Intelence (Etravirine) Label Updated to Include New Drug Interaction Information
“FDA recently updated the Intelence (etravirine) label to include drug-drug interaction information between etravirine and fluconazole, voriconazole, lopinavir/ritonavir tablets and clopidogrel. The major changes ... are summarized below.
“Etravirine - fluconazole and voriconazole: Co-administration of etravirine and fluconazole or voriconazole significantly increased etravirine exposures. The amount of safety data at these increased etravirine exposures is limited; therefore, etravirine and fluconazole or voriconazole should be co-adminstered with caution. No dose adjustments of Intelence, fluconazole or voriconazole is needed.
“Etravirine - lopinavir/ritonavir tablets: Intelence and Kaletra (lopinavir/ritonavir) tablets can be coadministered without dose adjustment[.]
“Etravirine - clopidogrel: Activation of clopidogrel to its active metabolite may be decreased when clopidogrel is co-administered with Intelence. Alternative to clopidogrel should be considered.”
The complete revised label is available at the FDA Web site.
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Study Findings Suggest Implications for Understanding HIV Bone Marrow Pathology and the Mechanisms by which HIV Causes Persistent Infection
“HIV causes a chronic infection characterized by depletion of CD4(+) T lymphocytes and the development of opportunistic infections. Despite drugs that inhibit viral spread, HIV infection has been difficult to cure because of uncharacterized reservoirs of infected cells that are resistant to highly active antiretroviral therapy (HAART) and the immune response. Here we used CD34(+) cells from infected people as well as in vitro studies of wild-type HIV to show infection and killing of CD34(+) multipotent hematopoietic progenitor cells (HPCs). In some HPCs, we detected latent infection that stably persisted in cell culture until viral gene expression was activated by differentiation factors. A unique reporter HIV that directly detects latently infected cells in vitro confirmed the presence of distinct populations of active and latently infected HPCs. These findings have major implications for understanding HIV bone marrow pathology and the mechanisms by which HIV causes persistent infection.”
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Study Suggests Potential for Triple-Class Virologic Failure in HIV-Infected People Undergoing Antiretroviral Therapy for Up to 10 Years
“Life expectancy of people with human immunodeficiency virus (HIV) is now estimated to approach that of the general population in some successfully treated subgroups. However, to attain these life expectancies, viral suppression must be maintained for decades. … We studied the rate of triple-class virologic failure (TCVF) in patients within the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) who started antiretroviral therapy (ART) that included a nonnucleoside reverse-transcriptase inhibitor (NNRTI) or a ritonavir-boosted protease inhibitor (PI/r) from 1998 onwards. We also focused on TCVF in patients who started a PI/r-containing regimen after a first-line NNRTI-containing regimen failed. … Of 45[,]937 patients followed up for a median (interquartile range) of 3.0 (1.5-5.0) years, 980 developed TCVF (2.1%). By 5 and 9 years after starting ART, an estimated 3.4% … and 8.6% … of patients, respectively, had developed TCVF. The incidence of TCVF rose during the first 3 to 4 years on ART but plateaued thereafter. There was no significant difference in the risk of TCVF according to whether the initial regimen was NNRTI or PI/r based (P = .11). By 5 years after starting a PI/r regimen as second-line therapy, 46% of patients had developed TCVF. … The rate of virologic failure of the 3 original drug classes is low, but not negligible, and does not appear to diminish over time from starting ART. If this trend continues, many patients are likely to need newer drugs to maintain viral suppression. The rate of TCVF from the start of a PI/r regimen after NNRTI failure provides a comparator for studies of response to second-line regimens in resource-limited settings.”
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