Journal Article

Comparison of a Rule-Based Algorithm with a Phenotype-Based Algorithm for the Interpretation of HIV Genotypes in Guiding Salvage Regimens in HIV-Infected Patients by a Randomized Clinical Trial: The Mutations and Salvage Study

Nicola Gianotti, Vincenzo Mondino, Maria Cristina Rossi, Elisabetta Chiesa, Ivano Mezzaroma, Nicoletta Ladisa, Giovanni Guaraldi, Carlo Torti, Pierluigi Tarquini, Paula Castelli, Aldo Di Carlo, Enzo Boeri, Wilco Keulen, Paula Mc Kenna and Adriano Lazzarin

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 42, issue 10, pages 1470-1480
Published in print May 2006 | ISSN: 1058-4838
Published online May 2006 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/503568
Comparison of a Rule-Based Algorithm with a Phenotype-Based Algorithm for the Interpretation of HIV Genotypes in Guiding Salvage Regimens in HIV-Infected Patients by a Randomized Clinical Trial: The Mutations and Salvage Study

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Background. There is still considerable uncertainty as to the best algorithm for interpreting human immunodeficiency virus (HIV) genotyping results.

Methods. A total of 318 subjects with HIV RNA levels of >1000 copies/mL were enrolled in 41 centers throughout Italy from 2001 through 2003, stratified on the basis of their drug history, randomized (1 : 1) to 2 arms to have their treatments modified on the basis of the results of HIV genotyping (as interpreted by virtual phenotype analysis or with use of a rule-based interpretation system), and followed up for 48 weeks. At least 1 nucleoside reverse-transcriptase inhibitor and 1 protease inhibitor had to be included in any new regimen; nonnucleoside reverse-transcriptase inhibitor—naive patients were also prescribed a nonnucleoside reverse-transcriptase inhibitor. Only drugs licensed in Italy were allowed. The primary end point was a decrease in HIV RNA level to <400 copies/mL by week 12 according to on-treatment analysis.

Results. The mean (± standard deviation) values at baseline were as follows: HIV RNA level, 4.1 ± 0.74 log10 copies/mL; CD4+ T lymphocyte count, 410 ± 262 cells/µL; reverse-transcriptase mutations, 4.8 ± 2.9; and protease mutations, 2.8 ± 2.5. There were 133 patients (41.8%) who were nonnucleoside reverse-transcriptase inhibitor naive and protease inhibitor experienced, 63 patients (19.8%) who were nonnucleoside reverse-transcriptase inhibitor experienced and protease inhibitor naive, and 122 patients (38.4%) who were 3-class experienced. A total of 192 patients completed 12 weeks of the treatment regimen assigned at baseline; at 12 weeks, 66.3% of patients in the virtual phenotype arm and 71.3% of patients in the rule-based interpretation arm had HIV RNA levels of <400 copies/mL (P = .46). No statistically significant difference between arms was observed by intention-to-treat analysis.

Conclusion. Both the virtual phenotype and rule-based interpretation methods of HIV genotyping can guide the selection of effective antiretroviral drugs for a salvage regimen.

Journal Article.  5039 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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