title: Didanosine plus stavudine with or without hydroxyurea in HIV-1-infected patients: 1 year follow-up. Swiss HIV Cohort Study.
abstract: A total of 144 human immunodeficiency virus (HIV)-infected patients (mean CD4 cell count, 367 cells/mm3) were included in a double-blind placebo-controlled trial testing the efficacy on surrogate markers of HIV progression of the combination didanosine (2',3'-dideoxyinosine or DDI) plus stavudine (2',3'-didehydro-2',3'-dideoxythymidine or D4T) with or without hydroxyurea. The primary end point was a reduction of HIV RNA levels to below 200 copies/ml after 12 weeks of treatment. The results showed that the triple combination was associated with a more profound decrease in HIV RNA with an increased proportion of patients with viraemia < 200 copies/ml. This effect persisted for the majority of the patients after a 48 week follow-up. In contrast, the increase in CD4 cell counts was less in patients treated with hydroxyurea because of lymphopenia, and adverse events were more frequent in hydroxyurea-treated patients. In conclusion, the addition of hydroxyurea consistently improved the antiviral activity of the didanosine/stavudine combination over a 48 week follow-up. Increased toxicity and decreased effect on CD4 cell counts might inspire caution.
authors.affiliation: Department of Internal Medicine, University Hospital, Geneva, Switzerland.
authors.forename: O T
authors.initials: OT
authors.lastname: Rutschmann
authors.forename: M
authors.initials: M
authors.lastname: Opravil
authors.forename: A
authors.initials: A
authors.lastname: Iten
authors.forename: R
authors.initials: R
authors.lastname: Malinverni
authors.forename: P L
authors.initials: PL
authors.lastname: Vernazza
authors.forename: H
authors.initials: H
authors.lastname: Bucher
authors.forename: E
authors.initials: E
authors.lastname: Bernasconi
authors.forename: L H
authors.initials: LH
authors.lastname: Perrin
authors.forename: S
authors.initials: S
authors.lastname: Yerly
authors.forename: B
authors.initials: B
authors.lastname: Hirschel
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000009:adverse effects / Q000627:therapeutic use*; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D006918:Hydroxyurea / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D018119:Stavudine; D016049:Didanosine; D006918:Hydroxyurea