The legal proceeding on the use of genotypic assays for the detection of HIV antiretroviral resistance in Italy: background and rationale for a consensus conference to establish guidelines.

Do the genotypic assays for the detection of antiretroviral resistance represent a useful tool in the management of HIV-infected patients? The rationale for this legal proceeding is all included in this question. No health care technology assessment has been performed on antiretroviral genotypic assays in HIV-infected patients. Assays to measure drug resistance are available only in specialized laboratories and warnings are related to possible expanded use of these assays in the absence of randomised studies with prolonged clinical endpoint and in the absence of unambiguous and exhaustive general recommendations for the use of resistance assays in clinical practice.