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
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:
- Stomach pain
- Changes in behavior
- thoughts or attempts of killing oneself
Incidence not known
- Bloody urine
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- 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
- right upper abdominal pain and fullness
- stomach discomfort
- swelling of the face, fingers, or lower legs
- troubled breathing
- unusual tiredness or weakness
- 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:
- Abnormal dreams
- bloated feeling
- excess air or gas in the stomach or bowels
- feeling of fullness
- feeling sad or empty
- loss of interest or pleasure
- passing gas
- stomach upset
- trouble concentrating
- trouble sleeping
For Healthcare Professionals
Applies to bictegravir / emtricitabine / tenofovir alafenamide: oral tablet
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]
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.
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]
Elevated amylase (greater than 2 x ULN) was reported in 2% of patients.[Ref]
Common (1% to 10%): Diarrhea, nausea, elevated amylase
Common (1% to 10%): Headache, dizziness[Ref]
Common (1% to 10%): Elevated creatine kinase
Frequency not reported: Osteonecrosis
-Postmarketing reports: Arthralgia[Ref]
Elevated creatine kinase (at least 10 x ULN) has been reported in 4% of patients.[Ref]
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
Frequency not reported: Suicidal ideation, suicide attempt, depression suicidal[Ref]
Common (1% to 10%): Fatigue, elevated low-density lipoprotein (LDL) cholesterol (fasted)
-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]
Decreased neutrophils (less than 750/mm3) have been reported in 2% of patients.[Ref]
Common (1% to 10%): Decreased neutrophils
-Uncommon (0.1% to 1%): Anemia[Ref]
Common (1% to 10%): Elevated serum creatinine
-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]
Uncommon (0.1% to 1%): Rash, pruritus
-Postmarketing reports: Angioedema
Tenofovir alafenamide-containing products:
Emtricitabine and tenofovir DF:
-Frequency not reported: Lactic acidosis
-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]
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]
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
- Which medicines should not be taken with Biktarvy?
- Can Biktarvy be used for PrEP or PEP?
- Does Biktarvy cause weight gain?
- What is Biktarvy used for?
- What if I miss a dose of Biktarvy?
- How fast or how long does it take Biktarvy to work?
- What is the generic name for Biktarvy?
- Does Biktarvy increase cholesterol?
- What is the difference between Biktarvy and Descovy?
More about Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide)
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- En Español
- 125 Reviews
- Drug class: antiviral combinations
- FDA Approval History
Related treatment guides
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.