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Harvoni yields 100% SVR12 in HBV/HCV coinfected cohort
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AMSTERDAM — All 111 of a cohort of patients in Taiwan coinfected with both hepatitis B and hepatitis C who were treated with Harvoni reached sustained virologic response at 12 weeks, according to data presented at the International Liver Congress.
Chun-Jen Liu, PhD, of the Graduate Institute of Clinical Medicine, Hepatitis Research Center and Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, said patients who are coinfected with HCV and HBV are still treated with peginterferon plus ribavirin for 24 or 48 weeks as the standard of care. In the current study, 111 patients underwent treatment with 12 weeks of Harvoni (ledipasvir/sofosbuvir, Gilead). “Key inclusion criteria included genotype 1, 2 or 3 HCV infection plus HBV infection,” Liu said. “The primary endpoint included SVR12.”
HBV DNA change from baseline and the number of patients requiring HBV therapy based on Taiwan guidelines served as key secondary endpoints. “Only four patients received HBV therapy before enrollment,” Liu said.
The SVR12 rate for the full cohort was 100%, according to Liu. “This included 18 patients with baseline cirrhosis,” Liu said. “Also, 46 patients with baseline RAS’s.”
Adverse events were reported in 60 patients, Liu added. “Grade 3 to 4 [adverse events] were found in only one patient,” he said. Medication was not terminated due to any adverse events, he added.
Overall, 63% of the cohort experienced HBV DNA reactivation, according to Liu. This included patients with low levels of baseline HBV DNA. “Five patients had a serum ALT elevation more than two times the upper limit of normal,” he said.
Two patients started HBV therapy according to Taiwan national guidelines. “Multivariate analysis results show that high baseline HBV DNA and high baseline ALT were associated with HBV reactivation,” Liu said.
The cohort comprised 61% of patients with genotype 1 and 39% genotype 2 disease. Two-thirds were treatment-naive and 85% did not have cirrhosis. Liu reported a mean baseline level of HBV DNA of 2.1 log10 IU/mL (range, 1.3–5.8). – by Rob Volansky
Reference: Liu CJ, et al. Abstract PS-098 Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.
Disclosure: Liu reports no relevant financial disclosures.