Incident AIDS or Death After Initiation of Human Immunodeficiency Virus Treatment Regimens Including Raltegravir or Efavirenz Among Adults in the United States

Clin Infect Dis. 2017 Jun 1;64(11):1591-1596. doi: 10.1093/cid/cix199.

Abstract

Background.: The long-term effectiveness of human immunodeficiency virus (HIV) treatments containing integrase inhibitors is unknown.

Methods.: We use observational data from the Centers for AIDS Research Network of Integrated Clinical Systems and the Centers for Disease Control and Prevention to estimate 4-year risk of AIDS and all-cause mortality among 415 patients starting a raltegravir regimen compared to 2646 starting an efavirenz regimen (both regimens include emtricitabine and tenofovir disoproxil fumarate). We account for confounding and selection bias as well as generalizability by standardization for measured variables, and present both observational intent-to-treat and per-protocol estimates.

Results.: At treatment initiation, 12% of patients were female, 36% black, 13% Hispanic; median age was 37 years, CD4 count 321 cells/µL, and viral load 4.5 log10 copies/mL. Two hundred thirty-five patients incurred an AIDS-defining illness or died, and 741 patients left follow-up. After accounting for measured differences, the 4-year risk was similar among those starting both regimens (ie, intent-to treat hazard ratio [HR], 0.96 [95% confidence interval {CI}, .63-1.45]; risk difference, -0.9 [95% CI, -4.5 to 2.7]), as well as among those remaining on regimens (ie, per-protocol HR, 0.95 [95% CI, .59-1.54]; risk difference, -0.5 [95% CI, -3.8 to 2.9]).

Conclusions.: Raltegravir and efavirenz-based initial antiretroviral therapy have similar 4-year clinical effects. Vigilance regarding longer-term comparative effectiveness of HIV regimens using observational data is needed because large-scale experimental data are not forthcoming.

Keywords: HIV; cohort study; comparative effectiveness; mortality.; raltegravir.

Publication types

  • Observational Study

MeSH terms

  • Acquired Immunodeficiency Syndrome / drug therapy
  • Acquired Immunodeficiency Syndrome / epidemiology*
  • Acquired Immunodeficiency Syndrome / mortality*
  • Adult
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • Benzoxazines / administration & dosage
  • Benzoxazines / adverse effects
  • Benzoxazines / therapeutic use*
  • CD4 Lymphocyte Count
  • Cohort Studies
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / epidemiology
  • HIV Infections / mortality
  • HIV Integrase Inhibitors / therapeutic use
  • HIV-1 / drug effects
  • Humans
  • Male
  • Middle Aged
  • RNA, Viral / blood
  • Raltegravir Potassium / administration & dosage
  • Raltegravir Potassium / adverse effects
  • Raltegravir Potassium / therapeutic use*
  • Reverse Transcriptase Inhibitors / administration & dosage
  • Reverse Transcriptase Inhibitors / adverse effects
  • Reverse Transcriptase Inhibitors / therapeutic use
  • Tenofovir / administration & dosage
  • Tenofovir / adverse effects
  • Tenofovir / therapeutic use
  • United States / epidemiology
  • Viral Load / drug effects
  • Young Adult

Substances

  • Anti-HIV Agents
  • Benzoxazines
  • HIV Integrase Inhibitors
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Raltegravir Potassium
  • Tenofovir
  • efavirenz