Safety and tolerability
ADVERSE REACTIONS
This study showed that Canocapavir was safe and tolerated over the 28 days of treatment. No serious AE occurred during the period of the trial. No patients withdrew from the study due to an AE, thus allowing the tolerability, antiviral, and PK analyses on data from all patients. A total of 76.7% (23/30) of the patients experienced 49 cases of AEs, in which 38 cases occurred in 75% of patients from the Canocapavir cohort, while 11 cases were from 83% of patients from the placebo cohort.In total, 50% (15/30) of the subjects experienced 31 cases of adverse reactions, in which 24 cases occurred in 50% of patients from the Canocapavir cohort, while 7 cases were from 50% of patients from the placebo cohort. Most adverse reactions were mild or moderate in severity and resolved without treatment. The incidence rates of adverse reactions in each cohort were as follows: 50 mg, 37.5% (3/8); 100 mg, 62.5% (5/8); 200 mg, 50.0% (4/8); and placebo, 50.0% (3/6). The incidence of adverse reactions among patients who received Canocapavir was not significantly correlated to its increased dose (Table Frequency of adverse reactions in each treatment cohort [case, number of subjects (%)]