Table 3

Study objectives and endpoints

Study objectivesStudy endpoints
Primary objectivePrimary endpoint
  • To characterise viral suppression rates (proportion of patients with HIV-1 RNA <50 copies/mL) at week 24 in the BIC/FTC/TAF arm

  • Proportion of patients with suppressed viral load (HIV-1 RNA<50 copies/mL) at week 24 in the BIC arm (as per FDA snapshot algorithm)

Secondary objectivesSecondary endpoints
  • To characterise viral suppression rates (proportion of patients with HIV-1 RNA <50 copies/mL) at weeks 12, 24 and 48 in the standard of care treatment (SOC) arm (currently, TDF 300 mg/3TC 300 mg/DTG 50 mg) and at weeks 12 and 48 in the BIC/FTC/TAF arm

  • To compare the pharmacokinetics (PK) of BIC when given twice daily and co-administered with Rifampicin during tuberculosis treatment vs when given alone after discontinuation of Rifampicin

  • To assess the incidence of TB associated IRIS in each arm, through week 24

  • To characterise the tolerability of treatment in each arm by assessing frequency of clinician- initiated treatment interruptions or switches through week 48

  • To assess frequency of ART drug resistance mutations in participants with detectable viral load at study visit weeks 24 and 48

  • Viral suppression rates (HIV-1 RNA<50 copies/mL) at weeks 12, 24 and 48 in the DTG arm and at 12 and 48 weeks in the BIC arm

  • PK of BIC when given two times per day and co-administered with Rifampicin vs during TB treatment vs when given alone after TB treatment completion

  • Incidence of TB associated IRIS through week 24, by arm

  • Grade 3 or higher AEs, SAEs; clinician-initiated treatment interruptions or switches through week 48

  • Frequency of ART drug resistance mutations in participants with detectable viral load at weeks 24 and 48

Exploratory objectivesExploratory endpoints
  • To determine the effects of pharmacogenetics (genetic variability in drug metabolising enzymes or drug transporters including but not limited to UGT1A, p-glycoprotein) on BIC/FTC/TAF PK

  • To compare the pharmacokinetics (PK) of TAF, intracellular TFV-DP, FTC and DTG when given twice daily and co-administered with Rifampicin during tuberculosis treatment vs when given alone after discontinuation of Rifampicin

  • To determine the PK of TB drugs

  • To describe the PK in hair of BIC, FTC, TAF during and after co-treatment with Rifampicin. To describe maternal and fetal outcomes among women who become pregnant on-study

  • PK of FTC, TAF and intracellular TFV-DP when given two times per day and co-administered with Rifampicin vs during TB treatment vs when given alone after TB treatment completion

  • PK of TB drugs

  • Effects of pharmacogenetics of drug metabolising enzymes or drug transporters (eg, UGT1A1, CYP3A, p-gp) on BIC/FTC/TAF/DTG PK

  • Association between hair PK and virologic suppression

  • AEs, adverse events; ART, antiretroviral treatment; BIC, bictegravir; FTC, emtricitabine; SAEs, serious AEs; TAF, tenofovir alafenamide; TB, tuberculosis.