title: Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach.
abstract: OBJECTIVE
  To assess the efficacy and safety of a once-daily antiretroviral regimen in HAART-experienced subjects with long-lasting viral suppression.
  
  
  METHODS
  One-hundred-and-sixty-nine patients with chronically suppressed viral load (limit of detection <50 copies/ml) were recruited. Based on patient willingness to simplify treatment, 84 of them continued receiving their usual treatment (BID Group) and 85 switched to once-daily didanosine/tenofovir/nevirapine (QD Group) in a non-randomized fashion.
  
  
  RESULTS
  At week 48, the proportion of patients with viral suppression in the QD and in the BID Group, respectively, was 97 vs 100% in the per-protocol analysis (P = 0.497), and 76 vs 86% for the intention-to-treat analysis (P = 0.176). Nevertheless, CD4 count decreased in the QD Group, with a mean decline of 95 cells/mm3 (95% CI: 45-145). Twelve subjects in the QD Group (14%) discontinued treatment due to adverse events, mainly nevirapine-related hepatitis (6%). No significant differences regarding the rate of acute pancreatitis or peripheral neuropathy were observed between both groups. A significant improvement in the lipid profile was only seen in the QD Group. High levels of adherence were observed in both groups during follow-up, as well as a good quality of life. At week 48, a reduction in effort to take medication (P < or = 0.001) and an increment in the satisfaction with the treatment (P < 0.001) was only seen in the QD group. No differences were observed in median nevirapine trough levels between patients on twice-daily nevirapine at baseline (4820 ng/ml) and subjects in the QD Group (6090 ng/ml, P = 0.30).
  
  
  CONCLUSIONS
  Treatment simplification to a once-daily antiretroviral regimen based on didanosine, tenofovir and nevirapine may be a valid approach in HIV-infected subjects with long-lasting viral suppression. Combination of standard doses of didanosine and tenofovir may have contributed to the CD4 cell decline observed with this QD regimen.
authors.affiliation: Lluita Contra la SIDA Foundation, Germans Trias i Pujol Hospital, Badalona, Spain. enegredo@ns.hugtip.scs.es
authors.forename: Eugènia
authors.initials: E
authors.lastname: Negredo
authors.forename: José
authors.initials: J
authors.lastname: Moltó
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Muñoz-Moreno
authors.forename: Enric
authors.initials: E
authors.lastname: Pedrol
authors.forename: Esteve
authors.initials: E
authors.lastname: Ribera
authors.forename: Pompeyo
authors.initials: P
authors.lastname: Viciana
authors.forename: M José
authors.initials: MJ
authors.lastname: Galindos
authors.forename: Celia
authors.initials: C
authors.lastname: Miralles
authors.forename: David
authors.initials: D
authors.lastname: Burger
authors.forename: Carmina
authors.initials: C
authors.lastname: Rodriguez Fumaz
authors.forename: Jordi
authors.initials: J
authors.lastname: Puig
authors.forename: Sílvia
authors.initials: S
authors.lastname: Gel
authors.forename: Eva
authors.initials: E
authors.lastname: Rodríguez
authors.forename: Sebastià
authors.initials: S
authors.lastname: Videla
authors.forename: Lidia
authors.initials: L
authors.lastname: Ruiz
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D016516:CD4-CD8 Ratio; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D016049:Didanosine / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D063065:Organophosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D010195:Pancreatitis / Q000139:chemically induced; D010349:Patient Compliance; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood; D000068698:Tenofovir
chemical_list: D019380:Anti-HIV Agents; D008055:Lipids; D063065:Organophosphonates; D012367:RNA, Viral; D019829:Nevirapine; D000068698:Tenofovir; D000225:Adenine; D016049:Didanosine