Technivie expands to HCV genotype 4 with compensated cirrhosis

The FDA approved expansion of the indication for Technivie to include patients with chronic hepatitis C genotype 4 with compensated cirrhosis, according to an FDA report.

The update follows the results of the AGATE-1 trial of Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie) combined with ribavirin. The study included 120 patients with HCV genotype 4 with compensated cirrhosis who were either treatment naive or pegylated interferon/ribavirin treatment experienced.

Fifty-nine patients received Technivie with ribavirin once daily for 12 weeks; the other 61 received Technivie for 16 weeks. Mean patient age was 56 years (range, 43-81 years).

Fifty patients experienced elevated bilirubin levels and 88 had anemia and/or a hemoglobin decrease greater or equal to 2 g/dL at or before 12 weeks of treatment. Nine of 64 patients with a history of cardiovascular disease or diabetes experienced cardiac events at or before 12 weeks and had a mean hemoglobin decrease of 3.9 g/dL (range, 1.1-5.3 g/dL). Two patients without such history experienced mild or moderate hypertension.

The most common adverse events were fatigue (25%), asthenia (25%) and headache (23%). Seven patients experienced clinical bilirubin or liver-related serious adverse events at or before 12 weeks of treatment. Six of these patients had elevated bilirubin levels.

Results from the 12-week cohort showed that 57 of the 59 patients achieved sustained virologic response at 12 weeks follow-up. Treatment with 16 weeks did not show an increase in SVR beyond the results of 12 weeks of treatment.

The FDA advises, prior to the initiation of treatment, to test all patients for evidence of current or prior hepatitis B and hepatic decompensation. Prior to the initiation of ribavirin, assess for underlying cardiac disease. During treatment, monitor patients for clinical signs and symptoms of hepatic decompensation, test direct bilirubin levels at baseline and during the first 4 weeks and discontinue Technivie if hepatic decompensation develops.

Reference: www.fda.gov