The effect of treatment intensification in HIV-infection:A study comparing treatment with ritonavir/saquinavir and ritonavir/saquinavir/stavudine

Autor: Sven A. Danner, Suzanne Jurriaans, M.E. van der Ende, Anthony J. Japour, J Pelgrom, F. De Wolf, M J Borst, Kees Brinkman, Elisabeth H. Gisolf, F. Van Wanzeele
Přispěvatelé: Internal medicine
Jazyk: angličtina
Rok vydání: 2000
Předmět:
Zdroj: Gisolf, E H, Jurriaans, S, Pelgrom, J, Van Wanzeele, F, Van der Ende, M E, Brinkman, K, Borst, M J, De Wolf, F, Japour, A J & Danner, S A 2000, ' The effect of treatment intensification in HIV-infection : A study comparing treatment with ritonavir/saquinavir and ritonavir/saquinavir/stavudine ', AIDS, vol. 14, no. 4, pp. 405-413 . https://doi.org/10.1097/00002030-200003100-00014
AIDS, 14(4), 405-413. Lippincott Williams and Wilkins
ISSN: 0269-9370
DOI: 10.1097/00002030-200003100-00014
Popis: Objective: To evaluate the effect of treatment with ritonavir (RTV)/saquinavir (SQV)/stavudine (D4T) or RTV/SQV alone, with treatment intensification if needed, in protease inhibitor- and D4T-naive HIV-1-infected individuals. Design: Multicentre, open-label, randomized controlled trial. Two-hundred and eight patients were randomized to receive treatment with RTV 400 mg/SQV 400 mg twice daily or RTV 400 mg/SQV 400 mg/D4T 40 mg twice daily. Intensification of study medication with reverse transcriptase inhibitors was permitted if serum HIV-RNA remained > 400 copies/ml after 12 weeks of treatment. Follow-up of this study was 48 weeks. Results: In a strict intention-to-treat analysis, counting all dropouts as virological failures, 63% [95% confidence interval (CI), 54-73%] of subjects in the RTV/SQV group (n = 104) reached a serum HIV-RNA < 400 copies/ml at week 48, as compared with 69% (95% CI, 60-78%) in the RTV/SQV/D4T group (n = 104; P = 0.379). In the on-treatment analysis these percentages were 88 and 91% respectively. Thirty-one patients intensified their study medication according to the protocol (28 in the RTV/SQV group, three in the RTV/SQV/D4T group). Thirty out of 31 (97%) patients had a serum HIV-RNA < 400 copies/ml at their last follow-up visit. Ten per cent of patients discontinued study medication due to adverse events. Conclusion: The concept of starting with a simple, potent regimen, that could be intensified if necessary, showed good virological results after 48 weeks in this study, comparable to starting with more drugs from the beginning. Longer follow-up is needed to determine the long-term efficacy of this treatment strategy. (C) 2000 Lippincott Williams and Wilkins.
Databáze: OpenAIRE