Boceprevir, Telaprevir to Usher in New Era of HCV Therapy

Megan Brooks

April 15, 2011

April 15, 2011 (Baltimore, Maryland) — Clinicians on the front line of managing patients with hepatitis C virus (HCV) infection are likely to look back on 2011 as a banner year.

"The excitement is that, in 2011, we anticipate that the US FDA [Food and Drug Administration] will review and approve 2 hepatitis C protease inhibitors — boceprevir and telaprevir — in combination with peginterferon and ribavirin," Mark S. Sulkowski, MD, from Johns Hopkins University School of Medicine, Baltimore, Maryland, noted in an interview with Medscape Medical News.

Merck and Co is developing boceprevir, and Vertex Pharmaceuticals is developing telaprevir. Both are awaiting approval in the United States.

These 2 drugs will "usher in a new era of direct antiviral therapy that will increase our ability to cure hepatitis C genotype 1," said Dr. Sulkowski, who gave the plenary talk here at the International Conference on Viral Hepatitis (ICVH) 2011 and served as course director for the conference.

The conference is sponsored jointly by the International Association of Physicians in AIDS Care (IAPAC), Johns Hopkins School of Medicine's Office of Continuing Medical Education, and the University of Bonn in Germany.

Decade-Long Dry Spell

There has not been a new HCV medication approved by the FDA since 1998, when the agency approved ribavirin in combination with standard interferon-alfa. In 2001, peginterferon was introduced, but that was just a "modification of interferon," Dr. Sulkowski noted.

"The addition of boceprevir and telaprevir to the HCV treatment armamentarium will be a major step forward for the clinical management of a disease that, to date, has left clinicians with few prescription options and patients with difficult treatment options," José M. Zuniga, PhD, MPH, president and CEO of the IAPAC, told Medscape Medical News.

Pivotal Boceprevir Data

Conference attendees heard a recap of the findings from 2 major studies (RESPOND-2 and SPRINT-2) published March 30 in the New England Journal of Medicine and reported at the time by Medscape Medical News.

Briefly, in the HCV Retreatment With HCV Serine Protease Inhibitor Boceprevir and PegIntron/Rebetol 2 (RESPOND-2) trial, adding boceprevir to standard peginterferon/ribavirin therapy resulted in significantly higher rates of sustained virologic response in previously treated adults with chronic HCV genotype 1 infection than standard therapy alone.

This finding in a group of HCV genotype 1–infected patients who have experienced treatment failure "represents a significant milestone for those patients who have either not responded to or relapsed after treatment with the current standard of care (peginterferon/ribavirin)," said Dr. Zuniga.

The Serine Protease Inhibitor Therapy 2 (SPRINT-2) trial had a study design similar to that of RESPOND-2, except that participants were previously untreated adults with HCV genotype 1 infection. Again, the addition of boceprevir in this group of patients significantly increased rates of sustained virologic response, compared with standard therapy alone.

Pivotal Telaprevir Data

Attendees at the first ICVH gathering also heard data from a planned interim analysis of an ongoing phase 2a double-blind study of telaprevir in combination with standard peginterferon/ribavirin therapy in 60 patients coinfected with HIV and HCV and naïve to interferon.

In this interim analysis, which looked for a rapid viral response, substantially more patients who received telaprevir-based therapy than who received standard therapy only achieved undetectable HCV RNA at week 4 and week 12.

For HIV/HCV-coinfected interferon-naïve patients, these results "hold promise" for the potential of telaprevir, in combination with current standard therapy, "to facilitate undetectable HCV viral load at weeks 4 and 12 of treatment," said Dr. Zuniga.

"While the study continues to assess whether this combination will also facilitate sustained virological response, it does confirm in coinfected patients a similar safety and tolerability profile for this combination, as previously reported for HCV-monoinfected patients," added Dr. Zuniga, who was not involved in the RESPOND-2 or SPRINT-2 studies.

HCV Screening to Take Center Stage

With improved HCV therapy coming, identifying people infected with HCV takes on greater importance, experts at the conference agreed.

"It's fairly clear when you look at hepatitis C in the United States that many patients with hepatitis C have not been diagnosed; they are unaware of their infection," Dr. Sulkowski noted.

"We need to do a better job of educating the public, as well as physicians, about hepatitis C, developing targeted screening programs, and then getting these patients into an evaluation process. Having more effective treatments, in many ways, creates a greater public health mandate to be more aggressive in identifying patients," he told Medscape Medical News.

Dr. Sulkowski reports receiving grants and serving as a research consultant to Abbott Laboratories, Boehringer Ingelheim, Gilead Sciences, Merck & Co., Novartis, Pharmasset, Roche Laboratories, and Vertex Pharmaceuticals; and serving on the advisory board of Pfizer Inc. Dr. Zuniga reports being a consultant to Bristol-Myers Squibb.

International Conference on Viral Hepatitis (ICVH) 2011: Abstracts 71283, 71306, and 71319. Presented April 12, 2011.

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