Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naïve patients: Findings from two randomized trials
| Autor: | Sanjaya K. Satapathy, Liyun Ni, Actg A study investigators, Richard Haubrich, Peter Ghali, Robert S. Brown, Anne F Luetkemeyer, Rescue, Xianlin Shen, Edward Tam, Minhee Kang, Lorenzo Rossaro, Parvez S. Mantry, Gregory Camus, Bill Guyer, Amanda Copans |
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| Rok vydání: | 2017 |
| Předmět: |
Liver Cirrhosis
Male Sustained Virologic Response Sofosbuvir HIV Infections Hepacivirus medicine.disease_cause law.invention chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial Pregnancy law 030212 general & internal medicine Fatigue education.field_of_study Coinfection Headache Middle Aged Female 030211 gastroenterology & hepatology Uridine Monophosphate medicine.drug Adult Ledipasvir medicine.medical_specialty Hepatitis C virus Population Antiviral Agents Article 03 medical and health sciences Acquired immunodeficiency syndrome (AIDS) Internal medicine Ribavirin medicine Humans education Adverse effect Aged Fluorenes Hepatology business.industry Hepatitis C Chronic medicine.disease Surgery Clinical trial chemistry Benzimidazoles business |
| Zdroj: | Liver International. 38:1010-1021 |
| ISSN: | 1478-3223 |
| DOI: | 10.1111/liv.13616 |
| Popis: | Author(s): Tam, Edward; Luetkemeyer, Anne F; Mantry, Parvez S; Satapathy, Sanjaya K; Ghali, Peter; Kang, Minhee; Haubrich, Richard; Shen, Xianlin; Ni, Liyun; Camus, Gregory; Copans, Amanda; Rossaro, Lorenzo; Guyer, Bill; Brown, Robert S; RESCUE and ACTG A5348 study investigators | Abstract: Background a aimsWe report data from two similarly designed studies that evaluated the efficacy, safety, and optimal duration of ledipasvir/sofosbuvir (LDV/SOF)n±nribavirin (RBV) for retreatment of chronic hepatitis C virus (HCV) in individuals who failed to achieve sustained virological response (SVR) with prior SOF-based, non-NS5A inhibitor-containing regimens.MethodsThe RESCUE study enrolled HCV mono-infected adults with genotype (GT) 1 or 4. Non-cirrhotic participants were randomized to 12nweeks of LDV/SOF or LDV/SOFn+nRBV. Compensated cirrhotic participants were randomized to LDV/SOFn+nRBV (12nweeks) or LDV/SOF (24nweeks). The AIDS Clinical Trials Group A5348 study randomized genotype 1 adults with HCV/HIV co-infection to LDV/SOFn+nRBV (12nweeks) or LDV/SOF (24nweeks). Both studies used SVR at 12nweeks post-treatment (SVR12) as the primary endpoint.ResultsIn the RESCUE study, 82 participants were randomized and treated, and all completed treatment. Overall, SVR12 was 88% (72/82); 81-100% in non-cirrhotic participants treated with LDV/SOF or LDV/SOFn+nRBV for 12nweeks and 80-92% in cirrhotic participants treated with LDV/SOFn+nRBV for 12nweeks or LDV/SOF for 24nweeks. Adverse events (AEs), mostly mild-to-moderate in severity, were experienced by 78% of participants, with headache and fatigue most frequently reported. One serious AE, not related to treatment, was observed. No premature discontinuations of study drug, or deaths occurred. In the A5348 study, seven participants were randomized (cirrhotic nn=n1; GT1a nn=n5) and all attained SVR12, with no serious AEs or premature discontinuations.ConclusionsIn this SOF-experienced, NS5A inhibitor-naive population, which included participants with cirrhosis or HCV/HIV co-infection, high SVR12 rates were achieved. |
| Databáze: | OpenAIRE |
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