Search: onr:"swepub:oai:gup.ub.gu.se/232208" >
Grazoprevir plus pe...
Grazoprevir plus peginterferon and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection: a randomized trial
-
- Lagging, Martin, 1965 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för biomedicin,Institute of Biomedicine
-
Brown, A. (author)
-
Mantry, P. S. (author)
-
show more...
-
Ramji, A. (author)
-
Weilert, F. (author)
-
Vierling, J. M. (author)
-
Howe, A. (author)
-
Gendrano, I. N. (author)
-
Hwang, P. (author)
-
Zhang, B. (author)
-
Wahl, J. (author)
-
Robertson, M. (author)
-
Mobashery, N. (author)
-
show less...
-
(creator_code:org_t)
- 2015-09-10
- 2016
- English.
-
In: Journal of Viral Hepatitis. - : Wiley. - 1352-0504. ; 23:2, s. 80-88
- Related links:
-
https://onlinelibrar...
-
show more...
-
https://gup.ub.gu.se...
-
https://doi.org/10.1...
-
show less...
Abstract
Subject headings
Close
- Grazoprevir (MK-5172, Merck & Co., Inc.) is a selective inhibitor of the hepatitis C virus (HCV) NS3/4a protease. The aim of this study was to evaluate the safety and efficacy of grazoprevir at doses of 25-100mg/day in combination with peginterferon and ribavirin (PEG-IFN/RBV). In this randomized, dose-ranging, multicentre trial, treatment-naive adults with chronic HCV genotype 1 infection received once-daily grazoprevir 25mg, 50mg or 100mg plus PEG-IFN/RBV for 12weeks. Patients with quantifiable HCV RNA (25IU/mL) at week 4 received an additional 12weeks of PEG-IFN/RBV. The primary endpoint was sustained virologic response (HCV RNA <25IU/mL 12weeks after completing therapy [SVR12]). Eighty-seven patients were randomly assigned and received 1 dose of therapy. Median time to undetectable HCV RNA was 16days in the 100-mg arm and 22days in the 25- and 50-mg arms. All patients except one had HCV RNA undetectable or unquantifiable at week 4 and received 12weeks of therapy. SVR12 was achieved by 13 of 24 (54.2%), 21 of 25 (84.0%) and 23 of 26 (88.5%) patients in the 25-, 50- and 100-mg arms, respectively (per-protocol analysis). Three patients discontinued as a result of nonserious adverse events (AEs) and three patients experienced serious AEs. Transaminase elevations occurred in two patients (one each in the 25- and 100-mg arms). Conclusion: These data support further study of the grazoprevir 100-mg dose. Phase 3 studies of grazoprevir 100mg in combination with elbasvir are currently ongoing (NCT01710501; protocol P038).
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Mikrobiologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Microbiology in the medical area (hsv//eng)
Keyword
- adverse event
- clinical trial
- direct-acting antiviral drugs
- resistance
- sustained virologic response
- combination therapy
- boceprevir
- sofosbuvir
- ledipasvir
- mk-5172
- Gastroenterology & Hepatology
- Infectious Diseases
- Virology
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
To the university's database
- By the author/editor
-
Lagging, Martin, ...
-
Brown, A.
-
Mantry, P. S.
-
Ramji, A.
-
Weilert, F.
-
Vierling, J. M.
-
show more...
-
Howe, A.
-
Gendrano, I. N.
-
Hwang, P.
-
Zhang, B.
-
Wahl, J.
-
Robertson, M.
-
Mobashery, N.
-
show less...
- About the subject
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Clinical Medicin ...
-
and Infectious Medic ...
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Clinical Medicin ...
-
and Gastroenterology ...
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Basic Medicine
-
and Microbiology in ...
- Articles in the publication
-
Journal of Viral ...
- By the university
-
University of Gothenburg