Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials
Autor: | Ewa Janczewska, Adrian Streinu-Cercel, Brian Conway, István Tornai, Richard Skoien, David R. Shaw, Alejandro Soza, Mudra Kapoor, Wayne Ghesquiere, Xuan Liu, Thomas Podsadecki, Florin Alexandru Caruntu, Y. Liu, Gregory J. Dore, Danielle Sullivan, Francisco Fuster, Yan Luo, Manuela Curescu, Adriana Motoc, Olav Dalgard, Campbell Andrew L, Victoria Aramă, Brygida Knysz, Włodzimierz Mazur, Joe Sasadeusz, Susan Greenbloom |
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Rok vydání: | 2016 |
Předmět: |
Cyclopropanes
Male Hepacivirus Pharmacology Direct-acting antivirals Gastroenterology Telaprevir Polyethylene Glycols chemistry.chemical_compound 0302 clinical medicine Pegylated interferon 2-Naphthylamine Anilides 030212 general & internal medicine Sustained virologic response Sulfonamides Dasabuvir Hepatitis C virus Interferon-free therapy Valine Middle Aged Recombinant Proteins Drug Therapy Combination Female 030211 gastroenterology & hepatology medicine.drug Adult medicine.medical_specialty Macrocyclic Compounds Genotype Proline Lactams Macrocyclic Alpha interferon Interferon alpha-2 Antiviral Agents 03 medical and health sciences Internal medicine medicine Humans Uracil Aged Hepatology business.industry Interferon-alpha Hepatitis C Chronic Ombitasvir Interleukin 28B chemistry Paritaprevir Ritonavir Carbamates business |
Zdroj: | Journal of Hepatology. 64:19-28 |
ISSN: | 0168-8278 |
Popis: | Background & AimsTelaprevir plus pegylated interferon/ribavirin (TPV+PegIFN/RBV) remains a therapeutic option for chronic hepatitis C virus (HCV) genotype (GT) 1 infection in many regions. We conducted two open-label, phase IIIb trials comparing safety and efficacy of all-oral ombitasvir/paritaprevir/ritonavir and dasabuvir±ribavirin (OBV/PTV/r+DSV±RBV) and TPV+PegIFN/RBV.MethodsTreatment-naïve (MALACHITE-I) or PegIFN/RBV-experienced (MALACHITE-II) non-cirrhotic, chronic HCV GT1-infected patients were randomized to OBV/PTV/r+DSV+weight-based RBV, OBV/PTV/r+DSV (treatment-naïve, GT1b-infected patients only), or 12weeks of TPV+PegIFN+weight-based RBV and 12–36 additional weeks of PegIFN/RBV. The primary endpoint was sustained virologic response 12weeks post-treatment (SVR12). Patient-reported outcome questionnaires evaluated mental and physical health during the studies.ResultsThree hundred eleven treatment-naïve and 148 treatment-experienced patients were randomized and dosed. Among treatment-naïve patients, SVR12 rates were 97% (67/69) and 82% (28/34), respectively, in OBV/PTV/r+DSV+RBV and TPV+PegIFN/RBV-treated GT1a-infected patients; SVR12 rates were 99% (83/84), 98% (81/83), and 78% (32/41) in OBV/PTV/r+DSV+RBV, OBV/PTV/r+DSV, and TPV+PegIFN/RBV-treated GT1b-infected patients. Among treatment-experienced patients, SVR12 rates were 99% (100/101) and 66% (31/47) with OBV/PTV/r+DSV+RBV and TPV+PegIFN/RBV. Mental and physical health were generally better with OBV/PTV/r+DSV±RBV than TPV+PegIFN/RBV. Rates of discontinuation due to adverse events (0–1% and 8–11%, respectively, p |
Databáze: | OpenAIRE |
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