New, desperately needed drug against hepatitis C approved

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As expected, the FDA has just approved Merck and Co.’s highly anticipated anti-hepatitis C drug, Victrelis (generic name, boceprevir).

There are about 3.2 million Americans infected with hepatitis C. The virus is known as a “silent killer” because patients with hepatitis C do not usually present with symptoms until decades later, when it causes liver damage that can ultimately lead to cirrhosis or liver cancer. It is most often spread through the use of needles contaminated with infected blood and, less often, through unprotected sex.

The new drug works as a protease inhibitor — mechanistically similar to some HIV drugs — and is the first specific antiviral drug to treat patients infected with HCV . The standard regimen of interferon and ribavirin is both replete with side-effects and not very effective. Victrelis will be added to that regimen after one month of that therapy alone. Clinical trials have shown that the drug substantially benefits patients by reducing the time needed for treatment to as little as 28 weeks, compared to the standard 48, thus lessening the duration of serious side effects of the current standard of care. Moreover, Victrelis plus interferon and ribavirin have been shown to achieve a sustained viral response (no detectable virus) for six months following discontinuation of therapy, which is considered to be a cure. The new drug, however, will cost $1,100 per week, amounting to between $26,400 and $48,400 for a full course of treatment.

Many experts predict that Vertex Pharmaceuticals’ rival HCV drug, telaprevir, will join Victrelis on the market within the month. ACSH’s Dr. Josh Bloom predicts that telaprevir will actually outsell Victrelis because “clinical trials data have shown telaprevir to be more effective.”