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Ombitasvir/paritaprevir/ritonavir and dasabuvir tablets for hepatitis C virus genotype 1 infection.

AbstractOBJECTIVE:
To review the data with ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection.
DATA SOURCES:
Phase I, II, and III trials and review articles were identified through MEDLINE (1996-January 2015) and PubMed (1996-January 2015), conference abstracts, and US national clinical trials registry, using the keywords NS3/4A protease inhibitor, NS5A inhibitor, NS5B polymerase inhibitor, ABT-450, ABT-267, ABT-333, paritaprevir, ombitasvir, and dasabuvir.
STUDY SELECTION AND DATA EXTRACTION:
Preclinical, phase I, II, and III studies describing pharmacology, pharmacokinetics, efficacy, safety, and tolerability were identified.
DATA SYNTHESIS:
Noncirrhotic patients with HCV genotype 1b experienced sustained virological response 12 weeks after completion of therapy (SVR12) rates of 96% to 100% when ombitasvir/paritaprevir/ritonavir and dasabuvir were administered for 12 weeks, regardless of inclusion of ribavirin. SVR12 rates of 95% to 97% were seen in noncirrhotic patients with HCV genotype 1a infection who received ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin for 12 weeks. Patients with Child-Pugh Class A cirrhosis also experienced high SVR12 rates (91.8%) when ombitasvir/paritaprevir/ritonavir and dasabuvir were administered with ribavirin for 12 weeks. Cirrhotic patients with HCV genotype 1a and a history of prior null response to peginterferon/ribavirin have higher SVR12 rates when ombitasvir/paritaprevir/ritonavir and dasabuvir and ribavirin are administered for 24 instead of 12 weeks (94.2% vs 88.6%). Adverse events are typically mild, most commonly consisting of fatigue, headache, nausea, and diarrhea.
CONCLUSION:
The regimen consisting of ombitasvir/paritaprevir/ritonavir and dasabuvir is highly efficacious in the treatment of HCV genotype 1 infection, with minimal adverse events. It is expected to play an important role in the armamentarium of novel agents that have a high chance of curing HCV infection.
AuthorsOlga M Klibanov, Stormi E Gale, Barbara Santevecchi
JournalThe Annals of pharmacotherapy (Ann Pharmacother) Vol. 49 Issue 5 Pg. 566-81 (May 2015) ISSN: 1542-6270 [Electronic] United States
PMID25680759 (Publication Type: Journal Article, Review)
Copyright© The Author(s) 2015.
Chemical References
  • Anilides
  • Antiviral Agents
  • Carbamates
  • Cyclopropanes
  • Drug Combinations
  • Lactams, Macrocyclic
  • Macrocyclic Compounds
  • Sulfonamides
  • Tablets
  • ombitasvir
  • Ribavirin
  • Uracil
  • Proline
  • 2-Naphthylamine
  • dasabuvir
  • Valine
  • Ritonavir
  • paritaprevir
Topics
  • 2-Naphthylamine
  • Anilides (therapeutic use)
  • Antiviral Agents (therapeutic use)
  • Carbamates (therapeutic use)
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Cyclopropanes
  • Drug Combinations
  • Drug Resistance, Viral
  • Drug Therapy, Combination
  • Genotype
  • Hepacivirus (genetics)
  • Hepatitis C, Chronic (drug therapy)
  • Humans
  • Lactams, Macrocyclic
  • Liver Cirrhosis (drug therapy)
  • Macrocyclic Compounds (therapeutic use)
  • Proline (analogs & derivatives)
  • Ribavirin (therapeutic use)
  • Ritonavir (therapeutic use)
  • Sulfonamides (therapeutic use)
  • Tablets
  • Uracil (analogs & derivatives, therapeutic use)
  • Valine

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