Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium

Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV

Time frame: Months 5 and 11

Proportion of participants that experience loss of virologic suppression by month 11

Time frame: Month 11

Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression

If a participant experiences loss of virologic suppression, then if an HIV resistance test was performed at that time, the resistance-associated mutations observed will be reported.

Time frame: Month 11

Proportion of participants with a viral blip at months 5 and 11

Time frame: Months 5 and 11

Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11

Time frame: Months 5 and 11

Proportion of participants that are adherent to treatment at months 5 and 11

LAI CAB/RPV must be taken every two months, which therefore requires that a target date be specified in advance of when the next treatment injection should be. This measure will evaluate the proportion of participants that presented to their clinic to receive their treatment either on the target date or within 7 days after (this will be considered adherent) and the proportion of participants that received their treatment more than 7 days after their target date (this will be considered non adherent)

Time frame: Months 5 and 11

Proportion of participants that discontinue their treatment over the study period

Time frame: Month 11

Incidence of discontinuation of treatment over the study period

This measure will be reported in person/years

Time frame: Month 11

Reasons for discontinuation of treatment over the study period

This measure will report all the reasons for which participants discontinued their treatment

Time frame: Month 11

Time to discontinuation of treatment over the study period

This measure will be reported by median time to discontinuation (months) and inter-quartile range

Time frame: Month 11

Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs

Time frame: Within the first 12 weeks of the study

Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11

Time frame: Months 5 and 11

Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11

Time frame: Months 5 and 11