| A prospective comparison of the two main indications of efavirenz in 2001 highly active antiretroviral therapy (HAART) regimens: first-line versus salvage use. | |
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MedLine Citation:
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PMID: 12003964 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To determine the efficacy of efavirenz introduction in first-line HAART compared with salvage multidrug regimens. PATIENTS AND METHODS: Prospective 15 month comparison of 107 consecutive HIV-infected patients starting efavirenz, according to laboratory and clinical outcome of first-line versus rescue drug use, therapeutic history and association of selected antimicrobial agents: naive patients were compared with nucleoside reverse transcriptase inhibitor (NRTI)-experienced patients in the first group, and patients in the second group who had one or more NRTI changed when starting a rescue treatment containing one or more novel protease inhibitors (PIs) were compared with those who did not. RESULTS: Efavirenz was administered with one or more novel NRTIs to 55 patients (27 antiretroviral-naive and 28 patients experienced with NRTIs only), compared with 52 patients who needed a multidrug salvage regimen after two or more failures of a 15-40 month PI-containing regimen. In an intention-to-treat analysis, con-sidering early interruption or an unsatisfactory virological course as a failure, only one patient on salvage therapy completed a favourable 15 month follow-up, compared with 31 patients experiencing first-line efavirenz-based HAART (P < 0.0001). The immunological response was less affected in both intensity and duration in patients undergoing rescue therapy. While no significant outcome difference was detected in the first group between naive and NRTI-experienced patients, among the salvage subjects the change of one or more NRTIs seemed to significantly improve virological and immunological outcome. Viral genotyping detected at least the K103N mutation in 41% of the 78 evaluable patients, despite lack of exposure to efavirenz and related compounds. Salvage patients had a significantly greater frequency of non-nucleoside RTI (NNRTI) resistance compared with the first-line group (P < 0.0001), in proportion to the extent of mutations affecting other drug classes (P < 0.0001). CONCLUSION: An efavirenz-based initial triple drug HAART proved significantly more effective than efavirenz adjunct to a rescue treatment performed after repeated failures of PI-based regimens. The unsatisfactory response of the salvage group was probably due to diffuse cross-resistance descending from previous therapy, even when NNRTIs were never administered. |
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Authors:
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Roberto Manfredi; Leonardo Calza; Francesco Chiodo |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article |
Journal Detail:
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Title: The Journal of antimicrobial chemotherapy Volume: 49 ISSN: 0305-7453 ISO Abbreviation: J. Antimicrob. Chemother. Publication Date: 2002 May |
Date Detail:
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Created Date: 2002-05-10 Completed Date: 2002-11-29 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7513617 Medline TA: J Antimicrob Chemother Country: England |
Other Details:
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Languages: eng Pagination: 723-9 Citation Subset: IM |
Affiliation:
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Department of Clinical and Experimental Medicine, Division of Infectious Diseases, University of Bologna, S. Orsola Hospital, Via Massarenti 11, I-40138 Bologna, Italy. manfredi@med.unibo.it |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Antiretroviral Therapy, Highly Active
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methods* Benzoxazines CD4 Lymphocyte Count Cohort Studies DNA, Viral / genetics Genotype HIV Infections / drug therapy*, immunology, virology HIV Protease Inhibitors / therapeutic use Humans Oxazines / therapeutic use* Prospective Studies Reverse Transcriptase Inhibitors / therapeutic use* Salvage Therapy / methods* Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Benzoxazines; 0/DNA, Viral; 0/HIV Protease Inhibitors; 0/Oxazines; 0/Reverse Transcriptase Inhibitors; 154635-17-3/efavirenz |
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