Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

CHANGES IN HIV-I RNA LEVELS MEASURED BY QUANTITATIVE PCR DURING TREATMENT WITH 3TC'™ MONOTHERAPY: CORRELATION WITH HIV-I DISEASE PROGRESSION

C Loveday, U Ayliffe, R van Leeuwen, R Tubiana, V Kitchen, A Hill, P Collis and R Tedder
Division of Virology, University College London Medical School, 46 Cleveland Street, London WI P 60B

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 2.3
AIDS 1994, Vol. 8 (Suppl. 4);S2-3

In a phase 1/11 dose escalation study of 3TC monotherapy (protocol NUCB200l), the levels of circulating HIV-I were measured using a quantitative polymerase chain reaction (PCR). Changes in the levels of virus were analysed to determine the effect of 3TC monotherapy on viral load, and to investigate the correlation between viral load and disease progression.

One hundred and four patients were treated in this study. A data cut off for this analysis was made after a median follow-up of 13 months. At study entry patients were' CDC disease stage II, III or IVC2, with a median baseline CD4 count of 215 (range 10 - 495). Patients were treated with 3TC at doses ranging from 0.5-20.0 mg/kg/day. During the follow-up period 12 patients progressed to AIDS. HIV-I RNA levels (copies per ml, c/ml) were measured at baseline, and after 4, 8 and 12 weeks of treatment in 98 patients for whom samples were available, as previously described (1).

HIV -I RNA levels fell by a median 43% after 12 weeks of treatment with 3TC (p=0.01, Wilcoxon test). but the median fall was not dose related (p=0.881. Spearman. Rank Correlation test). Progression to AIDS occured in 12/67 patients with >100 c/ml of HIV-l RNA after 12 weeks of treatment; no progressions had occured among 31 patients with <1000/ml at this time (p=0.024, log rank test).

Additional follow-up has occured after the data cut-off point for this analysis and will be presented. At this time we conclude that the levels of HIV-I fell during treatment with 3TC, although the degree of reduction in HIV-1 was not correlated with the dose of 3TC. The level of HIV-I RNA after 12 weeks of treatment appeared to be predictive for progression to AIDS.

[1.] Semple et al., J Virol Methods. 1993 Feb;41(2):167-79.

Presenting author: C Loveday

1994-11-18
2.3

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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