The objective of this study was to evaluate the efficacy and safety, and evolution of causes leading to change, of dual therapies based in Dolutegravir in patients requiring a change of virologically effective antiretroviral therapy.
Despite the high rate of virological suppression and low risk of toxicity, HIV-infected patients continue to need new antiretroviral strategies, such as dual therapies, because of different end-organ involvement (kidney, bone, cardiovascular..), intolerance or toxicity. To date, only a protease inhibitor (PI)-based regimen was able to permit the use of dual therapies (two antiretrovirals), especially in case of patients with history of virological failure to other regimens. However, the recent license of Dolutegravir, a integrase inhibitor with high genetic barrier, could help to clinicians to manage patients with intolerance or toxicity to nucleoside analogues without putting in risk virological suppression.
Study Type
OBSERVATIONAL
Enrollment
155
None. Patients initiating Dolutegravir-based dual therapy because of nucleoside analogues toxicity or intolerance will be followed up during a year
Ramon y Cajal Hospital
Madrid, Spain
Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy
Percent of patients remaining with HIV RNA level below 50 copies/ml, according to a missing=failure criteria
Time frame: 12 months
Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir
To collect adverse events (according to DAIDS grade events, 2009) and rate of discontinuation related with adverse events, of dual therapy after switching
Time frame: 12 months
Outcome of causes leading to switch the previous regimen
Evolution of causes de change: glomerular filtration rate during evolution, tubular dysfunction (proteinuria, phosphaturia, glycosuria, uricosuria),bone mineral density by DXA (dual X-ray absorptiometry), lipid disorders, adherence
Time frame: 12 months
Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir
Comparison of efficacy (HIV RNA level \< 50 c/ml) of the different dolutegravir-based dual therapies, according to accompanying drug (non nucleoside, especially rilpivirine), protease inhibitors (darunavir boosted with ritonavir or cobicistat), or nucleoside analogues (lamivudine).
Time frame: 12 months
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