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

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.

Study Overview

• Status: Unknown
• Conditions: Drug Use; Human Immunodeficiency Virus I Infection
• Intervention / Treatment: Drug: Bictegravir/emtricitabine/tenofovir alafenamide

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rossitta Yung; Phone Number: 303 604-642-6429; Email: rossitta.yung@vidc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Recruiting
      • Vancouver Infectious Diseases Centre
      • Contact: Rossitta Yung; Phone Number: 303 604-642-6429; Email: rossitta.yung@vidc.ca
      • Principal Investigator: Brian Conway, MD
    • Victoria, British Columbia, Canada, V8W 2G2
      • Recruiting
      • Victoria Cool Aid Society
      • Contact: Marion Selfridge; Phone Number: 250-385-1466; Email: marions@uvic.ca
      • Principal Investigator: Christopher Fraser, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: B/F/TAF; 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	Drug: Bictegravir/emtricitabine/tenofovir alafenamide; Taking one oral tablet of B/F/TAF once-daily for 72 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects that remain virally suppressed at week 48	The proportion of subjects with HIV RNA <40 copies/mL	Interim analysis of efficacy will be done at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with viral blips	Viral blips defined as detectable HIV viral load between 40-1000 copies/mL at week 72	Analysis will be done at 72 weeks
Changes of adherence	Changes of adherence from baseline at week 2, 8, 24, 48, and 72 with an adherence questionnaire	Analysis will be done at 72 weeks
Proportion of patients that achieved >90% adherence	Proportion of patients that achieved >90% adherence	Analysis will be done at 72 weeks
The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF	The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF	Analysis will be done at 72 weeks
The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72	The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72	Analysis will be done at 72 weeks
Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module	Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module	Analysis will be done at 72 weeks

Collaborators and Investigators

• Sponsor: Vancouver Infectious Diseases Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
• Other Study ID Numbers: Biktarvy Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes