SEATTLE — A treatment regimen of Harvoni for 12 weeks was safe and effective in treating patients coinfected with hepatitis C virus infection and HIV, according to data presented at CROI 2015.
“This phase 3 trial is a multicenter, open-label study that enrolled 335 chronically infected genotype 1 or 4 patients into a single arm of ledipasvir and sofosbuvir for 12 weeks,” Susanna Naggie, MD, MHS, of Duke Clinical Research Institute, said during her presentation. “There were broad inclusion criteria: [all were] treatment-naive and -experienced patients and [there was] a minimum of 20% of patients with compensated cirrhosis.”
Each patient received Harvoni (ledipasvir/sofosbuvir, Gilead Sciences), once a day for 12 weeks. The mean age of the patients was 52 years and 75% of patients had HCV genotype 1a, 23% had genotype 1b and 2% had genotype 4.
“Ninety-six percent of these patients achieved sustained virologic response [including] 96% of the genotype 1a and all of the genotype 4,” Naggie said. “There were 14 treatment failures; 10 patients suffered relapse, two on-treatment failures, one patient was lost to follow-up after achieving SVR4 and there was one unrelated death.”
According to the presentation, 95% of treatment-naive patients (142/150) and 97% of treatment-experienced patients (179/185) achieved SVR12. Ninety-four percent of patients with cirrhosis achieved SVR, as well as 96% without cirrhosis, according to Naggie.
Common adverse events experienced by patients included: headache (25%), fatigue (21%), diarrhea (11%), nausea (10%), arthralgia (7%) and upper respiratory tract infection (5%). There were no treatment discontinuations as a result of the regimen, nor did the treatment have any impact on HIV disease, according to the presentation.
“This very high SVR was achieved regardless of prior treatment status and regardless of whether patients had cirrhosis or not,” Naggie concluded. “In contrast to other large studies in HCV monoinfected patients, we did notice a lower sustained virologic response rate specifically in coinfected black patients. The population [pharmacokinetic] levels of ledipasvir and sofosbuvir did not suggest an explanation for this finding. We currently have ongoing studies to further explore this.” – by Melinda Stevens
Naggie S, et al. Abstract 152LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 23-26, 2015; Seattle.
Disclosure: Naggie reports having received research grants from AbbVie, Achillion, Bristol-Myers Squibb, Gilead Sciences, Janssen Therapeutics, Scynexis and Vertex. She also reports serving as a consultant for AbbVie, Achillion, Bristol-Myers Squibb, Gilead, Janssen, Vertex and Merck.