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

European Journal of Gastroenterology & Hepatology
V IsakovNancy S Shulman

Abstract

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%. 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. 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 h...Continue Reading

References

Apr 1, 2008·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·C M OlingerC P Muller
Jun 19, 2012·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Patrick MarcellinMario Rizzetto
Apr 15, 2014·The New England Journal of Medicine·Fred PoordadBarry Bernstein
Mar 11, 2016·World Journal of Hepatology·Vasily IsakovUNKNOWN P08160 Trial Investigators
Sep 20, 2016·Journal of Hepatology·Adriaan J van der Meer, Marina Berenguer
Sep 27, 2016·Journal of Hepatology·UNKNOWN European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu

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Citations

May 6, 2020·Hepatic Medicine : Evidence and Research·Konstantin ZhdanovMichael N Robertson

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Methods Mentioned

BETA
biopsy

Clinical Trials Mentioned

NCT02216422

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