During 2011-2014, HCV+ patients were treated with telaprevir or boceprevir, directly acting antivirals (DAAs), in conjunction with pegylated interferon and ribavirin in the University of Washington (UW) Hepatitis C (HCV) Project ECHO cohort.
Project ECHO is a service delivery and research collaboration between UW specialists and primary care providers in resource limited settings, using videoconferencing to provide treatment of HCV+ patients. Patients who started either DAA were analyzed for demographic and outcome measures. Cases were eliminated if no data existed. Study was conducted to demonstrate efficacy of DAAs and safety and efficacy of Project ECHO.
201 patients were presented; 52% were male, 11% Native American, 76% genotype 1, 23% cirrhotic and 7% HIV+. Average baseline viral load was 3,679,762 IU/ml.
A total of 139 patients were considered for treatment; 62 were not. Of the 139, 22 patients were infected with genotype 2/3 and ineligible for DAA-based therapy; 20 were recommended to begin treatment but did not; and 97 were treated. Of those who initiated treatment, 75 (59 telaprevir, 16 boceprevir) completed treatment; 22 stopped treatment due to serious adverse events (SAEs), viral relapse, or self-discontinuation.
Overall, 60% treated with either DAA achieved sustained viral response at 12 weeks post treatment (SVR12). 27% did not achieve SVR12, and 13% were lost to follow up. For boceprevir and telaprevir cohorts, SVR12 was 55% and 61% (p-value 0.7) respectively. Treatment failure was 27% and 27% (p-value 1.0). Predictors of treatment success in both groups include undetectable viral load at week 12 (p-values 0.02; 0.02). Predictors of telaprevir treatment failure include genotype 1a (p-value 0.02). Three (all in the telaprevir group) SAEs necessitated cessation. 28 AEs were reported.
Overall SVR12 for DAA-based treatment was 60%. Rates of SVR12 achieved are comparable to those in phase 3 clinical trials and demonstrate efficacy of Project ECHO to deliver safe and successful care to complicated and diverse patients. More SAE and AEs occurred in the telaprevir group.
Merck: Grant Investigator , Research grant
Tacere Therapeutics: Scientific Advisor , Consulting fee
Bristol Myers-Squibb: Scientific Advisor , Consulting fee