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Biktarvy Side Effects

Generic Name: bictegravir / emtricitabine / tenofovir alafenamide

Medically reviewed by Drugs.com. Last updated on May 27, 2020.

Note: This document contains side effect information about bictegravir / emtricitabine / tenofovir alafenamide. Some of the dosage forms listed on this page may not apply to the brand name Biktarvy.

For the Consumer

Applies to bictegravir/emtricitabine/tenofovir alafenamide: oral tablet

Warning

Oral route (Tablet)

Warning: Post treatment acute exacerbation of hepatitis BSevere acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and hepatitis B virus (HBV) and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of bictegravir / emtricitabine / tenofovir alafenamide.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 bictegravir / emtricitabine / tenofovir alafenamide. If appropriate, anti-hepatitis B therapy may be warranted.

Side effects requiring immediate medical attention

Along with its needed effects, bictegravir / emtricitabine / tenofovir alafenamide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bictegravir / emtricitabine / tenofovir alafenamide:

Less common

  • Stomach pain

Rare

  • Changes in behavior
  • thoughts or attempts of killing oneself

Incidence not known

  • Bloody urine
  • dark urine
  • decreased appetite
  • decreased frequency or amount of urine
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • general tiredness and weakness
  • hives or welts, itching, skin rash
  • increased blood pressure
  • increased thirst
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramping
  • nausea
  • right upper abdominal pain and fullness
  • sleepiness
  • stomach discomfort
  • swelling of the face, fingers, or lower legs
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • yellow eyes and skin

Side effects not requiring immediate medical attention

Some side effects of bictegravir / emtricitabine / tenofovir alafenamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

For Healthcare Professionals

Applies to bictegravir / emtricitabine / tenofovir alafenamide: oral tablet

General

In clinical trials, the most common side effects reported were diarrhea, nausea, and headache. This drug was discontinued due to side effects in 1% of patients.[Ref]

Hepatic

Elevated total bilirubin was reported in 15% of patients through week 96; grade 1 (1 to 1.5 times the upper limit of normal [1 to 1.5 x ULN]) and grade 2 (1.5 to 2.5 x ULN) increases were reported in 11% and 4% of patients, respectively. These increases were not associated with hepatic side effects or other liver-related laboratory abnormalities. Grade 3 bilirubin increases (not considered related to study drug) were reported in 4 patients using this drug (1%). No discontinuations due to hepatic side effects were reported through week 96 in clinical studies.

Elevated ALT (greater than 5 x ULN) and AST (greater than 5 x ULN) have each been reported in up to 2% of patients.

Out of 16 patients coinfected with HIV-1 and hepatitis B virus (HBV), hepatic flare (ALT greater than 10 x ULN) was reported in 1 patient; ALT returned to normal limits without interrupting therapy.

Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients coinfected with HIV-1 and HBV after discontinuation of products containing emtricitabine and/or tenofovir DF.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]

Very common (10% or more): Elevated total bilirubin (up to 15%)

Common (1% to 10%): Elevated AST, elevated ALT

Uncommon (0.1% to 1%): Hyperbilirubinemia

Frequency not reported: Hepatic flare

Emtricitabine and/or tenofovir disoproxil fumarate (DF):

-Frequency not reported: Severe hepatomegaly with steatosis, severe acute exacerbations of hepatitis B, liver decompensation, liver failure[Ref]

Gastrointestinal

Elevated amylase (greater than 2 x ULN) was reported in 2% of patients.[Ref]

Common (1% to 10%): Diarrhea, nausea, elevated amylase

Uncommon (0.1% to 1%): Vomiting, flatulence, dyspepsia, abdominal pain[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Musculoskeletal

Common (1% to 10%): Elevated creatine kinase

Frequency not reported: Osteonecrosis

Emtricitabine:

-Postmarketing reports: Arthralgia[Ref]

Elevated creatine kinase (at least 10 x ULN) has been reported in 4% of patients.[Ref]

Psychiatric

Suicidal ideation, suicide attempt, and depression suicidal were reported in less than 1% of patients; all events were serious and observed primarily in patients with history of depression, prior suicide attempt, or psychiatric illness.[Ref]

Common (1% to 10%): Abnormal dreams, insomnia, depression

Uncommon (0.1% to 1%): Suicidal behavior, anxiety, sleep disorders

Frequency not reported: Suicidal ideation, suicide attempt, depression suicidal[Ref]

Other

Common (1% to 10%): Fatigue, elevated low-density lipoprotein (LDL) cholesterol (fasted)

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipids[Ref]

Elevated LDL cholesterol (fasted) (greater than 190 mg/dL) has been reported in up to 3% of patients.[Ref]

Hematologic

Decreased neutrophils (less than 750/mm3) have been reported in 2% of patients.[Ref]

Common (1% to 10%): Decreased neutrophils

Emtricitabine:

-Uncommon (0.1% to 1%): Anemia[Ref]

Renal

Common (1% to 10%): Elevated serum creatinine

Tenofovir prodrugs:

-Frequency not reported: Renal impairment (including acute renal failure, Fanconi syndrome)[Ref]

Increased serum creatinine occurred with bictegravir due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. Increased serum creatinine was reported by 4 weeks of therapy and remained stable through 96 weeks; serum creatinine increased by 0.09 mg/dL from baseline to week 96. No discontinuations due to renal side effects were reported through week 96 in patients using this drug in clinical studies.

Renal impairment (including cases of acute renal failure and Fanconi syndrome) has been reported with the use of tenofovir prodrugs; no cases of Fanconi syndrome or proximal renal tubulopathy were reported in clinical trials of this drug.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus

Emtricitabine:

-Postmarketing reports: Angioedema

Tenofovir alafenamide-containing products:

-Postmarketing reports: Angioedema, urticaria[Ref]

Metabolic

Emtricitabine and tenofovir DF:

-Frequency not reported: Lactic acidosis

Antiretroviral therapy:

-Frequency not reported: Increased glucose[Ref]

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]

Immunologic

Combination antiretroviral therapy:

-Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)[Ref]

References

1. "Product Information. Biktarvy (bictegravir/emtricitabine/tenofovir)." Gilead Sciences, Foster City, CA.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.