Bictegravir / emtricitabine / tenofovir alafenamide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Yashasvi Aryaputra[2];
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Black Box Warning
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POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete Boxed Warning.
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Overview
Bictegravir / emtricitabine / tenofovir alafenamide is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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Condition 2
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
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Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
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Non–Guideline-Supported Use
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Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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Condition 2
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Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
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Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
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Non–Guideline-Supported Use
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Contraindications
- BIKTARVY is contraindicated to be co-administered with:
- dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events.
- rifampin due to decreased BIC plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to BIKTARVY.
Warnings
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POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete Boxed Warning.
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Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV
- Patients with HIV-1 should be tested for the presence of chronic hepatitis B virus (HBV) infection before or when initiating antiretroviral therapy.
- Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing FTC and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Patients coinfected with HIV-1 and HBV who discontinue BIKTARVY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions
- The concomitant use of BIKTARVY with certain other drugs may result in known or potentially significant drug interactions, some of which may lead to:
- Loss of therapeutic effect of BIKTARVY and possible development of resistance.
- Possible clinically significant adverse reactions from greater exposures of concomitant drugs.
- See TABLE 3 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during BIKTARVY therapy; review concomitant medications during BIKTARVY therapy; and monitor for the adverse reactions associated with the concomitant drugs.
Immune Reconstitution Syndrome
- Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.
- Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.
New Onset or Worsening Renal Impairment
- Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir prodrugs in both animal toxicology studies and human trials. In clinical trials of BIKTARVY, there have been no cases of Fanconi syndrome or Proximal Renal Tubulopathy (PRT). In clinical trials of BIKTARVY in subjects with no antiretroviral treatment history with eGFRs greater than 30 mL per minute, and in virologically suppressed subjects switched to BIKTARVY with eGFRs greater than 50 mL per minute, renal serious adverse events were encountered in less than 1% of subjects treated with BIKTARVY through Week 48. BIKTARVY is not recommended in patients with estimated creatinine clearance below 30 mL per minute.
- Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including non-steroidal anti-inflammatory drugs are at increased risk of developing renal-related adverse reactions.
- Prior to or when initiating BIKTARVY, and during treatment with BIKTARVY, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Lactic Acidosis/Severe Hepatomegaly with Steatosis
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including emtricitabine, a component of BIKTARVY, and tenofovir DF, another prodrug of tenofovir, alone or in combination with other antiretrovirals. Treatment with BIKTARVY should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Adverse Reactions
Clinical Trials Experience
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Postmarketing Experience
(Description)
Drug Interactions
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Drug 1
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Drug 2
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Drug 3
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Drug 4
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Drug 5
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Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bictegravir / emtricitabine / tenofovir alafenamide in women who are pregnant.
Labor and Delivery
(Description)
Nursing Mothers
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Pediatric Use
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Geriatic Use
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Gender
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Race
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Renal Impairment
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Hepatic Impairment
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Females of Reproductive Potential and Males
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Immunocompromised Patients
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Others
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Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
There is limited information regarding the compatibility of Bictegravir / emtricitabine / tenofovir alafenamide and IV administrations.
Overdosage
- No data are available on overdose of BIKTARVY in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with BIKTARVY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
- Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL per minute and a dialysate flow rate of 600 mL per minute). It is not known whether FTC can be removed by peritoneal dialysis.
- Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
Pharmacology
Bictegravir/emtricitabine/tenofovir alafenamide
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| Combination of | |
| Bictegravir | integrase inhibitor |
| Emtricitabine | nucleoside reverse transcriptase inhibitor |
| Tenofovir alafenamide | nucleotide reverse transcriptase inhibitor |
| Identifiers | |
| CAS number | ? |
| ATC code | J05 |
| PubChem | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
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| Legal status |
[[Prescription drug|Template:Unicode-only]](US) |
| Routes | ? |
Mechanism of Action
- BIKTARVY is a fixed dose combination of antiretroviral drugs bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF).
Structure
Bictegravir
Emtricitabine
Tenofovir Alafenamide
Pharmacodynamics
Cardiac Electrophysiology
- In a thorough QT/QTc trial in 48 healthy subjects, BIC at doses 1.5 and 6 times the recommended dose did not affect the QT/QTc interval and did not prolong the PR interval. In a thorough QT/QTc trial in 48 healthy subjects, TAF at the recommended dose or at a dose 5 times the recommended dose, did not affect the QT/QTc interval and did not prolong the PR interval. The effect of FTC on the QT interval is not known.
Effects on Serum Creatinine
- Mean change from baseline in serum creatinine in healthy subjects who received BIC 75 mg (1.5 times the approved recommended dosage) once daily with food for 14 days was 0.1 mg per dL on Days 7 and 14 compared to placebo. BIC did not have a significant effect on the estimated creatinine clearance or on the actual glomerular filtration rate (determined by the clearance of probe drug, iohexol).
Pharmacokinetics
- The pharmacokinetic (PK) properties of BIKTARVY components are provided in Table 4. The multiple dose PK parameters of BIKTARVY components (based on population pharmacokinetic analysis) are provided in Table 5.
Specific Populations
Patients with Renal Impairment
- No clinically relevant differences in the pharmacokinetics of BIC, TAF, or its metabolite tenofovir were observed between subjects with severe renal impairment (CLcr 15 to 29 mL per minute estimated by Cockcroft-Gault method) and healthy subjects.
Patients with Hepatic Impairment
- Bictegravir: Clinically relevant changes in the pharmacokinetics of BIC were not observed in subjects with moderate (Child-Pugh Class B) hepatic impairment.
- Emtricitabine: The pharmacokinetics of FTC has not been studied in subjects with hepatic impairment; however, FTC is not significantly metabolized by liver enzymes, so the impact of hepatic impairment should be limited.
- Tenofovir Alafenamide: Clinically relevant changes in the pharmacokinetics of TAF or its metabolite tenofovir were not observed in subjects with mild or moderate (Child-Pugh Class A and B) hepatic impairment.
Hepatitis B and/or Hepatitis C Virus Coinfection
- The pharmacokinetics of BIC, FTC, and TAF have not been evaluated in subjects coinfected with hepatitis B and/or C virus.
Geriatric Patients
- The pharmacokinetics of BIC, FTC, and TAF have not been fully evaluated in the elderly (65 years of age and older). Population pharmacokinetics analysis of HIV-infected subjects in Phase 3 trials of BIKTARVY showed that age did not have a clinically relevant effect on exposures of BIC and TAF up to 74 years of age.
Race and Gender
- No clinically relevant changes in the pharmacokinetics of BIC, FTC, and TAF were observed based on gender or race.
Drug Interaction Studies
- As BIKTARVY is a complete regimen for the treatment of HIV-1 infection, comprehensive information regarding potential drug-drug interactions with other antiretroviral agents is not provided.
- BIC is a substrate of CYP3A and UGT1A1.
- BIC is an inhibitor of OCT2 and MATE1. At clinically relevant concentrations, BIC is not an inhibitor of hepatic transporters OATP1B1, OATP1B3, OCT1, BSEP, renal transporters OAT1 and OAT3, or CYP (including CYP3A) or UGT1A1 enzymes.
- TAF is a substrate of P-gp and BCRP.
- At clinically relevant concentrations, TAF is not an inhibitor of drug transporters P-gp, BCRP, hepatic transporters OATP1B1, OATP1B3, OCT1, BSEP, renal transporters OAT1, OAT3, OCT2, MATE1, or CYP (including CYP3A) or UGT1A1 enzymes.
- Drug interaction studies were conducted with BIKTARVY or its components. Tables 6 and 7 summarize the pharmacokinetic effects of other drugs on BIC and TAF, respectively. Table 8 summarizes the pharmacokinetic effects of BIKTARVY or its components on other drugs.
Effect of Other Drugs on BIKTARVY Components
Effect of BIKTARVY Components on Other Drugs
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Bictegravir
- BIC was not carcinogenic in a 6-month rasH2 transgenic mouse study at doses of up to 100 mg/kg/day in males and 300 mg/kg/day in females. A carcinogenicity study in rats is ongoing.
- BIC was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays.
- BIC did not affect fertility, reproductive performance or embryonic viability in male and female rats at 29 times higher exposures (AUC) than in humans at the recommended dose of 50 mg BIC in BIKTARVY.
Emtricitabine
- In long-term carcinogenicity studies of FTC, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg per kg per day (25 times the human systemic exposure at the recommended dose of 200 mg per day in BIKTARVY) or in rats at doses up to 600 mg per kg per day (30 times the human systemic exposure at the recommended dose in BIKTARVY).
- FTC was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or mouse micronucleus assays.
- FTC did not affect fertility in male rats at approximately 140 times or in male and female mice at approximately 60 times higher exposures (AUC) than in humans given the recommended 200 mg daily dose in BIKTARVY. Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60 times higher than human exposures at the recommended 200 mg daily dose in BIKTARVY.
Tenofovir Alafenamide
- Since TAF is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after TAF administration compared to TDF administration, carcinogenicity studies were conducted only with TDF. Long-term oral carcinogenicity studies of TDF in mice and rats were carried out at exposures up to approximately 10 times (mice) and 4 times (rats) those observed in humans at the recommended dose of TDF (300 mg) for HIV-1 infection. The tenofovir exposure in these studies was approximately 151 times (mice) and 51 times (rat) those observed in humans after administration of the daily recommended dose of BIKTARVY. At the high dose in female mice, liver adenomas were increased at tenofovir exposures approximately 10 times (300 mg TDF) and 151 times (BIKTARVY) the exposure observed in humans. In rats, the study was negative for carcinogenic findings.
- TAF was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays.
- There were no effects on fertility, mating performance or early embryonic development when TAF was administered to male rats at a dose equivalent to 155 times (25 mg TAF) the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 14 days prior to mating through Day 7 of gestation.
Animal Toxicology and/or Pharmacology
- Minimal to slight infiltration of mononuclear cells in the posterior uvea was observed in dogs with similar severity after three and nine month administration of TAF; reversibility was seen after a three month recovery period. No eye toxicity was observed in the dog at systemic exposures of 7 (TAF) and 14 (tenofovir) times the exposure seen in humans with the recommended daily TAF dose in BIKTARVY.
Clinical Studies
Description of Clinical Trials
- The efficacy and safety of BIKTARVY were evaluated in the trials summarized in Table 9.
Clinical Trial Results in HIV-1 Subjects with No Antiretroviral Treatment History
- In Trial 1489, subjects were randomized in a 1:1 ratio to receive either BIKTARVY (N=314) or ABC/DTG/3TC (600 mg/50 mg/300 mg) (N=315) once daily. In Trial 1490, subjects were randomized in a 1:1 ratio to receive either BIKTARVY (N=320) or DTG + FTC/TAF (50 mg + 200 mg/25 mg) (N=325) once daily.
- In Trial 1489, the mean age was 34 years (range 18–71), 90% were male, 57% were White, 36% were Black, and 3% were Asian. 22% percent of patients identified as Hispanic/Latino. The mean baseline plasma HIV-1 RNA was 4.4 log10 copies/mL (range 1.3–6.5). The mean baseline CD4+ cell count was 464 cells per mm3 (range 0–1424) and 11% had CD4+ cell counts less than 200 cells per mm3. 16% of subjects had baseline viral loads greater than 100,000 copies per mL.
- In Trial 1490, the mean age was 37 years (range 18–77), 88% were male, 59% were White, 31% were Black, and 3% were Asian. 25% percent of patients identified as Hispanic/Latino. The mean baseline plasma HIV-1 RNA was 4.4 log10 copies/mL (range 2.3–6.6). The mean baseline CD4+ cell count was 456 cells per mm3 (range 2–1636) and 12% had CD4+ cell counts less than 200 cells per mm3. 19% of subjects had baseline viral loads greater than 100,000 copies per mL.
- In both trials, subjects were stratified by baseline HIV-1 RNA (less than or equal to 100,000 copies per mL, greater than 100,000 copies per mL to less than or equal to 400,000 copies per mL, or greater than 400,000 copies per mL), by CD4 count (less than 50 cells per mm3, 50-199 cells per mm3, or greater than or equal to 200 cells per mm3), and by region (US or ex-US).
- Treatment outcomes of Trials 1489 and 1490 through Week 48 are presented in Table 10.
- Treatment outcomes were similar across subgroups by age, sex, race, baseline viral load, and baseline CD4+ cell count.
- In Trials 1489 and 1490, the mean increase from baseline in CD4+ count at Week 48 was 233 and 229 cells per mm3 in the BIKTARVY and ABC/DTG/3TC groups, respectively, and 180 and 201 cells per mm3 in the BIKTARVY and DTG + FTC/TAF groups, respectively.
Clinical Trial Results in HIV-1 Virologically-Suppressed Subjects Who Switched to BIKTARVY
- In Trial 1844, the efficacy and safety of switching from a regimen of DTG + ABC/3TC or ABC/DTG/3TC to BIKTARVY were evaluated in a randomized, double-blind trial of virologically-suppressed (HIV-1 RNA less than 50 copies per mL) HIV-1 infected adults (N=563, randomized and dosed). Subjects must have been stably suppressed (HIV-1 RNA less than 50 copies per mL) on their baseline regimen for at least 3 months prior to trial entry and had no history of treatment failure. Subjects were randomized in a 1:1 ratio to either switch to BIKTARVY at baseline (N=282), or stay on their baseline antiretroviral regimen (N=281). Subjects had a mean age of 45 years (range 20–71), 89% were male, 73% were White, and 22% were Black. 17% of subjects identified as Hispanic/Latino. The mean baseline CD4+ cell count was 723 cells per mm3 (range 124–2444).
- In Trial 1878, the efficacy and safety of switching from either ABC/3TC or FTC/TDF (200/300 mg) plus ATV or DRV (given with either cobicistat or ritonavir) to BIKTARVY were evaluated in a randomized, open-label study of virologically-suppressed HIV-1 infected adults (N=577, randomized and dosed). Subjects must have been stably suppressed on their baseline regimen for at least 6 months, must not have been previously treated with any INSTI, and had no history of treatment failure. Subjects were randomized in a 1:1 ratio to either switch to BIKTARVY (N=290) or stay on their baseline antiretroviral regimen (N=287). Subjects had a mean age of 46 years (range 20–79), 83% were male, 66% were White, and 26% were Black. 19% of subjects identified as Hispanic/Latino. The mean baseline CD4+ cell count was 663 cells per mm3 (range 62–2582). Subjects were stratified by prior treatment regimen. At screening, 15% of subjects were receiving ABC/3TC plus ATV or DRV (given with either cobicistat or ritonavir) and 85% of subjects were receiving FTC/TDF plus ATV or DRV (given with either cobicistat or ritonavir).
- Treatment outcomes of Trials 1844 and 1878 through Week 48 are presented in Table 11.
- In Trial 1844, treatment outcomes between treatment groups were similar across subgroups by age, sex, race, and region. The mean change from baseline in CD4+ count at Week 48 was -31 cells per mm3 in subjects who switched to BIKTARVY and 4 cells per mm3 in subjects who stayed on ABC/DTG/3TC.
- In Trial 1878, treatment outcomes between treatment groups were similar across subgroups by age, sex, race, and region. The mean change from baseline in CD4+ count at Week 48 was 25 cells per mm3 in patients who switched to BIKTARVY and 0 cells per mm3 in patients who stayed on their baseline regimen.
How Supplied
- BIKTARVY tablets are purplish brown, capsule-shaped, and film-coated with "GSI" debossed on one side and "9883" on the other side. Each bottle contains 30 tablets (NDC 61958-2501-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure. Each BIKTARVY tablet contains 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF).
Storage
- Store below 30 °C (86 °F).
- Keep container tightly closed.
- Dispense only in original container.
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Patient Counseling Information
Post-treatment Acute Exacerbation of Hepatitis B in Patients with HBV Coinfection
- Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing FTC and/or TDF, and may likewise occur with discontinuation of BIKTARVY. Advise the patient to not discontinue BIKTARVY without first informing their healthcare provider.
Drug Interactions
- BIKTARVY may interact with certain drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or non-prescription medication or herbal products including St. John's wort.
Immune Reconstitution Syndrome
- Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Renal Impairment
- Advise patients to avoid taking BIKTARVY with concurrent or recent use of nephrotoxic agents. Renal impairment including cases of acute renal failure has been reported in association with the use of tenofovir prodrugs.
Lactic Acidosis and Severe Hepatomegaly
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to BIKTARVY. Advise patients that they should stop BIKTARVY if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity.
Missed Dosage
- Inform patients that it is important to take BIKTARVY on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance.
Pregnancy Registry
- Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to BIKTARVY.
Lactation
- Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk.
Precautions with Alcohol
Alcohol-Bictegravir / emtricitabine / tenofovir alafenamide interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
- Biktarvy
Look-Alike Drug Names
There is limited information regarding Bictegravir / emtricitabine / tenofovir alafenamide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.