Linked Life Data

21688986

Source:http://linkedlifedata.com/resource/pubmed/id/21688986

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
7
pubmed:dateCreated
2011-6-29
pubmed:abstractText
Abstract Our objective was to evaluate the liver toxicity of antiretroviral regimens including fosamprenavir plus ritonavir (FPV/r) 1400/100 mg once daily (QD) in HIV/hepatitis C virus (HCV)-coinfected patients. This was a prospective cohort study that included 117 HIV/HCV-coinfected patients who started FPV/r 1400/100 mg QD-based antiretroviral therapy (ART) and who neither had received a previous antiretroviral regimen containing FPV nor had a past history of virologic failure while receiving protease inhibitors (PI). The primary end point of the study was the occurrence of grade 3-4 liver enzymes elevations (LEE) within 1 year after starting FPV/r QD. Factors potentially associated with grade 3-4 LEE, including baseline liver fibrosis, were analyzed. Eleven (9%) patients had a grade 3-4 LEE during the follow-up, resulting in an incidence of severe liver toxicity of 9% (95% confidence interval 4.1-14.6%). None of these cases led to FPV/r discontinuation. Baseline liver fibrosis could be assessed in 97 (83%) patients. Six of 71 patients (8%) with significant fibrosis had a grade 3-4 LEE versus 2 of 26 (8%) without significant fibrosis (p=1.0). Twenty (21%) patients had cirrhosis at baseline. There were no cases of LEE among cirrhotics. In conclusion, the incidence of severe liver toxicity after 1 year of therapy with FPV/r QD-based ART in HIV/HCV-coinfected patients is similar to what has been reported with other boosted PIs. In addition, the presence of significant fibrosis or cirrhosis was not associated with the emergence of liver toxicity. Thus, ART regimens containing FPV/r QD may be considered safe in HIV/HCV-coinfected patients, including those with cirrhosis.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
1557-7449
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
25
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
395-402
pubmed:meshHeading
pubmed-meshheading:21688986-Adult, pubmed-meshheading:21688986-Anti-HIV Agents, pubmed-meshheading:21688986-CD4 Lymphocyte Count, pubmed-meshheading:21688986-Carbamates, pubmed-meshheading:21688986-Cohort Studies, pubmed-meshheading:21688986-Drug Therapy, Combination, pubmed-meshheading:21688986-Drug-Induced Liver Injury, pubmed-meshheading:21688986-Female, pubmed-meshheading:21688986-HIV Infections, pubmed-meshheading:21688986-Hepacivirus, pubmed-meshheading:21688986-Hepatitis C, pubmed-meshheading:21688986-Humans, pubmed-meshheading:21688986-Liver Cirrhosis, pubmed-meshheading:21688986-Male, pubmed-meshheading:21688986-Middle Aged, pubmed-meshheading:21688986-Phosphoric Acid Esters, pubmed-meshheading:21688986-RNA, Viral, pubmed-meshheading:21688986-Ritonavir, pubmed-meshheading:21688986-Sulfonamides
pubmed:year
2011
pubmed:articleTitle
Liver toxicity of antiretroviral combinations including fosamprenavir plus ritonavir 1400/100?mg once daily in HIV/hepatitis C virus-coinfected patients.
pubmed:affiliation
Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Sevilla, Spain.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Multicenter Study