Similar frequencies of AEs were observed for infections and infestations (36.6 and 33.1% for NVP XR and NVP IR, respectively) and for safety laboratory investigations (including aspartate aminotransferase, blood cholesterol and gamma-glutamyltransferase levels) (4.4 and 5.4%, respectively). Rash and hepatic events were BTK inhibitor considered AEs of special interest and both were infrequently observed. Rash was reported in three patients (1.0%) in the NVP XR group – two with grade 1 and one with grade 2 intensity. The two patients with grade 1 rash continued NVP treatment, while the patient with grade 2 rash discontinued NVP treatment. Hepatic events were observed in one NVP XR-treated patient, who acquired

acute HCV infection during the course of the study. This patient experienced fatigue and transient liver enzyme elevation, which returned to normal after 6 weeks. There were no differences between the two treatment groups in terms of safety laboratory tests or vital signs. The majority of abnormalities were

mild (DAIDS grade 1). Moderate or severe (grade 2 or 3) aspartate transaminase (AST) and alanine transaminase (ALT) elevations were infrequent in both treatment groups (2.7 and 3.8% of NVP XR-treated patients, respectively, compared with 4.8 and 4.7% of NVP IR-treated patients, respectively). There was one occurrence of grade 4 ALT enzyme elevation in the NVP XR group (Table 3c). The TRANxITION trial demonstrated that NVP XR was noninferior to NVP IR in maintaining AZD2014 supplier virological suppression in NVP-experienced patients who switched from NVP IR bid to NVP XR qd. Continued virological suppression was high in both treatment groups, and the noninferiority of the NVP XR formulation was demonstrated through a treatment difference of 1.0% (95% CI −4.3, 6.0). This was well above the lower margin of −12%, such that, even using a −10% margin, noninferiority would be demonstrated in this study. In addition, the noninferiority of NVP XR qd to NVP IR bid was supported by all secondary analyses, including the SNAPSHOT approach

analysis, different assays for VL, and different definitions of virological failure (one VL > 50 copies/mL or >400 copies/mL). The results with regard to the primary endpoint were consistent across subgroups, defined by race and Unoprostone gender. Treatment adherence was high for both treatment groups in the present study (≥ 98%). The added convenience of qd dosing, especially in combination with a qd nucleoside reverse transcriptase inhibitor (NRTI) backbone, will be important to patients, especially those with drug adherence issues. The NVP XR formulation was well tolerated. Although higher overall rates of AEs were associated with the NVP XR formulation, interpretation of this higher rate is difficult in the setting of an open-label, randomized trial in which both patients and investigators were aware of the new treatment that the patients on XR were receiving.