Date: 2014-11-08
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at The Liver Meeting® 2014, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, MA, November 7 – 11
Company: BMS (USA - NY)
Product: daclatasvir with asunaprevir and beclabuvir
Action mechanism:
Disease: patients with genotype 1 hepatitis C virus
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On November 8, 2014, BMS announced late-breaking data from the UNITY Trial program investigating a 12-week regimen of its all-oral daclatasvir (DCV) TRIO regimen – a fixed-dose combination of daclatasvir with asunaprevir (ASV) and beclabuvir (BCV) – in a broad range of patients with genotype 1 hepatitis C virus (HCV). The data will be presented at The Liver Meeting® 2014, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, MA, November 7 – 11. The primary endpoint for both studies was the percentage of patients who achieved cure, defined as HCV RNA<LLOQ TD/TND at post-treatment week 12 for treatment-naïve and treatment-experienced patients.
The UNITY-2 study, which evaluated cirrhotic patients in a 12-week regimen of the DCV-TRIO, showed sustained virologic response 12 weeks after treatment (SVR12) among 98% of treatment-naïve and 93% of treatment-experienced cirrhotic patients with ribavirin (RBV) and 93% of treatment-naïve and 87% of treatment-experienced cirrhotic patients without ribavirin.
The Phase 3 UNITY clinical trial program is an ongoing study investigating 12-week regimens of the DCV-TRIO fixed-dose combination (daclatasvir 30 mg plus asunaprevir 200 mg plus beclabuvir 75 mg) in non-cirrhotic and cirrhotic genotype 1 patients.
The open-label UNITY-1 study evaluated a 12-week regimen of the DCV-TRIO without ribavirin in treatment-naïve and -experienced non-cirrhotic patients. Non-cirrhotic treatment-naïve patients (n=312) and treatment-experienced patients (n=103) received the DCV-TRIO fixed-dose combination in one pill twice daily for 12 weeks, with 24 weeks of follow-up. The majority of the patients (73%) were genotype 1a, and 91% of all patients achieved SVR12. 92% of treatment-naive patients and 89% of treatment-experienced patients achieved cure, without the use of ribavirin.
In the UNITY-2 study, both cirrhotic treatment-naïve and treatment-experienced patients received the DCV-TRIO fixed-dose combination, one arm without ribavirin (n=102) and one with ribavirin (n=100). The study was double-blinded to ribavirin, and the majority of the patients (74%) were genotype 1a. The study showed 96% of all patients who received the DCV-TRIO with ribavirin achieved SVR12, and 90% of those who received the DCV-TRIO without ribavirin achieved SVR12.
In both UNITY-1 and UNITY-2 there were low rates of adverse events (AEs) leading to discontinuation and of serious adverse events (SAEs) overall. In UNITY-1 there were 7 SAEs, all considered not related to study treatment, and 3 AEs leading to treatment discontinuation. The most common AEs were headache (25.8%) and fatigue (16.6%). In UNITY-2, there were 3 SAEs related to treatment and 4 AEs leading to discontinuation. The most common AEs were headache and fatigue (both 19.8%).
