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Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials
Copyright policy )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<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.ConclusionsAmong 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.
Microsoft Academic Graph classification: Interleukin 28B Gastroenterology medicine.medical_specialty medicine Dasabuvir chemistry.chemical_compound chemistry Telaprevir medicine.drug business.industry business Internal medicine Pharmacology Ombitasvir Pegylated interferon Ritonavir Paritaprevir Alpha interferon
Hepatology, Hepatitis C virus, Telaprevir, Interferon-free therapy, Direct-acting antivirals, Sustained virologic response, 2-Naphthylamine, Adult, Aged, Anilides, Antiviral Agents, Carbamates, Cyclopropanes, Drug Therapy, Combination, Female, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Interferon alpha-2, Interferon-alpha, Lactams, Macrocyclic, Macrocyclic Compounds, Male, Middle Aged, Polyethylene Glycols, Proline, Recombinant Proteins, Sulfonamides, Uracil, Valine
Hepatology, Hepatitis C virus, Telaprevir, Interferon-free therapy, Direct-acting antivirals, Sustained virologic response, 2-Naphthylamine, Adult, Aged, Anilides, Antiviral Agents, Carbamates, Cyclopropanes, Drug Therapy, Combination, Female, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Interferon alpha-2, Interferon-alpha, Lactams, Macrocyclic, Macrocyclic Compounds, Male, Middle Aged, Polyethylene Glycols, Proline, Recombinant Proteins, Sulfonamides, Uracil, Valine
Microsoft Academic Graph classification: Interleukin 28B Gastroenterology medicine.medical_specialty medicine Dasabuvir chemistry.chemical_compound chemistry Telaprevir medicine.drug business.industry business Internal medicine Pharmacology Ombitasvir Pegylated interferon Ritonavir Paritaprevir Alpha interferon
- Akershus University Hospital Norway
- Melbourne Health Australia
- Royal Brisbane and Women's Hospital Australia
- University of Debrecen Hungary
- Royal Melbourne Hospital Australia
- Akershus University Hospital Norway
- Melbourne Health Australia
- Royal Brisbane and Women's Hospital Australia
- University of Debrecen Hungary
- Royal Melbourne Hospital Australia
- Pontificia Universidad Católica de Chile Chile
- Wrocław Medical University Poland
- Medical University of Silesia Poland
- Carol Davila University of Medicine and Pharmacy Romania
- Royal Adelaide Hospital Australia
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<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.ConclusionsAmong 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.