B/F/TAF Switch Study for HIV-HBV Coinfection

NCT03797014 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: HP00083844
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be followed on treatment for 48 weeks.

Conditions

HIV-1-infection; Hepatitis B

Keywords

HIV-1; Hepatitis B; HIV-HBV coinfection; Bictegravir; B/F/TAF; Tenofovir alafenamide; Biktarvy

Outcome Measures

Primary Outcomes (2)

• HIV-1 RNA at Week 24

  Proportion of participants with HIV-1 RNA \<50 copies/mL at Week 24 by US FDA Snapshot Algorithm

  Week 24

• HBV DNA at Week 24

  Proportion of participants with plasma HBV DNA \<29 IU/mL at Week 24 as defined by Missing=Failure Approach

  Week 24

Secondary Outcomes (8)

• HIV-1 RNA at Week 48

  Week 48

• HBV DNA at Week 48

  Week 48

• CD4 Cell Count Change at Week 24

  Baseline; Week 24

• CD4 Cell Count Change at Week 48

  Baseline; Week 48

• ALT Normalization at Week 24

  Week 24

Study Arms (1)

B/F/TAF

EXPERIMENTAL

Treatment group (1-arm study)

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.

Also known as: Bictegravir/emtricitabine/tenofovir alafenamide

B/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older at enrollment.
• Documented HIV-1 infection and currently on a stable regimen for at least 3 months if on an INSTI-based regimen (6 months if on a non-INSTI-based regimen) preceding the screening visit with documented plasma HIV-1 RNA ≤ 50 copies/mL for at least 3 months preceding the screening visit.
• No known history of resistance to tenofovir alafenamide (TAF), emtricitabine (FTC), or Bictegravir (BIC).
• Documented chronic hepatitis B infection, based on any of the following: a. Positive HBsAg result or nucleic acid test for HBV DNA (including qualitative, quantitative, and genotype testing) or positive HBeAg on two occasions at least 6 months apart (any combination of these tests performed 6 months apart is acceptable); or b. Negative immunoglobulin M (IgM) antibodies to HBV core antigen (anti-HBc IgM) AND a positive results on one of the following tests: HBsAg, HBeAg, or nucleic acid test for HBV DNA (including qualitative, quantitative, and genotype testing) prior to or at screening.
• No current or prior regimen containing three active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/entecavir or TDF/lamivudine (3TC)/entecavir).
• Must have a primary care provider(s) for medical management.
• Females of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-heterosexually active or practice sexual abstinence from screening and throughout the duration of the study. Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study drug dosing.
• Male subjects must be willing to abstain from heterosexual intercourse or use a condom throughout the study period.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Written informed consent must be obtained before any study procedure is performed.

You may not qualify if:

• Females who are pregnant or breastfeeding.
• Any known allergies to any of the components of B/F/TAF.
• Treatment with another investigational drug within three months of enrollment.
• Abnormal hematological and biochemical parameters at screening, including:
• Absolute neutrophil count (ANC) \< 750 cells/mm3.
• Platelets \< 50,000/mm3.
• Hemoglobin \< 8.5 g/dL.
• AST or ALT of \> 5 times upper limit of normal (ULN).
• Estimated GFR \< 30 mL/min/1.73 m2.
• Total bilirubin \> 1.5 times ULN.
• Previous or current history of malignancy, other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma. Note: Those with a history of malignancy who are in remission for two or more years may be included in the study.
• An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening.
• Subjects experiencing decompensated cirrhosis (e.g. ascites, encephalopathy, or variceal bleeding).
• Acute hepatitis in the 30 days prior to study entry.
• Active tuberculosis infection.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Gilead Sciences: collaborator

Study Sites (2)

Institute of Human Virology Clinical Research Unit

Baltimore, Maryland, 21201, United States

Location

Newlands Health

Philadelphia, Pennsylvania, 19114, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

This study did not achieve its enrollment target of 60 and was adversely affected by COVID-19 pandemic travel and research restrictions particularly during April 2020 to August 2020.

Results Point of Contact

• Title: Dr. Joel Chua
• Organization: Institute of Human Virology, University of Maryland Baltimore

jchua@ihv.umaryland.edu

14107065704

Study Officials

• Joel V Chua, MD

  Institute of Human Virology, University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This is an open-label phase 4 switch study to evaluate the efficacy, safety, and tolerability of FDC B/F/TAF in adults with HIV-1 and HBV coinfection.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: April 30, 2019
• Primary Completion: November 22, 2022
• Study Completion: May 5, 2023
• Last Updated: November 3, 2023
• Results First Posted: July 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)