Lipid Levels and Changes in Body Fat Distribution in Treatment-Naive, HIV-1–Infected Adults Treated With Rilpivirine or Efavirenz for 96 Weeks in the ECHO and THRIVE Trials

• Published in: Clinical infectious diseases Vol. 59; no. 3; pp. 425 - 434
• Main Authors: Tebas, Pablo, Sension, Michael, Arribas, José, Duiculescu, Dan, Florence, Eric, Hung, Chien-Ching, Wilkin, Timothy, Vanveggel, Simon, Stevens, Marita, Deckx, Henri
• Format: Journal Article
• Language: English
• Published: Oxford OXFORD UNIVERSITY PRESS 01.08.2014; Oxford University Press
• Subjects: Absorptiometry, Photon; Adolescent; Adult; Aged; Aged, 80 and over; AIDS; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral drugs; Antiviral agents; Benzoxazines - therapeutic use; Biological and medical sciences; Body fat; Body Fat Distribution; Cholesterols; Clinical trials; Dideoxynucleosides - therapeutic use; Drug Combinations; Drug therapy; Dyslipidemias; Fasting; Fats; Female; HIV; HIV 1; HIV Infections - drug therapy; HIV Reverse Transcriptase - antagonists & inhibitors; HIV-1 - drug effects; HIV/AIDS; Human immunodeficiency virus; Human viral diseases; Humans; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infectious diseases; Lamivudine - therapeutic use; Lipids; Low density lipoprotein; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Reverse Transcriptase Inhibitors - therapeutic use; Rilpivirine - therapeutic use; Tenofovir - therapeutic use; Triglycerides; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Young Adult; Zidovudine - therapeutic use; Human; Immunopathology; Antiretroviral agent; Benzoxazine derivatives; RNA-directed DNA polymerase; Adipose tissue; Acetylenic compound; Enzyme; Rilpivirine; Non nucleoside compound; Transferases; Enzyme inhibitor; Lipids; AIDS; Immune deficiency; Efavirenz; Infection; Allosteric inhibitor; Nucleotidyltransferases; Reverse transcriptase inhibitor; Viral disease; Adult; Antiviral; lipids; dual-energy x-ray absorptiometry; efavirenz; lipodystrophy; rilpivirine
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/cid/ciu234

Background. Pooled ECHO/THRIVE lipid and body fat data are presented from the ECHO (Efficacy Comparison in Treatment-Naïve, HIV-Infected Subjects of TMC278 and Efavirenz) and THRIVE (TMC278 Against HIV, in a Once-Daily Regimen Versus Efavirenz) trials. Methods. We assessed the 96-week effects on lipids, adverse events (AEs), and body fat distribution (dual-energy x-ray absorptiometry) of rilpivirine (RPV) and EFV plus 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in treatment-naive adults infected with human immunodeficiency virus type 1 (HIV-1). Results. Rilpivirine produced minimal changes in total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides. Compared with RPV, EFV significantly (P < .001) increased lipid levels. Decreases in the TC/HDL-C ratio were similar with RPV and EFV. Background N[t] RTI affected RPV-induced lipid changes; all levels increased with zidovudine/lamivudine (3TC) and abacavir/3TC (except triglycerides, which were unchanged). With emtricitabine/tenofovir, levels of HDL-C were increased, TC and LDL-C were unchanged, and triglycerides were decreased. With EFV, lipid levels increased in each N[t]RTI subgroup (except triglycerides were unchanged with abacavir/3TC). Fewer (P < .001) RPV-treated patients than EFV-treated patients had TC, LDL-C, and triglyceride levels above National Cholesterol Education Program cutoffs. More RPV-than EFV-treated patients had HDL-C values below these cutoffs (P = .02). Dyslipidemia AEs were less common with RPV than with EFV. Similar proportions of patients had a ≥10% decrease in limb fat (16% with RPV and 17% with EFV). Limb fat was significantly (P < .001) increased to a similar extent (by 12% with RPV and 11% with EFV). At week 96, patients receiving zidovudine/3TC had lost limb fat, and those receiving emtricitabine/tenofovir had gained it. Conclusions. Over the course of 96 weeks, RPV-based therapy was associated with lower increases in lipid parameters and fewer dyslipidemia AEs than EFV-based treatment. Body fat distribution changes were similar between treatments. The N[t]RTI regimen affected lipid and body fat distribution changes.