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BACKGROUND: Asymptomatic HIV-infected people who start ART early may feel less motivated and neglect compliance. This might promote the emergence of resistance. METHODS: In the Temprano trial, ART-naive HIV-infected adults with high CD4 counts were randomly assigned to start ART immediately (immediate group) or defer ART until the WHO criteria were met (deferred group). All participants were monitored for 30 months. Those in the deferred group who started ART were monitored for longer, until they had completed 30 months on ART. We compared the rate of virological failure and drug resistance between the immediate and deferred groups 30 months after ART initiation. RESULTS: Of the 2056 participants in Temprano, 1033 were assigned to start ART immediately and 1023 to defer ART. Of the latter, 488 started ART during trial follow-up. Patients in the deferred group who started ART had a lower median CD4 count (280 versus 465 cells/mm3) and a higher median plasma HIV-1 RNA (5.1 versus 4.7 log10 copies/mL) at baseline. During follow-up, participants in both groups had similar antiretroviral drug exposure. Thirty months after ART initiation, patients in the deferred group had a higher rate of virological failure (35.3% versus 29.9%, P = 0.04) and a lower genotypic susceptibility score (P = 0.04). CONCLUSIONS: Starting ART early decreases the risk of virological failure and drug resistance in the medium term. This benefit is of particular importance in countries where access to viral load monitoring and the number of antiretroviral drug lines is limited.

Background: In HIV-infected patients, hepatitis B virus (HBV)-coinfection increases the risk of disease progression. Tenofovir+emtricitabine/lamivudine (TDF/XTC)-based antiretroviral therapy (ART), which suppresses HIV and HBV replication, has the potential for decreasing this risk. Here, we analyze the association between HBV replication, early-ART, and mortality in West-African adults. Methods: The Temprano randomized-control trial assessed the benefits of immediately initiating versus deferring ART in HIV-infected adults with high CD4 counts. After trial completion, participants continued follow-up in a post-trial phase. We analyzed the association between HBV-status, immediate-ART, and mortality over the entire trial and post-trial follow-up using multivariable Cox proportional hazards regression. Results: 2052 HIV-infected adults (median baseline CD4=464/mm3) were followed for 9394 person-years. At baseline, 1862 (91%) were HIV-monoinfected and 190 (9%) HIV-HBV-coinfected. Of the latter, 135 (71%) had plasma HBV-DNA /=2000 IU/ml. The 60-month probability of death was 11.8% (95%CI=5.4-24.5) in coinfected patients with HBV-DNA >/=2000 IU/ml, 4.4% (95%CI=1.9-10.4) in coinfected patients with HBV-DNA /=2000 IU/ml and 0.90 (95%CI=0.36-2.24) in coinfected patients with HBV-DNA