INDICATION
BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of BIKTARVY.
Please see below for Important Safety Information for BIKTARVY.
Few Contraindications and Drug-Drug Interactions1
BIKTARVY® is contraindicated with two medications: dofetilide and rifampin
Established and Potentially Significant* Drug Interactions:
Alteration in Regimen May Be Recommended
| Concomitant Drug Class: Drug Name | Clinical Comment | ||||||||||||
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- For an aging patient population, which may have comorbidities, the safety profile and drug-drug interactions of a treatment are important considerations when choosing a therapy2
*Table is not all-inclusive.
†Drug-drug interaction study was conducted with either BIKTARVY or its components as individual agents.
‡Strong inducer of CYP3A and
§The induction potency of St. John’s wort may vary widely based on preparation.
No Known Dose Adjustments When BIKTARVY Is Coadministered With These Medications1
Drugs With No Clinically Significant Interactions With BIKTARVY
| Drug Class | Drug Within Class | ||||||||
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Warnings and Precautions1
| Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. |
| Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. |
|
New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)—containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. |
| Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. |
Established Safety Profile.
Demonstrated Long-Term Safety and Tolerability Profile in Treatment-Naïve Adults Through Week 1443,4
|
Study 1489 |
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| Adverse Reactions (ARs) (All Grades) Reported in ≥2% of Adults Who Received BIKTARVY |
BIKTARVY(n=314)
ABC/
DTG/3TC(n=315) |
Study 1490 BIKTARVY(n=320)
FTC/TAF
+DTG(n=325) |
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Frequencies of ARs are based on all adverse events attributed to trial drugs by the investigator. No ARs of Grade 2 or higher occurred in >1% of participants treated with BIKTARVY.
Study 1489 and 1490: Weight Change Through Week 144
Study 14893,4
In Study 1489, no adults discontinued BIKTARVY due to weight-related AEs through Week 1443-5
- In Study 1489, an AE of weight increase was reported for BIKTARVY (2.9%), ABC/DTG/3TC (4.1%), and weight decrease for BIKTARVY (1.9%), ABC/DTG/3TC (1.6%)
Study 14903,4
In Study 1490, no adults discontinued BIKTARVY due to weight-related AEs through Week 1443-5
- In Study 1490, an AE of weight increase was reported for BIKTARVY (2.5%), FTC/TAF+DTG (3.1%), and weight decrease for BIKTARVY (0.9%), FTC/TAF+DTG (0.9%)
In the OLEs through Week 240, 1 participant initially randomized to BIKTARVY discontinued due to obesity, which was considered to be related to the study drug by the investigator5
Median cumulative weight gain from baseline to Week 240, including the OLE, was 6.1 kg for participants initially randomized to BIKTARVY5
IMPORTANT SAFETY INFORMATION
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
3TC, lamivudine; ABC, abacavir; AE, adverse event; DTG, dolutegravir; FTC, emtricitabine; TAF, tenofovir alafenamide.
Study 1489: Changes in Hip BMD Through Week 1444
-
BMD declines of ≥7% at the total hip were experienced in 1% of BIKTARVY patients and 2% of ABC/DTG/3TC patients at Week 48, in 2% of BIKTARVY patients and 3% of ABC/DTG/3TC patients at Week 96, and in 5% of BIKTARVY patients and 4% of ABC/DTG/3TC patients at Week 1443
- Analysis was conducted in a subset of the study population (n=597)3
In the OLE:
- A mean change of −0.3% was observed from baseline at Week 240 (n=197)5
- BMD declines of ≥7% at the total hip were experienced in 8% of patients (n=15/197) at Week 2403,5
- Includes only participants initially randomized to BIKTARVY at Week 0, as these participants took BIKTARVY for 240 weeks5
The long-term clinical significance of changes in BMD is not known.
- BMD was assessed at baseline, Week 24, Week 48, Week 96, Week 144, Week 192, and Week 240 by dual-energy x-ray absorptiometry (DXA) scans3,5
Study 1489: Changes in Lumbar Spine BMD Through Week 1444
-
BMD declines of ≥5% at the lumbar spine were experienced in 10% of BIKTARVY patients and 6% of ABC/DTG/3TC patients at Week 48, in 12% of BIKTARVY patients and 6% of ABC/DTG/3TC patients at Week 96, and in 12% of BIKTARVY patients and 8% of ABC/DTG/3TC patients at Week 1443
- Analysis was conducted in a subset of the study population (n=603)3
In the OLE:
- A mean change of −0.2% was observed from baseline at Week 240 (n=201)5
- BMD declines of ≥5% at the lumbar spine were experienced in 20% of patients (n=41/201) at Week 2403,5
- Includes only participants initially randomized to BIKTARVY at Week 0, as these participants took BIKTARVY for 240 weeks5
The long-term clinical significance of changes in BMD is not known.
- BMD was assessed at baseline, Week 24, Week 48, Week 96, Week 144, Week 192, and Week 240 by dual-energy x-ray absorptiometry (DXA) scans3,5
BMD was measured only in Study 1489
IMPORTANT SAFETY INFORMATION (cont’d)
Drug Interactions
- Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
- Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.
BMD, bone mineral density; CI confidence interval; FTC emtricitabine; OLE, open-label extension.
Study 1489 and 1490: Changes in eGFR and Serum Creatine Through Week 144
Study 14894-7
- Median serum creatine increased by 0.1 mg/dL in the BIKTARVY arm and by 0.11 mg/dL in the ABC/DTG/3TC arm from baseline4
In the OLE:
- A median eGFR change of −8.2mL/min from baseline was observed at Week 240 (n=213)3,5
- Median serum creatine increased by 0.11 mg/dL in patients from baseline through Week 2403
- Includes only participants initially randomized to BIKTARVY at Week 0, as these participants took BIKTARVY for 240 weeks5
The long-term clinical significance of changes in eGFR is not known.
Study 14904,8,9
- Median serum creatine increased by 0.11 mg/dL in the BIKTARVY arm and by 0.12 mg/dL in the FTC/TAF+DTG arm from baseline4
In the OLE:
- A median eGFR change of -8.5mL/min from baseline was observed at Week 240 (n=217)3,5
- Median serum creatine increased by 0.11mg/dL in patients from baseline through Week 240 (n=217)3
- Includes only participants initially randomized to BIKTARVY at Week 0, as these participants took BIKTARVY for 240 weeks5
The long-term clinical significance of changes in eGFR is not known.
IMPORTANT SAFETY INFORMATION (cont’d)
Warnings and Precautions
-
New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) ‹30 mL /min except in virologically suppressed adults ‹15 mL /min who are receiving chronic hemodialysis. Patients with impaired renal function and /or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function orevidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
eGFR, estimated glomerular filtration rate; OLE, open-label extension.
Study 1489 and 1490: Median Change in Fasting Lipids from Baseline Through Week 144
Study 14894
- In the OLE at Week 240, median changes in fasting lipids from baseline were as follows (n=202): Total-C: +20 mg/dL, LDL-C: +22 mg/dL, HDL-C: +5mg/DL, Triglycerides: +11mg/dL, Total-C:HDL-C ratio: 0.03
- Includes only participants initially randomized to BIKTARVY at Week 0, as these participants took BIKTARVY for 240 weeks
*Except for Triglycerides, which are (n=255) at Week 144
Median Change in Fasting Lipids from Baseline
Study 14904
- In the OLE at Week 240, median changes in fasting lipids from baseline were as follows (n=208): Total-C:+22mg/dL, LDL-C: +17mg/dL, HDL-C: +4mg/DL, Triglycerides: +10mg/dL, Total-C:HDL-C ratio:0.13
- Includes only participants initially randomized to BIKTARVY at Week 0, as these participants took BIKTARVY for 240 weeks
BIKTARVY® Had Similar Incidence of Laboratory Abnormalities to Comparators
Study 14894
Study 14904
BIKTARVY is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). For patients weighing ≥25 kg. BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCl <30 mL/min) except in virologically suppressed patients with CrCl <15 mL/min on chronic hemodialysis. BIKTARVY is not recommended for patients weighing ≥14 kg with CrCl <30 mL/min.
IMPORTANT SAFETY INFORMATION (cont’d)
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
- Lactation:Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CrCl, creatine clearance; LDL, low-density lipoprotein; OLE, open-label extension; ULN, upper limit of normal.
The majority (84%) of ARs associated with BIKTARVY were Grade 13
Demonstrated Safety and Tolerability Profile in Virologically Suppressed Adults Through Week 481,3,10,11
| Adverse Reactions (ARs) (All Grades) Reported in ≥2% of Adults Who Switched to BIKTARVY |
Study 1844 BIKTARVY(n=282)
ABC/
DTG/3TC(n=281) |
Study 1878 BIKTARVY(n=290)
ATV- or DRV-Based Regimen(n=287)
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Frequencies of ARs are based on all adverse events attributed to trial drugs by the investigator.
- The majority of adverse reactions associated with BIKTARVY were Grade 1 in Study 1878 (76%) and in Study 1844 (58%)
- The most common ARs (incidence ≥5%; all grades) in clinical trials of treatment-naïve adults who received BIKTARVY were diarrhea, nausea, and headache
- Overall, the safety profile of BIKTARVY in virologically suppressed adults was similar to that in treatment-naïve adults
Study 184410,12
In Study 1844, no adults discontinued BIKTARVY due to weight-related adverse events through Week 48
- In participants who continued on or switched to BIKTARVY during OLE, changes from baseline in body weight were consistent with changes reported through Week 48
- *Low participant numbers out to Week 168 (n=12); median change at Week 168: +2.1 kg.
- †This analysis includes participants initially randomized to BIKTARVY and participants who switched to BIKTARVY during the OLE.
IMPORTANT SAFETY INFORMATION (cont’d)
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
AE, adverse event; DTG, dolutegravir; FTC, emtricitabine; TAF, tenofovir alafenamide.
Study 18782,11,13
In Study 1878, no adults discontinued BIKTARVY due to weight-related adverse events through Week 48
- In participants who continued on or switched to BIKTARVY during the extension phase, changes from baseline in body weight were consistent with changes reported through Week 48
- *This analysis includes participants initially randomized to BIKTARVY and participants who switched to BIKTARVY during the extension phase.
IMPORTANT SAFETY INFORMATION (cont’d)
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
AE, adverse event; DTG, dolutegravir; FTC, emtricitabine; TAF, tenofovir alafenamide.
Demonstrated Safety and Tolerability Profile in Virologically Suppressed Adult Women Through Week 483
| Adverse Reactions (ARs) (All Grades) Reported in >1 Adult Women Who Switched to BIKTARVY |
Study 1961 BIKTARVY(n=234)
INSTI- or PI-
Based Regimen(n=236) |
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Through Week 48, no woman discontinued due to AEs in either treatment arm14
Demonstrated Safety and Tolerability Profile in Virologically Suppressed Adults Aged ≥65 Years Through Week 963,15,16
| Adverse Reactions (ARs) (All Grades) Reported in ≥1% of Virologically Suppressed Adults Aged ≥65 Years Through Week 96 |
Study 4449
BIKTARVY
(N=86) |
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Frequencies of ARS are based on all adverse events attributed to trial drugs by the investigator. No ARs of grade 3 or 4 occurred with BIKTARVY.
At Week 96, there were 2 (2.3%) Grade 3-4 study drug-related AEs in adults aged ≥65 years
Demonstrated Safety and Tolerability Profile in Virologically Suppressed Children and Adolescents17,18
- No one discontinued due to adverse events in cohort 1 (ages 12 to ‹18 years)
- 1 patient discontinued due to adverse events in cohort 2 (ages 6 to ‹12 years)
- No one discontinued due to adverse events in cohort 3 (ages 2 and up)
Minimal Discontinuations Due to Adverse Events in Treatment-Naïve Adults3-5
Treatment-Naïve Adults4,5
Through Week 144
Study 1489
0.0%
BIKTARVY(n=314)
1.6%
ABC/DTG/3TC(n=315)
Study 1490
1.9%
BIKTARVY(n=320)
1.8%
FTC/TAF+DTG(n=325)
Through Week 240 (including OLE)5 in participants initially randomized to BIKTARVY
Study 1489
1.3%
BIKTARVY(n=314)
Study 1490
1.9%
BIKTARVY(n=320)
No treatment-naïve adults discontinued BIKTARVY due to renal-, hepatic-, or bone-related adverse events through Week 240. One adult discontinued due to a weight-related AE through Week 240, which was evaluated by the investigator to be related to study drug.4,5
- BIKTARVY is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). For patients weighing ≥25 kg. BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCl <30 mL/min) except in virologically suppressed patients with CrCl <15 mL/min on chronic hemodialysis. BIKTARVY is not recommended for patients weighing ≥14 kg with CrCl <30 mL/min.1
Minimal Discontinuations Due to Adverse Events in Virologically Suppressed Patients1,3,10-19
Virologically Suppressed Adults3,10-13
Through Week 48
Study 1844
2.1%
BIKTARVY(n=282)
0.7%
ABC/DTG/3TC(n=281)
Study 1878
0.7%
BIKTARVY(n=290)
0.3%
ATV- or DRV-
based Regimen (n=287)
Through Week 168 (including OLE)
Study 1844
1.3%
BIKTARVY(n=547)
Through Week 96 (including Extension)
Study 1878
1.1%
BIKTARVY(n=534)
Virologically Suppressed Adult Women14,19
Through Week 48
Study 1961
0.0%
BIKTARVY(n=234)
0.0%
INSTI- or PI-
based Regimen (n=236)
Through Week 96 (including Extension)
Study 1961
0.2%
BIKTARVY(n=462)
Virologically Suppressed Adults Aged ≥65 Years16
Through Week 96
Study 4449
5.8%
BIKTARVY(N=86)
Virologically Suppressed Children and Adolescents1,17,18
Through Week 96
Study 1474
0.0%
Aged ≥12 to ‹18 years, ≥35 kg Cohort 1 (n=50)
2.0%
Aged ≥6 to ‹12 years, ≥25 kg Cohort 2 (n=50)
Through Week 24
Study 1474
0.0%
Aged ≥2 years, ≥14 kg to ‹25 kg Cohort 3 (n=22)
No virologically suppressed patients discontinued BIKTARVY due to renal-or bone-related adverse events at any clinical trial timepoints. One virologically suppressed patient discontinued due to a hepatic-related adverse event (Study 1961) and 1 virologically suppressed patient discontinued due to a weight-related adverse event (Study 4449); both were found to be related to study drug.3,10-19
- Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus
Please see below for Important Safety Information for BIKTARVY.
INDICATION
BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of BIKTARVY.
Please see below for Important Safety Information for BIKTARVY.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
Warnings and precautions
- Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
- Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
- New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. - Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Adverse reactions
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
Drug interactions
- Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
- Enzymes/transporters: Drugs that induce
P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibitP-gp , BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. - Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For these pediatric patients, who are unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
- Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
- Hepatic impairment: Not recommended in patients with severe hepatic impairment.
- Prior to or when initiating: Test patients for HBV infection.
- Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
- Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
Please see full Prescribing Information for BIKTARVY® and DESCOVY®, including BOXED WARNINGS.
3TC, lamivudine; ABC, abacavir; AE, adverse event; Al, aluminum; ATV, atazanavir; BIC, bictegravir; Ca, calcium; CrCl, creatinine clearance; DRV, darunavir; DTG, dolutegravir; Fe, iron; FTC, emtricitabine; HCV, hepatitis C virus; INSTI, integrase strand transfer inhibitor; Mg, magnesium; NSAIDs, nonsteroidal anti-inflammatory drugs; PI, protease inhibitor; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
References: 1. BIKTARVY. Package insert. Gilead Sciences, Inc.; 2021. 2. Burgess MJ, Zeuli JD, Kasten MJ. Management of HIV/AIDS in older patients-drug/drug interactions and adherence to antiretroviral therapy. HIV/AIDS (Auckl). 2015;7:251-264. 3. Data on file. Gliead Sciences, Inc. 4. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400. 5. Wohl DA, Pozniak A, Workowski K, et al. B/F/TAF five-year outcomes in treatment-naïve adults. Poster presented at: Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; Virtual. Poster 494. 6. Wohl DA, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e355-e363. 7. Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390(10107):2063-2072. 8. Stellbrink H-J, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372. 9. Sax PE, Pozniak A, Montes ML, et al. 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Lancet HIV. 2018;5(7):e347-e356. 12. Brar I, Ruane P, Ward D, et al. Long-term follow-up after a switch to bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir, abacavir, and lamivudine. Poster presented at: IDWeek: October 21-25, 2020; Washington, DC. Poster 1028. 13. Rockstroh J, Molina J-M, Post F, et al. Long-term follow-up after a switch to bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) from a boosted protease inhibitor-based regimen. Poster presented at: HIV Drug Therapy Glasgow 2020; October 5-8, 2020; Virtual. Poster P036. 14. Kityo C, Hagins D, Koenig E, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed HIV-1 infected women: a randomized, open-label, multicenter, active-controlled, phase 3, noninferiority trial. J Acquir Immune Defic Syndr. 2019;82(3):321-328. 15. Maggiolo F, Rizzardini G, Molina J-M, et al. 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