Third International Congress Drug Therapy in HIV Infection 3-7 November 1996 Glasgow, UK

FUNCTIONAL CAPACITY OF T CELLS AND IMMUNOLOGIC RESPONSE IN NAÏVE HIV-1 PATIENTS TREATED WITH COMBINATIONS OF REVERSE TRANSCRIPTASE INHIBITORS

N Pakker, E Kroon, D Hall, M Roos, JSG Montaner, D Cooper, S Vella, J Lange, M Koot, P Reiss for the BI 1046 INCAS Study Team
Boehringer Ingelheim Pharmaceuticals, Inc. P.O. Box 368 / 900 Ridgebury Road, Ridgefield, CT 06877 USA

Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. OP2.1
AIDS 1996, Vol. 10 (Suppl. 2);S10

In a multicentre trial of 151 antiretroviral naïve patients the effect of treatment on viral replication and lymphocyte subsets was investigated. In a subpopulation the effect of treatment on the functional capacity of T cells as a marker for the qualitative response of the immune system was studied.

Patients were to be treated for at least 12 months with nevirapine (NVP)+ zidovudine (ZDV), didanosine (DDI) + ZDV or NVP + DDI + ZDV, functional capacity assayed for 7, 9, and 10 patients, respectively. In all patients CD4+ T cell numbers, CD8+ T cell numbers, and plasma HIV RNA load were measured monthly. For the subpopulation, proliferative capacity to CD3 mAb with and without costimulation with CO28 mAb was measured at every visit.

Although a persistent reduction in virus load and increased CD4+ count were observed for all treatments, the triple therapy was clearly superior by 12 months. All three treatment regimens led to increased T cell function throughout one year of treatment. The most prominent restoration of functional capacity, paralleled by an elevation in CD4+ count and improved CD4/CD8 ratio, was observed in patients assigned to triple therapy. The triple therapy appeared to be superior during the last three months, with the peak median change from baseline at week 48 for aCD3 and 40 weeks for aCD3CD28. Initially the combination therapy with DDI+ZDV equaled the response of the triple therapy, but after 6 months an advantage for triple therapy was apparent in both functional assays.

In conclusion, combination therapy with NVP+DDI+ZDV in treatment naïve patients demonstrates that sustained suppression of viral replication with reverse transcriptase inhibitors can result in both qualitative and quantitative immune restoration. Nevirapine provides new opportunities for combination treatment and the observed long term beneficial effect of triple therapy on the immune system is expected to contribute to immune reconstitution in both numeric and functional aspects.

Presenting author: N Pakker

1996-11-03
OP2.1

Originally published in AIDS Volume 10, Supplement 2 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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