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 (2) , Carine Grondin (2) , Diane Descamps (3) , Yazdan Yazdanpanah (1, 4) , Charlotte Charpentier (3) , Nathalie Colin de Verdiere (5) , Sophie Tabuteau (2) , François Raffi (6) , André Cabie (7) , Geneviève Chene (2) , Patrick Yeni (1)

1 Service de maladies infectieuses et tropicales
2 Epidémiologie et Biostatistique [Bordeaux]
3 Laboratoire de Virologie
4 ATIP-Avenir Inserm - Modélisation, Aide à la Décision, et Coût-Efficacité en Maladies Infectieuses
5 Service des Maladies Infectieuses et Tropicales
6 Maladies infectieuses et tropicales
7 CIC - Antilles Guyane - Centre d'Investigation Clinique Antilles-Guyane

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.

Domaines: Microbiologie et Parasitologie

Véronique Joly, Catherine Fagard, Carine Grondin, Diane Descamps, Yazdan Yazdanpanah, et al.. 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).. Antimicrobial Agents and Chemotherapy, 2013, 57 (2), pp.758-65. ⟨10.1128/AAC.01662-12⟩. ⟨hal-00875126⟩