An ongoing clinical trial for patients with chronic hepatitis C infection (HCV), previously limited to those with genotype 1, has been expanded to include genotypes 2, 3 and 4. Individuals with an HCV genotype other than 1, have had very limited access to these types of trials. The overall purpose of the study is to administer an all-oral drug combination therapy, which includes Bristol-Myers Squibb’s daclatasvir (NS5A replication complex inhibitor) and Gilead’s sofosbuvir (nucleotide NS5B inhibitor), to HCV patients for 24 weeks
Genotypes notwithstanding, potential enrollees must meet certain other eligibility requirements. Along with having chronic HCV, eligible patients need to also exhibit significant, life-threatening complications often associated with unchecked HCV. One example is decompensated cirrhosis, a hazardous escalation of symptoms characterized by internal bleeding, ascites (fluid in the belly), jaundice (yellowing of eyes and skin) and effects on neurological functioning. Other inclusion criteria is being a post-liver transplant subject with chronic HCV recurrence with either advanced fibrosis (scarring that can lead to cirrhosis or liver failure) or fibrosing cholestatic hepatitis (severe, progressive liver dysfunction) and who have a serious/life-threatening condition or experienced an event that has decreased their life expectancy to less than 12 months.
The official title of the trial, which is being sponsored by Bristol-Myers Squibb, is “A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination with Sofosbuvir for the Treatment of Post-Liver Transplant Subjects with Chronic Hepatitis C.” The identifying code for the study is NCT02161939.
Source: www.clinicaltrials.gov
