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M94A2871.TXT
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1994-10-25
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Document 2871
DOCN M94A2871
TI Antiretroviral therapy effect on CD4+ cell counts. A way to evaluate
drug efficacy.
DT 9412
AU D'Offizi G; Ferrara R; Pinter E; Rosso R; Prozzo A; Pontesilli O; Aiuti
F; Department of Clin. Immunology and Allergology, Univ. of Rome La;
Sapienza, Italy.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):206 (abstract no. PB0254). Unique
Identifier : AIDSLINE ICA10/94369704
AB OBJECTIVE: CD4+ lymphocyte count is a very important surrogate marker to
evaluate antiretroviral drug efficacy. In this study we tested drug
efficacy on CD4+ cell number calculating the slope of the linear
regression line for CD4+ cell during zidovudine and didanosine therapy.
METHODS: We retrospectively calculated the slope of the linear
regression line by the least squares method of CD4+ cell in HIV+
patients on zidovudine and on didanosine therapy. We evaluated the
clinical aspects of HIV-1 patients: sex, age, CDC stage after 12 and 24
months of therapy, drug toxicity and risk factor. RESULTS: 185 HIV+
patients after 12 months of zidovudine therapy at dosage of 500/600 mg
daily showed an average increase of 75 +/- 124 CD4+ lymphocyte count.
After 24 months increase was 16 +/- 43. We defined high responder
patients whose slope was higher than the mean slope (21 on 130 patients
after 12 months of treatment) and no responders those patients with
decrease of CD4 cell number (negative slope) despite of zidovudine
therapy (14 on 130 patients after 12 months of therapy). 101 HIV+
patients after 12 months of didanosine at dosage of 400 mg daily were
evaluated calculating the slope of the linear regression line.
Zidovudine toxicity was characterized by mild anemia (1.5%), nausea
(11%), skin hyperpigmentation (15%), myopathy (3.8%). Didanosine
toxicity was characterized by hyperamylasemia (7.8%). DISCUSSION AND
CONCLUSIONS: The slope calculation of linear regression line can be
useful to evaluate the antiretroviral efficacy on CD4+ cell counts.
After 12 months of treatment we can identify no responder patients and
modify the antiretroviral therapy approach.
DE Antiviral Agents/*THERAPEUTIC USE Comparative Study Didanosine/ADVERSE
EFFECTS/*THERAPEUTIC USE Drug Evaluation/*METHODS Human HIV
Infections/BLOOD/*DRUG THERAPY Least-Squares Analysis Leukocyte
Count/*DRUG EFFECTS Retrospective Studies Treatment Outcome *T4
Lymphocytes Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE MEETING
ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).