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Despite the success of combination antiretroviral therapy, a significant proportion of patients experience a loss of virologic, immunologic, or clinical benefit from their current regimens. Frequently, these patients have limited options for alternative treatment regimens. Developing safe and effective therapies for treatment-experienced patients, particularly for those with documented three- or four-class antiretroviral drug resistance is a public health priority that poses significant challenges. Causes of treatment failure are diverse as are target patient populations with respect to the type and duration of treatment experience. These aspects of patient care necessitate individualized treatment plans and make standardization of objectives and study designs for development of new therapies difficult. Issues in study design include the choice of adequate control arms, appropriate endpoints, and reasonable expectations for duration of response and safety considerations.
The Salvage Therapy II workshop was held 16-17 April 2004, to discuss these issues with HIV-treating clinicians, clinical research investigators, pharmaceutical industry representatives, regulatory authorities and interested HIV-community leaders. The workshop focused on issues concerning heavily treatment-experienced patients, specifically patients who are three- or four-drug classes experienced with limited or no options for suppressive antiviral regimens. This review summarizes the proceedings from this meeting and represents both a consensus of the views expressed during the workshop as determined by the authors as well as the views of the authors themselves. The review also highlights the discussions on challenges that surround new therapy development and clinical management of treatment-experienced patients.
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