Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild‐moderate fibrosis: Results from a real‐world cohort

Puigvehí, Marc; Cuenca, B. de; Viu, Ana; Diago, M.; Turnés, Juan; Gea, Francisco; Pascasio, J.M.; Lens, Sabela; Cabezas, Joaquín; Badía, Ester; Olveira, Antonio; Morillas, Rosa María; Torras, Xavier; Montoliu, Silvia; Cordero, P.; Castro, José Luis; Salmerón, Javier; Molina, Esther; Sánchez-Ruano, Juan José; Moreno, J.J.; Antón, M.D.; Moreno, José María Ruiz; Vega, Juan de la; Calleja, José Luís; Carrión, J.A.

doi:10.1111/liv.13950

Cited by 5 publications

(3 citation statements)

References 31 publications

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“…Our study has the advantage of a larger sample size, with 428 patients receiving the 8-week OPrD regimen and 1,407 receiving the 12-week regimen. The SVR12 observed in our study, irrespective of treatment duration or population subset, compares similarly with the rates reported in the above-mentioned real-world studies [10,11]. With few patients discontinuing treatment (around 2% in each treatment group), our study underlines the effectiveness of the OPrD combination in treatment-naive patients with HCV with mild or moderate liver fibrosis who completed the treatment, irrespective of its duration.…”

Section: Effectiveness Analysissupporting

confidence: 89%

“…In the GARNET study, which was a multinational, single-arm, open-label trial with 166 patients, the SVR12 was 98% [9]. In the first real-world study of the 8-week OPrD treatment regimen conducted in 200 treatment-naive patients with mild to moderate fibrosis, the overall SVR12 rate in the intentionto-treat population was 96% [10]. In a recent analysis of a post-marketing observational study conducted across 13 countries [11] in which only 82 patients were treated with the 8-week regimen of OPrD, the SVR12 was 96.3% in the intention-to-treat population.…”

Section: Effectiveness Analysismentioning

confidence: 99%

“…The 8-week regimen seems to be a more convenient option in real-life settings, with the potential of reducing the overall health care burden and improving patient compliance [9]. However, the data on the shorter regimen of OPrD in routine practice shows conflicting results from several studies with relatively small sample sizes [10,11].…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of 8- and 12-Week Treatment with Ombitasvir/ Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve HCV Patients in a Real-Life Setting in Romania: the AMETHYST Study

Trifan

Stanciu

Iliescu

et al. 2021

JGLD

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Background and Aims: The 12-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir (OPrD) has shown high efficacy and tolerability in clinical trials for the treatment of chronic hepatitis C virus (HCV). The shorter 8-week regimen has been recently incorporated into clinical guidelines and on-label indications, but real-world evidence on its use is limited. Given this knowledge gap, the AMETHYST study aimed to evaluate the effectiveness of the 8- and 12-week regimens of OPrD in treatment-naive patients with HCV with mild to moderate liver fibrosis in Romanian clinical practice. Methods: This was a secondary data collection study analyzing data from a 1-year Patient Support Program in HCV in Romania. Patients received OPrD treatment for 8 or 12 weeks. The effectiveness endpoint was sustained virologic response 12 weeks post-treatment (SVR12). Results: A total of 1,835 treatment-naive patients with HCV with mild or moderate fibrosis were included in the study. Of these, 426 and 1,375 completed the 8-week and 12-week regimens, respectively. SVR12 was 98.1% in the 8-week treatment group and 98.7% in the 12-week treatment group. Conclusion: The study provides real-world evidence that 8-week and 12-week treatment regimens of OPrD are highly effective in treatment-naive patients with HCV with mild to moderate liver fibrosis.

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Section: Effectiveness Analysissupporting

confidence: 89%