Biktarvy is a complete treatment regimen for human immunodeficiency virus type 1 (HIV-1) infection. To ensure the effectiveness of medication, patients and medical staff must have a comprehensive understanding of its potential side effects, severe adverse reactions that require vigilance, and precautions for use.

Side Effects of Biktarvy (Biktarvy)

Common Side Effects

Incidence of diarrhea: 3%–6%.

Incidence of nausea: 3%–6%.

Incidence of headache: 4%–5%.

Other less common adverse reactions include fatigue, abnormal dreams, dizziness, insomnia, and abdominal bloating, with an incidence of approximately 2%–3%.

In pediatric patients, the observed incidence of adverse reactions is around 11%, of which 76% are mild, mainly manifested as abdominal discomfort.

Severe Side Effects of Biktarvy (Biktarvy)

Acute Exacerbation of Hepatitis B After Treatment Discontinuation

For patients coinfected with HIV-1 and hepatitis B virus (HBV), severe acute exacerbation of hepatitis B has been reported following discontinuation of products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and this may also occur upon discontinuation of Biktarvy.

Medical staff should closely monitor liver function and conduct clinical and laboratory follow-up for at least several months.

If appropriate, anti-hepatitis B treatment may be required, especially for patients with advanced liver disease or cirrhosis, as post-treatment exacerbation of hepatitis can lead to hepatic decompensation and liver failure.

Immune Reconstitution Inflammatory Syndrome

Immune reconstitution inflammatory syndrome has been reported in patients receiving combined antiretroviral therapy.

In the initial stage of combined antiretroviral therapy, patients with an immune system response may develop inflammatory reactions to latent or residual opportunistic infections, which may require further evaluation and treatment.

Autoimmune diseases (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) have also been reported to occur in the context of immune reconstitution.

Precautions for Biktarvy (Biktarvy)

Testing Requirements Before and During Treatment

Patients should be tested for hepatitis B virus infection before initiating or starting Biktarvy treatment.

At the start of Biktarvy treatment and during the treatment period, serum creatinine, estimated creatinine clearance rate, urine glucose, and urine protein should be assessed for all patients based on clinical conditions.

In patients with chronic kidney disease, serum phosphorus levels should also be evaluated.

Contraindicated Concomitant Medications

Dofetilide: Due to the potential for increased plasma concentrations of dofetilide and associated severe and/or life-threatening events.

Rifampicin: Due to the reduction in bictegravir (BIC) plasma concentrations, which may lead to loss of therapeutic effect and development of resistance to Biktarvy.