NIAID Reports Tenofovir/Emtricitabine is Better than Abacavir/Lamivudine in Antiretroviral-Naïve, HIV-Infected Individuals with High Viral Loads
“For HIV-infected individuals starting antiretroviral therapy (ART), it has been unclear which of two commonly used drug combinations is safer and more effective: abacavir plus lamivudine or tenofovir plus emtricitabine.
“Now, the first published results of a study known as A5202 indicate that the tenofovir + emtricitabine combination works better in a subgroup of treatment-naïve individuals. …
“In the study, nearly 2,000 HIV-infected men and women starting ART were assigned at random to one of four daily regimens containing either abacavir + lamivudine or tenofovir + emtricitabine together with either efavirenz or ritonavir-boosted atazanavir. …
“Both abacavir + lamivudine and tenofovir + emtricitabine reduced the amount of HIV in most study participants. However, among individuals who had high viral loads (100,000 copies or more of HIV RNA per milliliter of blood) at entry into the study, the treatment regimens containing abacavir + lamivudine were significantly less effective at controlling HIV than the regimens containing tenofovir + emtricitabine. In addition, among participants with high initial viral loads, those who received abacavir + lamivudine experienced their first serious side effect sooner than those who received tenofovir + emtricitabine.
“First announced in February 2008, these findings were taken into account in the formulation of the U.S. Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. There, the tenofovir + emtricitabine combination (in addition to one or more other antiretroviral drugs) is listed as a preferred option for treating HIV-infected individuals who are starting antiretroviral therapy.”
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Maraviroc Approved for Treatment-Naïve Adults
“On November 20, 2009, the Food and Drug Administration approved a supplemental NDA [new drug application] to expand the indication for Selzentry (maraviroc) to include combination antiretroviral treatment of therapy naïve adults infected with CCR5-tropic HIV-1 virus. Maraviroc was previously approved (8/6/2007) for treatment of therapy experienced adult patients infected with CCR5-tropic HIV-1 virus. The expanded indication is based upon data collected through 96 weeks from Study A4001026, demonstrating safety and efficacy.”
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Norvir (Ritonavir) Product Label Updated
"On November 23, 2009, FDA approved changes to the Norvir package insert (product label) to include drug-drug interaction information for concurrent ritonavir administration with:
- inhaled medicines such as salmeterol or salmeterol in combination with fluticasone propionate (Serevent, Advair)
- sildenafil (Revatio)
“Also other revisions to the Contraindications, Warnings, Precautions: Drug Interactions and Dosage and Administration [were made]."
The complete revised labeling will be available at the FDA Web site.
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Etravirine Label Updated With 48-Week Data
“On November 24, 2009, FDA approved revisions to the INTELENCE (etravirine) labeling to include updated results through 48 weeks of dosing for the two Phase 3 trials TMC125-C206 and TMC125-C216 in treatment-experienced patients. This constitutes the required confirmatory data for Traditional approval....
“Co-administration of INTELENCE™ with drugs that are substrates of CYP3A, CYP2C9, and/or CYP2C19 or are transported by P-glycoprotein may alter the therapeutic effect or adverse reaction profile of the co-administered drug(s)."
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