Date: 2014-11-08
Type of information: Presentation of results at a congress
phase: 3
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 and sofosbuvir
Action
mechanism: direct-acting antiviral agent/nucleotide analog. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. This direct-acting agent interferes directly with the HCV life cycle by suppressing viral replication.
Disease: genotype 3 hepatitis C (HCV) patients
Therapeutic area: Infectious diseases
Country:
Trial
details: This Phase 3 open-label clinical trial enrolled 152 genotype 3 HCV patients; 101 treatment-naïve patients and 51 treatment-experienced patients in 2 cohorts each received daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks, with 24 weeks of follow-up. The primary endpoint was SVR12 rates, defined as HCV RNA < LLOQ target detected or not detected at follow-up week 12 in treatment-naïve and treatment-experienced patients.
Latest
news: * On November 8, 2014, BMS announced late-breaking data from the landmark ALLY Trial investigating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C (HCV) patients. The results of the study, which showed sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced patients, have been 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.
These results build upon the existing body of data on the daclatasvir and sofosbuvir combination. Data from an open-label, randomized study of daclatasvir with sofosbuvir in genotypes 1, 2, and 3 demonstrated that the 24-week regimen of daclatasvir and sofosbuvir (± ribavirin) achieved SVR12 in 89% of patients with genotype 3. The ALLY study presented at The Liver Meeting investigates the regimen for 12 weeks, halving the previous treatment duration. Other ongoing ALLY studies examine diverse HCV populations across all genotypes: cirrhotic and post-liver transplant patients, as well as treatment-naïve and treatment-experienced patients who are co-infected with HIV.
In the ALLY-3 study, the daclatasvir and sofosbuvir combination regimen was well tolerated, with no deaths, treatment-related serious adverse events, or discontinuations due to adverse events. The most frequent side effects (≥5%) were headache (19.7%), fatigue (19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%), abdominal pain and arthralgia (both 5.3%). Additionally, there were 17 (11.2%) treatment failures, with 16 relapses post-treatment and 1 rebound at the end of treatment. There were no viral breakthroughs in this ribavirin-free regimen.
