A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)
Phase of Trial: Phase III
Latest Information Update: 05 Feb 2016
At a glance
- Drugs Daclatasvir (Primary) ; Sofosbuvir (Primary)
- Indications Hepatitis C; HIV-1 infections
- Focus Registrational; Therapeutic Use
- Acronyms ALLY-2
- Sponsors Bristol-Myers Squibb
- 05 Feb 2016 Results published in Bristol-Myers Squibb Company media release.
- 28 Jan 2016 According to a Bristol-Myers Squibb media release the European Commission has approved the expansion of indication for Daklinza (daclatasvir) to be used in combination with sofosbuvir, with or without ribavirin in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV in all 28 Member States of the European Union. The approval is based on the ALLY-1 and ALLY-2 studies.
- 06 Oct 2015 According to a Bristol-Myers Squibb media release, the U.S. FDA has accepted for filing and review supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin.The new sNDAs accepted by the FDA for review include data from the ALLY-1 and ALLY-2 clinical trials.