ANTIRETROVIRAL THERAPY FOR HIV-INFECTION IN 1996 - RECOMMENDATIONS OFAN INTERNATIONAL PANEL

Objective.-To provide clinical recommendations for antiretroviral ther apy for human immunodeficiency virus (HIV) disease with currently (mid 1996) available drugs, When to start therapy, what to start with, whe n to change, and what to change to were addressed. Participants.-A 13- member panel representing international expertise in antiretroviral re search and HIV patient care was selected by the International AIDS Soc iety-USA. Evidence.-Available clinical and basic science data, includi ng phase 3 controlled trials, clinical endpoint data, virologic and im munologic endpoint data, interim analyses, studies of HIV pathophysiol ogy, and expert opinions of panel members were considered. Recommendat ions were limited to drugs available in mid 1996. Process.-For each qu estion posed, 1 or more member(s) reviewed and presented available dat a. Recommendations were determined by group consensus (January 1996); revisions as warranted by new data were incorporated by group consensu s (February-May 1996). Conclusions.-Recent data on HIV pathogenesis, m ethods to determine plasma HIV RNA, clinical trial data, and availabil ity of new drugs point to the need for new approaches to treatment. Th erapy is recommended based on CD4(+) cell count, plasma HIV RNA level, or clinical status, Preferred initial drug regimens include nucleosid e combinations; at present protease inhibitors are probably best reser ved for patients at higher progression risk. For treatment failure or drug intolerance, subsequent regimen considerations include reasons fo r changing therapy, available drug options, disease stage, underlying conditions, and concomitant medication(s). Therapy for primary (acute) infection, high-risk exposures to HIV, and maternal-to-fetal transmis sion are also addressed. Therapeutic approaches need to be updated as new data continue to emerge.