Biktarvy vs. Symtuza for HIV-Related Weight Gain

Overseen By Smit Rajput, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: East Carolina University

Must be taking: Antiretrovirals

Must not be taking: Insulin, Antidepressants, Antipsychotics, others

Disqualifiers: Morbid obesity, Substance abuse, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two HIV treatments to see which one causes more weight gain. It focuses on people with HIV who are experiencing weight gain from their medications. Researchers will study tiny molecules called micro-RNAs to understand why this weight gain happens. One type of treatment has been associated with more weight gain compared to other treatments.

Do I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot be on medications associated with weight changes or those that interact with Symtuza or Biktarvy.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that are known to interact significantly with Symtuza or Biktarvy, as well as those associated with weight loss or gain, like insulin or antidepressants.

What data supports the idea that Biktarvy vs. Symtuza for HIV-Related Weight Gain is an effective drug?

The available research shows that both Biktarvy and Symtuza are effective in managing HIV, but when it comes to weight gain, there is no significant difference between them. In a study of people with HIV who switched to regimens containing Biktarvy or Symtuza, up to 18% experienced excessive weight gain, but this was similar across different treatments. This suggests that neither drug is particularly better or worse than the other in terms of weight gain. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Biktarvy or Symtuza for managing HIV-related weight gain?

Research shows that people with HIV who switched to regimens containing components of Biktarvy or Symtuza experienced some weight gain, but there was no significant difference in weight gain between these regimens. This suggests that while weight gain can occur, it is not unique to these specific drugs. ^{1 2 3 4 5}

What safety data exists for Biktarvy and Symtuza in treating HIV-related weight gain?

Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) has a good safety profile, particularly in terms of renal and bone health, and is effective in maintaining virologic suppression. It is suitable for patients with poor adherence or those needing rapid treatment initiation. Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is recommended for HIV-1 treatment and may be better tolerated than other regimens, but long-term safety data is still needed. Both treatments have been evaluated for their impact on body mass index and weight gain in people living with HIV-1. ^{1 2 3 4 6}

Is Biktarvy or Symtuza safe for humans?

Both Biktarvy and Symtuza have been shown to be generally safe for humans. Symtuza is noted for its good safety profile, particularly in terms of bone and kidney health, while Biktarvy is considered well-tolerated compared to other similar treatments. However, as with any medication, potential interactions with other drugs should be considered. ^{1 2 3 4 6}

Is the drug Biktarvy a promising treatment for HIV-related weight gain?

Biktarvy is a single-tablet regimen that combines three drugs to treat HIV. It is known for its convenience and effectiveness in controlling the virus. However, studies suggest that people using Biktarvy may experience weight gain, which is a common concern with this type of HIV treatment. ^{1 2 3 4 7}

What makes the drugs Biktarvy and Symtuza unique for treating HIV-related weight gain?

Biktarvy and Symtuza are unique because they are single-tablet regimens that simplify treatment by combining multiple drugs into one pill, which can help with adherence. Symtuza includes a protease inhibitor that offers a high genetic barrier to resistance, while Biktarvy is based on an integrase strand transfer inhibitor, which may be associated with weight gain. ^{1 2 3 4 7}

Research Team

Paul Cook, MD

Principal Investigator

East Carolina University

Eligibility Criteria

This trial is for adults over 18 with HIV and a viral load of at least 1000 copies/ml who haven't started treatment yet. They need internet access via smartphone and must be willing to consent. Excluded are those on weight-altering drugs, bedbound individuals, prisoners, pregnant women, people with extreme obesity or cachexia, or active substance abusers.

Inclusion Criteria

My HIV viral load is 1000 copies/ml or higher.

Have access to a smartphone with internet access

Willing to provide written informed consent

Exclusion Criteria

Pregnant females

My BMI is either 40 or higher, or 20 or lower.

Unwilling or unable to comply with protocol requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Symtuza or Biktarvy once daily to study the effect on microRNA profiles and weight gain

48 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Biktarvy
• Symtuza

Trial Overview The study compares the effects of two HIV medications—Biktarvy and Symtuza—on microRNAs in the body and their potential link to weight gain over 48 weeks. It also looks at calorie intake's role in medication-related weight changes.

Participant Groups

Group I: Symtuza Experimental Treatment 1 Intervention

15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily.

Group II: Biktarvy Experimental Treatment 1 Intervention

15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily.

Biktarvy is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Biktarvy for:

• HIV-1 infection

Approved in United States as Biktarvy for:

• HIV-1 infection

Approved in Canada as Biktarvy for:

• HIV-1 infection

Approved in Japan as Biktarvy for:

• HIV-1 infection

Approved in Switzerland as Biktarvy for:

• HIV-1 infection

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Findings from Research

In a study of 2250 people living with HIV-1, those starting treatment with bictegravir/FTC/TAF (BIC/FTC/TAF) experienced significantly greater increases in body mass index (BMI) and weight compared to those on darunavir/cobicistat/FTC/TAF (DRV/c/FTC/TAF) over 12 months.

Patients on BIC/FTC/TAF were more likely to gain at least 5% or 10% in weight and BMI, indicating that while both treatments are effective, the choice of regimen may impact weight management and overall health in people living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body mass index increase and weight gain among people living with HIV-1 initiated on single-tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide in the United States. Emond, B., Rossi, C., Côté-Sergent, A., et al.[2022]

Symtuza® (cobicistat-boosted darunavir with emtricitabine and tenofovir alafenamide) is the first single-tablet regimen based on a protease inhibitor, offering a convenient option for lifelong HIV treatment that enhances adherence due to reduced pill burden.

This regimen is effective and has a high genetic barrier to resistance, making it suitable for naive patients, especially those at risk of poor adherence and with low potential for drug-drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symtuza® (DRV/c/FTC/TAF) in the management of treatment-naive HIV-patients. Gómez Ayerbe, C., Santos González, J., Palacios Muñoz, R.[2021]

Symtuza® is the first single tablet regimen for HIV-1 treatment that combines two nucleos(t)ide analogues and a boosted protease inhibitor, providing a convenient and effective option for patients.

This combination not only shows efficacy against various HIV strains but also reduces the risk of bone and renal toxicity associated with other treatments, making it a safer choice for a wider range of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology of Symtuza® (DRV/c/FTC/TAF). Curran, A., Navarro, J.[2021]

Symtuza® is a single-tablet regimen combining darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, offering a potent and safe treatment option for HIV, particularly due to its high genetic barrier to resistance and renal safety profile.

Phase 3 studies have shown that Symtuza® is non-inferior to other treatments in achieving and maintaining virologic suppression, making it a preferred choice for patients with previous treatment failures or those needing rapid initiation of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symtuza® in clinical practice. Luis Casado, J., Fontecha, M., Monsalvo, M., et al.[2021]

In a study of 5,536 virologically suppressed people with HIV switching to regimens containing tenofovir alafenamide/emtricitabine (TAF/FTC), 18% experienced excessive weight gain of 5% or more within 28 weeks, and 9% gained 10% or more within 54 weeks.

Despite the observed weight gain, there were no statistically significant differences in the risk of excessive weight gain among the different treatment regimens (darunavir/cobicistat, elvitegravir/cobicistat, dolutegravir, or bictegravir), indicating similar safety profiles regarding weight changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excessive Weight Gain: Current Antiretroviral Agents in Virologically Suppressed People with HIV. Hsu, RK., Brunet, L., Fusco, JS., et al.[2023]

In a study involving 631 treatment-naive adults with HIV-1, the fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide was found to be non-inferior to the combination of dolutegravir, abacavir, and lamivudine at week 96, with 88% of participants achieving undetectable HIV-1 RNA levels.

Bictegravir was associated with fewer adverse events compared to dolutegravir, with only 28% of participants reporting drug-related side effects, and no participants discontinuing treatment due to adverse events, highlighting its safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Wohl, DA., Yazdanpanah, Y., Baumgarten, A., et al.[2022]

In a study of 160 people living with HIV, those starting treatment with the bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) regimen experienced an average weight gain of 3.8 kg and an increase in BMI after 48 weeks, indicating significant weight changes in treatment-naïve individuals.

Individuals switching to the BIC/FTC/TAF regimen also gained weight, averaging 2.8 kg, highlighting that weight gain is a common concern for both new and switching patients on this antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight gain and metabolic disturbances in people living with HIV who start antiretroviral therapy with, or switch to, bictegravir/emtricitabine/tenofovir alafenamide after 48 weeks of treatment: A real-world prospective study. Mata Marín, JA., Velasco-Penagos, JC., Mauss, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Body mass index increase and weight gain among people living with HIV-1 initiated on single-tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide in the United States. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

Symtuza® (DRV/c/FTC/TAF) in the management of treatment-naive HIV-patients. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

Pharmacology of Symtuza® (DRV/c/FTC/TAF). [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Symtuza® in clinical practice. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Excessive Weight Gain: Current Antiretroviral Agents in Virologically Suppressed People with HIV. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Weight gain and metabolic disturbances in people living with HIV who start antiretroviral therapy with, or switch to, bictegravir/emtricitabine/tenofovir alafenamide after 48 weeks of treatment: A real-world prospective study. [2023]