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

Vasily Isakov, Dzmitry Paduta, Rolando M Viani, Jeffrey V Enejosa, Viktor Pasechnikov, Olga Znoyko, Pavel Ogurtsov, Pavel O Bogomolov, Marina V Maevskaya, Xiaotian Chen, Nancy S Shulman

Journal: European journal of gastroenterology & hepatology 2018;30(9):1073-1076

PMID: 29762255

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Abstract

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.

Address: Department of Gastroenterology and Hepatology, Federal Research Center for Nutrition, Biotechnology and Food Safety.; Minsk City Infectious Clinic, Minsk, Belarus.; AbbVie Inc., North Chicago, Illinois, USA.; Stavropol State Medical University State, Budgetary Educational Institution of Higher Professional Education of Ministry of Health of Russian Federation, Stavropol, Russia.; Moscow State University of Medicine and Dentistry.; Peoples Friendship University of Russia (RUDN University).; Moscow Regional Research Clinical Institute.; I.M. Sechenov First Moscow State Medical University, Clinik of Internal Disease, Moscow.

DOI: 10.1097/MEG.0000000000001166

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MeSH Terms: 2-Naphthylamine, Adult, Aged, Anilides, Antiviral Agents, Carbamates, Cyclopropanes, Drug Combinations, Drug Therapy, Combination, Female, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Lactams, Macrocyclic, Liver Cirrhosis, Macrocyclic Compounds, Male, Middle Aged, Proline, Republic of Belarus, Ribavirin, Ritonavir, Russia, Sulfonamides, Sustained Virologic Response, Time Factors, Treatment Outcome, Uracil, Valine