Virus Genotype 3 in a French Early Access Programme
Christophe Hézode, Pascal Lebray, Victor De Ledinghen, Fabien Zoulim, Vincent Di Martino, Nathalie Boyer, Dominique Larrey, Danielle Botta-Fridlund, Christine Silvain, Hélène Fontaine, Louis D'Alteroche, Vincent Leroy, Marc Bourliere, Isabelle Hubert-Fouchard, Dominique Guyader, Isabelle Rosa, Eric Nguyen-Khac, Larysa Fedchuk, Raoudha Akremi, Yacia Bennai, Anne Filipovics, Yue Zhao, Jean-Pierre Bronowicki
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Key Points
• A real-world early-access programme treated HCV genotype 3-infected patients with
highly advanced disease and no other treatment options with daclatasvir plus
sofosbuvir. Many would have been ineligible for a randomized study.
• Sustained virologic response after 24 weeks of treatment was 89%: 98% without
cirrhosis; 86% with cirrhosis (including decompensated cirrhosis). There was no
incremental benefit with concomitant ribavirin.
• Only 1% of patients were recorded to have discontinued for an adverse event
• Daclatasvir and sofosbuvir, with or without ribavirin, was effective and well tolerated
in this real-world cohort of HCV genotype 3 infected patients with advanced disease.
Abstract
Background and aims
Optimally effective treatment for hepatitis C virus (HCV) genotype 3 (GT3) is urgently needed, particularly in advanced liver disease. Daclatasvir (DCV) plus sofosbuvir (SOF) was efficacious in phase 3 studies. Real-world data for DCV+SOF in advanced GT3 infection are presented from the French Temporary Authorisation for Use programme, which allowed patients in need without other treatment options access to DCV ahead of its market authorization.
Background and aims
Optimally effective treatment for hepatitis C virus (HCV) genotype 3 (GT3) is urgently needed, particularly in advanced liver disease. Daclatasvir (DCV) plus sofosbuvir (SOF) was efficacious in phase 3 studies. Real-world data for DCV+SOF in advanced GT3 infection are presented from the French Temporary Authorisation for Use programme, which allowed patients in need without other treatment options access to DCV ahead of its market authorization.
Methods
Patients with F3/F4 fibrosis and/or extrahepatic HCV manifestations, post-liver-transplant HCV recurrence, and/or indication for liver/kidney transplant, were treated with DCV+SOF (60+400 mg daily) for a recommended duration of 24 weeks. Addition of ribavirin (RBV) and/or shorter treatment were at physician's discretion. The primary efficacy analysis was sustained virologic response at post-treatment week 12 (SVR12; modified intention-to-treat). Safety was assessed by spontaneous adverse event reporting.
Patients with F3/F4 fibrosis and/or extrahepatic HCV manifestations, post-liver-transplant HCV recurrence, and/or indication for liver/kidney transplant, were treated with DCV+SOF (60+400 mg daily) for a recommended duration of 24 weeks. Addition of ribavirin (RBV) and/or shorter treatment were at physician's discretion. The primary efficacy analysis was sustained virologic response at post-treatment week 12 (SVR12; modified intention-to-treat). Safety was assessed by spontaneous adverse event reporting.
Results
The efficacy population comprised 333 patients, mostly cirrhotic (77%, of whom 18% were decompensated) and treatment-experienced (72%). After 24 weeks of DCV+SOF, SVR12 was 89% (174/196) overall (95% CI 83.6–92.5%), 98% (43/44) without cirrhosis (95% CI 88.2–99.6%) and 86% (129/150) with any degree of cirrhosis (95% CI 79.5–90.7%), without SVR12 increase in those who received additional RBV for 24 weeks (SVR12 82% [50/61; 95% CI 70.5–89.6%]). Among 516 GT3-infected patients with safety data, 5 discontinued for adverse events and 11 died.
The efficacy population comprised 333 patients, mostly cirrhotic (77%, of whom 18% were decompensated) and treatment-experienced (72%). After 24 weeks of DCV+SOF, SVR12 was 89% (174/196) overall (95% CI 83.6–92.5%), 98% (43/44) without cirrhosis (95% CI 88.2–99.6%) and 86% (129/150) with any degree of cirrhosis (95% CI 79.5–90.7%), without SVR12 increase in those who received additional RBV for 24 weeks (SVR12 82% [50/61; 95% CI 70.5–89.6%]). Among 516 GT3-infected patients with safety data, 5 discontinued for adverse events and 11 died.
Conclusions
DCV+SOF achieved high SVR12 rates and was well tolerated in this large real-world cohort of GT3-infected patients with advanced liver disease, without benefit of ribavirin in those treated 24 weeks.
http://onlinelibrary.wiley.com/doi/10.1111/liv.13383/full
DCV+SOF achieved high SVR12 rates and was well tolerated in this large real-world cohort of GT3-infected patients with advanced liver disease, without benefit of ribavirin in those treated 24 weeks.
http://onlinelibrary.wiley.com/doi/10.1111/liv.13383/full
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