In:
Antiviral Therapy, SAGE Publications, Vol. 8, No. 2 ( 2003-02), p. 163-171
Abstract:
To compare the efficacy and safety of a triple nucleoside combination to a protease inhibitor-containing triple regimen as first-line antiretroviral therapy (ART) in HIV-1-infected patients. Design Open-label study in HIV-1-infected ART-naive adults, randomized to receive either Combivir® (lamivudine 150 mg/zidovudine 300 mg twice daily) + abacavir (300 mg twice daily), or Combivir® + nelfinavir (750 mg every 8 h) for 48 weeks. Plasma HIV-1 RNA, CD4 cell count and adverse events were assessed at baseline and weeks 4, 8, 16, 24, 32, 40 and 48. Results 195 subjects (131 men, 64 women), median age 34 years, were randomized: 98 received combivir/abacavir and 97 combivir/nelfinavir. Baseline median plasma HIV-1 RNA was 4.2 log 10 copies/ml [Interquartile range (IQR): 3.7-4.5.2] and 4.1 log 10 copies/ml (IQR: 3.8–4.6), respectively. Baseline median CD4 cell count was 387 cells/mm 3 (IQR: 194–501) and 449 cells/mm 3 (IQR: 334–605), respectively. Nine patients (3 vs 6, respectively) did not start treatment or did not have any available efficacy data. At week 48, using the intent to treat analysis (switch/missing equals failure), plasma HIV-1 RNA was 〈 50 copies/ml in 54/95 (57%) and 53/91 (58%) of subjects, respectively. Median CD4 increase was +110 and +120 cells/mm 3 , respectively. Possible hypersensitivity reactions to abacavir were reported in four subjects (4%). Conclusion The triple nucleoside combination combivir/abacavir is well tolerated as a first-line ART regimen in HIV-1-infected adults, with comparable antiviral activity to a nelfinavir-containing regimen at week 48.
Type of Medium:
Online Resource
ISSN:
1359-6535
,
2040-2058
DOI:
10.1177/135965350300800211
Language:
English
Publisher:
SAGE Publications
Publication Date:
2003
detail.hit.zdb_id:
2118396-X
SSG:
15,3
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