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Abacavir, Didanosine and Stavudine versus Ritonavir, Saquinavir, Zidovudine and Lamivudine or Nelfinavir, Nevirapine, Zidovudine and Lamivudine in antiretroviral naive HIV patients



Abacavir, Didanosine and Stavudine versus Ritonavir, Saquinavir, Zidovudine and Lamivudine or Nelfinavir, Nevirapine, Zidovudine and Lamivudine in antiretroviral naive HIV patients



Abstracts of the Interscience Conference on Antimicrobial Agents & Chemotherapy 42: 261



Background: Abacavir (ABC) is usually included in triple NRTI regimes along with Zidovudine (ZDV) and Lamivudine (LAM) despite the cross-resistance observed between ABC and the two other drugs. The potency of the regiment has been questioned. We evaluated an alternate triple NRTI regimen with presumed less cross-resistance. Methods: A randomised, controlled, open-label study in 178 antiretroviral naive HIV infected patients. The patients were randomised to ABC, Stavudine and Didanosine (A/S/D; n=60) or Ritonavir, Saquinavir, ZDV and LAM (R/S; n=60) or Nelfinavir, Nevirapine, ZDV and LAM (N/N; n=58). R/S was given as 400/400mg BID. The comparison between N/N and R/S was part of a larger study and will not be reported here. The primary end point was plasma viral load (pVL) 20 copies/mL). Patients remained under follow-up after premature discontinuation of randomised therapy. Results of 48 weeks of follow-up are reported. Results: At baseline the median CD4 count was 161 cells/mm3 and pVL 5.0 log10 copies/mL Significantly more patients in the A/S/D than in the N/N arm discontinued any of the study drugs within 48 weeks (63% v 45%, p=0.04) but no difference was observed towards R/S (57%, p=0.46). In the A/S/D arm neuro-toxicity (27%) and hypersensitivity were significantly more common and the plasma lactate levels were higher. At week 48, 41%, 56% and 66% in the A/S/D, R/S, and N/N arm respectively had a pVL <20 copies/mL (P<0.01 for A/S/D v N/N, p=0.12 for A/S/D v R/S). Among patients with baseline pVL >20.000 or AIDS the R/S and the N/N arm had significantly better virological response. No difference was observed in on treatment virological analyses and in changes in CD4 count. Conclusion: A triple NRTI regime with Abacavir, Didanosine and Stavudine had lower efficacy and more adverse reactions than a PI/NNRTI or double PI containing HAART. The use of this triple NRTI regime cannot be recommended.

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