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Ombitasvir/paritaprevir/ritonavir plus ribavirin for 24 weeks in patients with HCV GT4 and compensated cirrhosis ( AGATE‐I Part II )

2019; Wiley; Volume: 2; Issue: 3 Linguagem: Inglês

10.1002/hsr2.92

2398-8835

Tarik Asselah, Negar N. Alami, Christophe Moreno, Stanislas Pol, Stylianos Karatapanis, Michael Gschwantler, Yves Horsmans, Ioannis Elefsiniotis, Dominique Larrey, Carlo Ferrari, Mario Rizzetto, A. Orlandini, José Luís Calleja, Savino Bruno, Gretja Schnell, Roula Qaqish, Rebecca Redman, Edward Tam, Sarah Kopecky‐Bromberg, Yao Yu, Niloufar Mobashery,

Liver Disease Diagnosis and Treatment

Abstract Background and Aims AGATE‐I Part I previously reported high sustained virologic response rates in hepatitis C genotype 4 patients with cirrhosis, with 12 and 16 weeks' treatment with a combination of two direct‐acting antivirals, ombitasvir and paritaprevir (codosed with ritonavir), plus ribavirin. Part II, reported here, extended the trial to include a 24‐week treatment arm to fully assess treatment duration in patients with chronic hepatitis C genotype 4 infection and compensated cirrhosis. Methods Enrollment took place between June and November of 2015. Treatment‐naive and interferon‐experienced patients with chronic hepatitis C genotype 4 infection and compensated cirrhosis were enrolled into Arm C; patients previously treated with a sofosbuvir‐based regimen were enrolled into Arm D. All patients received a 24‐week treatment with ombitasvir, paritaprevir, and ritonavir plus ribavirin. The primary outcome was the proportion of patients with a sustained virologic response (hepatitis C virus RNA < 25 IU/mL) at posttreatment week 12 in the intention‐to‐treat population. The safety population included all patients who received at least one dose of study drug. Results In total, 64 patients were enrolled into AGATE‐I Part II. Sustained virologic response at posttreatment week 12 was achieved in 57 of 61 patients (93.4%; 97.5% confidence interval, 92.6‐97.7) in Arm C and 3 of 3 patients (100%) in Arm D. Two patients were missing SVR12 data, and two prematurely discontinued treatment. The most common adverse events for Arm C were fatigue (16 [26%]) and asthenia (15 [25%]). Results were comparable with those reported in Part I. Conclusions AGATE‐I Part II indicates that extending treatment beyond 12 weeks in genotype 4–infected patients with compensated cirrhosis does not offer additional benefit.