Oral Abstract Presentations|
Clinical Trials in Resource-Limited Settings
Session Day and Time: Thursday 4 - 6:15 pm
Presentation Time: 5:00
Room: Ballroom C
Background: The magnitude of the AIDS epidemic in Malawi has prompted the Ministry of Health to develop an antiretroviral program despite the limitation of the health infrastructure. In October 2001, Triomune (D4T 40 mg/3TC 150 mg/NVP 200 mg) became the first line antiretroviral medication in the program. While the price ($35/month) limits the program to the upper middle class, evaluation of this program will be critical to scaling up antiretroviral therapy nationally.
Methods: All patients (pts) seeking initiation of Triomune or continuation of antiretroviral therapy at the Lilongwe Central Hospital between September 2001 and June 2002 were evaluated retrospectively for demographics, laboratory results, retention in care, mortality, and adverse events. Toxicity was monitored clinically. Analysis is through September 2002, so that each participant has the potential of at least 3 months (mos) of follow-up time; monitoring of the program is ongoing. Loss to follow-up was defined as no visits in the past 90 days or confirmed death. Paired t-test was used for CD4 changes.
Results: 348/452 patients presenting to the clinic received at least one prescription of Triomune. Reasons for not initiating therapy included death, cost, TB therapy, and high CD4 count. Median baseline CD4 count was 70 cells/mm3. The mean CD4 increase in pts receiving 6 mos of treatment was 107 cells/mm3 (n = 46). Medication was fairly well tolerated with only 4% (13/348) of pts discontinuing therapy for severe toxicity (10 rash, 1 hepatitis, 2 peripheral neuropathy). Drug interruptions were documented in 21% of pts; cost and TB therapy were the most common reasons for interruption. Documented mortality rate was 27/452 (6%); Cryptococcal meningitis and Kaposi Sarcoma were the most common causes of death. Drop out rate by intent to treat analysis was 52% over the 12-month evaluation period; 19% of clients attended only their initial visit. CD4 was significantly lower among those pts confirmed dead (39 vs 110, p < 0.0001) and those lost to follow-up (92 vs 119, p = 0.017).
Conclusions: Pts retained in the program experienced marked clinical and immunologic improvement with Triomune. Severe toxicity rates were low though the high drop-out rate limits interpretation. While advanced baseline disease and medication cost likely contribute to poor retention, operations research to identify other factors must be prioritized to advance antiretroviral therapy in Malawi.