![\"Tatyana](\"https:\/\/www.healio.com\/~\/media\/images\/collections\/hepatology\/resources\/editorial-features\/take-homes-in-hcv\/kushner_tatyana_headshot_80x106.jpg?w=80\")
\n <\/div>\nThe B-Well 1 and B-Well 2 studies found that among individuals with baseline HbsAg less than or equal to 3,000 <\/span>IU\/mL, 20% and 19% achieved functional cure, respectively, as did 25% and 28% of those with baseline HBsAg less than or equal to 1,000 IU\/mL. This is the first phase 3 study to date to achieve functional cure in a significant proportion of study participants.<\/span><\/p>\n Although the phase 2b B-Clear study had previously shown that 9% to 10% of patients treated with bepirovirsen achieved functional cure in a smaller cohort, it identified a cut point of 3,000 IU\/mL of HBsAg, under which up to 25% of patients were able to achieve functional cure. This led to the development of the phase 3 program, in which only patients with HbsAg less than or equal to 3,000 <\/span>IU\/mL were included. These phase 3 results confirm that functional cure can be achieved in these individuals, but that rates are highest among those with baseline HBsAg less than or equal to 1,000 <\/span>IU per mL.<\/span><\/p>\n Notably, although bepirovirsen was well-tolerated overall, 24% of treated patients experienced flares in their ALT level of at least three times the upper limit of normal during treatment, although many of these flares were associated with declines in HbsAg. There were other adverse events reported, including injection-site reactions, renal dysfunction and hematologic abnormalities, which were monitored closely during the trial. Most of these events were not severe.<\/span><\/p>\n As such, results will hopefully contribute to potential approval of bepirovirsen for treatment of chronic HBV and a functional cure in select individuals, study authors said.<\/span><\/p>\n There are a few limitations to the study worth noting. The population included was predominantly Asian and male, and results may not be fully extrapolated to patient populations from other demographic backgrounds or genotypes of HBV infection. Most patients were HbeAg negative, and therefore HbeAg-positive patients were not as well studied, although this reflects the patient population most seen in clinical practice.<\/span><\/p>\n No patients were included that had HbsAg titers greater than 3,000 IU\/mL, and it will be unlikely that patients with higher HbsAg levels would benefit from this treatment.<\/span><\/p>\n Nonetheless, the results of this study are potentially practice changing and <\/span>\u2014 for the first time in HBV drug development history <\/span>\u2014 can potentially lead to a functional cure among many individuals living with chronic HBV.<\/span><\/p>\n Further research should evaluate predictors of response among those individuals with HBsAg less than 1,000 IU\/mL and less than 3,000 IU\/mL, as well as data on potential stopping rules for treatment of individuals who do not respond to treatment. Additionally, it will be important to understand the degree of monitoring that will be required for individuals who initiate treatment with this regimen, if approved for use in clinical practice.<\/span><\/p>\n All of this being said, these data are a historic moment in HBV history. For the first time, we can begin to tell our patients that functional cure is finally attainable.<\/span><\/p>\n Reference:<\/b><\/p>\n