Impact of a modified directly administered antiretroviral treatment intervention on virological outcome in HIV-infected patients treated in Burkina Faso and Mali.

OBJECTIVE: This study explores whether viral load measurements can be used in resource-limited settings to target those in need of adherence assistance. It was hypothesized that high plasma viral loads (pVLs) (>/=500 HIV-1 RNA copies/mL) were the result of poor antiretroviral therapy adherence and amenable to improvement with adherence assistance.
DESIGN: A single-arm, multicentre pilot study was conducted from November 2003 to March 2004 on 606 treatment-experienced patients who had initiated an antiretroviral regimen in Mali and Burkina Faso >/=6 months before study enrolment. In these patients, those whose pVL was >/=500 copies/mL were offered 1 month of modified directly administered antiretroviral treatment (mDAART) with weekly follow-up visits from pharmacists or adherence counsellors.
METHODS: An adherence questionnaire was given to all cohort patients and viral load was used to screen for patients with >/=500 copies/mL. mDAART participants included cohort patients with >/=500 copies/mL, who completed the adherence questionnaire. Genotypic analyses were conducted on samples taken prior to and after the intervention. The intervention was considered effective when there was a decrease of >/=1 log(10) in pVL.
RESULTS: mDAART was effective in over one-third of the intervention participants, while in two-thirds no decrease in pVL was observed. The majority of mDAART participants had major resistance mutations.
CONCLUSIONS: pVL measurement was useful to identify patients who needed adherence assistance. However, because it was performed >/=6 months after starting treatment, mDAART came too late for most participants, as they had already developed important resistance mutations that might have been avoided with better laboratory monitoring.