Tenofovir alafenamide maintains virological control in HBV with renal, hepatic impairment
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Key takeaways:
- A high proportion of patients with chronic HBV and renal or hepatic impairment maintained viral suppression at 24 weeks after switching to tenofovir alafenamide.
- Tenofovir alafenamide was safe and well-tolerated.
Tenofovir alafenamide was safe and maintained virological response in patients with chronic hepatitis B virus infection and renal or hepatic impairment who switched from tenofovir disoproxil fumarate or other antivirals, according to data.
“Several studies have evaluated the efficacy and safety of switching from tenofovir disoproxil fumarate or entecavir to tenofovir alafenamide in virally suppressed patients with chronic hepatitis B, and results have been generally favorable,” Harry L.A. Janssen, MD, of the department of gastroenterology and hepatology at Erasmus Medical Center, and colleagues wrote in The Lancet Gastroenterology & Hepatology. “Considering these and other findings, tenofovir alafenamide is also considered a preferred treatment for patients with chronic hepatitis B who are at risk for tenofovir disoproxil fumarate-associated renal and bone toxicities.”
They continued, “Clinical data are sparse for tenofovir alafenamide use in patients with chronic hepatitis B who have more advanced renal impairment or hepatic decompensation.”
In an open-label, multicenter, phase 2 study, researchers evaluated the safety and efficacy of switching to tenofovir alafenamide among 124 adult patients with chronic HBV who were virally suppressed on nucleoside or nucleotide analogues and had renal or hepatic impairment.
In the two-part study, researchers enrolled 93 patients (mean age, 64 years; 74% men) with moderate to severe renal impairment (cohort 1, n = 78) or end-stage renal disease (cohort 2, n = 15) in part A and 31 patients (mean age, 55 years; 68% men) with hepatic impairment, including decompensation, in part B.
All patients switched to once-daily oral tenofovir alafenamide 25 mg for 96 weeks. The primary endpoint was the proportion of patients with viral suppression, defined as HBV DNA less than 20 IU/mL, at week 24. Researchers also assessed safety signals at 96 weeks.
According to results, 85% of patients completed the study. At week 24, 97.8% (95% CI, 92.4-99.7) of patients in part A achieved the primary endpoint (cohort 1, 97.4%; cohort 2, 100%), as did 100% (95% CI, 88.8-100) of patients in part B.
In addition, researchers reported a median change in estimated glomerular filtration rate of 1 mL/min in cohort 1 and –2.4 mL/min among part B participants at 96 weeks. Mean changes in spine and hip bone mineral density were 1.02% and 0.2%, respectively, for patients in part A and –0.25% and 0.28%, respectively, for those in part B.
The most common adverse event at 96 weeks was upper respiratory tract infection — observed in 15% in part A and 19% in part B. Serious adverse events were reported in 22% and 32%, respectively, although none were related to treatment. No treatment-related deaths were reported.
“When patients with chronic hepatitis B and renal or hepatic impairment switched to tenofovir alafenamide, virological response was maintained,” Janssen and colleagues wrote. “Tenofovir alafenamide was well-tolerated and renal and bone parameters either remained stable or improved.”
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