Recent study showered 100 percent sustained virologic response at 12 weeks in patients with hepatitis C genotype 1b who received treatment with an interferon- and ribavirin-free combination drug.
AbbVie announced promising results from a recent study that showed all patients in a clinical trial to test the company’s hepatitis C treatment among people with compensated liver cirrhosis were cured of the virus.
For 12 weeks patients took Viekirax + Exviera, a drug cocktail that blocks proteins that help replicate the hepatitis C virus without the use of ribavirin or interferon. Viekirax is a fixed-dose combination of an NS3/4 protease inhibitor (paritaprevir), an NS5A inhibitor (ombitasvir), and ritonavir, a potent cytochrome P450 3A4 inhibitor used as a pharmacokinetic enhancer. Exviera is a non-nucleoside NS5B polymerase inhibitor (dasabuvir).
Study results showed that 60 out of 60 patients (100%) had sustained virologic response at 12 weeks after the end of treatment, AbbVie said in a news release. When a patient achieves sustained virologic response it is an indication that the hepatitis C virus is not detectable in the blood stream and is typically viewed as a sign of a cure.
Hepatitis C is a blood-borne virus that can become chronic if left untreated and eventually may lead to serious harm to the liver, including cirrhosis, cancer of the liver, or a need for a liver transplant. Roughly 150 million people worldwide are believed to be infected with the virus but a lack of symptoms can allow the disease to go undetected for years while it slowly damages the organ.
The TURQOISE-III phase 3b clinical trial involved patients with chronic infection of hepatitis C genotype 1b virus. All patients had compensated liver cirrhosis and had either never been treated for the virus or had received treatment with pegylated interferon and ribavirin without success.The most commonly reported adverse events were fatigue, diarrhea, and headache and no patients stopped treatment because of adverse events, according to the news release.
“Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens," said Jordan J. Feld, MD,a research director and clinician scientist at Toronto Center for Liver Disease, in Toronto, Canada, who serves on the AbbVie advisory board. "The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks."
The TURQOISE-III study is part of AbbVie’s hepatitis C program which aims to enhance development of new treatment for the disease, AbbVie Vice President of Pharmaceutical Development Scott Brun, MD, said in the release. Plans for its phase 3b program call for enrollment of more than 2,800 patients with hepatitis C genotype 1 at 200 or more study centers worldwide.