As a triple-combination fixed-dose formulation for the treatment of HIV-1 infection, Biktarvy consists of three antiretroviral drugs: bictegravir, emtricitabine, and tenofovir alafenamide.

How Effective is Biktarvy in Treatment?

High-Efficiency Antiviral Mechanism

Biktarvy achieves potent antiviral effects through the synergistic action of its three components.

Bictegravir, as an integrase strand transfer inhibitor (INSTI), blocks the integration of viral DNA into the host cell genome.

Emtricitabine and tenofovir alafenamide, which act as nucleoside reverse transcriptase inhibitors (NRTIs), work together to inhibit the viral reverse transcription process.

This triple mechanism of action makes Biktarvy a complete anti-HIV treatment regimen, eliminating the need for additional antiretroviral drugs.

Clinical Efficacy Performance

In clinical trials, Biktarvy has demonstrated excellent viral suppression ability, effectively reducing HIV-1 RNA levels.

Biktarvy shows stable therapeutic effects both in treatment-naive patients and in treatment-experienced patients who have already achieved virologic suppression (and are switching to this regimen).

The once-daily oral administration schedule of Biktarvy significantly improves patients' medication adherence, and its feature of being taken with or without food further enhances the convenience of medication use.

Suitable Population for Biktarvy

Main Indication Scope

Biktarvy is indicated for the treatment of HIV-1 infection in adults, specifically including two groups of patients:

First, treatment-naive patients who have never received antiretroviral therapy before.

Second, patients who have achieved virologic suppression (HIV-1 RNA below the lower limit of detection) for at least 3 months under their current antiretroviral treatment regimen, with no history of treatment failure and no known drug-resistant mutations to any component of Biktarvy. For such patients switching therapy, Biktarvy can replace their original treatment regimen.

Medication Monitoring for Biktarvy

Pre-Treatment Baseline Assessment

Screening for hepatitis B virus (HBV) infection: Patients with co-infection of HIV and HBV may experience severe acute exacerbation of hepatitis B after discontinuing Biktarvy.

Renal function assessment: Including tests for serum creatinine, estimated creatinine clearance, urine glucose, and urine protein.

For patients with chronic kidney disease, additional measurement of serum phosphorus levels is required.

Routine Monitoring During Treatment

Renal function monitoring: All patients should undergo regular assessments of serum creatinine, estimated creatinine clearance, urine glucose, and urine protein during treatment. Patients with chronic kidney disease also need to have their serum phosphorus levels monitored. If clinically significant renal function decline or signs of Fanconi syndrome occur, consideration should be given to discontinuing Biktarvy.

Hepatic function monitoring: This is particularly important for patients with co-infection of HIV and HBV. If such patients discontinue Biktarvy, their hepatic function must be closely monitored for at least several months, as severe acute exacerbation of hepatitis B may occur.

Metabolic monitoring: Regularly assess metabolic indicators such as blood lipids and blood glucose, and pay attention to potential metabolic abnormalities.

Monitoring for Special Conditions

Immune reconstitution inflammatory syndrome (IRIS): During the initial stage of treatment, an inflammatory response to latent or residual opportunistic infections may occur, requiring close observation and timely management.

Lactic acidosis/hepatic steatosis: Although rare, if relevant symptoms or abnormal laboratory findings appear, Biktarvy should be discontinued immediately and appropriate measures taken.

Mental health monitoring: Patients with a history of depression or mental illness need special attention to mood changes, as rare cases of severe mental adverse reactions (such as suicidal ideation) have been reported.