Sequential HBV treatment with tenofovir alafenamide for patients with chronic hepatitis B: week 96 results from a real-world, multicenter cohort study

• Published in: Hepatology international Vol. 16; no. 2; pp. 282 - 293
• Main Authors: Ogawa, Eiichi, Nakamuta, Makoto, Koyanagi, Toshimasa, Ooho, Aritsune, Furusyo, Norihiro, Kajiwara, Eiji, Dohmen, Kazufumi, Kawano, Akira, Satoh, Takeaki, Takahashi, Kazuhiro, Azuma, Koichi, Yamashita, Nobuyuki, Yamashita, Naoki, Sugimoto, Rie, Amagase, Hiromasa, Kuniyoshi, Masami, Ichiki, Yasunori, Morita, Chie, Kato, Masaki, Shimoda, Shinji, Nomura, Hideyuki, Hayashi, Jun
• Format: Journal Article
• Language: English
• Published: New Delhi Springer India 01.04.2022; Springer Nature B.V
• Subjects: Antigens; Antiretroviral drugs; Antiviral drugs; Cohort analysis; Colorectal Surgery; Data analysis; Deoxyribonucleic acid; DNA; Epidermal growth factor receptors; Glomerular filtration rate; Hepatitis; Hepatitis B; Hepatology; Interferon; Kidney diseases; Medicine; Medicine & Public Health; Original Article; Patients; Safety; Surgery; Tenofovir; Viruses; Hepatitis B virus; Sequential therapy; Tenofovir alafenamide; Tenofovir disoproxil fumarate; Entecavir
• ISSN: 1936-0533; 1936-0541
• DOI: 10.1007/s12072-021-10295-3

Background and aims Outcome data of sequential hepatitis B virus treatment with tenofovir alafenamide (TAF) are limited. We aimed to assess the effectiveness and renal safety of TAF in chronic hepatitis B (CHB) patients who were previously treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), or a nucleos(t)ide analogue (NA) combination. Methods This multicenter, retrospective, cohort study included 458 consecutive CHB patients who switched to TAF monotherapy after at least 2 years of treatment with another NA. The longitudinal virological/laboratory responses were evaluated up to 96 weeks after switchover. Chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m 2 . Results The proportions of complete viral suppression (CVS) (HBV DNA < 20 IU/mL) at week 96 were 99.0%, 98.5%, and 98.4% in the prior ETV ( n  = 198), TDF ( n  = 137), and NA combination ( n  = 123) groups, respectively. Almost all patients with HBV DNA of 20–2000 IU/mL at baseline achieved CVS at week 96. On multivariable generalized estimated equation analysis, a low quantitative hepatitis surface antigen (qHBsAg) level at baseline was associated with a lower follow-up qHBsAg level (coefficient 0.81, p  < 0.001). The eGFR showed greater improvement in patients with CKD compared to those without (coefficient 21.7, p  < 0.001). However, the increase of eGFR reached a peak between weeks 24 and 48. Conclusions Based on this longitudinal data analysis up to 96 weeks, sequential NA therapy with a switch to TAF is a good option to achieve high viral suppression and renal safety.