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

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Nicola GianottiMutations and Salvage (MuSa) Study Group

Abstract

There is still considerable uncertainty as to the best algorithm for interpreting human immunodeficiency virus (HIV) genotyping results. 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. The mean (+/- standard deviation) values at baseline were as follows: HIV RNA level, 4.1+/-0.74 log(10) copies/mL; CD4(+) T lymphocyte count, 410+/-262 cells/microL; reverse-transcriptase mutations, 4.8+/-2.9; and protease mutations, 2.8+/-2.5. There were 133 patients (41.8%) who were...Continue Reading

References

Jan 25, 2002·AIDS·Cristina TuralUNKNOWN Havana Study Group
Nov 15, 2005·AIDS·Jonathan ElfordGraham Hart

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Citations

Aug 21, 2008·Journal of Medical Virology·Annalisa SaracinoUNKNOWN Mutations, Salvage Study Group
Nov 10, 2018·The Cochrane Database of Systematic Reviews·Theresa AvesLawrence Mbuagbaw
Nov 1, 2006·Current Opinion in HIV and AIDS·Andrew N PhillipsJens D Lundgren

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