Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.
In: Journal of Hepatology, Vol. 64, no. 2, p. 301-307 (2016, 2016
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Zugriff:
BACKGROUND & AIMS: Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12weeks in patients with HCV genotype 1b infection and compensated cirrhosis. METHODS: Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12weeks of ombitasvir/paritaprevir/ritonavir (25/150/100mg once daily) and dasabuvir (250mgtwicedaily). Key inclusion criteria were hemoglobin ⩾10g/dl, albumin ⩾2.8g/dl, platelet count ⩾25×10(9)/L, creatinine clearance ⩾30ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25IU/ml) 12weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug. RESULTS: Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90×10(9)/L, and 17% with albumin <3.5g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant. CONCLUSIONS: The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT02219503.
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Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.
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Autor/in / Beteiligte Person: | Feld, Jordan J ; Moreno, Christophe ; Trinh, Roger ; Tam, Edward ; Bourgeois, Stefan ; Horsmans, Yves ; Elkhashab, Magdy ; Bernstein, David E ; Younes, Ziad ; Reindollar, Robert W ; Larsen, Lois ; Fu, Bo ; Howieson, Kevin ; Polepally, Akshanth R ; Pangerl, Andreas ; Shulman, Nancy S ; Poordad, Fred ; UCL - SSS/IREC-Institut de recherche expérimentale et clinique ; UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie ; UCL - (SLuc) Service de gastro-entérologie |
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Zeitschrift: | Journal of Hepatology, Vol. 64, no. 2, p. 301-307 (2016, 2016 |
Veröffentlichung: | Elsevier BV, 2016 |
Medientyp: | academicJournal |
ISSN: | 0168-8278 (print) ; 1600-0641 (print) |
DOI: | 10.1016/j.jhep.2015.10.005 |
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