Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis
Journal of Viral Hepatitis Jun 19, 2019
Poordad F, et al. - Given a possible limitation to the use of ribavirin in hepatitis C virus (HCV) infected patients treated with interferon-free direct-acting antivirals due to its association with adverse events, researchers conducted this open-label, multicentre, Phase 3 study (The GEODE-II study) evaluating ombitasvir/paritaprevir/ritonavir + dasabuvir (OBV/PTV/r + DSV) with low-dose ribavirin for 12 weeks for its safety and efficacy in genotype 1a-infected patients without cirrhosis. Intention-to-treat analysis revealed the sustained virologic response at post-treatment Week 12 (SVR12) rate of 89.5%. They did not note noninferiority vs OBV/PTV/r + DSV plus full-dose ribavirin. Modified ITT analysis showed SVR12 rate of 94.9%, showing good efficacy in patients who completed 12-weeks treatment. Because of premature treatment discontinuation or missing SVR12 data, they noted no achievement of SVR12 in six patients. The high rate of nonvirologic failures may be related to the high prevalence of patients with a history of psychosocial disorders.
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