Vertex Four-Drug Hepatitis C Combo Shows Promise

Half of the hepatitis C virus (HCV)-infected participants in a small midstage trial receiving a four-drug combination that included two Vertex Pharmaceuticals medications were able to discontinue treatment after 12 weeks, the company reported.

According to Vertex, 400 milligrams of its experimental oral drug VX-222 (a polymerase inhibitor) was administered with its recently approved Incivek (a protease inhibitor) and the standard regimen of pegylated interferon and ribavirin. The trial, known as Zenith, also revealed that 12 weeks after the combo discontinuation, 93 percent of those patients retained undetectable HCV levels.

Those patients not eligible to stop treatment at 12 weeks received another 12 weeks of standard therapy. All 13 who continued in the trial appeared cured at 24 weeks, Vertex said.

Although Sanford Bernstein analyst Geoffrey Porges considers the results of the study "more encouraging" than expected, he cautions that the trial had incomplete results, and that the drugs' "tolerability and safety will need to be established in much larger trials."

Between 130 million and 170 million people worldwide are chronically infected with HCV, 350,000 of whom die annually, says the World Health Organization.

Incivek and a similar Merck & Co. drug, Victrelis, hold out the promise of substantially higher cure rates while simultaneously halving the standing 48-week treatment regimens of older drugs alone.

Trial participants had the most common and more difficult to treat genotype 1 form of the disease and were new to treatment. Side effects, which caused six patients to discontinue treatment, included fatigue, nausea, diarrhea, anemia, itchiness, and rash.

JPMorgan analyst Geoff Meacham echoed Porges' assessment that the trial was "encouraging," noting no instances of severe diarrhea or kidney failure.

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