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M94A2854.TXT
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1994-10-25
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Document 2854
DOCN M94A2854
TI HIV-1 viremia changes and development of drug-related viral mutations in
patients (pts) receiving long-term combination therapy with AZT/ddI.
DT 9412
AU Kojima E; Shirasaka T; Anderson BD; Chokekijchal S; Steinberg S; Broder
S; Yarchoan R; Mitsuya H; National Cancer Institute, Bethesda, MD.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):21 (abstract no. 056B). Unique
Identifier : AIDSLINE ICA10/94369721
AB OBJECTIVE: To investigate viremia changes and the development of
drug-related viral mutations in pts with advanced HIV-1 infection
receiving AZT and ddl in combination. METHODS: HIV-1 virion numbers in
serum (VPs) from a subset of 26 pts randomized to received AZT and ddl
in an alternating (A: 600 mg/day AZT for 3 wk and 500 mg/day ddl for 3
wk) or simultaneous (S: 300 mg AZT plus 250 mg ddl daily) regimen (see
J. Infect. Dis. 169:9, 1994) were determined by PCR following reverse
transcription of viral RNA. RESULTS: 13 pts in A and S arms had median
entry CD4 counts of 227 and 174/mm3, respectively. Both arms had a
significant reduction in VPs during the first 2-3 mos (approximately 8x
(p = 0.0002) and approximately 31x (p = 0.0005) lower than at entry for
A and S, respectively); however, the reduction was greater in S arm than
in A arm (p = 0.0051 both at wk 2 and 9). After 1 yr, VPs remained
significantly lower in both arms (13x (p = 0.0005) for A; 9x (p =
0.0024) for S), but there was no difference between the arms (p = 0.37).
The reduction was still present after 1.5 and 2 yrs (5x and 19x lower (p
= 0.039 and 0.039) for A; 8x and 8x lower (p = 0.0049 and 0.014) for S,
respectively). 18/26 (69%) pts developed the mutation at codon 215 by 1
yr. By contrast, only 1/26 (4%) pts had the Leu74-->Val mutation,
although 8/9 (89%) pts receiving ddl monotherapy in other NCl trials
developed this mutation (p = 0.00005). DISCUSSION/CONCLUSIONS: The data
suggest that S is more active than A in vivo for 2 to 3 mos and that the
inclusion of AZT blocks or retards the emergence of the Leu74-->Val
mutation. Determination of the overall durability of the anti-viremic
effect of A and S regimens and clinical implications of the results
require further research.
DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/MICROBIOLOGY
Didanosine/*ADMINISTRATION & DOSAGE Drug Administration Schedule Drug
Therapy, Combination Human HIV-1/*DRUG EFFECTS/GENETICS Mutation/DRUG
EFFECTS Viremia/DRUG THERAPY Virion/DRUG EFFECTS
Zidovudine/*ADMINISTRATION & DOSAGE CLINICAL TRIAL MEETING ABSTRACT
RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).