Harvoni Achieves Almost 100% Response Rate in Real-World Population
May 25, 2016
In a real-world cohort of patients with genotype 1 hepatitis C virus and HIV, the hepatitis C drug Harvoni (ledpasvir/sofosbuvir; Gilead), with or without ribavirin, achieved an almost 100% sustained virologic response rate.
The findings came from a study to evaluate real-world outcomes of Harvoni in a heterogeneous population of 140 patients who initiated therapy with Harvoni, with or without ribavirin, between October 2014 and March 2015. Patients received treatment for 8, 12, or 24 weeks. The results of the study were presented by investigator Kris V. Kowdley, MD (Liver Care Network, Swedish Medical Center, Seattle, WA) at Digestive Disease Week 2016 (May 21-24; San Diego, CA).
Rates of sustained virologic response at Week 12 (SVR12) were 100% in the 8-week group (n = 8), 98% in the 12-week group (n = 112), and 97% in the 24-week group (n = 30).
Responses were also compared between patients with baseline HCV RNA levels above and below 6 million IU/mL. For patients with genotype 1a HCV, SVR12 was 100% regardless of baseline viral load. For patients with genotype 1b, SVR12 was 95% for those with a baseline viral load of less than 6 million IU/mL and 100% for patients with a viral load above that threshold.
Dr Kowdley concluded that the real-world effectiveness of Harvoni in a heterogeneous population is similar to what was reported in clinical trials of the drug.