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Maraviroc/raltegravir simplification strategy following 6 months of quadruple therapy with tenofovir/emtricitabine/maraviroc/raltegravir in treatment-naive HIV patients
- Source :
- Journal of Antimicrobial Chemotherapy, Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), 2016, 71 (11), pp.3235-3241. ⟨10.1093/jac/dkw273⟩, Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), 2016, 71 (11), pp.3235-3241. 〈10.1093/jac/dkw273〉
- Publication Year :
- 2016
- Publisher :
- HAL CCSD, 2016.
-
Abstract
- International audience; OBJECTIVE: We assessed the virological efficacy of a 6 month maraviroc/raltegravir simplification strategy following 6 months of quadruple therapy combining tenofovir disoproxil fumarate/emtricitabine with maraviroc/raltegravir. METHODS: HIV-1-infected naive patients were enrolled in an open label, single-arm, Phase 2 trial. All patients received maraviroc 300 mg twice daily, raltegravir 400 mg twice daily and tenofovir/emtricitabine for 24 weeks. Patients with stable HIV-RNA \\textless50 copies/mL stopped tenofovir/emtricitabine at week (W) 24 and pursued maraviroc/raltegravir until W48. The primary endpoint was the virological response defined by HIV-RNA \\textless50 copies/mL at W48. RESULTS: Thirty-three patients were analysed. Patients were mostly male (94%), Caucasians (91%), MSM (82%); their median age was 42 years. At baseline, median CD4 cell count was 453 cells/mm3 and HIV-RNA was 4.3 log copies/mL. All patients had CCR5-tropic viruses by genotropism and phenotropism assays. All but one patient had an HIV-RNA \\textless 50 copies/mL at W24 and entered the simplification phase. Virological success was maintained at W48 in 88% (90% CI 79%-97%) of patients. N155H mutation was detected at failure in one patient. No tropism switch was observed. Raltegravir and maraviroc plasma exposure were satisfactory in 92% and 79% of 41 samples from 21 patients. Five severe adverse events (SAEs) were observed up to W48; none was related to the study drugs. Four patients presented grade 3 AEs; none was related to the study. No grade 4 AE was observed. No patient died. CONCLUSIONS: Maraviroc/raltegravir maintenance therapy following a 6 month induction phase with maraviroc/raltegravir/tenofovir/emtricitabine was well tolerated and maintained virological efficacy in these carefully selected patients
- Subjects :
- 0301 basic medicine
Male
HIV Infections
[ SDV.CAN ] Life Sciences [q-bio]/Cancer
Raltegravir Potassium
Maraviroc
chemistry.chemical_compound
0302 clinical medicine
Maintenance therapy
Antiretroviral Therapy, Highly Active
Clinical endpoint
Medicine
Emtricitabine
Pharmacology (medical)
030212 general & internal medicine
virus diseases
Middle Aged
Viral Load
3. Good health
virology
Infectious Diseases
Treatment Outcome
Viruses
Female
France
Viral load
medicine.drug
Microbiology (medical)
Adult
medicine.medical_specialty
Adolescent
Patients
Anti-HIV Agents
030106 microbiology
[SDV.CAN]Life Sciences [q-bio]/Cancer
Tropism
Maintenance Chemotherapy
methods
03 medical and health sciences
Young Adult
Cyclohexanes
Internal medicine
Humans
Adverse effect
Tenofovir
therapy
business.industry
Hiv
Triazoles
Raltegravir
chemistry
Mutation
HIV-1
pharmacology
business
Subjects
Details
- Language :
- English
- ISSN :
- 03057453 and 14602091
- Database :
- OpenAIRE
- Journal :
- Journal of Antimicrobial Chemotherapy, Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), 2016, 71 (11), pp.3235-3241. ⟨10.1093/jac/dkw273⟩, Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), 2016, 71 (11), pp.3235-3241. 〈10.1093/jac/dkw273〉
- Accession number :
- edsair.doi.dedup.....4e85a0a627fcea0a7ccb69912ebcce7c