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Randomized Controlled Trial
. 2013 Feb;57(2):758-65.
doi: 10.1128/AAC.01662-12. Epub 2012 Nov 19.

Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo)

Véronique Joly  1 , Catherine Fagard, Carine Grondin, Diane Descamps, Yazdan Yazdanpanah, Charlotte Charpentier, Nathalie Colin de Verdiere, Sophie Tabuteau, François Raffi, André Cabie, Geneviève Chene, Patrick Yeni; S 130 Apollo Trial Group
Collaborators, Affiliations
Randomized Controlled Trial

Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo)

Véronique Joly et al. Antimicrob Agents Chemother. 2013 Feb.

Abstract

We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of <100/mm(3) or stage B/C disease with CD4 counts of <200/mm(3). Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥ 200/mm(3) at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm(3), and the median HIV-1 RNA load was 5.4 log(10) copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥ 200/mm(3) at week 24 were 34% and 38% in the ENF and control arms, respectively (P = 0.53). The proportions of patients with HIV-1 RNA loads of <50 copies/ml were 74% and 58% at week 24 in the ENF and control arms, respectively (P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up (P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression.

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Figures

Fig 1
Fig 1
ANRS 130 Apollo trial profile.
Fig 2
Fig 2
Median CD4 cell count from week 0 to week 48, ANRS 130 Apollo trial (ENF, enfuvirtide; data points are medians, and errors bars are omitted for clarity).
Fig 3
Fig 3
Proportion of patients with HIV-1 RNA loads of <50 copies/ml, ANRS 130 Apollo trial (ENF, enfuvirtide; data points are medians, and errors bars are omitted for clarity).
See this image and copyright information in PMC

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