Background: It is unknown whether ribavirin (RBV) coadministration modifies the early rate of decline of hepatitis C virus (HCV) RNA in the liver versus plasma compartments, specifically. Methods: This partially randomized, open-label, phase 2 study enrolled treatment-naive, noncirrhotic patients with HCV genotype 1a. Patients were randomized 1:1 into Arms A and B, and then enrolled in Arm C. Patients received ombitasvir/paritaprevir/ritonavir plus dasabuvir for 12 weeks with either: no RBV for the first 2 weeks followed by weight-based dosing thereafter (Arm A), weight-based RBV for all 12 weeks (Arm B), or low-dose RBV (600 mg) once daily for all 12 weeks. Fine needle aspiration (FNA) was used to determine HCV RNA decline within liver. Results:Baseline HCV RNA was higher and declined more rapidly in plasma than liver; however, RBV dosing did not impact either median plasma or liver HCV RNA decline during the first 2 weeks of treatment. Liver-to-plasma drug concentrations were variable over time. The most common adverse event was pain associated with FNA. Conclusions: Coadministration of RBV had minimal visible impact on the plasma or liver kinetics of HCV RNA decline during the first 2 weeks of treatment, regardless of RBV dosing.
RCT Entities:
Background: It is unknown whether ribavirin (RBV) coadministration modifies the early rate of decline of hepatitis C virus (HCV) RNA in the liver versus plasma compartments, specifically. Methods: This partially randomized, open-label, phase 2 study enrolled treatment-naive, noncirrhotic patients with HCV genotype 1a. Patients were randomized 1:1 into Arms A and B, and then enrolled in Arm C. Patients received ombitasvir/paritaprevir/ritonavir plus dasabuvir for 12 weeks with either: no RBV for the first 2 weeks followed by weight-based dosing thereafter (Arm A), weight-based RBV for all 12 weeks (Arm B), or low-dose RBV (600 mg) once daily for all 12 weeks. Fine needle aspiration (FNA) was used to determine HCV RNA decline within liver. Results: Baseline HCV RNA was higher and declined more rapidly in plasma than liver; however, RBV dosing did not impact either median plasma or liver HCV RNA decline during the first 2 weeks of treatment. Liver-to-plasma drug concentrations were variable over time. The most common adverse event was pain associated with FNA. Conclusions: Coadministration of RBV had minimal visible impact on the plasma or liver kinetics of HCV RNA decline during the first 2 weeks of treatment, regardless of RBV dosing.
Authors: Jordan J Feld; Christophe Moreno; Roger Trinh; Edward Tam; Stefan Bourgeois; Yves Horsmans; Magdy Elkhashab; David E Bernstein; Ziad Younes; Robert W Reindollar; Lois Larsen; Bo Fu; Kevin Howieson; Akshanth R Polepally; Andreas Pangerl; Nancy S Shulman; Fred Poordad Journal: J Hepatol Date: 2015-10-22 Impact factor: 25.083
Authors: Andrew J Ocque; Colleen E Hagler; Robin DiFrancesco; Gene D Morse; Andrew H Talal Journal: J Chromatogr B Analyt Technol Biomed Life Sci Date: 2017-03-24 Impact factor: 3.205
Authors: Peter Ferenci; David Bernstein; Jacob Lalezari; Daniel Cohen; Yan Luo; Curtis Cooper; Edward Tam; Rui T Marinho; Naoky Tsai; Anders Nyberg; Terry D Box; Ziad Younes; Pedram Enayati; Sinikka Green; Yaacov Baruch; Bal Raj Bhandari; Florin Alexandru Caruntu; Thomas Sepe; Vladimir Chulanov; Ewa Janczewska; Giuliano Rizzardini; Judit Gervain; Ramon Planas; Christophe Moreno; Tarek Hassanein; Wangang Xie; Martin King; Thomas Podsadecki; K Rajender Reddy Journal: N Engl J Med Date: 2014-05-04 Impact factor: 91.245
Authors: Daryl T-Y Lau; Penny Mar Fish; Mala Sinha; David M Owen; Stanley M Lemon; Michael Gale Journal: Hepatology Date: 2008-03 Impact factor: 17.425
Authors: Stefan Zeuzem; Ira M Jacobson; Tolga Baykal; Rui T Marinho; Fred Poordad; Marc Bourlière; Mark S Sulkowski; Heiner Wedemeyer; Edward Tam; Paul Desmond; Donald M Jensen; Adrian M Di Bisceglie; Peter Varunok; Tarek Hassanein; Junyuan Xiong; Tami Pilot-Matias; Barbara DaSilva-Tillmann; Lois Larsen; Thomas Podsadecki; Barry Bernstein Journal: N Engl J Med Date: 2014-04-10 Impact factor: 91.245
Authors: Ashwin Balagopal; Laura M Smeaton; Jeffrey Quinn; Charles S Venuto; Gene D Morse; Vincent Vu; Beverly Alston-Smith; Daniel E Cohen; Jorge L Santana-Bagur; Donald D Anthony; Mark S Sulkowski; David L Wyles; Andrew H Talal Journal: J Infect Dis Date: 2020-07-23 Impact factor: 7.759