By Michael Smith, North American Correspondent, MedPage Today
Published: November 12, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
SAN FRANCISCO -- In patients with both HIV and hepatitis C virus, response rates to a direct-acting agent that targets the liver virus were high, a researcher said here.
In an interim analysis of a randomized controlled trial, treatment with the protease inhibitor telaprevir (Incivek), combined with standard therapy, led to 24-week response rates of 71%, according to Kenneth Sherman, MD, of the University of Cincinnati College of Medicine.
In contrast, 55% of patients getting standard treatment alone had undetectable hepatitis C virus after 24 weeks, Sherman reported at the annual meeting of the American Association for the Study of Liver Diseases.
The study is the second to report encouraging results in coinfected patients when standard therapy is combined with a direct-acting agent. In October, researchers reported that boceprevir (Victrelis), the other approved direct-acting agent, yielded a 24-week response rate of 70.5%.
Sherman told MedPage Today that it's important to remember that the findings are interim results from a phase II study. Still, "the response rates are excellent (and) there are no surprises in the adverse event profile."
Indeed, the 24-week sustained virologic response rate -- defined as undetectable hepatitis C after 24 weeks of treatment -- is similar to the rate seen when telaprevir used in patients who only have the liver virus, he said.
Importantly, the researchers saw no adverse effect on HIV control, he said.
The 60 patients were randomly assigned to receive 12 weeks of standard therapy with pegylated interferon-alfa and ribavirin, or to receive the same treatment with the addition of telaprevir. In either case, the initial 12 weeks was to be followed by a further 36 weeks on peginterferon and ribavirin alone.
The patients, all with the difficult to treat genotype 1 hepatitis C virus, were also stratified by their anti-HIV regimen into three groups:
• No therapy
• Efavirenz-based triple therapy
• -based triple therapy
Sherman said the 24-week responses were similar in all three groups, ranging from 86% to 67%.
The study allowed the use of efavirenz (Sustiva), although the dose of telaprevir had to be boosted to compensate, Sherman said. In contrast, patients in the boceprevir study could not use an efavirenz-based regimen during treatment with the drug.
Safety and tolerability was similar to what has been seen in mono-infected patients, Sherman said. Pruritus, headache, nausea, and rash were more commonly reported by telaprevir patients, while insomnia and weight loss were more frequent among those getting standard treatment alone.
The results are "almost a doppelganger" of the earlier trial report concerning boceprevir in coinfected patients, according to Raymond Chung, MD, of Massachusetts General Hospital in Boston, who was not involved in the study.
The responses reported by Sherman are "very encouraging," Chung told MedPage Today in a telephone interview. "There appears to be no adverse effect on HIV control, at least at the 24-week mark," he said.
While there has been concern about drug interactions, especially for patients taking efavirenz, Chung said most people providing HIV care may be preparing coinfection patients by switching their regimens in advance of hepatitis treatment.
"Remember, this is a short-term switch," he said.
While the results with telaprevir are interim, he said, "it wouldn't be straining to imagine" sustained virologic response rates of 55% in coinfected patients, taking relapses into account. "That would be a real advance," Chung said.
The study was sponsored by Vertex Pharmaceuticals. Sherman reported financial links with the company and with Bristol-Myers Squibb, Tibotec, Merck, Johnson & Johnson, Baxter, Regulus, GSK, SciClone, Boehringer Ingelheim, Merck/Schering Plough, Genentech/Roche, Gilead, and Anadys.
Chung reported financial links with Merck, Gilead, Pfizer, and Romark.
Primary source: Hepatology
Source reference:
Sherman KE, et al "Telaprevir combination with peginterferon alfa - 2a/ribavirin in HCV/HIV coinfected patients: 24-week treatment interim analysis" Hepatology 2011; Abstract LB-8.
Source
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