JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Can we stop CD4+ testing in patients with HIV-1 RNA suppression on antiretroviral treatment?

AIDS 2013 November 14
BACKGROUND: It is unclear whether regular CD4 testing is necessary for all patients during long-term antiretroviral treatment, after patients achieve full HIV-1 RNA suppression.

METHODS: In the AntiRetroviral Therapy with TMC114 Examined in Naïve Subjects (ARTEMIS) trial, 689 treatment-naïve patients were randomized to tenofovir/emtricitabine and either darunavir/ritonavir or lopinavir/ritonavir. The number of patients with CD4 cell counts equal or above 200 copies/ml and HIV-1 RNA below 50 copies/ml at week 48 was assessed. For these patients, we assessed whether CD4 cell counts fell below 200 cells/μl from week 49 to week 192, while HIV-1 RNA suppression was maintained.

RESULTS: Of the 520 responders, five (1.0%) progressed to an AIDS-defining event during the first 48 weeks of the trial, whereas 19 of the 169 non-responders (11.2%) developed AIDS-defining events during this time (P = 0.001, Fisher's Exact test). Of the 449 patients with sustained HIV-1 RNA suppression below 400 copies/ml from week 49 to week 192, five patients (1.1%) had reductions in CD4 cell count below 200 cells/μl on two consecutive visits. These were all short-term reductions, with follow-up results equal or above 200 cells/μl.

CONCLUSIONS: There was a benefit to testing for CD4 cell count in the first 48 weeks of treatment, to identify patients who have immuno-virological discordance and therefore a higher risk of progression to AIDS. However, after 48 weeks of antiretroviral treatment, for the 'responder' patients in the ARTEMIS trial who had both HIV-1 RNA below 50 copies/ml and rises in CD4 cell count equal or above 200 cells/μl, there appears to be little clinical benefit from continued testing for CD4 cell count.

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