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

COMBINATION 3TC (LAMIVUDINE) ZDV (ZIDOVUDINE) VS ZDV MONOTHERAPY IN ZDV NAÏVE HIV-1 POSITIVE PATIENTS WITH CD4 OF 100-400 CELLS/MM3

C. Katlama
The European Lamivudine HIV Working Group Hôpital Pitié-Salpétriere Paris, France

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 7.5
AIDS 1994, Vol. 8 (Suppl. 4);S6

This double-blind controlled trial compared the safety and efficacy of 24 weeks treatment with combination 3TC (300mg bid)/ZDV (200mg tid) versus ZDV monotherapy (200mg tid). Inclusion criteria were CD4 counts of 100-400 cells/mm³ and less than 4 weeks of prior ZDV treatment. 129 patients were randomised (65 to 3TC/ZDV, 64 to ZDV) and assessed for treatment efficacy using surrogate marker measurements. Clinical adverse events, laboratory toxicities and symptoms of HIV-1 disease at baseline, week 2, week 4 and then every four weeks to week 24. After 24 weeks, all patients were offered open-label treatment with 3TC and ZDV.

Patients were predominantly male (75%), Caucasian (82%), asymptomatic (83%) and had acquired HIV-1 by sexual contact (90%). The median baseline CD4 count was 251 cells. and 16% of patients were p24 antigen positive. All baseline characteristics recorded were comparable between the two treatment arms.

With ZDV monotherapy, the median CD4 rise was +29 cells after 8 weeks, falling to 15 cells below baseline at 24 weeks. On 3TC/ZDV combination, CD4 counts rose to +76 cells at 8 weeks. and this rise was sustained at +63 cells above baseline at 24weeks(p<0.0001 for difference between treatments).Falls in p24 antigen, ICD p24 antigen. cellular viraemia, beta-2-microglobulin and neopterin were greater and sustained for longer periods with 3TCIZDV combination therapy than with ZDV monotherapy.

There were no significant differences between the treatment arms in incidence of Grade III/IV clinical or laboratory toxicity. 9 patients on 3TC/ZDV and 6 patients on ZDV had withdrawn from randomised treatment by week24. 3TC/ZDV appears well tolerated in this patient population and provides significant surrogate marker benefit for at least 24 weeks. Follow up data on the surrogate marker efficacy and tolerability of 3TCIZDV for 48 weeks of treatment in will be presented.

Presenting author: C. Katlama

1994-11-18
7.5

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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