Journal ArticleDOI
ABT-450/r–Ombitasvir and Dasabuvir with or without Ribavirin for HCV
Peter Ferenci,David E. Bernstein,Jacob Lalezari,Daniel E. Cohen,Yan Luo,Curtis Cooper,Edward Tam,Rui Tato Marinho,Naoky Tsai,A. Nyberg,Terry Box,Ziad Younes,Pedram Enayati,Sinikka Green,Yaacov Baruch,Bal R. Bhandari,Florin Alexandru Caruntu,Thomas Sepe,Vladimir Chulanov,Ewa Janczewska,Giuliano Rizzardini,J. Gervain,Ramon Planas,Christophe Moreno,Tarek Hassanein,Wangang Xie,M. King,Thomas Podsadecki,K. Rajender Reddy +28 more
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TLDR
Twelve weeks of treatment with ABT-450/r-ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained virologic response among previously untreated patients with HCV genotype 1 infection.Abstract:
Background The interferon-free regimen of ABT-450 with ritonavir (ABT-450/r), ombitasvir, and dasabuvir with or without ribavirin has shown efficacy in inducing a sustained virologic response in a phase 2 study involving patients with hepatitis C virus (HCV) genotype 1 infection. We conducted two phase 3 trials to examine the efficacy and safety of this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis. Methods We randomly assigned 419 patients with HCV genotype 1b infection (PEARL-III study) and 305 patients with genotype 1a infection (PEARL-IV study) to 12 weeks of ABT-450/r–ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg of ombitasvir), dasabuvir (250 mg twice daily), and ribavirin administered according to body weight or to matching placebo for ribavirin. The primary efficacy end point was a sustained virologic response (an HCV RNA level of <25 IU per milliliter) 12 weeks after the end of treatment. Results The study regimen resulted in high rates of sustained virologic response among patients with HCV genotype 1b infection (99.5% with ribavirin and 99.0% without ribavirin) and among those with genotype 1a infection (97.0% and 90.2%, respectively). Of patients with genotype 1b infection, 1 had virologic failure, and 2 did not have data available at post-treatment week 12. Among patients with genotype 1a infection, the rate of virologic failure was higher in the ribavirin-free group than in the ribavirin group (7.8% vs. 2.0%). In both studies, decreases in the hemoglobin level were significantly more common in patients receiving ribavirin. Two patients (0.3%) discontinued the study drugs owing to adverse events. The most common adverse events were fatigue, headache, and nausea. Conclusions Twelve weeks of treatment with ABT-450/r–ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained virologic response among previously untreated patients with HCV genotype 1 infection. Rates of virologic failure were higher without ribavirin than with ribavirin among patients with genotype 1a infection but not among those with genotype 1b infection. (Funded by AbbVie; PEARL-III and PEARL-IV ClinicalTrials.gov numbers, NCT01767116 and NCT01833533.)read more
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Roger Williams,Richard Aspinall,Mark A Bellis,Ginette Camps-Walsh,Matthew E. Cramp,Anil Dhawan,James Ferguson,Daniel M. Forton,Graham R. Foster,Sir Ian Gilmore,Matthew Hickman,Mark Hudson,Deirdre Kelly,Andrew Langford,Martin Lombard,Louise Longworth,Natasha K. Martin,Kieran Moriarty,Philip N. Newsome,John O'Grady,Rachel Pryke,Harry Rutter,Stephen D. Ryder,Nick Sheron,Thomas J. Smith +24 more
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References
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Journal ArticleDOI
Diagnosis, management, and treatment of hepatitis C: An update
TL;DR: This document has been approved by the AASLD, the Infectious Diseases Society of America, and the American College of Gastroenterology.
Journal ArticleDOI
Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection
Ira M. Jacobson,John G. McHutchison,Geoffrey Dusheiko,Adrian M. Di Bisceglie,K. Rajender Reddy,Natalie Bzowej,Patrick Marcellin,Andrew J. Muir,Peter Ferenci,Robert Flisiak,Jacob George,Mario Rizzetto,Daniel Shouval,Ricard Sola,R. Terg,Eric M. Yoshida,Nathalie Adda,Leif Bengtsson,Abdul J. Sankoh,Tara L. Kieffer,Shelley George,Robert S. Kauffman,Stefan Zeuzem,Vertex Phar +23 more
TL;DR: Telaprevir with peginterferon-ribavirin was associated with significantly improved rates of sustained virologic response in patients with HCV genotype 1 infection who had not received previous treatment, with only 24 weeks of therapy administered in the majority of patients.
Journal ArticleDOI
Boceprevir for Untreated Chronic HCV Genotype 1 Infection
TL;DR: The addition of boceprevir to standard therapy with peginterferon–ribavirin, as com pared with standard therapy alone, significantly increased the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection.
Journal ArticleDOI
Sofosbuvir for previously untreated chronic hepatitis C infection
Eric Lawitz,Alessandra Mangia,David L. Wyles,Maribel Rodriguez-Torres,Tarek Hassanein,Stuart C. Gordon,Michael Schultz,M. Davis,Zeid Kayali,K. Rajender Reddy,Ira M. Jacobson,Kris V. Kowdley,L. Nyberg,G. Mani Subramanian,Robert H. Hyland,Sarah Arterburn,Deyuan Jiang,John McNally,Diana M. Brainard,William T. Symonds,John G. McHutchison,Aasim Sheikh,Zobair M. Younossi,Edward Gane +23 more
TL;DR: In a single-group study of sofosbuvir combined with peginterferon-ribavirin, patients with predominantly genotype 1 or 4 HCV infection had a rate of sustained virologic response of 90% at 12 weeks.
Journal ArticleDOI
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection
Mark S. Sulkowski,David F. Gardiner,Maribel Rodriguez-Torres,K. Rajender Reddy,Tarek Hassanein,Ira M. Jacobson,Eric Lawitz,Anna S. Lok,Federico Hinestrosa,Paul J. Thuluvath,Howard J. Schwartz,David R. Nelson,Gregory T. Everson,Timothy Eley,Megan Wind-Rotolo,Shu-Pang Huang,Min Gao,Dennis Hernandez,Fiona McPhee,Diane Sherman,R. Hindes,William T. Symonds,Claudio Pasquinelli,Dennis M. Grasela +23 more
TL;DR: Once-daily oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients infected with HCV genotype 1, 2, or 3, including patients with no response to prior therapy with telaprevir or boceprevir.
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