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news.Vertex Pharmaceutical's hepatitis C candidate, VX-950, has generated impressive positive results in a phase II study in which all 12 patients treated with the drug had undetectable levels of the virus after 28 days of treatment.
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The study enrolled 12 treatment-naive patients with genotype 1 HCV who received VX-950 in a tablet formulation at a dose of 750mg every eight hours for 28 days in combination with standard doses of pegylated interferon and ribavirin. At the end of 28 days, patients stopped taking VX-950 but continued with their standard regimen of pegylated interferon and ribavirin.
In addition to all 12 patients having undetectable hepatitis C levels at the end of treatment with the Vertex drug, 11 of the 12 patients continued to have hepatitis C levels below the limit of detection when measured after 12 weeks of follow-on therapy.
“With the combination of VX-950, pegylated interferon and ribavirin, we observed unprecedented antiviral activity,” said Dr Eric Lawitz, of Alamo Medical Research in San Antonio, who presented the study results at the Digestive Disease Week conference.
All patients completed dosing and no serious adverse events were reported. The most common adverse events observed in the study were flu-like illness, fatigue, headache, nausea, anemia, depression, itching and rash.