Drug & Device Development

Adding telaprevir shortens HCV treatment for many

Last Updated: 2011-02-24 16:40:11 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Adding telaprevir to interferon alfa and ribavirin shortens primary treatment for hepatitis C virus (HCV) type 1, no matter whether telaprevir is given two or three times a day, a multicenter study shows.

More than 80% of patients in the study had a sustained virologic response regardless of telaprevir dosing regimen.

The type of interferon used-alfa-2a or alfa-2b-also didn't seem to affect treatment success. More than two-thirds of patients required only 24 weeks of treatment, compared to the standard 48 weeks, according to a paper in the February Gastroenterology.

Forty-eight weeks of treatment with either type of interferon alfa plus ribavirin will produce a sustained virologic response in 40% to 50% of patients with HCV genotype 1, Dr. Patrick Marcellin of the Hopital Beaujon in Clichy, France and colleagues write.

They defined a sustained virologic response as undetectable HCV levels 24 weeks after the end of treatment.

To date, they add, studies have looked at telaprevir combined with peginterferon alfa-2a plus ribavirin -- but not with peginterferon alfa-2b. To investigate whether one type might be more effective than the other, and also to identify the optimum dosing schedule for telaprevir, the researchers assigned 161 patients to open-label telaprevir at either dosing schedule (every 8 or every 12 hours), plus interferon alfa-2a or alfa-2b, plus ribavirin, for 12 weeks. Patients then had 12 or 36 weeks more of triple therapy, depending on their virologic response.

Across the groups, sustained viral response rates were 81% to 85%.

Sixty-eight percent of the patients had only 24 weeks of therapy. An intent-to-treat analysis found no difference in sustained virological response between the telaprevir groups when they were pooled by dosing schedule, nor were there any differences between the study participants given peginterferon alfa-2a or peginterferon alfa-2b.

The study is the first to compare the two interferon types when used with the same protease inhibitor, Dr. Marcellin and his team note.

In previous trials, telaprevir led to lower rates of sustained virologic response. In the current study, the authors say, "improved management of adverse events, which included the option to continue on peginterferon alfa/ribavirin despite premature discontinuation of telaprevir, might have led to the high treatment completion (80%) and trial completion (93%) rates, improved SVR rate, and low relapse rate (6%)."

They admit that the study was small and open-label, and it excluded cirrhosis patients and other harder-to-treat individuals. But still, they say, it "provides important, clinically relevant insights."

In particular, the authors write, their findings "show the potential utility of a response-guided therapy approach, enabling eligible patients to benefit from a shorter overall duration of treatment (24 weeks) compared with current therapy with 48 weeks of peginterferon/ribavirin."

The study was funded by Janssen Pharmaceuticals and Vertex Pharmaceuticals.

SOURCE: http://bit.ly/ebU9oX

Gastroenterology 2011.