Ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin for chronic hepatitis C virus genotype 1b-infected cirrhotics (TURQUOISE-IV)
Isakov V., Paduta D., Viani R. M., Enejosa J. V., Pasechnikov V., Znoyko O., Ogurtsov P., Bogomolov P. O., Maevskaya M. V., Chen X., Shulman N. S.
European Journal of Gastroenterology and Hepatology
Vol.30, Issue9, P. 1073-1076
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.1097/MEG.0000000000001166
Аннотация:
Objective An estimated 336 per 100 000 people in Russia are infected with hepatitis C virus, including up to 75[%] with genotype (GT) 1b. In the TURQUOISE-II/-III trials, a 12-week regimen of the direct-acting antiviral agents ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) in GT1b-infected patients with compensated cirrhosis resulted in 12-week sustained virologic response (SVR) rates of 100[%]. Patients and methods In TURQUOISE-IV, GT1b-infected patients (n=36) from Russia and Belarus with compensated cirrhosis, who were treatment naive or previously treated with pegylated interferon/ribavirin (RBV), received OBV/PTV/ritonavir+DSV+RBV for 12 weeks. The primary efficacy end point was SVR at 12 weeks. Safety assessments included adverse event (AE) monitoring and laboratory testing. Results At baseline, patients had Child-Pugh scores of 5 (92[%]) or 6 (8[%]). Overall, 69[%] were treatment experienced (44[%] prior null responders, 32[%] relapsers, and 16[%] partial responders). All
Ключевые слова:
3D; cirrhosis; direct-acting antiviral; hepatitis C virus; TURQUOISE-IV
bilirubin; dasabuvir; hemoglobin; ombitasvir; paritaprevir; ribavirin; ritonavir; ABT-267; ABT-333; ABT-450; anilide; antivirus agent; carbamic acid derivative; macrocyclic compound; ribavirin; ritonavir; sulfonamide; uracil; adult; adverse drug reaction; aged; anemia; Article; asthenia; Belarus; Child Pugh score; chronic hepatitis C; compensated liver cirrhosis; coughing; creatinine clearance; disease severity; drug efficacy; female; headache; hemoglobin blood level; Hepatitis C virus subtype 1b; human; hyperbilirubinemia; major clinical study; male; multicenter study; open study; patient monitoring; phase 3 clinical trial; priority journal; risk assessment; Russian Federation; sustained virologic response; treatment duration; analogs and derivatives; chronic hepatitis C; clinical trial; combination drug therapy; complication; drug combination; drug effect; genetics; genotype; Hepacivirus; liver cirrhosis; middle aged; sustained virologic response; time factor; treatment outcome; viro
Язык текста: Английский
ISSN: 1473-5687
Isakov V.
Paduta D.
Viani R. M.
Enejosa J. V.
Pasechnikov V.
Znoyko O.
Ogurtsov P.
Bogomolov P. O.
Maevskaya M. V. Marina Viktorovna 1958-
Chen X.
Shulman N. S.
Исаков В.
Падута Д.
Виани Р. М.
Енейоса Й. В.
Пасечников В.
Зноyко О.
Огурцов П.
Богомолов П. О.
Маевская М. В. Марина Викторовна 1958-
Чен Х.
Шулман Н. С.
Ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin for chronic hepatitis C virus genotype 1b-infected cirrhotics (TURQUOISE-IV)
Текст визуальный непосредственный
European Journal of Gastroenterology and Hepatology
Lippincott Williams & Wilkins
Vol.30, Issue9 P. 1073-1076
2018
Статья
3D cirrhosis direct-acting antiviral hepatitis C virus TURQUOISE-IV
bilirubin dasabuvir hemoglobin ombitasvir paritaprevir ribavirin ritonavir ABT-267 ABT-333 ABT-450 anilide antivirus agent carbamic acid derivative macrocyclic compound ribavirin ritonavir sulfonamide uracil adult adverse drug reaction aged anemia Article asthenia Belarus Child Pugh score chronic hepatitis C compensated liver cirrhosis coughing creatinine clearance disease severity drug efficacy female headache hemoglobin blood level Hepatitis C virus subtype 1b human hyperbilirubinemia major clinical study male multicenter study open study patient monitoring phase 3 clinical trial priority journal risk assessment Russian Federation sustained virologic response treatment duration analogs and derivatives chronic hepatitis C clinical trial combination drug therapy complication drug combination drug effect genetics genotype Hepacivirus liver cirrhosis middle aged sustained virologic response time factor treatment outcome viro
Objective An estimated 336 per 100 000 people in Russia are infected with hepatitis C virus, including up to 75[%] with genotype (GT) 1b. In the TURQUOISE-II/-III trials, a 12-week regimen of the direct-acting antiviral agents ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) in GT1b-infected patients with compensated cirrhosis resulted in 12-week sustained virologic response (SVR) rates of 100[%]. Patients and methods In TURQUOISE-IV, GT1b-infected patients (n=36) from Russia and Belarus with compensated cirrhosis, who were treatment naive or previously treated with pegylated interferon/ribavirin (RBV), received OBV/PTV/ritonavir+DSV+RBV for 12 weeks. The primary efficacy end point was SVR at 12 weeks. Safety assessments included adverse event (AE) monitoring and laboratory testing. Results At baseline, patients had Child-Pugh scores of 5 (92[%]) or 6 (8[%]). Overall, 69[%] were treatment experienced (44[%] prior null responders, 32[%] relapsers, and 16[%] partial responders). All