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New Drug Duo Treats Hepatitis C Without Interferon

Researchers seek safer treatments (August 15)

A new study published in the New England Journal of Medicine suggests that an experimental drug duo may cure some cases of hepatitis C without the need for interferon (IFN) therapy.

The phase 2b trial, conducted in 362 people with chronic hepatitis C, found that the combination of faldaprevir (a protease inhibitor) and deleobuvir (a non-nucleoside polymerase inhibitor) — administered along with ribavirin — cleared the virus from up to 69 percent of patients without the use of IFN.

The patients were randomly assigned to one of five treatment groups: faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily, plus ribavirin, for 16, 28, or 40 weeks (TID16W, TID28W, or TID40W, respectively); faldaprevir 120 mg once daily and deleobuvir 600 mg twice daily, plus ribavirin, for 28 weeks (BID28W); or faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily, without ribavirin, for 28 weeks (TID28W-NR). The study’s primary endpoint was a sustained virologic response 12 weeks after the completion of treatment.

The primary endpoint was met in 59 percent of patients in the TID16W group, in 59 percent of patients in the TID28W group, in 52 percent of patients in the TID40W group, in 69 percent of patients in the BID28W group, and in 39 percent of patients in the TID28W-NR group. The response was significantly higher with TID28W than with TID28W-NR (P = 0.03).

Rates of a sustained virologic response 12 weeks after the completion of therapy ranged from 56 percent to 85 percent among patients with genotype 1b infection versus 11 percent to 47 percent among patients with genotype 1a infection. In addition, 12-week response rates ranged from 58 percent to 84 percent among patients with the IL28B CC genotype versus 33 percent to 64 percent among patients with non-CC genotypes.

Rash, photosensitivity, nausea, vomiting, and diarrhea were the most common adverse events.

Although ribavirin is more tolerable than IFN, it destroys red blood cells and can cause serious fatigue and other problems. Researchers are working on developing hepatitis C regimens that bypass IFN and ribavirin altogether.

Sources: NEJM; August 15, 2013; and Medical Xpress; August 15, 2013.

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