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
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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