The results of the OSTEODOLU study on the possible benefits of a change of medication have been published19/01/2017
The Journal of Antimicrobial Chemotherapy, published in October 2016 an article entitled “Switching from a ritonavir-boosted PI to dolutegravir as an alternative strategy in virologically suppressed HIV-infected individuals” about the results of the OSTEODOLU, a clinical studu developed by the Fight AIDS Foundation.
The OSTEODOLU study was conducted between 2013 and 2015 with the participation of patients in the "Germans Trias i Pujol" Hospital, the "Santa Creu i Sant Pau" Hospital and the San Carlos Clinical Hospital. The objective of the study was to show that, in patients with vundetectable iral load (amount of HIV in the blood) a change of medication – from protease inhibitor drugs to an integrase inhibitor [*] - could be a good simplification strategy and could improve bone mineral density.
[*] Antiretroviral drugs are classified into several families depending on how they fight the virus. Each class of drugs has been manufactured to combat a specific stage in the life cycle of HIV: two of these classes or families are protease inhibitors (known by their abbreviation, PI) and integrase inhibitors.
Dolutegravir is a second-generation integrase inhibitor. Its easy dosage and antiviral potency make this drug a good alternative to build simplification regimens. However, there was no available clinical data to support this change in medication in people with HIV under treatment and with an undetectable viral load. On the other hand, and related to bone mineral density, a first study suggested an increase after a change from protease inhibitors to raltegravir, a first-generation integrase inhibitor, but there was no further data.
The OSTEODOLU study, in which 73 patients took part, followed the following methodology: participants were randomly divided into two groups; one of them continued with their usual treatment consisting of abacavir / lamivudina (Kivexa) plus a protease inhibitor (PI) boosted with ritonavir; the other group changed from the PI to dolutegravir. During one year, several follow-up visits were performed to carry out the routine analysis and, in addition, to measure the bone activity through analytical markers and also performing the control of the evolution of bone density with a bone densitometry (DEXA).
The conclusions of the study, explained in detail in the article published in the Journal of Antimicrobial Chemotherapy, indicate that the dolutegravir + Kivexa combination was safe and well tolerated in patients on viral suppression (undetectable viral load) who previously included in their treatment a boosted PI. At the end of the study, 97.3% of the patients who had switched to dolutegravir and 91.7% of those who maintained the enhanced PI had maintained viral suppression. The lipid profile improved with the change in therapy although, probably because of the short-term follow-up, there were no significant changes in bone mineral density, except for a trend towards an improvement in the lumbar area.