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Chronic Hepatitis B in HIV PatientNCT03425994

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment for HIV/HBV-coinfection

An observational study of Chronic Hepatitis B in HIV Patient and Kidney Injury, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Tenofovir alafenamide (TAF), active against both HIV and HBV, demonstrates similar antiviral efficacy but improved renal and bone safety compared to tenofovir disoproxil fumarate (TDF) in HIV-1-infected patients. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Elvitegravir/Cobicistat/Emtricitabine
Type of treatment
Pill or oral medicine
How many people
275 participants
Where
1 siteTaiwan
Study dates
6 Feb 2018to 11 Oct 2019
How long will I take part?
48 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HIV/HBV-coinfected patients

Who may be able to join

  • Aged ≥ 20 years
  • Diagnosed with HIV and HBV-coinfection. HBV infection is defined as positive HBsAg for 6 months or longer before enrollment of the study
  • Serum HBV DNA load <9 log10 IU/mL
  • On Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) or TDF plus lamivudine (3TC) as backbone plus a 3rd agent for HIV infection for 6 months or longer
  • Plasma HIV RNA load <50 copies/mL twice over the past 12 months
  • No known resistance mutations to Integrase strand transfer inhibitors (InSTIs), and no previous history of HIV treatment failure under InSTIs-containing combination antiretroviral therapy (cART). HIV treatment failure is defined as a plasma HIV RNA load >400 copies/mL after 6 months of InSTIs-containing cART.
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  • No known resistance mutations to TDF, 3TC, or FTC, and no previous history of HIV treatment failure while on TDF, 3TC, or FTC-containing cART. HIV treatment failure is defined as a plasma HIV RNA load >400 copies/mL after 6 months of TDF, 3TC, or FTC-containing cART.
  • Baseline eGFR (estimated glomerular filtration rate) ≥30 mL/min per 1.73m2 (calculated by CKD-EPI equation)
  • AST and ALT ≤2-fold the upper limit of normal
  • Able to sign the written informed consent

Who cannot join

  • Active opportunistic illness
  • On treatment of tuberculosis
  • Pregnancy or lactation
  • Hepatic decompensation (Child-Pugh C)
  • Allergic to TDF, TAF, 3TC, FTC, or InSTIs
  • Intolerance of InSTIs
  • Hepatitis C virus (HCV)-coinfection and plan to start treatment with direct-acting antiviral agents or interferon/ribavirin within 48 weeks
  • Concurrent use of rifamycins, phenytoin, and other drugs that are contraindicated with EVG/cob/FTC/TAF

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Genvoya) as Maintenance Treatment of HIV-1/Hepatitis B Virus (HBV)-Coinfected Patients: an Observational Study

Tenofovir alafenamide (TAF), active against both HIV and HBV, demonstrates similar antiviral efficacy but improved renal and bone safety compared to tenofovir disoproxil fumarate (TDF) in HIV-1-infected patients. HIV-1-infected patients whose estimated glomerular filtration rate (eGFR) between 30-69 mL/min were shown to have minimal change in eGFR and improved proteinuria, albuminuria, and bone mineral density after switching to a single-tablet regimen containing Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (EVG/cob/FTC/TAF). For treatment of chronic HBV infection, a similar proportion of HBV-monoinfected patients who received TAF and those who received TDF achieved undetectable HBV DNA at 48 weeks of therapy. Although TAF is effective for HIV and HBV suppression, data on efficacy of TAF are limited among patients co-infected with both viruses. Currently, only one open-label, single-arm study had investigated the efficacy and safety of TAF in HIV/HBV-coinfected patients. In this study, 72 HIV/HBV-coinfected patients switching to EVG/cob/FTC/TAF were enrolled, and 91.7% of them maintained or achieved virologic suppression for both HIV and HBV at 48 weeks of therapy. Seroconversion occurred in 2.9% of HBsAg-positive participants and in 3.3% of HBeAg-positive participants. Improvements in eGFR and declines in markers of bone turnover of the participants were observed. The limitations of the above study are the small sample size. Taiwan is a country hyperendemic for HBV infection, with 19.8% of HIV-positive patients who were born before the implementation of nationwide neonatal vaccination in 1986 had concurrent chronic HBV infection. To further the understanding of the difference between TAF- and TDF-containing combination antiretroviral therapy among HIV/HBV-coinfected patients, the investigators plan to conduct an observational study to evaluate the efficacy and safety of EVG/cob/FTC/TAF as maintenance treatment of HIV/HBV-coinfected patients.

Being tested
Elvitegravir/Cobicistat/Emtricitabine
Medical subject headings
Bone Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elvitegravir/Cobicistat/EmtricitabineDrug

    Also called Genvoya

    Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide 150mg/150mg/200mg/10mg (Genvoya) film coated tablet

Study groups in NCT03425994
Study groupRoleWhat they receive
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir AlafenamideElvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Genvoya) tablet by mouth, once daily for 48 weeks
Receives: Drug: Elvitegravir/Cobicistat/Emtricitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with undetectable plasma HBV DNA load

    Proportion of patients achieving undetectable plasma HBV DNA load (defined as <128 copies/mL)

    Measured: 48 weeks

Secondary outcomes (13)

  1. Decreases of plasma HBV DNA load

    Decreases of plasma HBV DNA load (in log10 copies/mL)

    Measured: 48 weeks

  2. Proportion of patients with plasma HIV RNA load <50 copies/mL

    Proportion of patients achieving plasma HIV RNA load <50 copies/mL

    Measured: 48 weeks

  3. Liver function

    Change of serum aspartate aminotransferase (AST) and alanine transaminase (ALT)

    Measured: 48 weeks

  4. Number of patients with change of HBV serology markers

    Number of patients with HBsAg loss, hepatitis B e-antigen (HBeAg) loss, or appearance of anti-HBs and anti-HBe

    Measured: 48 weeks

  5. Serum creatinine

    Changes of serum creatinine from baseline

    Measured: 48 weeks

  6. Number of patients with an increase of serum creatinine

    Number of patients with an increase of serum creatinine by ≥0.3 mg/dL or ≥50% from baseline

    Measured: 48 weeks

  7. Estimated glomerular filtration rate

    Changes of serum estimated glomerular filtration rate (eGFR, [mL/min per 1.73m2], calculated by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) from baseline

    Measured: 48 weeks

  8. Number of patients with a decline of estimated glomerular filtration rate

    Number of patients with a decline of estimated glomerular filtration rate (eGFR, calculated by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) by 15 mL/min per 1.73m2 or 20% from baseline

    Measured: 48 weeks

  9. Urine protein-creatinine ratio

    Change of urine protein-creatinine ratio (UPCR) from baseline

    Measured: 48 weeks

  10. Urine albumin-creatinine ratio

    Change of urine albumin-creatinine ratio (UACR) from baseline

    Measured: 48 weeks

  11. Urine β-2 microglobulin

    Change of β-2 microglobulin from baseline

    Measured: 48 weeks

  12. Bone disease

    Change of bone mineral density

    Measured: 48 weeks

  13. Adverse drug reaction

    Number and types of adverse drug reaction related to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start6 Feb 2018
  3. Primary completion22 Feb 2019
  4. Study completion11 Oct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
275 participants (actual)
Target duration
48 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT03425994
Sponsor's protocol ID
201710056RIPB
Status last verified
Aug 2019
First submitted
11 Jan 2018
Last updated
28 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15.

    PubMed 25890673

  • Pozniak A, Arribas JR, Gathe J, Gupta SK, Post FA, Bloch M, Avihingsanon A, Crofoot G, Benson P, Lichtenstein K, Ramgopal M, Chetchotisakd P, Custodio JM, Abram ME, Wei X, Cheng A, McCallister S, SenGupta D, Fordyce MW; GS-US-292-0112 Study Team. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):530-7. doi: 10.1097/QAI.0000000000000908.

    PubMed 26627107

  • Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.

    PubMed 28404091

  • Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22.

    PubMed 28404092

  • Gallant J, Brunetta J, Crofoot G, Benson P, Mills A, Brinson C, Oka S, Cheng A, Garner W, Fordyce M, Das M, McCallister S; GS-US-292-1249 Study Investigators. Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B-Coinfected Adults. J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):294-298. doi: 10.1097/QAI.0000000000001069.

    PubMed 27171740

  • Huang YS, Cheng CY, Liou BH, Lu PL, Cheng SH, Lee YT, Liu CE, Sun HY, Yang CJ, Tang HJ, Lin SP, Ho MW, Huang SH, Tsai HC, Lee CH, Hung CC; Taiwan HIV Study Group. Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment in HIV/HBV-Coinfected Patients. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):473-481. doi: 10.1097/QAI.0000000000002589.

    PubMed 33273214

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis B in HIV Patient and Kidney Injury, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with undetectable plasma HBV DNA load (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03425994, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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