Ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin for chronic hepatitis C virus genotype 1b-infected cirrhotics (TURQUOISE-IV)

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 patients achieved SVR at 12 weeks (36/36; 100%). No patient experienced a serious AE or discontinued treatment prematurely. Treatment-emergent AEs possibly related to study drugs occurring in greater than or equal to 10% of patients were asthenia (19%), anemia (14%), cough (14%), and headache (11%); most events were mild in severity. Clinically significant laboratory abnormalities were infrequent. Conclusion In Russian and Belarusian patients with hepatitis C GT1b infection and compensated cirrhosis, 100% achieved SVR at 12 weeks after 12 weeks' treatment with OBV/PTV/ritonavir+DSV+RBV. The treatment was well tolerated. © 2018 Wolters Kluwer Health, Inc. All rights reserved.

Isakov V.1 , Paduta D.7 , Viani R.M.8 , Enejosa J.V.8 , Pasechnikov V.6 , Znoyko O. 2 , Ogurtsov P. 3 , Bogomolov P.O.4 , Maevskaya M.V.5 , Chen X.8 , Shulman N.S.8
Lippincott Williams and Wilkins
Номер выпуска
  • 1 Department of Gastroenterology and Hepatology, Federal Research Center for Nutrition, Biotechnology and Food Safety, Kashirskoe Shosse 21, Moscow, 115446, Russian Federation
  • 2 Moscow State University of Medicine and Dentistry, RUDN University, Moscow, Russian Federation
  • 3 Peoples Friendship University of Russia, RUDN University, Moscow, Russian Federation
  • 4 Moscow Regional Research Clinical Institute, Clinik of Internal Disease, Moscow, Russian Federation
  • 5 I.M. Sechenov First Moscow State Medical University, Clinik of Internal Disease, Moscow, Russian Federation
  • 6 Stavropol State Medical University State, Budgetary Educational Institution of Higher Professional, Education of Ministry of Health of Russian Federation, Stavropol, Russian Federation
  • 7 Minsk City Infectious Clinic, Minsk, Belarus
  • 8 AbbVie Inc., North Chicago, IL, United States
Ключевые слова
3D; cirrhosis; direct-acting antiviral; hepatitis C virus; TURQUOISE-IV
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