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Hepatitis C Triple Combo Scores Big in Phase III Trials
Positive results have been reported from a clinical trial program investigating a 12-week, fixed-dose, all-oral regimen of daclatasvir 30 mg, asunaprevir 200 mg, and beclabuvir 75 mg (TRIO, Bristol-Myers Squibb) in patients with genotype-1 hepatitis C virus (HCV) infection. The program consisted of two phase III trials: UNITY 1 and UNITY 2.
The data were presented at the annual meeting of the American Association for the Study of Liver Diseases (AASLD), held November 7–11 in Boston, Massachusetts.
The primary endpoint of both trials was the percentage of patients who achieved a “cure” (defined as HCV RNA less than the lower limit of quantification [LLOQ], target detected [TD] or target not detected [TND)] at post-treatment week 12 for treatment-naïve and treatment-experienced patients.
The open-label UNITY-1 study evaluated the TRIO regimen without ribavirin in treatment-naïve and treatment-experienced non-cirrhotic patients. Both the non-cirrhotic treatment-naïve patients (n = 312) and treatment-experienced patients (n = 103) received the TRIO fixed-dose combination in one pill twice daily for 12 weeks, with 24 weeks of follow-up. Most of the patients (73%) were genotype 1a.
A sustained viral response 12 weeks after treatment (SVR12) was achieved by 91% of all patients; 92% of treatment-naïve patients and 89% of treatment-experienced patients achieved a cure without the use of ribavirin.
In the UNITY-2 trial, both cirrhotic treatment-naïve and cirrhotic treatment-experienced patients received the TRIO fixed-dose combination, one arm with ribavirin (n = 100) and the other arm without ribavirin (n = 102). The study was double-blinded to ribavirin, and most of the patients (74%) were genotype 1a.
In this study, SVR12 was demonstrated in 98% of treatment-naïve and 93% of treatment-experienced cirrhotic patients with ribavirin, and in 93% of treatment-naïve and 87% of treatment-experienced cirrhotic patients without ribavirin.
Seven serious adverse events (SAEs) occurred in the UNITY-1 trial. All were considered not related to study treatment, and three led to treatment discontinuation. The most common AEs were headache (25.8%) and fatigue (16.6%). In UNITY-2, three SAEs were related to treatment, and four led to discontinuation. The most common AEs were headache and fatigue (both 19.8%).
An estimated 2.7 million to 3.9 million people are chronically infected with HCV in the U.S. According to the World Health Organization, up to 20% of people with chronic HCV infection will develop cirrhosis; of those, up to 20% may progress to liver cancer.
Source: Bristol-Myers Squibb; November 8, 2014.