*Robust: Defined as maintained efficacy, which is dependent on patient adherence. Adherence is impacted by tolerability and simplicity of treatment.^9–12
†Efficacy: In RCTs in treatment-naïve participants, BIKTARVY^® was non-inferior (VL<50 copies/mL) to ABC/3TC/DTG (Study 1489) and DTG + FTC/TAF (Study 1490) at Weeks 48 (primary endpoint), 96 and 144 (secondary endpoints).^1,2  Pooled efficacy for BIKTARVY^® (VL<50 copies/mL, n=634, M=F) at Weeks 48 and 144 was 91% and 82% respectively.^1,2 After the optional 96 week open-label extension phase (from Weeks 144 through 240), participants taking BIKTARVY^® since baseline achieved and maintained high rates of virologic suppression (VL<50 copies/mL: 99% [n=426/432] M=E, 67% [n=426/634] M=F).³ In RCTs in virologically-suppressed participants, BIKTARVY^® was non-inferior (VL≥50 copies/mL, M=F) at the Week 48 primary endpoint to comparator regimens of ABC/3TC/DTG (Study 1844) and ATV- or DRV-based regimens (Study 1878).^1,2  BIKTARVY^® efficacy at Week 48 (VL<50 copies/mL, M=F) was 94% in Study 1844 (n=282) and 92% in Study 1878 (n=290).^1,2  Participants who switched to BIKTARVY^® at baseline or from Week 48 in an optional open-label extension (Study 1844 total exposed to BIKTARVY^® n=547, Study 1878 n=534) maintained high levels of viral suppression (VL<50 copies/mL, M=E) through 96 weeks in Study 1844 (100%, n=283/283)⁴ and Study 1878 (100%, n=318/318).⁵ Resistance: In pivotal (registrational) Phase 3 RCTs, there was 0 treatment-emergent resistance to the components of BIKTARVY^® in the final resistance analysis populations.^1–6

^‡Pivotal: Defined as the four registrational trials for BIKTARVY^® (studies 1489, 1490, 1844 and 1878).

^§Tolerability and discontinuation due to adverse events (AEs): In Studies 1489 and 1490 of treatment-naïve participants receiving BIKTARVY® through 144 weeks, the most frequently reported AEs were headache (5%), diarrhoea (5%) and nausea (4%).^1,2 In these studies, discontinuation due to AEs was 1% at Week 48,^1,2 1% at Week 144 (n=6/634)¹³ and 1.6% (n=10/634) at week 240³ for participants initially randomised to BIKTARVY®. Cumulative deaths were reported in 1^,14,15 6¹³ and 9³ (1.4%) participants by weeks 48, 144 and 240.

In virologically suppressed participants at Week 48, 2% (6/282) discontinued BIKTARVY® due to AEs in Study 1844, and 1% (2/290) in Study 1878.^7,8 Across both studies (1844 and 1878), <2% of the 1081 participants discontinued treatment with BIKTARVY® due to AEs through the open-label extension study phase.^4,5 By week 48, death was reported in 2 (1%) and 1 (<1%) of participants in studies 1844⁷ and 1878⁸ respectively. One participant in the 1844 study died during OLE phase.⁴ Please refer to the Summary of Product Characteristics for the full list of AEs and product safety profile.

^‖Small STR with flexible once-daily dosing. Each BIKTARVY^® 50 mg/200 mg/25 mg film-coated tablet is approximately 15 mm x 8mm.^1,2 BIKTARVY^® can be taken with or without food. BIKTARVY^® should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium; and at least 2 hours before iron supplements, or taken together with food.^1,2