Prognostic value of virological and immunological responses after 6 months of antiretroviral treatment in adults with HIV-1 infection in sub-Saharan Africa

Background: HIV RNA monitoring is not available in most antiretroviral treatment (ART) programs in sub-Saharan Africa; switch to second-line therapy is mostly guided by clinical/immunological criteria. This may lead to unnecessary disease progression and drug resistance accumulation. We investigated the prognostic value of virological and immunological status 6 months after ART initiation with respect to death, loss to follow-up, and treatment switch. Methods: We considered treatment-naive HIV-1-infected patients, starting ART with available 6-month visit and subsequent follow-up, enrolled in a prospective cohort comprising 5 ART sites in 3 sub- Saharan countries. Outcome measures included the time from 6-month visit to death for all causes, loss to follow-up, and switch to second line. Results: Of 2539 patients, 62% were females, their median pre- ART CD4 count was 215 cells per microliter, median HIV RNA 4.6 Log10 copies per milliliter, 30% were on WHO stage 3/4. At 6 months, 85% had HIV RNA ≤1000 copies per milliliter. During 3112 person-years follow-up after the 6-month visit, 91 patients died. Death was predicted by 6-month HIV RNA ≥10,000 copies per milliliter, adherence, and 6-month CD4 10,000 and CD4 ≥200) to 0.95 (with HIV RNA 1000 and CD4 $200). Loss to follow-up (1.95 per 100 person-years follow-up) was predicted by the 6-month HIV RNA .10,000 copies per milliliter and adherence but not by CD4. Switch to second line (6.94 per 100 person-years follow-up) was predicted by 6-month HIV RNA and CD4. Conclusions: In patients starting ART in sub-Saharan Africa, 6- month HIV RNA independently predicts subsequent survival, retention to care, and switch to second-line therapy. This measure warrants further evaluation as specific time point monitoring option. Copyright © 2012 by Lippincott Williams & Wilkins.