AIDS Weekly

New HIV/AIDS research from E. Dejesus et al outlined

AIDS Weekly Library Library Home This article was published in AIDS Weekly, which you can subscribe to online.

"Patients on stable ART with HIV-1 RNA <200 copies per milliliter for >= 3 months were stratified by prior nonnucleoside reverse transcriptase inhibitor-based or protease inhibitor-based therapy and randomized (2:1) to simplify treatment to EFV/FTC/TDF or to stay on their baseline regimen (SBR). Efficacy and safety assessments were. performed at baseline and at weeks 4, 12, 24, 36, and 48. Additional patient-reported outcomes included the following: adherence by visual analog scale, quality of life by SF-36 (v2) survey, HIV Symptom Index, and the Preference of Medication and Perceived Ease of the Regimen for Condition questionnaires. Three hundred patients (EFV/FTC/TDF 203, SBR 97) were evaluated (prior protease inhibitor-based ART, 53%; nonnucleoside reverse transcriptase inhibitor-based ART, 47%). The arms were well balanced at baseline with 88% males, 29% blacks, and a mean age of 43 years; CD4 was 540 cells per cubic millimeter, 96% had HIV-1 RNA <50 copies per milliliter, and 88% were on their first ART regimen. Through 48 weeks, 89% vs. 88% in the EFV/FTC/TDF vs. SBR arms, respectively, maintained HIV-1 RNA <200 copies per milliliter by time to loss of virologic response algorithm (intent to treat, noncompleters = failures) with the difference (95% confidence interval) between arms of 1.1% (-6.7% to 8.8%), indicating noninferiority of EFV/FTC/TDF vs. SBR. Similarly, maintenance of HIV-1 RNA <50 copies per milliliter by time to loss of virologic response algorithm was 87% vs. 85% for EFV/FTC/TDF vs. SBR, respectively [difference (95% confidence interval) 2.6% (-5.9% to 11.1%)]. Discontinuation rates were similar (EFV/FTC/TDF 11%, SBR 12%); more discontinuations for adverse events occurred in the EFV/FTC/TDF arm vs. SBA (5% vs. 1%), most commonly for nervous system symptoms. More patients withdrew consent in the SBR arm vs. EFV/FTC/TDF (7% vs. 2%). Estimated glomerular filtration rate (by Modification of Diet in Renal Disease) remained unchanged over 48 weeks in both arms (median change < 1 mL.min(-1).1.73 m(-2)). A decrease in fasting triglycerides was observed at 48 weeks in the EFV/FTC/TDF vs. SBR arm (-20 vs. -3.0 mg/dL; P = 0.035). Adherence of >= 96% was reported by visual analog scale in both anus at baseline and at all study visits," wrote E. Dejesus and colleagues.

The researchers concluded: "Simplification to EFV/FTC/TDF maintained high and comparable rates of virologic suppression vs. SBR through 48 weeks."

Dejesus and colleagues published their study in Jaids - Journal of Acquired Immune Deficiency Syndromes (Simplification of Antiretroviral Therapy to a Single-Tablet Regimen Consisting of Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Versus Unmodified Antiretroviral Therapy in Virologically Suppressed HIV-1-Infected Patients. Jaids - Journal of Acquired Immune Deficiency Syndromes, 2009;51(2):163-174).

For additional information, contact E. Dejesus, Orlando Immunology Center, 1701 N Mills Avenue, Orlando, FL 32803, USA.

Publisher contact information for the Jaids - Journal of Acquired Immune Deficiency Syndromes is: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA.

Keywords: United States, Orlando, HIV/AIDS, AIDS, Acquired Immune Deficiency Syndrome, Acquired Immunodeficiency Syndrome, Anti-HIV, Antivirals, Drugs, Efavirenz, Emtricitabine, Enzyme Research, Enzymes, Enzymology, HIV, Human Immunodeficiency Virus, Immunology, Nonnucleoside Reverse Transcriptase Inhibitor, Nucleoside Reverse Transcriptase Inhibitor, Nucleoside and Nucleotide Reverse Transcriptase InhibitorsAntiretroviral, Pharmaceuticals, Protease Inhibitor, Protease Inhibitors, Proteins, Proteomics, Quality of Life, Sexually Transmitted Disease, Tenofovir Disoproxil Fumarate, Therapy, Treatment, Virology.

This article was prepared by AIDS Weekly editors from staff and other reports. Copyright 2009, AIDS Weekly via NewsRx.com.