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Size and duration of zidovudine benefit in 1003 HIV-infected patients: U.S. Army, Navy, and Air Force natural history data

Gardner, LI and Harrison, SH and Hendrix, CW and Blatt, SP and Wagner, KF and Chung, RCY and Harris, RW and Cohn, DL and Burke, DS and Mayers, DL (1998) Size and duration of zidovudine benefit in 1003 HIV-infected patients: U.S. Army, Navy, and Air Force natural history data. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 17 (4). 345 - 353. ISSN 1077-9450

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Abstract

Objectives: The study's objectives were to determine the size and duration of benefits of early versus delayed versus late treatment with zidovudine (ZDV) on disease progression and mortality in HIV-infected patients, and whether patients rapidly progressing before ZDV treatment had a different outcome from those not rapidly progressing before ZDV. Design: The design was an inception cohort of 1003 HIV-infected patients. One hundred and seventy-four of the 1003 patients were treated before CD4 counts fell to < 400 x 109/L, ('early treatment'); 183 of 1003 patients were treated after CD4 counts fell to <400 x 109/L but before clinical disease developed ('delayed treatment'); and 646 of the 1003 patients had either been treated after clinical disease developed or had not been treated at all by the end of follow-up ('late treatment'). Outcomes were progression to clinical HIV disease and mortality. Results: The relative risk (RR) of progression for early versus delayed treatment was 0.58 (p < .03), and durability of ZDV benefits on progression was estimated at no more than 2.0 years; however, this estimate had wide confidence intervals. The RR of progression for delayed versus late treatment was 0.54 p < .0001, and durability of ZDV benefits was estimated at 1.74 years; this estimate had narrow confidence intervals. Survival was better for the early versus delayed treatment (RR = 0.55), but this difference was not statistically significant. In the subgroup of patients with more rapid CD4 decline prior to ZDV therapy, significant benefits on progression were observed for early versus delayed ZDV therapy (RR = 0.42, p = .02) and delayed versus late ZDV therapy (RR = 0.51; p = .0004). Duration of benefit was estimated to be 4.5 years (early versus delayed) and 1.7 years (delayed versus late). For patients with less rapid pre-ZDV decline in CD4 levels, a significant progression benefit was observed for delayed versus late therapy (RR = 0.50; p = .02). Duration of benefit in this subgroup was estimated to be 1.8 years. No significant benefit was found for early versus delayed treatment (RR = 1.12) in the less rapid pre-ZDV CD4 cell decline subgroup. Conclusions: Early treatment compared with delayed treatment was associated with a sizable reduction in HIV progression, but the duration of benefits was estimated to last only about 2 years. Delayed treatment compared with late treatment with ZDV was associated with substantial reduction of progression, but this reduction was also clearly limited in duration. Benefits on progression and mortality for the early treatment group were heavily dependent on the pre-ZDV CD4 slope. In the subgroup of patients with the most rapid pre-ZDV CD4 cell declines, the duration of benefit was much longer, possibly as long as 4 years.


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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Gardner, LI
Harrison, SH
Hendrix, CW
Blatt, SP
Wagner, KF
Chung, RCY
Harris, RW
Cohn, DL
Burke, DSdonburke@pitt.eduDONBURKE
Mayers, DL
Centers: Other Centers, Institutes, or Units > Center for Vaccine Research
Date: 1 April 1998
Date Type: Publication
Access Restriction: No restriction; Release the ETD for access worldwide immediately.
Journal or Publication Title: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Volume: 17
Number: 4
Page Range: 345 - 353
DOI or Unique Handle: 10.1097/00042560-199804010-00009
Institution: University of Pittsburgh
Schools and Programs: Graduate School of Public Health > Epidemiology
Refereed: Yes
ISSN: 1077-9450
Date Deposited: 07 May 2015 19:12
Last Modified: 02 Feb 2019 16:57
URI: http://d-scholarship.pitt.edu/id/eprint/24599

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