title: 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).
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.
authors.affiliation: Service des Maladies Infectieuses et Tropicales, Assistance Publique Hôpitaux de Paris, Groupe Hospitalier Bichat Claude Bernard, HUPNVS, Université Paris Diderot, Paris 7, PRES Sorbonne Paris Cité, EA 4409 Paris France. veronique.joly@bch.aphp.fr
authors.forename: Véronique
authors.initials: V
authors.lastname: Joly
authors.forename: Catherine
authors.initials: C
authors.lastname: Fagard
authors.forename: Carine
authors.initials: C
authors.lastname: Grondin
authors.forename: Diane
authors.initials: D
authors.lastname: Descamps
authors.forename: Yazdan
authors.initials: Y
authors.lastname: Yazdanpanah
authors.forename: Charlotte
authors.initials: C
authors.lastname: Charpentier
authors.forename: Nathalie
authors.initials: N
authors.lastname: Colin de Verdiere
authors.forename: Sophie
authors.initials: S
authors.lastname: Tabuteau
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: André
authors.initials: A
authors.lastname: Cabie
authors.forename: Geneviève
authors.initials: G
authors.lastname: Chene
authors.forename: Patrick
authors.initials: P
authors.lastname: Yeni
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects*; D003521:Cyclopropanes; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D004338:Drug Combinations; D000068679:Emtricitabine; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007108:Immune Tolerance; D061466:Lopinavir / Q000627:therapeutic use; D008297:Male; D063065:Organophosphonates / Q000627:therapeutic use; D010446:Peptide Fragments / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000627:therapeutic use; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D004338:Drug Combinations; D015700:HIV Envelope Protein gp41; D063065:Organophosphonates; D010446:Peptide Fragments; D012367:RNA, Viral; C558899:lopinavir-ritonavir drug combination; D003841:Deoxycytidine; D000077560:Enfuvirtide; D061466:Lopinavir; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; C098320:efavirenz; D019438:Ritonavir