title: WITHDRAWN. Effectiveness and safety of first-line tenofovir + emtricitabine + efavirenz for patients with HIV.
abstract: BACKGROUND
  The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to treatment, issues of adherence and viral resistance are major challenges limiting its success. There is a need for an effective and safe first-line regimen, to cope with the ever-increasing incidence of non-adherence and primary resistance. A more recent first-line treatment regimen consists of Tenofovir (TDF, 300 mg) + Emtricitabine (FTC, 200 mg) + Efavirenz (EFV, 600 mg).
  
  
  OBJECTIVE
  To evaluate the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV.
  
  
  METHODS
  We searched the Cochrane Central Register of Controlled Trials, EMBASE, GATEWAY, LILACS, PubMed, AEGIS, and the WHO prospective clinical trials registry in November 2011.
  
  
  METHODS
  Randomized controlled trials evaluating the effects of TDF + FTC + EFV compared with other HAART regimens.
  
  
  METHODS
  Two reviewers independently assessed trial eligibility and risk of bias, and extracted data from the included study.
  
  
  RESULTS
  Only one study involving 517 antiretroviral-naive HIV infected adults was included in this review. Participants were randomly assigned to receive either a regimen of TDF (300 mg), FTC (200mg), and EFV (600mg ) once daily; or a regimen of fixed-dose zidovudine (AZT) (300 mg) and lamivudine (3TC) (150 mg) twice daily plus EFV (600mg) once daily. Significantly more patients in the TDF-FTC group reached and maintained HIV RNA levels of less than 50 copies per milliliter compared to the AZT- 3TC group (RR 1.13; 95% CI 1.02 to 1.25). Also, more participants in the TDF-FTC group had greater increase from baseline CD4 cell counts compared to the AZT-3TC group (190 vs. 158 cells per mm(3)). More patients in the AZT-3TC group than in the TDF-FTC group had adverse events resulting in discontinuation of the study drugs (9% vs. 4%, respectively; P = 0.02). There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
  
  
  CONCLUSIONS
  Only one trial has shown beneficial effects and safety of TDF+ FTC + EFV as first-line treatment for patients with HIV. The effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV cannot be assessed on the basis of only one trial. Further studies evaluating the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV are needed.
authors.affiliation: Community Medicine, UNTH/Comprehensive Health Centre, Nsukka, Nigeria. innocentomeje@yahoo.com.
authors.forename: Innocent
authors.initials: I
authors.lastname: Omeje
authors.forename: Charles I
authors.initials: CI
authors.lastname: Okwundu
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004338:Drug Combinations; D000068257:Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D063065:Organophosphonates / Q000627:therapeutic use*; D010078:Oxazines / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D000068257:Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D063065:Organophosphonates; D010078:Oxazines; D018894:Reverse Transcriptase Inhibitors; D003841:Deoxycytidine; D000225:Adenine