Skip to content
Evevident
Original paper
2011NEJMInfectious Disease

HPTN 052

Prevention of HIV-1 infection with early antiretroviral therapy

RCTHIV prevention

On this page

Overview

Early ART in HIV-positive partners dramatically reduced linked HIV transmission to uninfected partners.

Clinical takeaway

HPTN 052 established treatment as prevention and provided trial-level support for viral suppression as a public-health prevention strategy.

Key result

Early ART cut linked HIV transmission by 96% (1 vs 27 linked transmissions; HR 0.04).

Practice impact

Supports immediate ART both for individual benefit and prevention of transmission.

Evidence

Study design

Randomized controlled trial.

Enrollment

1,763

Follow-up

Median 1.7 years at the interim analysis (extended in later follow-up).

Geography

Multinational

Clinical question

Does early ART reduce HIV transmission in serodiscordant couples?

Population

  • HIV-serodiscordant couples in which the infected partner had a CD4 count of 350-550 cells/mm3.

Intervention

Immediate (early) antiretroviral therapy.

Comparator

Delayed ART (started at CD4 <=250 or an AIDS-defining illness).

Primary outcome

Linked HIV-1 transmission to the previously uninfected partner.

Early ART in the HIV-positive partner reduced linked sexual transmission by 96%, establishing treatment as prevention.

Hazard ratio / 0.04 / CI 95% CI 0.01-0.27 / p=<0.001

Key results

  • Linked transmissions: 1 in the early-ART group vs 27 in the delayed-ART group; HR 0.04 (95% CI 0.01-0.27; p<0.001), a 96% relative reduction.
  • Nearly all transmissions occurred from partners not yet virally suppressed.
  • Early ART also reduced clinical events (notably extrapulmonary tuberculosis) in the infected partner.

Harms

  • Antiretroviral therapy carries drug-specific toxicities and requires sustained adherence.
  • Prevention benefit depends on achieving and maintaining viral suppression.

Clinical Use

When to cite

  • When explaining treatment as prevention in HIV and the evidence that suppressive ART reduces sexual transmission.

Practice impact

  • Supports immediate ART both for individual benefit and prevention of transmission.

Applicability

  • Most applicable to HIV-serodiscordant couples; the treatment-as-prevention principle extends broadly to any virally suppressed person with HIV.

Limitations

  • Couples received intensive adherence counseling and follow-up not always available in routine care.
  • Prevention depends on achieving and sustaining viral suppression.
  • Predominantly heterosexual couples, though the biologic principle generalizes.

Common misinterpretations

  • The benefit is transmission prevention through viral suppression; it does not imply zero risk without sustained undetectable viral load.
  • HPTN 052 tested early ART for prevention; START later confirmed early ART also benefits the treated individual regardless of CD4 count.

Related evidence

START - Similar Question

Citation

Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493-505. doi:10.1056/NEJMoa1105243

The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy.