783 Integration of Antiretroviral Therapy into An Existing Tuberculosis Directly Observed Therapy Program in a Resource Constrained Setting (START Study) C Jack*1, G Friedland2, U Lalloo1, W El-Sadr3, S Cassol1, M Murrman3, Q Abdool Karim1, S Abdool Karim1 1N Mandela Sch of Med, Univ of Natal, Durban, South Africa; 2Yale Univ, New Haven, CT; and 3Columbia Univ, New York, NY
Background: Tuberculosis (TB) is the leading cause of morbidity and mortality among persons with HIV/AIDS in sub-Saharan Africa. Up to 2/3 of patients (pts) with TB are co-infected with HIV in South Africa and even with successful TB therapy, mortality from HIV/AIDS related diseases is very high. Treatment of both diseases requires special attention to medication adherence. TBDOT infrastructure exists in many resource-constrained settings and are potential sites for introduction and monitoring of antiretroviral therapy (ART). The feasibility, benefit, and risks of integrating TB and HIV/AIDS therapy using existing TBDOT programs, potentially improving both HIV and TB outcomes, has not been explored.
Methods: Consenting patients with smear + pulmonary TB seen at Prince Zulu Communicable Disease Clinic, Durban, South Africa, are offered HIV counseling and testing, and if HIV+, offered ART. Once-a-day regimen of ddI+3TC+efavirenz is co-administered with TBDOT standard regimen (isoniazid+rifampin+pryazinamide+ethambutol x 2 months [mos] and isoniazid+rifampin x 4 mos) 5 days/wk at DOT visits and self-administered on weekends. Pts are monitored for efficacy, weekend adherence, side effects, and toxicity by standardized history, physical exams, and laboratory tests. After completion of TB therapy, pts are referred to HIV clinic for continued ART and HIV care. TB clinic staff training, logistics, and drug supply issues are addressed.
Results: From 2/02-7/02, 92 pts were screened; 59 (64%) were HIV+, 20 enrolled (15 women, 5 men); mean age 31 yrs (18-52 yrs); mean CD4 230 cells, range 24-499 cells (6 < 200, 14 -200-500); mean viral load (VL) 5.75 log, range 3.81-6.26 log. At 4 mos, 78% had VL <50 copies; and a mean rise in CD4 count of 69 cells. Medication has been well tolerated and without significant GI, hepatic, skin, or neurologic toxicity. Weekend adherence has been excellent. By 2 mos 18/20 pts had negative TB smears. Staff interest and patient acceptance has been high with only 1 dropout.
Conclusions: This pilot study demonstrates that TBDOT programs can serve as important entry points for identification of HIV and introduction and monitoring of ART. Once-daily ART and TB therapy co-administration appears safe and effective. Staff and pt interest and response is excellent. Expansion of this strategy to a randomized trial of benefits and risks of concurrent vs deferred ART and operational aspects of integrating TB and HIV/AIDS care has commenced.
