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.
Study Type
OBSERVATIONAL
Enrollment
275
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide 150mg/150mg/200mg/10mg (Genvoya) film coated tablet
National Taiwan University Hospital
Taipei, Taiwan
Proportion of patients with undetectable plasma HBV DNA load
Proportion of patients achieving undetectable plasma HBV DNA load (defined as \<128 copies/mL)
Time frame: 48 weeks
Decreases of plasma HBV DNA load
Decreases of plasma HBV DNA load (in log10 copies/mL)
Time frame: 48 weeks
Proportion of patients with plasma HIV RNA load <50 copies/mL
Proportion of patients achieving plasma HIV RNA load \<50 copies/mL
Time frame: 48 weeks
Liver function
Change of serum aspartate aminotransferase (AST) and alanine transaminase (ALT)
Time frame: 48 weeks
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
Time frame: 48 weeks
Serum creatinine
Changes of serum creatinine from baseline
Time frame: 48 weeks
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
Time frame: 48 weeks
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
Time frame: 48 weeks
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
Time frame: 48 weeks
Urine protein-creatinine ratio
Change of urine protein-creatinine ratio (UPCR) from baseline
Time frame: 48 weeks
Urine albumin-creatinine ratio
Change of urine albumin-creatinine ratio (UACR) from baseline
Time frame: 48 weeks
Urine β-2 microglobulin
Change of β-2 microglobulin from baseline
Time frame: 48 weeks
Bone disease
Change of bone mineral density
Time frame: 48 weeks
Adverse drug reaction
Number and types of adverse drug reaction related to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide
Time frame: 48 weeks
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