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DOI: 10.1055/s-0039-1695324
Real World Experience of Prescribing Tenofovir Alafenamide for Chronic Hepatitis B Patients in Germany
Publication History
Publication Date:
13 August 2019 (online)
Background:
Tenofovir alafenamide (TAF) was licensed in Germany for the treatment of chronic hepatitis B (CHB) patients in April 2017. Due to pricing policies for TAF in comparison to generic entecavir (ETV) and tenofovir disoproxil fumarate (TDF), TAF has been used very limited for mono-infected CHB patients in Germany so far and real life data are scarce. This study aimed to summarize the first available real-world data for TAF from 19 experienced CHB treatment centers in Germany.
Methods:
Patient data were collected retrospectively from 19 treatment centers using centralized electronic data bases. Baseline characteristics and reasons to choose TAF over ETV and TDF for naive or pretreated CHB patients were investigated.
Results:
Out of 20 CHB treatment centers, academically based and non-academic hospitals, as well as private offices, 19 centers have started treatment with TAF so far. 129 patients have been reported, 89 male and 40 female, median age 54,4 years, range 22 – 90. 120 Patients have been switched from previous NUC therapy, whereas in 9 patients TAF was started in naïve patients. There is a trend that ID physicians have enrolled more patients on TAF than hepatologists. The strongest reason to choose TAF was renal insufficiency (n = 107). Interestingly, in a considerable amount of patients, TAF was started in patients still without renal insufficiency or with borderline kidney function as a potential nephroprotection with the expectation of long-term nucleos(t)ide analogue (NUC) therapy. Another reason to start TAF included bone disease such as osteoporosis, chronic use of prednisolone or history of fragility fractures (n = 24). Renal insufficiency and bone disease were the two factors most often addressed in combination. Other reasons included incomplete viral suppression with ETV or TDF (n = 12), or other comorbidities (n = 21), while drug – resistance was not a reason to start using TAF.
Conclusion:
Most patients were switched to TAF from ETV or TDF. The main reason to choose TAF in pretreated or naive patients was an already existing renal insufficiency or the expectation of inducing renal insufficiency with other NUCs or multi-drug interactions during long-term antiviral therapy, in accordance with national and international guidelines.
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