Fixed-dose combination emtricitabine/tenofovir/efavirenz initiated during acute HIV infection; 96-week efficacy and durability

AIDS. 2016 Nov 28;30(18):2815-2822. doi: 10.1097/QAD.0000000000001255.

Abstract

Background: Updated guidelines recommend immediate antiretroviral treatment (ART) during acute HIV infection (AHI), but efficacy data on regimens during AHI are limited.

Methods: We provide final data on a prospective, single-arm 96-week open-label study of once-daily emtricitabine/tenofovir/efavirenz initiated during AHI. The primary endpoint was the proportion of responders with HIV RNA less than 200 copies/ml by week 24. We examined time to viral suppression, retention, and CD8 cell activation through week 96 in relation to baseline characteristics.

Results: Between January 2005 and December 2011, 92 AHI participants enrolled. Most participants (78%) were men who have sex with men (MSM), and 42% were young MSM (18-25 years of age). Two participants withdrew leaving 90 patients for analysis. Eighty-one (90%) remained on therapy and achieved viral suppression to less than 200 copies/ml by week 24, and 71 (79%) to less than 50 copies/ml at week 48. The median time from ART initiation to suppression less than 200 copies/ml was 65 days (range 7-523) and to less than 50 copies/ml was 105 days (range 14-523). The frequency of immune activation declined from a median of 67% to 16% through week 96. Retention on study was maintained in 92% of participants at week 48 and in 83% through week 96. Among 75 participants retained through week 96, 92% were suppressed to less than 50 copies/ml. Among 39 young MSM, 79% completed a week 96 visit and 67% were suppressed at week 96.

Conclusion: ART during AHI resulted in rapid and sustained viral suppression with high rates of retention in care and on ART in this cohort including a large proportion of young MSM.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-HIV Agents / administration & dosage*
  • Benzoxazines / administration & dosage*
  • CD8-Positive T-Lymphocytes / immunology
  • Drug Combinations
  • Emtricitabine / administration & dosage*
  • Female
  • HIV Infections / drug therapy*
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Prospective Studies
  • RNA, Viral / blood
  • Sustained Virologic Response
  • Tenofovir / administration & dosage*
  • Treatment Outcome
  • Viral Load
  • Young Adult

Substances

  • Anti-HIV Agents
  • Benzoxazines
  • Drug Combinations
  • RNA, Viral
  • Tenofovir
  • Emtricitabine
  • efavirenz