Prevention of HIV-1 infection with early antiretroviral therapy

Topic:

HIV Prevention

Authors:

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team

External Link:

Link to article

BACKGROUND:

Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.

METHODS:

In nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death.

RESULTS:

As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01).

CONCLUSIONS:

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. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).

N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18. PubMed PMID: 21767103; PubMed Central PMCID: PMC3200068

Categories

CRS
Topics

Clinical Trials

A5329: Interferon –Free Therapy for Chronic Hepatitis C...

A5329 is a study for people who are infected with both HIV and the Hepatitis C virus (HCV) and have never taken Hepatitis C...

Read More

NWCS 445: Novel Biomarkers to Shorten TB Treatment

Objectives: Primary: To develop a highly predictive algorithm that identifies TB patients who will be cured by treatment...

Read More

A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Read More

A5337: Safety and Efficacy of Sirolimus for HIV Reservoir...

When a person becomes infected with HIV the immune system (the system that helps fight infection) is weakened (partly because...

Read More

A5342: Evaluating the Safety, Tolerability, and Effect of a...

The purpose of this study is to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody...

Read More