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).