Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed

Vancouver Infectious Diseases Centre

Status and phase: Unknown; Phase 4

Conditions: Human Immunodeficiency Virus I Infection; Drug Use

Treatments: Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04132674

Biktarvy Study

Details and patient eligibility

About

In an effort to engage more HIV-infected PWUD into care, and ensure treatment adherence and efficacy, simplification of older, multi-tablet regimens is required. Newer, more potent molecules can also overcome resistant that has persisted with previous regimens, while simultaneously providing a high barrier to resistance. The co-formulation of B/F/TAF is a viable switch-option for patients who have experienced lower adherence with previous regimens due to high pill burden, or for those requiring a more potent regimen due to emergent resistances. The formal evaluation of B/F/TAF in this context will allow us to optimize care for HIV-infected PWUD.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant is ≥19 years of age infected with HIV-1

2. Participant has an undetectable viral load <40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following:

   1. Transient HIV viremia (episodes of HIV viral load between 40-1000 copies/mL) in the past 12 months, OR Virologic breakthrough (HIV viral load > 1000 copies/mL) in the past 12 months, OR Documented instances of non-adherence for a period of more than 7 days or...
   2. Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)
   3. Participant has a history or current indication of illicit drug use.
   4. Patients infected with HCV and or HBV can be included in this study.
   5. If female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator.

Exclusion criteria

1. They have any documented history of integrase inhibitor resistance

2. They exhibit any of the following:

   1. Creatinine Clearance Rate < 30 ml/min
   2. Hemoglobin < 10.0 g/dL
   3. Absolute neutrophil count <750 cells/mL
   4. Platelet count < 50,000 /mL
   5. ALT or AST >5x upper limit of normal (ULN)
   6. Creatinine > 1.5x ULN

3. They are taking medication that is contraindicated with any component of B/F/TAF.

4. They are pregnant or breastfeeding.

5. They do not/have not ever used any form of illicit drug use.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

B/F/TAF

Other group

Description:

Switching participants who are currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy) to one oral tablet of B/F/TAF once-daily for 72 weeks

Treatment:

Drug: Bictegravir/emtricitabine/tenofovir alafenamide