Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks

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• 作者：Jordan J. Feld¹ ; ^{jordan.feld@uhn.ca" class="auth_mail" title="E-mail the corresponding author} ; Christophe Moreno² ; Roger Trinh³ ; Edward Tam⁴ ; Stefan Bourgeois⁵ ; Yves Horsmans⁶ ; Magdy Elkhashab⁷ ; David E. Bernstein⁸ ; Ziad Younes⁹ ; Robert W. Reindollar¹⁰ ; Lois Larsen³ ; Bo Fu³ ; Kevin Howieson³ ; Akshanth R. Polepally³ ; Andreas Pangerl³ ; Nancy S. Shulman³ ; Fred Poordad¹¹
• 关键词：HCV ; hepatitis C virus ; GT ; genotype ; SVR ; sustained virologic response ; SVR12 ; sustained virologic response 12  ; weeks post-treatment ; PegIFN ; pegylated interferon ; RBV ; ribavirin ; DAA ; direct-acting antiviral ; OBV ; ombitasvir ; PTV ; paritaprevir ; r ; ritonavir ; DSV ; dasabuvir ; INR ; international normalized ratio ; LLOQ ; lower limit of quantification ; CI ; confidence interval ; AEs ; adverse events
• 刊名：Journal of Hepatology
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：64
• 期：2
• 页码：301-307
• 全文大小：671 K

文摘

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 12 weeks in patients with HCV genotype 1b infection and compensated cirrhosis.

Methods

Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12 weeks of ombitasvir/paritaprevir/ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily). Key inclusion criteria were hemoglobin ⩾10 g/dl, albumin ⩾2.8 g/dl, platelet count ⩾25 × 10⁹/L, creatinine clearance ⩾30 ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25 IU/ml) 12 weeks 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 × 10⁹/L, and 17% with albumin <3.5 g/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 12 weeks 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.