“…19 One possible explanation for this finding is that recurrent AEs are less frequently captured over longer-term treatment. PwCF experience elevations in transaminase levels due to underlying hepatic disease and treatment with concomitant medications, including antibiotics [32][33][34] ; the transaminase data in study 661-110 were generally consistent with previous experience with TEZ/IVA and background transaminase elevations occurring in pwCF. 20,21 Consistent with the PBO-controlled parent studies, there was no evidence of an increased incidence of respiratory TEAEs associated with extended TEZ/IVA treatment.…”