November 15, 2012
Hep C Protease Inhibitor Incivek Is Safe, Effective for HIV Coinfection
People living with both HIV and the hepatitis C virus (HCV) experience high hepatitis cure rates from an Incivek (telaprevir)–based triple combination therapy, compared with those taking interferon and ribavirin alone, aidsmap reports. Vertex Pharmaceuticals presented the results of its Phase II trial at the annual meeting of the American Association for the Study of Liver Diseases (AALSD) in Boston. The findings echoed and re-affirmed previous results announced at the 2012 Conference on Retroviruses and Opportunistic Infections in March.
The randomized controlled trial examined the effects of Incivek along with pegylated interferon and ribavirin among HCV treatment-naive coinfected people with HCV genotype-1, the most common strain and the most difficult to treat. Divided into two arms, the study examined 13 participants with CD4 counts above 500 who had not yet taken antiretrovirals (ARVs) for HIV, as well as 47 patients on ARVs with a stable viral load. All participants randomly received either Incivek or a placebo along with pegylated interferon and ribavirin for 12 weeks, followed by another 36 weeks of just the peg-interferon plus ribavirin combination.
Across the board, 74 percent of those taking Incivek triple combination therapy maintained a sustained virological response (SVR, considered a cure) 24 weeks after finishing treatment, while only 45 percent of the control group achieved the same. Those not taking antiretrovirals experienced respective SVR rates of 71 and 33 percent. Side effects were elevated among those taking Incivek, with the most notable increased including itching, headache, nausea, skin rash and dizziness. However, the overall safety and tolerability profile of the triple combination therapy proved comparable to previous studies of people living with only hepatitis C.
To read the aidsmap article, click here.
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