Biktarvy Demonstrates 100% Virus Suppression and Long-Term Safety in Korean HIV Patients

Recent long-term clinical data from the BICSTaR study and domestic post-marketing surveillance reveal that Biktarvy maintains 100% viral suppression rates in Korean human immunodeficiency virus (HIV) patients over 24 months, shifting the primary clinical objective of antiretroviral therapy from basic viral suppression to sustained, stable long-term disease management.

Modern clinical management of HIV infection has evolved significantly. Antiretroviral therapy has successfully transformed a once fatal diagnosis into a manageable chronic condition. Contemporary medical frameworks now prioritize maintaining a stable, undetectable viral load over simple suppression, emphasizing long-term metabolic health, drug persistence, and overall patient quality of life.

Modern single-tablet regimens ensure viral suppression and metabolic stability

• Sustained Viral Suppression: Clinical evaluations demonstrate that modern single-tablet regimens can securely keep the virus at undetectable levels over multi-year observation windows.
• Metabolic Stability: Long-term data indicate minimal disruption to patient body weight, lipid profiles, and metabolic health markers during continuous treatment.
• Treatment Persistence: High continuation rates reflect minimal drug-related adverse events, supporting uninterrupted adherence in routine clinical practice.

BICSTaR 24-Month Cohort Data and Viral Suppression Rates

The multinational prospective observational BICSTaR study evaluated the real-world effectiveness, safety, and treatment persistence of Biktarvy among 2,380 HIV-infected individuals across 14 countries, including South Korea. Prior 12-month analyses involving cohorts from South Korea, Taiwan, and Singapore showed that 98.2% of treatment-naive patients and 97.0% of treatment-experienced patients achieved or maintained an undetectable viral load of HIV RNA below 50 copies per mL.

This suppression efficacy remained consistent in the 24-month Korean cohort analysis. Results confirmed that 100% of both treatment-naive and treatment-experienced patients maintained viral suppression or achieved undetectable status at the two-year mark. Immunological markers demonstrated clear recovery. Median CD4+ cell counts rose significantly by 252 cells per microliter in treatment-naive patients and 69 cells per microliter in treatment-experienced patients, alongside notable improvements in CD4/CD8 ratios.

Treatment persistence rates at 24 months reached 100% for treatment-naive individuals and 96.1% for treatment-experienced participants. Crucially, zero cases of drug-related adverse events leading to treatment discontinuation were reported across the two-year observation period. Large-scale domestic post-marketing surveillance involving 2,761 South Korean patients observed over 48 weeks corroborated these findings, showing that 97.19% of patients with verifiable HIV RNA data maintained or achieved undetectable viral loads, with serious drug-related adverse events occurring in only 0.04% of cases.

BICSTaR Korean Cohort & Post-Marketing Surveillance Efficacy Metrics

Study Cohort	Observation Period	Viral Suppression Rate	Treatment Persistence
BICSTaR Treatment-Naive (Korea)	24 Months	100%	100%
BICSTaR Treatment-Experienced (Korea)	24 Months	100%	96.1%
Domestic Post-Marketing Surveillance	48 Weeks	97.19%	Not Reported

Metabolic Health and Long-Term Safety Profiles

As the life expectancy of HIV-infected individuals continues to rise, managing metabolic health parameters such as body weight and blood lipid profiles has become an essential component of comprehensive care.

In the 24-month BICSTaR Korean cohort analysis, the median weight change was recorded at 2.0 kg for treatment-naive individuals and 1.0 kg for treatment-experienced participants. Body mass index variation in the treatment-naive group registered at 0.6 kg per square meter without clinically significant deviations. Standard lipid parameters, including triglycerides, high-density lipoprotein, and low-density lipoprotein, remained stable over the 24-month duration.

Additional insights from Study 4449, which focused on HIV-infected patients aged 65 and older, demonstrated that metabolic parameters remained stable throughout treatment. At 96 weeks, the median weight change was 0.0 kg, with a notable reduction of 19 mg per dL in fasting triglycerides compared to baseline measurements. Long-term studies spanning five years in treatment-naive individuals show that weight gain peaks early in the therapeutic timeline before plateauing, reflecting a natural return-to-health effect as immune function and viral suppression stabilize.

Long-Term Outlook for Chronic Viral Management

Real-world evidence from domestic cohorts shows the reliability of contemporary single-tablet regimens in maintaining viral suppression and immunological health over extended periods. As clinical guidelines increasingly prioritize sustained tolerability and metabolic stability alongside viral control, long-term observational data will continue guiding personalized treatment strategies for aging populations living with HIV.

Clinical studies on bictegravir and antiretroviral therapy safety

• BICSTaR Study Group. Real-world effectiveness, safety, and treatment persistence of bictegravir/emtricitabine/tenofovir alafenamide in HIV-infected patients. Multinational Prospective Observational Study.
• Study 4449 Clinical Trial Group. Evaluation of metabolic parameters and safety of bictegravir-based regimens in older adults living with HIV.
• Domestic Post-Marketing Surveillance Report. Post-marketing evaluation of antiretroviral therapy safety and viral suppression in South Korean clinical settings.