Safety and tolerability
death, Hypertriglyceridemia, cryptococcal meningitis, weight gain, appendicitis
HYPERTRIGLYCERIDEMIA, CRYPTOCOCCAL MENINGITIS, APPENDICITIS, MENINGEAL TUBERCULOSIS, INTESTINAL TUBERCULOSIS
The study drugs were well tolerated. Nine clinical AEs (grade 1: 17% [8/47] and grade 2: 2% [1/47]) were classified as possibly related to study treatment. The most frequent laboratory abnormalities were elevated aspartate transaminase/alanine transaminase (grade 2: 20% [9/45]) without an increase in bilirubin. Hypertriglyceridemia (grade 2) was observed in 13.3% (6/45) of the participants.Five participants presented SAEs, although none were considered related to study treatment, and two resulted in the participant’s discontinuation from the study (one was a suicide attempt after 8 weeks of treatment and the other, a meningeal tuberculosis at week 4, leading to death). Although external factors were identified in the case of suicidal attempt, after discussing with the medical team, it was decided to discontinue ART. The other 3 SAEs included cryptococcal meningitis at day 5, intestinal tuberculosis at week 20, and appendicitis at week 24 that resulted in hospital admission. These three participants finalized the protocol.Given that weight gain has been reported for DTG-based regimens, changes at week 48 were analyzed for exploratory reasons. Participants increased their weight, on average, by 2.6% compared to their weight at the baseline visit. In absolute terms, there was an increase of 1.5 kilos on average between baseline and week 48; this difference was not statistically significant (