title: Efficacy and safety of a quadruple combination Combivir + abacavir + efavirenz regimen in antiretroviral treatment-naive HIV-1-infected adults: La Francilienne.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of a protease inhibitor sparing, quadruple therapy (Combivir + abacavir + efavirenz) in antiretroviral treatment-naive HIV-1-infected adults.
  
  
  METHODS
  Multicenter open-label pilot study. Clinical and biological assessments were performed at baseline and at weeks 2, 4, 8, 16, 24, 32, 40, 48.
  
  
  RESULTS
  Thirty-one subjects enrolled with a median baseline viral load (VL) of 4.69 log10 copies/mL and CD4 cell count of 322 cells/mm3. At week 48, 90% (intention-to-treat [ITT] switch included) and 77% (ITT switch = failure) patients had a VL <50 copies/mL. These results were similar in the population (n = 13) with a VL >100,000 copies/mL at baseline. Combivir + abacavir + efavirenz demonstrated an early antiretroviral response: 58% of patients had plasma HIV-1 RNA <50 copies/mL at week 8. Using a modified assay, the percentage of patients with VL <5 copies/mL at week 48 was 55% (17/31) and 42% (13/31) using ITT (switch included) and ITT (switch = failure), respectively. Median VL decreased by -4.0 log10 copies/mL at week 48 (ITT). Median CD4+ cell count change from baseline at week 48 was +129 cells/mm3 (ITT). Most patients experienced at least one drug-related adverse event that was not considered treatment-limiting by the investigator. There were no cases of abacavir hypersensitivity reactions.
  
  
  CONCLUSIONS
  Safety and efficacy results from this study demonstrated that the quadruple regimen Combivir/abacavir/efavirenz is generally safe and displays potent and durable antiretroviral activity in antiretroviral treatment-naive HIV-1-infected patients, offering a promising therapeutic option in a PI-sparing strategy.
authors.affiliation: Hôpital Garches, France. p.de-truchis@rpc.ap-hop-paris.fr
authors.forename: Pierre
authors.initials: P
authors.lastname: de Truchis
authors.forename: Gilles
authors.initials: G
authors.lastname: Force
authors.forename: Yves
authors.initials: Y
authors.lastname: Welker
authors.forename: Denis
authors.initials: D
authors.lastname: Mechali
authors.forename: Marc
authors.initials: M
authors.lastname: Pulik
authors.forename: Kadoudja
authors.initials: K
authors.lastname: Chemlal
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Rouveix
authors.forename: Alain
authors.initials: A
authors.lastname: Devidas
authors.forename: Danielle
authors.initials: D
authors.lastname: Praindhui
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Mamet
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D003521:Cyclopropanes; D015224:Dideoxynucleosides / Q000627:therapeutic use*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005602:France; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000627:therapeutic use*; D010865:Pilot Projects; D012367:RNA, Viral / Q000032:analysis; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use*; D000099227:Abacavir
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D015224:Dideoxynucleosides; D004338:Drug Combinations; D017320:HIV Protease Inhibitors; D019259:Lamivudine; D010078:Oxazines; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine; D000099227:Abacavir; C109078:lamivudine, zidovudine drug combination; C098320:efavirenz