title: Abacavir/lamivudine fixed-dose combination with ritonavir-boosted darunavir: a safe and efficacious regimen for HIV therapy.
abstract: BACKGROUND
  Current treatment guidelines recommend the use of tenofovir (TDF) and emtricitabine (FTC) along with a third agent to treat HIV-positive adults. However, other treatment options, including the use of abacavir (ABC) and lamivudine (3TC) when used with ritonavir-boosted darunavir (DRV/r), have rarely been studied.
  
  
  OBJECTIVE
  We evaluated the safety and efficacy of the coformulation of ABC/3TC administered with DRV/r in treatment-naïve and treatment-experienced patients.
  
  
  METHODS
  HIV-infected adults who received an open-label combination of ABC/3TC/ DRV/r were followed in a community clinic in Montréal. Patients had no resistance to any of the compounds in their regimen. Viral load (VL), CD4 cell count, AST, ALT, and creatinine levels were examined throughout the 48 weeks of follow-up.
  
  
  RESULTS
  Sixty-seven patients with a mean age of 45 years were enrolled. Two did not return for follow-up and were excluded. Thirty-five (52%) were treatment- experienced and the remaining were treatment-naïve. HLA-B*5701 test results were available for 56 patients and none were positive. At baseline, mean VL was 4.8 log for treatment-naïve and 2.3 log for experienced patients. Twelve patients discontinued the study regimen prior to reaching the endpoint. At week 48, 79% had a VL <50. Median CD4 cell gain was higher among treatment-naïve patients (273 cells) than among treatment-experienced patients (102 cells) (P = .002). No patient experienced any grade 2 or higher liver enzyme elevation throughout the study.
  
  
  CONCLUSIONS
  The new combination of ABC/3TC/DRV/r demonstrates a high rate of antiviral activity with no major toxicity. The drug combination appears to be generally safe and well tolerated.
authors.affiliation: Clinique médicale l'Actuel, Montréal, Québec, Canada. Benoit.Trottier@lactuel.ca
authors.forename: Benoit
authors.initials: B
authors.lastname: Trottier
authors.forename: Nimâ
authors.initials: N
authors.lastname: Machouf
authors.forename: Réjean
authors.initials: R
authors.lastname: Thomas
authors.forename: Serge
authors.initials: S
authors.lastname: Gallant
authors.forename: Danièle
authors.initials: D
authors.lastname: Longpré
authors.forename: Sylvie
authors.initials: S
authors.lastname: Vézina
authors.forename: Michel
authors.initials: M
authors.lastname: Boissonnault
authors.forename: Stéphane
authors.initials: S
authors.lastname: Lavoie
authors.forename: Danielle
authors.initials: D
authors.lastname: Legault
authors.forename: Harold
authors.initials: H
authors.lastname: Dion
authors.forename: Vinh Kim
authors.initials: VK
authors.lastname: Nguyen
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D000069454:Darunavir; D015224:Dideoxynucleosides / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D000069454:Darunavir; D015224:Dideoxynucleosides; D004338:Drug Combinations; D019259:Lamivudine; D019438:Ritonavir; D013449:Sulfonamides; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir