Footnotes:
Prescribing Information:
*BIKTARVY® was assessed in four Phase 3, randomised clinical trials: two double-blind trials in treatment-naive adults through to 144 weeks (Study 1489 [BIKTARVY® vs ABC/3TC/DTG, n=629] and Study 1490 [BIKTARVY® vs DTG + FTC/ TAF, n=645]) and two in virologically suppressed adults through to 48 weeks (Study 1844 [double-blind trial, switching from DTG + ABC/3TC or ABC/3TC/DTG to BIKTARVY®, n=563] and Study 1878 [openlabel trial, switching from ABC/3TC or FTC/TDF plus boosted ATV or DRV to BIKTARVY®, n=577]).1 The primary endpoint of Studies 1489 and 1490 was HIV-1 RNA <50 copies/mL at Week 48, as defined by the US FDA snapshot algorithm, with a prespecified non-inferiority margin of –12%.3,4 The primary endpoint of Studies 1844 and 1878 was HIV-1 RNA ≥50 copies/mL at Week 48, as defined by the US FDA snapshot algorithm, with a prespecified noninferiority margin of 4%.5,6 Efficacy defined as viral load <50 copies/mL.1
Consult the Summary of Product Characteristics (SmPC) before prescribing.
**Defined as maintained efficacy, which is dependent on patient adherence. Adherence is impacted by tolerability and simplicity of treatment.8–11 †At Week 144, in Study 1489 (BIKTARVY® [n=314] vs ABC/3TC/DTG [n=315]) efficacy was 82% vs 84% (95% CI: –2.6 [–8.5– 3.4]) and in Study 1490 (BIKTARVY® [n=320] vs DTG + FTC/TAF [n=325]) efficacy was 81% vs 84% (95% CI: –1.9 [–7.8–3.9]), with BIKTARVY® demonstrating noninferior efficacy vs comparator in both trials. 2 At Week 48, in Study 1844 (BIKTARVY® [n=282] vs ABC/3TC/DTG [n=281]) efficacy was 94% vs 95% (95% CI: –1.4 [–5.5–2.6]) and in Study 1878 (BIKTARVY® [n=290] vs ABC/3TC or FTC/TDF plus boosted ATV or DRV [n=287]) efficacy was 92% vs 89% (95% CI: 3.2 [–1.6–8.2]).1 ‡At Week 144, in pooled treatment-naïve patient data from Study 1489 (n=629) and Study 1490 (n=645), and Week 48 in Study 1844 (n=563), there were 0 cases of treatment emergent resistance to study regimens [BIKTARVY® (n=0/834), ABC/3TC/DTG (n=0/315) and DTG + FTC/ TAF (n=0/325)].2,5 At Week 24, in Study 1878 (n=577) one participant in the ABC/3TC plus boosted DRV group developed treatment-emergent resistance; no participants in the BIKTARVY® group developed treatmentemergent resistance through Week 48.6 § At Week 144, in patients receiving BIKTARVY®, the most frequently reported study-drug-related adverse reactions (≥5%) in Study 1489 were diarrhoea 6% (n=19/314), nausea 6% (n=18/314) and headache 5% (n=16/314); in Study 1490 they were headache 4% (n=14/320), diarrhoea 3% (n=10/320) and nausea 3% (n=10/320).2 ll 44-week data on AEs leading to study drug discontinuation % (n). Study 1489 (vs ABC/3TC/DTG): 0% (n=314) vs 2% (n=5 /315); Study 1490 (vs FTC/TAF + DTG): 2% (n=6/320) vs 2% (n=6/325).2 48-week data on AEs leading to study drug discontinuation % (n). No discontinuations due to weight gain in Study 1489 or Study 1490. Study 1844 (vs ABC/3TC/DTG): 2% (n=6/282) vs 1% (n=2/281); Study 1878 (vs boosted DRV or ATV + 2 NRTIs): 1% (n=2/290) vs <1% (n=1/287).5,6 ¶Small STR with flexible daily dosing. Each BIKTARVY® tablet is approximately 15 mm x 8 mm.1 References: 1. BIKTARVY® (BIC/FTC/TAF) Summary of Product Characteristics. 2. Orkin C, et al. Lancet HIV. 2020; 7: e389 e400. 3. Sax PE, et al. Lancet. 2017; 390: 2073–2082. 4. Gallant J, et al. Lancet. 2017; 390: 2063–2072. 5. Molina JM, et al. Lancet HIV. 2018; 5: e357–e365. 6. Daar ES, et al. Lancet HIV. 2018; 5: e347–e356. 7. Wohl D. et al. Patient. 2018; 11: 561–573. 8. US Department of Health and Human Sciences (DHHS). Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. June 2021. Available from: https://clinicalinfo.hiv. gov/sites/default/ files/guidelines/documents/ AdultandAdolescentGL.pdf (Accessed June 2021) 9. Cihlar T and Fordyce M. Curr Opin Virol. 2016; 18: 50–56. 10. Trottier B, et al. J Int AIDS Soc. 2014; 17(4 Suppl 3): 19765. 11. Orkin C, et al. HIV Med. 2018; 19: 18–32. Abbreviations: 3TC, lamivudine ABC, abacavir AE, adverse event ATV, atazanavir BIC, bictegravir CI, confidence interval DRV, darunavir DTG, dolutegravir FDA, Food and Drug Administration FTC, emtricitabine PLWH, people living with HIV RNA, ribonucleic acid STR, single-tablet regimen TAF, tenofovir-alafenamide fumarate TFV, tenofovir TDF, tenofovir disoproxil fumarate US, United States
BIKTARVY® bictegravir 50mg/emtricitabine 200mg/ tenofovir alafenamide 25mg film-coated tablets. INDICATION: Treatment of adults with HIV-1 infection without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir DOSAGE: Adults: One tablet, once daily, taken orally and whole with/without food. Elderly: No dose adjustment is required in patients ≥ 65 years. Renal impairment: Patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min: No dose adjustment required. Patients with CrCl ≥ 15 mL/min and < 30 mL/min or Patients with end stage renal disease (ESRD, CrCl < 15 mL/min) who are not receiving chronic haemodialysis: Should be avoided. Patients with ESRD on chronic haemodialysis: No dose adjustment, but only use if potential benefit outweighs the potential risks. Hepatic impairment: Mild/moderate hepatic impairment: no dose adjustment required. Severe hepatic impairment: not recommended. Paediatric population (<18 years): Safety and efficacy has not been established. Refer to SmPC for full information CONTRAINDICATIONS: Hypersensitivity to active substances / any excipients. Co-administration with rifampicin and St John’s wort. Refer to SmPC for full information. WARNINGS/ PRECAUTIONS: Should not be co-administered with other antiretroviral products. Limited safety and efficacy data in HCV co-infection. Tenofovir alafenamide is active against HBV. Co-infected HIV/HBV patients should be closely monitored for at least several months following discontinuation for symptoms of severe acute exacerbations of hepatitis. Should not be administered simultaneously with magnesium/aluminium-containing antacids or iron supplements under fasted conditions. See SmPC for more information on liver disease, weight and metabolic parameters, risk of mitochondrial dysfunction following exposure in utero, immune reactivation syndrome, opportunistic infections, osteonecrosis with CART therapy or nephrotoxicity and patients with ESRD on chronic haemodialysis. Co- administration: Biktarvy is not recommended for coadministration with atazanavir, carbamazepine, ciclosporin (IV or oral use), oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, or sucralfate. Excipients: Contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium free’. Refer to SmPC for full information on warnings and precautions. INTERACTIONS: See SmPC for full list. PREGNANCY/LACTATION: Use only if potential benefit justifies the potential risk. Breast-feeding: not recommended. Refer to SmPC for full information. DRIVING/USING MACHINERY: dizziness has been reported. SIDE EFFECTS: Refer to SmPC for full information Common (≥1/100 to <1/10): depression, abnormal dreams, headache, dizziness, diarrhoea, nausea, fatigue. Serious adverse events: suicidal ideation, suicide attempt behaviour (particularly in patients with a pre-existing history of depression or psychiatric illness), anxiety, sleep disorders, angioedema and Stevens-Johnson syndrome. LEGAL CATEGORY: POM. PACK: Bottle of 30 film-coated tablets. PRICE: UK NHS List Price - £879.51; Éire/ Ireland – POA. MARKETING AUTHORISATION NUMBER: Great Britain: PLGB 11972/0008 Ireland and United Kingdom (Northern Ireland: EU/1/18/1289/001 & EU/1/18/1289/002 FURTHER INFORMATION: Gilead Sciences Ltd, 280 High Holborn, London, WC1V 7EE, UK; Great Britain & Northern Ireland: +44 (0) 8000 113700, For Ireland: +353 214 825 999. E-mail: ukmedinfo@gilead.com. Biktarvy is a trademark. DATE OF PREPARATION: March 2021; UK-HIV-2021-03-0032. Additional monitoring required. Adverse events should be reported. For Great Britain and Northern Ireland, reporting forms and information can be found at www.mhra. gov.uk/yellowcard/ or via the Yellow Card app (download from the Apple App Store or Google Play Store). Adverse events should be reported to Gilead (safety_FC@gilead.com) or +44 (0) 1223 897500.
Adverse events should be reported. For Ireland, reporting forms and information can be found at www.hpra.ie and can be reported to HPRA on +353 1 6764971. Adverse events should be reported to Gilead (safety_FC@gilead.com) or +44 (0) 1223 897500.
UK-BVY-0701 | June 2022