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001-es BibID:	BIBFORM076632
035-os BibID:	(WoS)000366665700007 (Scopus)84961817155
Első szerző:	Dore, Gregory J.
Cím:	Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients : the MALACHITE-I/II trials / Gregory J. Dore, Brian Conway, Yan Luo, Ewa Janczewska, Brygida Knysz, Yan Liu, Adrian Streinu-Cercel, Florin Alexandru Caruntu, Manuela Curescu, Richard Skoien, Wayne Ghesquiere, Włodzimierz Mazur, Alejandro Soza, Francisco Fuster, Susan Greenbloom, Adriana Motoc, Victoria Arama, David Shaw, Istvan Tornai, Joseph Sasadeusz, Olav Dalgard, Danielle Sullivan, Xuan Liu, Mudra Kapoor, Andrew Campbell, Thomas Podsadecki
Dátum:	2016
ISSN:	0168-8278
Megjegyzések:	BACKGROUND & AIMS: Telaprevir 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. METHODS: Treatment-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. RESULTS: Three 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<0.05) and rates of hemoglobin decline to <10g/dl (0-4% and 34-47%, respectively, p<0.05) were lower for OBV/PTV/r+DSV?RBV than TPV+PegIFN/RBV. CONCLUSIONS: Among non-cirrhotic, HCV GT1-infected patients, SVR12 rates were 97-99% with 12week, multi-targeted OBV/PTV/r+DSV?RBV regimens and 66-82% with 24-48 total weeks of TPV+PegIFN/RBV. OBV/PTV/r+DSV?RBV was associated with a generally better mental and physical health, more favorable tolerability, and lower rates of treatment discontinuation due to adverse events.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Journal Of Hepatology. - 64 : 1 (2016), p. 19-28. -
További szerzők:	Conway, Brian Luo, Yan Janczewska, Ewa Knysz, Brygida Liu, Yan Streinu-Cercel, Adrian Caruntu, Florin Alexandru Curescu, Manuela Skoien, Richard Ghesquiere, Wayne Mazur, Włodzimierz Soza, Alejandro Fuster, Francisco Greenbloom, Susan Motoc, Adriana Arama, Victoria Shaw, David Tornai István (1954-) (belgyógyász, gasztroenterológus) Sasadeusz, Joseph Dalgard, Olav Sullivan, Danielle Liu, Xuan Kapoor, Mudra Campbell, Andrew Podsadecki, Thomas
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