin alone.

Its safety and efficacy in patients with HCV and HIV-1 are unknown.

Dr Sulkowski and colleagues examined the safety and efficacy of telaprevir plus PEG-IFN-α2a–ribavirin in patients with genotype 1 HCV and HIV-1.

The team evaluated the pharmacokinetics of telaprevir, and antiretrovirals during coadministration.

The researchers performed a randomized, double-blind, placebo-controlled study in 16 international multicenter sites.

The team randomly assigned 62 patients with HCV genotype 1 and HIV-1 who were HCV treatment–naive and receiving 0 or 1 of 2 antiretroviral regimens to telaprevir plus PEG-IFN-α2a–ribavirin or placebo plus PEG-IFN-α2a–ribavirin for 12 weeks, plus 36 weeks of PEG-IFN-α2a–ribavirin.

The research team measured HCV RNA concentrations.

Pruritus, headache, nausea, rash, and dizziness were higher with telaprevir plus PEG-IFN-α2a–ribavirin during the first 12 weeks.

During this period, serious adverse events occurred in 5% of those receiving telaprevir plus PEG-IFN-α2a–ribavirin, and 0% of those receiving placebo plus PEG-IFN-α2a–ribavirin.

The same number in both groups discontinued treatment due to adverse events.

Sustained virologic response occurred in 74% of patients receiving telaprevir plus PEG-IFN-α2a–ribavirin, and 45% of patients receiving placebo plus PEG-IFN-α2a–ribavirin.

Rapid HCV suppression was seen with telaprevir plus PEG-IFN-α2a–ribavirin.

The team observed that 2 patients had on-treatment HCV breakthrough with telaprevir-resistant variants.

Patients treated with antiretroviral drugs had no HIV breakthroughs, antiretroviral exposure was not substantially modified by telaprevir.

Dr Sulkowski's team concludes, "In patients with HCV and HIV-1, more adverse events occurred with telaprevir versus placebo plus PEG-IFN-α2a–ribavirin."

"These were similar in nature and severity to those in patients with HCV treated with telaprevir."

"With or without concomitant antiretrovirals, sustained virologic response rates were higher in patients treated with telaprevir versus placebo plus PEG-IFN-α2a–ribavirin."

Annals of Internal Medicine 2013; 159(2): 86-96
18 July 2013