Opravil M, Ledergerber B, Furrer H, Gallant S, Hirschel B, Meienberg F, Wagels T, Bernasconi E, Rickenbach M, Weber R; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 8th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 8th 2001 Chic Ill. 2001 Feb 4-8; 8: 277 (abstract no. LB6).
Univ Hosp Zurich.
Background: The value of early initiation of highly active antiretroviral therapy (HAART) is increasingly questioned. To evaluate the clinical benefit, harms, and inconvenience of such a strategy, we performed a nested case-control study within the prospective, multicenter SHCS. Methods: Treatment-naive asymptomatic SHCS participants with CD4 >350/mm3 starting HAART between 1/1996 and 12/1999 (cases) were matched with untreated controls by baseline time, HIV RNA, CD4 count, i.v. drug use, age, and gender. First CDC B or C events and mortality were compared by multivariate Cox regression analysis. Results: 363 cases, 28% of whom were female and 25% infected by i.v. drug use, were matched to 363 controls. Baseline CD4 count was median 487 and 498/mm3, HIV RNA was 4.2 and 4.1 log c./mL, respectively. During median follow up time of 2.1 and 1.3 years, cases had significantly higher CD4 counts and lower HIV RNA. Frequency of clinical events was 4.7% vs. 17.1% for CDC B/C, 1.1% vs. 4.4% for CDC C, and 1.1% vs. 3.3% for death (excluding suicide/homicide) in cases and controls, respectively. In multivariate analysis, the hazard ratio for a CDC B/C event was 0.15 (95% CI: 0.09-0.27) for cases vs. controls, 2.04 (1.31.-2.9) per log HIV RNA, and 1.77 (1.08-2.9) for i.v. drug use vs. other risk groups (CD4, hemoglobin, age, and sex were not significantly predictive). Among cases, only 107 (29%) remained on the initial regimen. Reasons for stopping at least one drug was virologic failure in 3.3%, intolerance in 17.9%, "other" in 43.5%, and unknown in 24.0% (more detailed re-assessment in progress). ART was interrupted at least once by 44.6% of cases, and 29.2% had no ART anymore at the end of follow up. Conclusion: The initiation of ART in asymptomatic patients with high CD4 counts significantly delays progression to CDC B or C events and death. However, over the follow up time examined, the risk of progression to AIDS or death was low and must be counter balanced against the burden of therapy, as evidenced by frequent drug changes and treatment interruptions.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antigens, CD4
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- Case-Control Studies
- Centers for Disease Control and Prevention (U.S.)
- Disease Progression
- Female
- HIV
- HIV Infections
- HIV Seropositivity
- Humans
- Longitudinal Studies
- immunology
- reverse transcriptase, Human immunodeficiency virus 1
Other ID:
UI: 102244552
From Meeting Abstracts