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

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. 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.

Conditions

• Chronic Hepatitis B in HIV Patient
• Kidney Injury
• Bone Diseases

Interventions

DRUG

Elvitegravir/Cobicistat/Emtricitabine

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

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch

  collaborator OTHER

• National Taiwan University Hospital, Yun-Lin Branch

  collaborator OTHER

• Far Eastern Memorial Hospital

  collaborator OTHER

• Taoyuan General Hospital

  collaborator OTHER_GOV

• Mackay Memorial Hospital

  collaborator OTHER

• Chung Shan Medical University

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Changhua Christian Hospital

  collaborator OTHER

• Chi Mei Medical Hospital

  collaborator OTHER

• Kaohsiung Veterans General Hospital.

  collaborator OTHER

• Kaohsiung Medical University Chung-Ho Memorial Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• E-DA Hospital

  collaborator OTHER

• Lotung Poh-Ai Hospital

  collaborator OTHER

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Chien-Ching Hung · National Taiwan University Hospital

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-06

Primary Completion

2019-02-22

Completion

2019-10-11

Countries

• Taiwan

Study Locations