Biktarvy is a triple-combination antiretroviral drug containing bictegravir, emtricitabine, and tenofovir alafenamide. It is used for the treatment of HIV-1 infection in adults. As a complete treatment regimen, it demonstrates good efficacy; however, potential side effects and precautions must be heeded during administration.

What Are the Side Effects of Biktarvy?

Common Side Effects

Gastrointestinal reactions: Diarrhea (6%), nausea (5%), bloating or dyspepsia (<2%).

Neurological symptoms: Headache (5%), dizziness (2%), insomnia (2%).

Others: Fatigue (3%), abnormal dreams (3%).

Severe Side Effects of Biktarvy That Require Vigilance

Acute Exacerbation of Hepatitis B (in Patients with Concurrent HIV/HBV Infection)

Risk: Patients with concurrent hepatitis B may experience worsening hepatitis, or even liver failure, after discontinuing the drug.

Measures: Hepatitis B virus screening is mandatory before starting medication. Liver function should be continuously monitored for several months after drug discontinuation, and anti-hepatitis B treatment should be initiated if necessary.

Immune Reconstitution Inflammatory Syndrome (IRIS)

Manifestations: During the initial phase of treatment, inflammatory responses to latent infections (such as tuberculosis, cytomegalovirus) or autoimmune diseases (such as Graves' disease) may occur.

Management: Further evaluation and targeted treatment are required.

Renal Impairment

Risk: Occasional cases of acute kidney injury or Fanconi syndrome (renal tubular dysfunction) may occur.

Monitoring: Before and during medication, regular tests for serum creatinine, urine protein, and urine glucose are necessary; patients with chronic kidney disease should additionally undergo serum phosphorus testing.

Contraindication: Contraindicated in patients with a creatinine clearance (CLcr) of <30 mL/min.

Lactic Acidosis and Hepatic Steatosis

Symptoms: A rare but serious metabolic complication, characterized by nausea, abdominal pain, and hepatomegaly.

Management: Discontinue the drug immediately and seek medical attention.

Precautions for Biktarvy Administration

Contraindicated Drugs

Absolute contraindications: Dofetilide (may cause arrhythmia), rifampin (reduces drug efficacy).

Drugs requiring caution:

Antiepileptic drugs (carbamazepine, phenytoin): Alternative drugs should be used instead.

Drugs containing polyvalent cations (e.g., aluminum/magnesium antacids, calcium/iron supplements): Administration should be separated by an interval of at least 2 hours.

Medication in Special Populations

Renal impairment: No dosage adjustment is needed for patients with a creatinine clearance (CLcr) of ≥30 mL/min; contraindicated in patients with severe renal impairment.

Hepatic impairment: No dosage adjustment is needed for patients with mild to moderate hepatic impairment; contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).

Pregnant and lactating women: The benefits and risks should be weighed; breastfeeding is prohibited in HIV-infected patients.

Drug Interactions

Effects on metabolism: Concurrent use with strong CYP3A inducers (e.g., St. John's wort) should be avoided.

Monitoring requirements: Dosage adjustment is necessary when used concomitantly with metformin; caution is required when used together with nephrotoxic drugs (e.g., nonsteroidal anti-inflammatory drugs/NSAIDs).