Five-year follow-up of patients enrolled in the NEAT 001/ANRS 143 randomized clinical trial: NEAT 001/ANRS 143 LONG TERM study. (25th March 2020)

• Record Type: Journal Article
• Authors: Raffi, François; Gaultier, Aurélie; Pozniak, Anton; Molina, Jean-Michel; Jessen, Heiko; Antinori, Andrea; Soria, Albane; Cavellec, Morane; Le Thuaut, Aurélie; Ningre, Maelle; de Wit, Stéphane
• Is Part Of: Journal of antimicrobial chemotherapy. Volume 75:Number 6(2020)
• Page Start: 1618
• Page End: 1622
• Publication Date: 2020-03-25
• Subjects: Anti-infective agents -- Periodicals; Chemotherapy -- Periodicals; 615.58
• DOI: 10.1093/jac/dkaa056
• Languages: English
• ISSNs: 0305-7453

Abstract

Abstract: Background: Few long-term data are available in subjects having initiated ART with an NRTI-sparing regimen. Objectives: Outcomes of subjects enrolled in the NEAT 001/ANRS 143 randomized clinical trial (comparing ritonavir-boosted darunavir + raltegravir versus ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were retrospectively collected, through anonymized electronic case report forms, up to 6 years post-enrolment. Methods: The last NEAT 001 visit (Week 96) was conducted in 745/805 randomized subjects (363/401 ritonavir-boosted darunavir + raltegravir and 382/404 ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine). Of these, 430 were enrolled in NEAT 001/ANRS 143 LONG TERM (NLT) study (201 raltegravir, 229 tenofovir disoproxil fumarate/emtricitabine), with a median follow-up of 44.4 months. Results: During NLT follow-up, the proportion of AIDS, non-AIDS events, virological rebound and serious adverse events, discontinuation for virological failure and for adverse events did not differ between groups; discontinuations for virological failure since NEAT 001 inclusion were more frequent in subjects with baseline CD4 <200 cells/mm 3 (11.9% versus 5.3%; P = 0.077). At last follow-up, a quarter of subjects (22.2% for ritonavir-boosted darunavir + raltegravir and 29.7% for ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were still receiving their initial regimen. Integrase inhibitor exposure was not associated with weight gain ( P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase ( P = 0.067). Conclusions: After a median of 5.6 years, subjects initiating ritonavir-boosted darunavir + raltegravir or ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine experienced few serious clinical adverse events. Most discontinuations were for reasons unrelated to adverse events or virological failure.