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Early ART and IPT in HIV-Infected African Adults With High CD4 Count (Temprano Trial)...."Early ART >500 CD4s Significantly reduced Severe HIV Morbidity"
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AUTHORS CONCLUDE: "Early ART and 6-month IPT significantly and independently reduced severe HIV morbidity, with no overall increased risk for grade 3-4 adverse events....For patients with CD4 >500, early ART significantly reduced severe HIV morbidity"...."we will transmit results to WHO & to Cote d'Ivoire Ministry of Health soon and could change recommendations for starting ART & INH"
"study objective was to assess the efficacy of early ART &/or IPT (Isoniazid Preventive Therapy) to reduce severe morbidity in HIV-1 infected adults......included individuals with <800 CD4s....primary outcomes: severe HIV morbidity (all cause mortality, any AIDS defining-event, severe bacterial diseases, and non AIDS cancers....secondary outcome: any other grade 3-4 morbidity....2056 patients included in analysis.....849 (41%) had CD4s over 500....78% were women....average age 35.....median follow-up 29.9 months.....main result: 44% reduction in risk with early ART"
Primary Endpoint for Patients with >500 CD4s......44% reduction in risk with early ART
Early ART and IPT in HIV-Infected African Adults With High CD4 Count (Temprano Trial)
Reported by Jules Levin
CROI 2015 Feb 23-26, Seattle, WA
webcast:
http://www.croiwebcasts.org/console/player/25757?mediaType=slideVideo&
Christine Danel1, Delphine Gabillard1, Jerome Le Carrou1, Xavier Anglaret1, Raoul Moh2, Serge Eholie2, Herve Menan3, Anani Badje4, Gerard Kouame4, Jean Baptiste Ntakpe4
1 U897, Inserm, Bordeaux, France;2 Departement des Maladies Infectieuses et Tropicales, Universite Felix Houphouet Boigny, Abidjan, Cote d'Ivoire;4 Programme PACCI, Abidjan, Cote d'Ivoire;3 CeDReS, CHU de Treichville, Abidjan, Cote d'Ivoire
Background: We present the final results of the Temprano ANRS 12136 trial that assessed the benefits of early ART and/or early 6-month isoniazid prophylaxis (IPT, 300 mg/day) among HIV-infected adults with high CD4 counts and no WHO criteria for starting ART.
Methods: Temprano was a randomized 2x2 factorial superiority trial conducted in 9 HIV care centers in Cote d'Ivoire from March 2008 through January 2015. Inclusion criteria were: HIV-1 infection, age >18 years, CD4 nadir 800/ul, and no criteria for starting ART according to the most recent WHO guidelines. Participants were randomized to one of four arms: ART initiation according to WHO criteria (WHOART); immediate 6-month IPT plus ART initiation according to WHO criteria (WHOART-IPT); immediate ART initiation (EarlyART); immediate 6-month IPT plus immediate ART initiation (EarlyART-IPT). First-line ART consisted of tenofovir plus emtricitabine plus either efavirenz, zidovudine or lopinavir/ritonavir. The primary endpoint was severe HIV morbidity (AIDS-defining diseases, non-AIDS-defining malignancy, or non-AIDS-defining invasive bacterial diseases),or any-cause mortality at 30 months. The secondary endpoint was any other grade 3-4 defining morbidity. We used multivariate Cox proportional models to compare outcomes between the WHOART and EarlyART arms, and between the IPT and no IPT arms. We tested for interaction between earlyART and IPT.
Results: Of 2,076 patients randomized, 2,056 were included in the analysis (78% were women; 91% classified at WHO stage 1-2; median age 35 years; median CD4 nadir 465/ul; median HIV-1 viral load 4.7 log10 copies/ml). They were followed for 4,755 patient-years, during which 47 died, 175 experienced 204 episodes of severe morbidity (TB 85, invasive bacterial diseases 56, other AIDS-defining diseases 11, non-AIDS malignancy 5), 287 experienced 364 episodes of severe grade 3-4 morbidity (hematologic 256, hepatic 31 renal, 22, cardiovascular 9, others 46), and 44 (2.2%) were lost-to-follow up. There was no interaction between EarlyART and IPT. The risk of severe morbidity was 44% lower with EarlyART vs. WHOART (Table) and 35% lower with IPT vs. no IPT. EarlyART significantly decreased morbidity overall and when restricted to patients with baseline CD4 >500/ul. The risk of Grade 3-4 morbidity did not differ between strategies.
Conclusions: In Cote d'Ivoire, both immediate ART and IPT dramatically and independently decreased the risk of severe morbidity, and should be recommended as the standard of care for HIV.
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