Biktarvy

Last reviewed on RxList: 2/17/2021
Biktarvy Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Biktarvy?

Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) is a three-drug combination of a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and two HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

What Are Side Effects of Biktarvy?

Common side effects of Biktarvy include:

  • diarrhea,
  • nausea,
  • headache,
  • fatigue,
  • abnormal dreams,
  • dizziness, and
  • insomnia

Dosage for Biktarvy

Biktarvy is a three-drug fixed dose combination product containing 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of Biktarvy is one tablet taken once daily with or without food.

What Drugs, Substances, or Supplements Interact with Biktarvy?

Biktarvy may interact with:

  • other antiretroviral medications,
  • dofetilide,
  • anticonvulsants,
  • antimycobacterials,
  • St John's wort,
  • antacids containing aluminum or magnesium,
  • supplements containing calcium or iron,
  • metformin,
  • acyclovir,
  • cidofovir,
  • ganciclovir,
  • valacyclovir,
  • valganciclovir,
  • aminoglycosides (e.g., gentamicin), and
  • high-dose or multiple nonsteroidal anti-inflammatory drugs (NSAIDs)

Tell your doctor all medications and supplements you use.

Biktarvy During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Biktarvy; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Biktarvy during pregnancy. Because of the potential for HIV transmission, breastfeeding while using Biktarvy is not recommended.

Additional Information

Our Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Biktarvy Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
  • lactic acidosis--muscle pain or weakness, numbness or cold feeling, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, or feeling very weak or tired; or
  • liver problems--swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Biktarvy affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • nausea, diarrhea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Biktarvy (Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets)

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Biktarvy Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Severe Acute Exacerbations of Hepatitis B [see WARNINGS AND PRECAUTIONS].
  • Immune Reconstitution Syndrome [see WARNINGS AND PRECAUTIONS].
  • New Onset or Worsening Renal Impairment [see WARNINGS AND PRECAUTIONS].
  • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials In Adults With No Antiretroviral Treatment History

The primary safety assessment of BIKTARVY was based on Week 48 data from two randomized, double-blind, active-controlled trials, Trial 1489 and Trial 1490, that enrolled 1274 HIV-1 infected adult subjects with no antiretroviral treatment history. A total of 634 subjects received one tablet of BIKTARVY once daily [see Clinical Studies].

The most common adverse reactions (all Grades) reported in at least 5% of subjects in the BIKTARVY group in either Trial 1489 or Trial 1490 were diarrhea, nausea, and headache. The proportion of subjects who discontinued treatment with BIKTARVY, abacavir [ABC]/dolutegravir [DTG]/ lamivudine [3TC]), or DTG + FTC/TAF, due to adverse events, regardless of severity, was 1%, 1%, and <1%, respectively. Table 1 displays the frequency of adverse reactions (all Grades) greater than or equal to 2% in the BIKTARVY group.

Table 1 Adverse Reactionsa (All Grades) Reported in ≥ 2% of HIV-1 Infected Adults with No Antiretroviral Treatment History Receiving BIKTARVY in Trials 1489 or 1490 (Week 48 analysis)

Adverse ReactionsTrial 1489Trial 1490
BIKTARVY
N=314
ABC/DTG/ 3TC
N=315
BIKTARVY
N=320
DTG + FTC/TAF
N=325
Diarrhea6%4%3%3%
Nausea5%17%3%5%
Headache5%5%4%3%
Fatigue3%3%2%2%
Abnormal dreams3%3%<1%1%
Dizziness2%3%2%1%
Insomnia2%3%2%<1%
a. Frequencies of adverse reactions are based on all adverse events attributed to trial drugs by the investigator. No adverse reactions of Grade 2 or higher occurred in ≥ 1% of subjects treated with BIKTARVY.

Additional adverse reactions (all Grades) occurring in less than 2% of subjects administered BIKTARVY in Trials 1489 and 1490 included vomiting, flatulence, dyspepsia, abdominal pain, rash, and depression.

Suicidal ideation, suicide attempt, and depression suicidal occurred in <1% of subjects administered BIKTARVY; all events were serious and primarily occurred in subjects with a preexisting history of depression, prior suicide attempt or psychiatric illness.

The majority (87%) of adverse events associated with BIKTARVY were Grade 1.

Clinical Trials In Virologically Suppressed Adults

The safety of BIKTARVY in virologically-suppressed adults was based on Week 48 data from 282 subjects in a randomized, double-blind, active-controlled trial (Trial 1844) in which virologically-suppressed subjects were switched from either DTG + ABC/3TC or ABC/DTG/3TC to BIKTARVY; and Week 48 data from 290 subjects in an open-label, active-controlled trial in which virologically-suppressed subjects were switched from a regimen containing atazanavir (ATV) (given with cobicistat or ritonavir) or darunavir (DRV) (given with cobicistat or ritonavir) plus either FTC/TDF or ABC/3TC, to BIKTARVY (Trial 1878). Overall, the safety profile in virologically-suppressed adult subjects in Trials 1844 and 1878 was similar to that in subjects with no antiretroviral treatment history [see Clinical Studies].

Clinical Trial In Adults With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis

The safety of FTC and TAF (components of BIKTARVY) was evaluated in a single arm, open-label trial (Trial 1825) in virologically-suppressed adults with ESRD (estimated creatinine clearance of less than 15 mL/min) on chronic hemodialysis treated with FTC+TAF in combination with elvitegravir and cobicistat as a fixed-dose combination tablet for 96 weeks (N=55). The most commonly reported adverse reaction (adverse event assessed as causally related by investigator and all grades) was nausea (7%). Serious adverse events were reported in 65% of subjects and the most common serious adverse events were pneumonia (15%), fluid overload (7%), hyperkalemia (11%) and osteomyelitis (7%). Overall 7% of subjects permanently discontinued treatment due to an adverse event. In an extension phase of Trial 1825 in which 10 subjects switched to BIKTARVY for 48 weeks, the safety findings were similar to those in the initial phase of the open-label trial [see Use In Specific Populations, Clinical Studies].

Laboratory Abnormalities

The frequency of laboratory abnormalities (Grades 3–4) occurring in at least 2% of subjects receiving BIKTARVY in Trials 1489 and 1490 are presented in Table 2.

Table 2 Laboratory Abnormalities (Grades 3–4) Reported in ≥ 2% of Subjects Receiving BIKTARVY in Trials 1489 or 1490 (Week 48 analysis)

Laboratory Parameter AbnormalityaTrial 1489Trial 1490
BIKTARVY
N=314
ABC/DTG/3TC
N=315
BIKTARVY
N=320
DTG + FTC/TAF
N=325
Amylase (>2.0 x ULN)2%2%2%2%
ALT (>5.0 × ULN)1%1%2%1%
AST (>5.0 × ULN)2%1%1%3%
Creatine Kinase (≥10.0 × ULN)4%3%4%2%
Neutrophils (<750 mm3)2%3%2%1%
LDL-cholesterol (fasted) (>190 mg/dL)2%3%3%3%
ULN = Upper limit of normal
a. Frequencies are based on treatment-emergent laboratory abnormalities.

Changes in Serum Creatinine

BIC has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function [see CLINICAL PHARMACOLOGY]. Increases in serum creatinine occurred by Week 4 of treatment and remained stable through Week 48. In Trials 1489 and 1490, median (Q1, Q3) serum creatinine increased by 0.10 (0.03, 0.17) mg per dL from baseline to Week 48 in the BIKTARVY group and was similar to the comparator groups who received ABC/DTG/3TC, or DTG + FTC/TAF. There were no discontinuations due to renal adverse events through Week 48 in BIKTARVY clinical trials.

Changes in Bilirubin

In Trials 1489 and 1490, total bilirubin increases were observed in 12% of subjects administered BIKTARVY through Week 48. Increases were primarily Grade 1 (1.0 to 1.5 x ULN) (9%) and Grade 2 (1.5 to 2.5 x ULN) (3%). Graded bilirubin increases in the ABC/DTG/3TC, and DTG + FTC/TAF groups, were 4% and 6%, respectively. Increases were primarily Grade 1 (3% ABC/DTG/3TC and 5% DTG + FTC/TAF) or Grade 2 (1% ABC/DTG/3TC and 1% DTG + FTC/TAF). There were no discontinuations due to hepatic adverse events through Week 48 in BIKTARVY clinical studies.

Clinical Trials In Pediatric Subjects

The safety of BIKTARVY was evaluated in HIV-1 infected virologically-suppressed subjects between the ages of 12 to less than 18 years and weighing at least 35 kg (N=50) through Week 48 (cohort 1), and in virologically-suppressed subjects between the ages of 6 to less than 12 years and weighing at least 25 kg (N=50) through Week 24 (cohort 2) in an open label clinical trial (Trial 1474) [see Clinical Studies]. No new adverse reactions or laboratory abnormalities were identified compared to those observed in adults. Adverse reactions were reported in 10% of pediatric subjects. The majority (85%) of adverse reactions were Grade 1. No Grade 3 or 4 adverse reactions were reported. The adverse reaction reported by more than one subject (regardless of severity) was abdominal pain (n=2). One subject (1%) had Grade 2 adverse reactions of insomnia and anxiety that led to discontinuation of BIKTARVY. The other adverse reactions that occurred in single subjects were similar to those seen in adults.

Postmarketing Experience

The following events have been identified during post approval use of products containing TAF. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders

Angioedema and urticaria

Read the entire FDA prescribing information for Biktarvy (Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets)

© Biktarvy Patient Information is supplied by Cerner Multum, Inc. and Biktarvy Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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