Integrase strand transfer inhibitors (INSTI) inhibit HIV replication by preventing the integration of proviral HIV DNA into the host’s genome. INSTIs are used as part of combination antiretroviral therapy (cART) regimens for both treatment-naive and treatment experienced patients. Four INSTIs have been approved so far for the treatment of HIV infection: first generation elvitegravir (EVG) and raltegravir (RAL), and second generation dolutegravir (DTG) and bictegravir (BIC). Cabotegravir (CAB) is studied in phase III clinical trials.

DTG was approved for the treatment of HIV-1 by the FDA in 2013. In clinical practice, virological failure to dolutegravir is rare and often without selection of known resistance mutations. Considering the anticipated widespread use of dolutegravir globally, a better understanding of relevant resistance is urgently needed. The ROSETTA registry aims at systematically collecting otherwise scattered information on individual patient cases failing second generation integrase inhibitors, with the goal to correctly inform policy and future use of DTG and other INSTIs in the treatment of HIV infected patients.

Attending physicians of patients who are experiencing virological failure on a second generation integrase inhibitor-containing regimen are invited to contribute data to the registry. Genotypic resistance analyses, drug level testing, and in selected cases phenotypic resistance analyses, will be performed. Results relevant for individual patient care will be reported back to the submitter. Submission of the data does not affect original ownership of data. Data of the registry will be published following the ESAR guidance for authorship.

If you are interested to join this collaboration, please click here.

Would you like assistance for patients failing integrase inhibitors, interpretation of drug resistance results or consultation to inform future therapy? ESAR offers the possibility to ask all your questions to an expert panel, please click here.