Letter regarding PrEP

Dear Colleague,

The results of the recently published Global iPrEX study (N Engl J Med November 23, 2010 (10.1056/NEJMoa1011205), demonstrated for the first time that, in the controlled environment of a clinical trial, the daily use of a co-formulation of two antiretroviral medications, tenofovir and emtricitabine (brand name Truvada®), could prevent the sexual acquisition of HIV in gay and bisexual men and transgender women, when combined with a comprehensive package of prevention services - monthly HIV testing, condom provision, counseling, and management of other sexually transmitted diseases. These study findings are an important contribution to knowledge about HIV prevention.

The New York State Department of Health AIDS Institute (AIDS Institute) is encouraged about the potential of adding pre-exposure prophylaxis (PrEP) to the menu of evidence-based HIV prevention interventions. However, many questions remain about how PrEP medications should be used outside of a clinical trial in real-life settings. These questions related to the effectiveness of PrEP in populations other than those studied and in the absence of the comprehensive, intensive prevention services provided in the study. In addition, there are still many questions, including adherence, drug resistance, long-term safety, increased risk taking behavior, and access to medications.

The AIDS Institute is dedicated to exploring these questions, with the realization that relying on the use of antiretroviral medications alone will not completely prevent sexual acquisition of HIV and will not prevent at all other sexually transmitted infections.

To thoroughly review the implications of the study and determine next steps, the AIDS Institute is eliciting advice from the New York State Medical Care Criteria Committee (an advisory group of clinicians responsible for developing guidelines for HIV care), participating in a CDC-sponsored expert meeting in March, and expanding consultations with stakeholders. Meanwhile, we urge individuals and clinical providers to await more guidance before making use of antiretroviral drugs for HIV prevention purposes.

The AIDS Institute remains committed to stopping transmission of HIV through evidence-based interventions. We believe the most effective prevention strategy will be one that combines different approaches (behavioral, structural, and biomedical).

We will be updating this information in the coming weeks/months. For additional information, please refer to the PrEP fact sheet on the CDC website.

Sincerely,

Humberto Cruz
Director
AIDS Institute