Article Text
Abstract
Background and Importance The combination of cabotegravir and rilpivirine (C/R) is the first commercialised long-acting injectable for treating HIV-1. Real-life data in Spain is still scarce.
Aim and Objectives To analyse the effectiveness and safety of patients treated with C/R in a tertiary hospital.
Material and Methods A descriptive observational study of patients treated with C/R from 1 February 2023 (date of inclusion in the Hospital Drug Guide) until 31 August 2023 in a tertiary hospital. All patients on an oral regimen and with an undetectable viral load (VL) were included. Those that came from the pivotal trials were excluded. Effectiveness was measured as the percentage of patients who remained with undetectable VL on 24 September 2023. To measure safety, the adverse reactions (AR) recorded in the electronic medical records were reviewed.
Results One hundred and seventy-five patients were included: 156 cis-men (89%), 18 cis-women (10%) and one trans-woman (1%), with a median age of 45 years (IQR=36–57). The most common prior treatments were bictegravir/emtricitabine/tenofovir alafenamide (48%) and dolutegravir/lamivudine (23%). One hundred and thirty-seven patients had at least one analysis since the first administration, 15 had two, and the rest had no analysis since the first administration of C/R. Only two patients (1.1%) had detectable VL in their first analysis (log 1.64 and 1.74), but in both, a new analysis was done at 29 and 7 days, respectively, and again had undetectable VL.
The most prevalent AR was pain at the administration site (53.0%), followed by diarrhoea (2.2%), fatigue (1.7%), pyrexia (1.7%), headache (1.7%), and induration (0.6%). The rest of the patients (39.1%) did not present any AR. Two patients (1.1%) discontinued treatment due to AR, one due to pain at the site of administration and another due to fatigue and weight loss [DS1] . The duration of AR had a median of 2 days, and all of them resolved within 7 days of administration.
Conclusion and Relevance The intramuscular association of cabotegravir and rilpivirine effectively maintains VL supressed and it is safe. The most reported adverse reaction is pain at the injection site.
Conflict of Interest No conflict of interest.