March 6, 2014
A 12-week course of three direct-acting antivirals cured at least 99% of previously untreated people with genotype-1b hepatitis C infection, according to a study presented by Rajender Reddy, M.D., at CROI 2014 in Boston.
The phase-3 study, known as PEARL III, followed 419 treatment-naive patients with hepatitis C genotype 1b (the most common genotype of hepatitis C). All participants received the triple-drug, fixed-dose combination known as "3D" for 12 weeks and were randomized to also receive either ribavirin (210 patients) or a placebo (209 patients).
Cure rates were extremely high in both study arms. 99% of patients in the ribavirin-sparing arm and 99.5% of patients in the ribavirin arm achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12). One case of virologic rebound occurred at week 10 of treatment, while two patients who achieved a virologic response at the end of treatment were subsequently lost to follow-up. Other than these cases there were no treatment failures. There were no significant differences by baseline characteristics, including IL28B genotype.
Treatment was well tolerated. There were no treatment discontinuations due to adverse events and the most common adverse events reported during the study were headache and fatigue, which each occurred in just over one-in-five patients. Pruritis and nausea were the only adverse events that occurred more frequently in the ribavirin arm. Haemoglobin levels fell below the lower limit of normal in 51.4% of patients in the ribavirin arm compared with 3.4% in the ribavirin-sparing arm, and 9% of participants in the ribavirin arm developed anaemia compared to none in the ribavirin-sparing arm. The ribavirin dose was reduced in 9% of patients in the ribavirin arm. All of these patients achieved SVR12.
The researchers concluded that for patients with genotype-1b hepatitis C, a 12-week course of "3D" is highly effective and safe, and if approved by regulatory agencies could become the first interferon-free and ribavirin-free combination for hepatitis C. AbbVie, which is developing the drug, plans to submit it for U.S. Food and Drug Administration approval later this year.
Warren Tong is the research editor for TheBody.com and TheBodyPRO.com.
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