From bench to clinic: Accessing promising investigational medications for patients with HIV infection in an urban Family Health Center

Abstract

Background: Patients who experience failure of treatment for human immunodeficiency virus and who have no other treatment options can sometimes obtain promising investigational medications through expanded access programs. However, psychosocial and socioeconomic factors, common among underserved populations, create barriers to enrollment at referral centers. To increase access for unstable patients, an urban family health center developed the capacity to provide investigational medications directly to patients. This article describes that process and the treatment outcomes. Methods: The necessary steps to implement the program were outlined and accomplished. Patient outcomes were analyzed and the project's value to the organization and its clients was evaluated. Results: Twenty-five patients received one or more investigational antiretroviral medications. Within 24 weeks of enrollment, the majority of patients achieved undetectable viral levels (80% achieved <400 copies/mL and 64% achieved <50 copies/mL), with a median decrease of 49,173 copies/mL (P = .0002) and a median increase in CD4 lymphocyte count of 95 cells/mm3 (P < .0001). Conclusion: Community health centers can mitigate barriers to access and meet the needs of unstable patients who have no therapeutic options by incorporating access to promising investigational treatments into primary care. The use of centralized institutional review boards can increase efficiency of the review process, but provisions to address local cultural and social issues should be included.