TITLE: Changes of serum HBsAg levels in HBeAg-negative chronic hepatitis B patients treated with tenofovir
AUTHORS (FIRST NAME, LAST NAME): George V. Papatheodoridis1, Christos K. Triantos2, Emilia Hadziyannis1, Konstantinos Zisimopoulos2, Anastasia Georgiou1, Katerina Margariti1, Melanie Deutsch1, Vasiliki Nikolopoulou1, Spilios Manolakopoulos1
INSTITUTIONS (ALL): 1. 2nd Department of Internal Medicine, Hippokration General Hospital of Athens, Athens, Greece.
2. Department of Gastroenterology, University Hospital of Patras, Patras, Greece.
ABSTRACT BODY: Background/Aim: Serum HBsAg represents the only serological marker of chronic HBV infection in HBeAg-negative chronic hepatitis B (CHB) patients effectively treated with nucleos(t)ide analogue(s) [NA(s)] and therefore HBsAg decline may be an important predictor of on-therapy and most importantly off-treatment remission. We studied the changes of serum HBsAg levels in a cohort of patients with HBeAg-negative compensated CHB who had been treated with tenofovir disoproxil fumarate (TDF) for at least 12 months.
Methods: Until April 2013, 137 patients (M/F: 102/35, mean age: 58±16 years) who started therapy with TDF 300mg daily between 2008 and 2011 have been included. TDF has been given for a mean of 32±15 months. Of the 137 patients, 69 were naive to NAs (Group A), while 68 had been exposed to other NAs (lamivudine resistance: 59, telbivudine resistance: 6, other: 3) (Group B). TDF was given as monotherapy in group A and in combination with lamivudine, at least during the initial period, in group B patients. Stored serum samples taken before and at 6, 12, 24 and 36 months after TDF initiation were tested for serum HBsAg levels on the Architect analyzer (Abbott Labs).
Results: Before TDF, Group A and B patients had median serum levels of ALT 78 and 49 IU/L (P<0.001), HBV DNA 5.8 and 3.3 log10 IU/mL (p<0.001) and HBsAg 3.5 and 3.2 log10 IU/mL (p=0.177), respectively. Virological remission rates (HBV DNA undetectable by PCR) were 93% at 12 months and 98% beyond 12 months, without any difference between Groups A and B. Compared to before TDF, levels of HBsAg decreased by a median of 0.06, 0.12, 030 and 0.37 log10 IU/mL at 6, 12, 24 and 36 months, respectively (p0.350 for all comparisons). No decline of HBsAg levels was observed in 24%, 18% and 16% of patients at 12, 24 and 36 months of TDF therapy. Three patients cleared HBsAg, while the cumulative rates of HBsAg levels <500 IU/mL were 17%, 27% and 43% and of HBsAg levels <100 IU/mL 11%, 17% and 17% at 12, 24 and 36 months of TDF therapy.
Conclusions: In both NA(s) naive and experienced patients with HBeAg-negative CHB, TDF therapy decreases significantly serum HBsAg levels, but the rate of HBsAg decline is slow with a median of <0.5 log10 IU/mL at 36 months. However, a proportion of such patients could achieve relatively low HBsAg levels with approximately 4/10 and 1/6 of them reaching levels <500 and <100 IU/mL, respectively.
not that much decrease but definitely superior to other antivirals especially if the trend goes increasing year by year helping for the final pegintf add on:
levels of HBsAg decreased by a median of 0.06, 0.12, 030 and 0.37 log10 IU/mL at 6, 12, 24 and 36 month
yes there is variability but tenofovir has been the only one to give hbsag clearance at about 17 years of use.
it could be faster though because they based the decline on a 4 years decline study if i remember correct, all other antivirals had such a little decline over 4 years that clearance was at 30-35 for etv and no clearance for the others
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