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Drug Combo Kills Hepatitis C Virus Within 6 Weeks

Patients receive NS5A inhibitor plus sofosbuvir in mid-stage trial

Positive interim results have been reported from an ongoing interferon-free, ribavirin-free, phase II study evaluating the efficacy, safety, and tolerability of 6 weeks of treatment with ACH-3102 (50 mg), an investigational second-generation nonstructural protein 5A (NS5A) inhibitor, and sofosbuvir (400 mg), a nucleotide polymerase inhibitor marketed as Sovaldi (Gilead), in treatment-naïve patients with genotype-1 hepatitis C virus (HCV) infection. The combination treatment is being developed by Achillion Pharmaceuticals.

The study’s primary objective is to determine the sustained viral response 12 weeks (SVR12) after the completion of therapy.

Initially, 18 patients, including six observational patients, were enrolled into an 8-week treatment cohort. After the achievement of 100% SVR12 (12/12) in the 8-week cohort, a 6-week treatment cohort was initiated. The mean baseline HCV RNA viral load was 10 million (7 log10) IU/mL, including seven patients with a baseline HCV RNA viral load exceeding 6 million (6.78 log10) IU/mL. Of the 12 active-treatment patients, seven were genotype 1a and five were genotype 1b.

Twelve weeks after the completion of therapy, all treated patients (12/12) achieved SVR12, independent of baseline viral load, gender, and interleukin (IL) 28B status, in the 6-week treatment arm. In addition, 100% of patients (12/12) in the 8-week treatment arm have achieved SVR24.

The combination of ACH-3102 and sofosbuvir was well-tolerated, with no serious adverse events, no discontinuations due to adverse events, and no clinically significant laboratory or electrocardiogram abnormalities.

HCV is the most common cause of viral hepatitis. It has been estimated that more than 150 million people are infected with HCV worldwide, including more than 5 million people in the U.S. Three-fourths of the HCV patient population is undiagnosed. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure, or death.

Sources: Achillion Pharmaceuticals; February 9, 2015; and ACH-3102; February 2015.

 

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