The median time of exposure to DTG+

The median time of exposure to DTG+RPV and CAR was 364 days(52 weeks)for both studies and for the pooled data(Table 8).There were 2 subjects in the CAR group for whom study treatment was interrupted more than 10% of total time in the Early Switch Phase and this subject was not included in the PP Population(201636 CSR Section 5.2; 201637 CSR Section 5.2).For those subjects randomized to DTG+RPV in the Early Switch Phase, there was no schedule to switch treatment(and no Week 52 assessment visit).As a result, their exposure within the Early Switch Phase was considered to be 52 weeks(364 days)unless they withdrew earlier in the study.Extent of exposure for CAR is calculated using medication start and stop dates.The late switch from CAR to DTG+RPV takes place at the Week 52 visit but there is variability in the actual day that subjects attend the clinic.As a result, in contrast with the DTG+RPV group, there were some subjects with less than 52 weeks of treatment and others with at least 52 weeks of treatment.In the Early Switch Phase, exposure was comparable between DTG+RPV and CAR.Summary of Extent of Exposure during the Early Switch Phase in Studies 201636, 201637, and Pooled Data(Safety Population)Duration of dosing in subject yearsaNote:Dose interruptions are not excluded.Cumulative sum across subjects of(treatment stop date-treatment start date+1)divided by 365.25For CAR subjects, exposure in the Early Switch Phase is calculated to the day prior to switching to DTG+RPV or to withdrawal where withdrawal took place sooner.For DTG+RPV subjects, exposure in the Early Switch Phase is calculated as 52 weeks(364 days)or to withdrawal if withdrawal took place sooner.Primary Efficacy Results:Subjects with Plasma HIV-1 RNA