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  • IDDF2024-ABS-0208 No resistance to tenofovir alafenamide (TAF) in adult, HBeAg-positive and HBeAg-negative participants with chronic hepatitis B infection treated with TAF for up to 8 years

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Clinical Hepatology
IDDF2024-ABS-0208 No resistance to tenofovir alafenamide (TAF) in adult, HBeAg-positive and HBeAg-negative participants with chronic hepatitis B infection treated with TAF for up to 8 years
  1. Henry Chan1,
  2. Patrick Marcellin2,
  3. Calvin Pan3,
  4. Roberto Mateo4,
  5. Tahmineh Yazdi4,
  6. Silvia Chang4,
  7. Dong Han4,
  8. Lindsey May4,
  9. Caleb Marceau4,
  10. Christopher Richards4,
  11. Savrina Manhas4,
  12. Pui Yan Ho4,
  13. Robert Li4,
  14. Simin Xu4,
  15. Clarissa Martinez4,
  16. Yang Liu4,
  17. Nadine Peinovich4,
  18. Andrew Lopez4,
  19. Frida Abramov4,
  20. John Flaherty4,
  21. Hongmei Mo4,
  22. Dr Shalimar5,
  23. Namiki Izumi6,
  24. Young-Suk Lim7,
  25. Maria Buti8
  1. 1Faculty of Medicine, The Chinese University of Hong Kong, China
  2. 2Hepatology department, Hôpital Beaujon, APHP, INSERM, University of Paris, France
  3. 3NYU Langone Health, New York University Grossman School of Medicine, USA
  4. 4Gilead Sciences, USA
  5. 5All India Institute of Medical Sciences, India
  6. 6Department of Gastroenterology and Hepatology, Japanese Red Cross Musashino Hospital, Japan
  7. 7Asan Medical Center, University of Ulsan College of Medicine, Korea, South
  8. 8Hospital Universitario Vall d’Hebron and CIBEREHD del Instituto Carlos III, Spain

Abstract

Background TAF resistance has not been detected after up to three years of treatment in CHB patients. Here, we report results from annual resistance surveillance from years 3 through 8 of TAF treatment.

Methods Two randomized, double-blind (DB), active-controlled trials to evaluate TAF treatment of hepatitis e antigen (HBeAg)-negative and HBeAg-positive participants with CHB were conducted over 8 years (384 weeks). Sequence analysis of the pol/RT region was attempted for any participant who experienced a viral breakthrough, viral blip, or persistent viremia with HBV DNA ≥69 IU/mL at annual intervals and for any participant who discontinued the study drug with HBV DNA ≥69 IU/mL. Participants that developed substitutions at conserved pol/RT sites or at polymorphic residues (if observed in ≥2 participants within the study) were also phenotyped against TAF.

Results Out of 1298 participants, the percentage of participants who qualified for resistance analysis annually from Week 144 to Week 384 remained low (range 1.7 – 8.4%). Among those qualifying for sequencing, the proportions with persistent viremia progressively declined with time, with only 3 participants being persistently viremic by Year 8. The viral load of these 3 participants at baseline was >108 log10 IU/mL and declined over time but did not reach 69 IU/mL. During the 5-year open-label period where all participants received TAF, conserved site substitutions in the HBV viral pol/RT were observed in 13 participants.

Conclusions Overall, no resistance to TAF was detected in adult CHB participants with positive or negative HBeAg who received TAF therapy for up to 8 years.

https://doi.org/10.1136/gutjnl-2024-IDDF.190

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