title: Tenofovir DF/emtricitabine and efavirenz combination therapy for HIV infection in patients treated for tuberculosis: the ANRS 129 BKVIR trial.
abstract: BACKGROUND
  HIV-infected patients with TB need simplified, effective and well-tolerated antiretroviral regimens.
  
  
  METHODS
  The French ANRS 129 BKVIR open trial evaluated the once-daily tenofovir DF/emtricitabine and efavirenz combination, started within 12 weeks after TB treatment initiation, in antiretroviral-naive HIV-1-infected patients. Success was defined as an HIV-1 RNA <50 copies/mL and TB cure at 48 weeks.
  
  
  RESULTS
  TB was confirmed microbiologically (90%) or histologically (10%) in 69 patients (71% male; median age 43 years; 54% born in Africa). The median time between TB treatment initiation and antiretroviral therapy was 8 weeks (range 1-22 weeks). At baseline, median HIV-1 RNA was 5.4 log10 copies/mL and median CD4 cell count 74 cells/mm(3). In the ITT analysis, combined success at week 48 was achieved in 57/69 patients (83%, 95% CI 74-92). Twelve patients did not achieve virological success, and TB was not cured in one of them. Among the 47 patients who fully adhered to the strategy, the success rate was 96% (95% CI 90-100) and was not affected by low rifampicin and isoniazid serum concentrations. Forty-nine serious adverse events were reported in 31 patients (45%), and 11 led to antiretroviral drug interruption. All adverse events resolved. The immune reconstitution inflammatory syndrome occurred in 23 patients (33%, 95% CI 22-44), and was associated with a low baseline BMI (P = 0.03) and a low haemoglobin level (P = 0.02).
  
  
  CONCLUSIONS
  These results support the use of tenofovir DF/emtricitabine and efavirenz combination therapy for HIV infection in patients with TB.
authors.affiliation: Université Paris Descartes, APHP, Hôpital Necker Enfants Malades, Centre d'Infectiologie Necker-Pasteur, IHU Imagine, Paris, France olivier.lortholary@aphp.fr.
authors.forename: Olivier
authors.initials: O
authors.lastname: Lortholary
authors.affiliation: Université Bordeaux, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Roussillon
authors.affiliation: Université Bordeaux, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Boucherie
authors.affiliation: Hôpital Avicenne, Laboratoire de Toxicologie et de Suivi Thérapeutique, Bobigny, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Padoin
authors.affiliation: Université Paris Descartes EA 3620, Sorbonne Paris Cité, AP-HP, Laboratoire de Virologie, CHU Necker-Enfants Malades, Paris, France.
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Chaix
authors.affiliation: AP-HP, Hôpital Pitié-Salpêtrière, Service de Médecine Interne, Paris, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Breton
authors.affiliation: AP-HP, Hôpital Lariboisière, Service de Médecine Interne, Paris, France.
authors.forename: Agathe
authors.initials: A
authors.lastname: Rami
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, CR7, INSERM, U1135, Centre d'Immunologie et des Maladies Infectieuses, CIMI, team E13 (Bacteriology), F-75013, Paris, France AP-HP, Hôpital Pitié-Salpêtrière, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries aux Antituberculeux, Bactériologie-Hygiène, F-75013, Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Veziris
authors.affiliation: Hôpital Villeneuve St-Georges, Service des Maladies Infectieuses et Tropicales, Villeneuve S-Georges, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Patey
authors.affiliation: AP-HP, Hôpital Pitié-Salpêtrière, Service des Maladies Infectieuses et Tropicales, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Caumes
authors.affiliation: Hôpital Brabois, Service des Maladies Infectieuses, Nancy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: May
authors.affiliation: Université Paris Diderot Paris 7, Hôpital St-Louis and INSERM U941, Paris, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, CR7, INSERM, U1135, Centre d'Immunologie et des Maladies Infectieuses, CIMI, team E13 (Bacteriology), F-75013, Paris, France AP-HP, Hôpital Pitié-Salpêtrière, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries aux Antituberculeux, Bactériologie-Hygiène, F-75013, Paris, France.
authors.forename: Jérome
authors.initials: J
authors.lastname: Robert
authors.affiliation: Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Tod
authors.affiliation: Université Bordeaux, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Fagard
authors.affiliation: Université Bordeaux, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, F-33000 Bordeaux, France CHU de Bordeaux, Pôle de santé publique, Service d'information médicale, F-33000 Bordeaux, France.
authors.forename: Geneviève
authors.initials: G
authors.lastname: Chêne
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D000995:Antitubercular Agents / Q000008:administration & dosage; D048588:Benzoxazines / Q000008:administration & dosage*; D003521:Cyclopropanes; D004359:Drug Therapy, Combination / Q000379:methods; D000068679:Emtricitabine / Q000008:administration & dosage*; D005260:Female; D005602:France; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068698:Tenofovir / Q000008:administration & dosage*; D016896:Treatment Outcome; D014376:Tuberculosis / Q000188:drug therapy*; D019562:Viral Load
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D000995:Antitubercular Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D000068698:Tenofovir; D000068679:Emtricitabine; C098320:efavirenz