Long-term trajectories of hepatic and metabolic biomarkers after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral therapy-experienced people with HIV with and without hepatic coinfection: Data from the ICONA cohort
•Hepatic injury markers declined over 2 years after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV.•Reduction was stronger in patients with hepatitis B surface antigen+ and those with baseline chronic enzyme elevation.•Lipid parameters increased mainly in th...
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| Vydáno v: | International journal of infectious diseases Ročník 161; s. 108081 |
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| Hlavní autoři: | , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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Canada
Elsevier Ltd
01.12.2025
Elsevier |
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| ISSN: | 1201-9712, 1878-3511 |
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| Abstract | •Hepatic injury markers declined over 2 years after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV.•Reduction was stronger in patients with hepatitis B surface antigen+ and those with baseline chronic enzyme elevation.•Lipid parameters increased mainly in the first 6 months post-switch, then stabilized.•No significant lipid profile differences were reported by hepatitis B virus/hepatitis C virus coinfection status.•Except for low-density lipoprotein, hepatic/metabolic biomarker changes stayed normal, with limited clinical impact.
Long-term effects of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on hepatic, renal, and metabolic parameters remain poorly characterized, especially in people with HIV (PWH) and hepatitis B virus coinfection.
We analyzed 24-month trajectories before and after the switch to TDF/TAF in antiretroviral therapy-experienced, virologically suppressed participants from the ICONA cohort, excluding those who started antiviral treatment or had detectable hepatitis C virus-RNA during the study period. Mean values at 18 (T–18) and 6 months (T–6) pre-switch, at switch, and 6, 12, and 24 months post-switch (T+6, T+12, T+24) were assessed using adjusted mixed linear models.
At 6 months, alanine aminotransferase (ALT) decreased modestly by –3.05 (–6.42, 0.31) U/l, remaining stable at T+24; similar toother liver damage markers. In participants with chronic liver enzyme elevation, ALT reductions were more marked (–20.5 to –22.6 U/l from T+6 to T+24). Total cholesterol, low-density lipoprotein cholesterol (LDL-Chol), and triglycerides increased by 14.46, 10.70, and 11.56 mg/dl, respectively, at T+6, and then stabilized thereafter. PWH with baseline LDL-Chol <100 mg/dl showed larger LDL increases. Compared with HIV-monoinfected individuals, hepatitis B surface antigen+ individuals had higher ALT and lower estimated glomerular filtration rate on TDF; differences attenuated after switching to TAF (P <0.001 and P = 0.002). No lipid trajectory differences emerged by coinfection status.
Greater hepatic improvement was noticed after TDF-to-TAF switch in PWH with hepatitis B virus coinfection, with no differences in lipid increases compared with monoinfected patients. |
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| AbstractList | •Hepatic injury markers declined over 2 years after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV.•Reduction was stronger in patients with hepatitis B surface antigen+ and those with baseline chronic enzyme elevation.•Lipid parameters increased mainly in the first 6 months post-switch, then stabilized.•No significant lipid profile differences were reported by hepatitis B virus/hepatitis C virus coinfection status.•Except for low-density lipoprotein, hepatic/metabolic biomarker changes stayed normal, with limited clinical impact.
Long-term effects of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on hepatic, renal, and metabolic parameters remain poorly characterized, especially in people with HIV (PWH) and hepatitis B virus coinfection.
We analyzed 24-month trajectories before and after the switch to TDF/TAF in antiretroviral therapy-experienced, virologically suppressed participants from the ICONA cohort, excluding those who started antiviral treatment or had detectable hepatitis C virus-RNA during the study period. Mean values at 18 (T–18) and 6 months (T–6) pre-switch, at switch, and 6, 12, and 24 months post-switch (T+6, T+12, T+24) were assessed using adjusted mixed linear models.
At 6 months, alanine aminotransferase (ALT) decreased modestly by –3.05 (–6.42, 0.31) U/l, remaining stable at T+24; similar toother liver damage markers. In participants with chronic liver enzyme elevation, ALT reductions were more marked (–20.5 to –22.6 U/l from T+6 to T+24). Total cholesterol, low-density lipoprotein cholesterol (LDL-Chol), and triglycerides increased by 14.46, 10.70, and 11.56 mg/dl, respectively, at T+6, and then stabilized thereafter. PWH with baseline LDL-Chol <100 mg/dl showed larger LDL increases. Compared with HIV-monoinfected individuals, hepatitis B surface antigen+ individuals had higher ALT and lower estimated glomerular filtration rate on TDF; differences attenuated after switching to TAF (P <0.001 and P = 0.002). No lipid trajectory differences emerged by coinfection status.
Greater hepatic improvement was noticed after TDF-to-TAF switch in PWH with hepatitis B virus coinfection, with no differences in lipid increases compared with monoinfected patients. Long-term effects of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on hepatic, renal, and metabolic parameters remain poorly characterized, especially in people with HIV (PWH) and hepatitis B virus coinfection. We analyzed 24-month trajectories before and after the switch to TDF/TAF in antiretroviral therapy-experienced, virologically suppressed participants from the ICONA cohort, excluding those who started antiviral treatment or had detectable hepatitis C virus-RNA during the study period. Mean values at 18 (T ) and 6 months (T ) pre-switch, at switch, and 6, 12, and 24 months post-switch (T , T , T ) were assessed using adjusted mixed linear models. At 6 months, alanine aminotransferase (ALT) decreased modestly by -3.05 (-6.42, 0.31) U/l, remaining stable at T ; similar toother liver damage markers. In participants with chronic liver enzyme elevation, ALT reductions were more marked (-20.5 to -22.6 U/l from T to T ). Total cholesterol, low-density lipoprotein cholesterol (LDL-Chol), and triglycerides increased by 14.46, 10.70, and 11.56 mg/dl, respectively, at T , and then stabilized thereafter. PWH with baseline LDL-Chol <100 mg/dl showed larger LDL increases. Compared with HIV-monoinfected individuals, hepatitis B surface antigen+ individuals had higher ALT and lower estimated glomerular filtration rate on TDF; differences attenuated after switching to TAF (P <0.001 and P = 0.002). No lipid trajectory differences emerged by coinfection status. Greater hepatic improvement was noticed after TDF-to-TAF switch in PWH with hepatitis B virus coinfection, with no differences in lipid increases compared with monoinfected patients. Highlights•Hepatic injury markers declined over 2 years after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV. •Reduction was stronger in patients with hepatitis B surface antigen+ and those with baseline chronic enzyme elevation. •Lipid parameters increased mainly in the first 6 months post-switch, then stabilized. •No significant lipid profile differences were reported by hepatitis B virus/hepatitis C virus coinfection status. •Except for low-density lipoprotein, hepatic/metabolic biomarker changes stayed normal, with limited clinical impact. Objectives: Long-term effects of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on hepatic, renal, and metabolic parameters remain poorly characterized, especially in people with HIV (PWH) and hepatitis B virus coinfection. Methods: We analyzed 24-month trajectories before and after the switch to TDF/TAF in antiretroviral therapy-experienced, virologically suppressed participants from the ICONA cohort, excluding those who started antiviral treatment or had detectable hepatitis C virus-RNA during the study period. Mean values at 18 (T–18) and 6 months (T–6) pre-switch, at switch, and 6, 12, and 24 months post-switch (T+6, T+12, T+24) were assessed using adjusted mixed linear models. Results: At 6 months, alanine aminotransferase (ALT) decreased modestly by –3.05 (–6.42, 0.31) U/l, remaining stable at T+24; similar toother liver damage markers. In participants with chronic liver enzyme elevation, ALT reductions were more marked (–20.5 to –22.6 U/l from T+6 to T+24). Total cholesterol, low-density lipoprotein cholesterol (LDL-Chol), and triglycerides increased by 14.46, 10.70, and 11.56 mg/dl, respectively, at T+6, and then stabilized thereafter. PWH with baseline LDL-Chol <100 mg/dl showed larger LDL increases. Compared with HIV-monoinfected individuals, hepatitis B surface antigen+ individuals had higher ALT and lower estimated glomerular filtration rate on TDF; differences attenuated after switching to TAF (P <0.001 and P = 0.002). No lipid trajectory differences emerged by coinfection status. Conclusions: Greater hepatic improvement was noticed after TDF-to-TAF switch in PWH with hepatitis B virus coinfection, with no differences in lipid increases compared with monoinfected patients. |
| ArticleNumber | 108081 |
| Author | Mazzotta, Valentina Gazzola, Lidia Squillace, Nicola Caputo, Sergio Lo Cozzi-Lepri, Alessandro Saracino, Annalisa Poliseno, Mariacristina Gagliardini, Roberta Tavelli, Alessandro d’Arminio Monforte, Antonella Puoti, Massimo Santantonio, Teresa Antonia Antinori, Adndrea |
| Author_xml | – sequence: 1 givenname: Mariacristina orcidid: 0000-0002-9896-489X surname: Poliseno fullname: Poliseno, Mariacristina email: polisenomc@gmail.com organization: Clinic of Infectious Diseases, Dep artment of Precision Medicine and Jonian Area (DiMePre-J), University of Bari “Aldo Moro”, Bari, Italy – sequence: 2 givenname: Sergio Lo surname: Caputo fullname: Caputo, Sergio Lo organization: Unit of Infectious Diseases, University of Foggia, Foggia, Italy – sequence: 3 givenname: Alessandro surname: Tavelli fullname: Tavelli, Alessandro organization: ICONA Foundation, Milan, Italy – sequence: 4 givenname: Roberta surname: Gagliardini fullname: Gagliardini, Roberta organization: National Institute for Infectious Diseases “L. Spallanzani", IRCCS, Rome, Italy – sequence: 5 givenname: Lidia surname: Gazzola fullname: Gazzola, Lidia organization: Clinic of Infectious Diseases, San Paolo Hospital, ASST Santi Paolo e Carlo, Italy – sequence: 6 givenname: Annalisa surname: Saracino fullname: Saracino, Annalisa organization: Clinic of Infectious Diseases, Dep artment of Precision Medicine and Jonian Area (DiMePre-J), University of Bari “Aldo Moro”, Bari, Italy – sequence: 7 givenname: Teresa Antonia surname: Santantonio fullname: Santantonio, Teresa Antonia organization: Unit of Infectious Diseases, University of Foggia, Foggia, Italy – sequence: 8 givenname: Nicola surname: Squillace fullname: Squillace, Nicola organization: Infectious Disease Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy – sequence: 9 givenname: Massimo surname: Puoti fullname: Puoti, Massimo organization: Division of Infectious Diseases, Department of Medicine, ASST Grande Ospedale MetropolitanoNiguarda, University of Milan Bicocca, Milan, Italy – sequence: 10 givenname: Valentina surname: Mazzotta fullname: Mazzotta, Valentina organization: National Institute for Infectious Diseases “L. Spallanzani", IRCCS, Rome, Italy – sequence: 11 givenname: Adndrea surname: Antinori fullname: Antinori, Adndrea organization: National Institute for Infectious Diseases “L. Spallanzani", IRCCS, Rome, Italy – sequence: 12 givenname: Antonella surname: d’Arminio Monforte fullname: d’Arminio Monforte, Antonella organization: ICONA Foundation, Milan, Italy – sequence: 13 givenname: Alessandro surname: Cozzi-Lepri fullname: Cozzi-Lepri, Alessandro organization: Institute for Global Health, UCL, University College London, London, UK |
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| Keywords | ALT HIV/HBV coinfection Tenofovir alafenamide Tenofovir disoproxil fumarate Cholesterol |
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| Snippet | •Hepatic injury markers declined over 2 years after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV.•Reduction was... Highlights•Hepatic injury markers declined over 2 years after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV.... Long-term effects of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on hepatic, renal, and metabolic parameters remain... Objectives: Long-term effects of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on hepatic, renal, and metabolic parameters... |
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| SubjectTerms | Adenine - analogs & derivatives Adenine - therapeutic use Adult Alanine Alanine Transaminase - blood ALT Anti-HIV Agents - therapeutic use Biomarkers - blood Cholesterol Cohort Studies Coinfection - drug therapy Drug Substitution Female Hepatitis B - complications Hepatitis B - drug therapy HIV Infections - complications HIV Infections - drug therapy HIV Infections - metabolism HIV/HBV coinfection Humans Infectious Disease Liver - drug effects Liver - metabolism Male Middle Aged Pulmonary/Respiratory Tenofovir - analogs & derivatives Tenofovir - therapeutic use Tenofovir alafenamide Tenofovir disoproxil fumarate |
| Title | Long-term trajectories of hepatic and metabolic biomarkers after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral therapy-experienced people with HIV with and without hepatic coinfection: Data from the ICONA cohort |
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