Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care
Nucleos(t)ide analogues
10 evidence topics · 7 sources
Preferred agents and selection criteria: AASLD/IDSA 2025 guideline
Treatment goals and indications: AASLD/IDSA 2025 guideline
Preferred initial therapy: AASLD 2018 guidance
“The AASLD recommends antiviral therapy for adults with immune-active CHB (HBeAg negative or HBeAg positive) to decrease the risk of liver-related complications” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“The AASLD recommends peg-IFN, entecavir, or tenofovir (TDF) as preferred initial therapy for adults with immune-active CHB” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“TAF is also a preferred initial therapy for adults with immune-active CHB.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“Consider TAF or entecavir in patients with or at risk for renal dysfunction or bone disease.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“However, in recommending peg-IFN, tenofovir, and entecavir as preferred therapies, the most important factor considered was the lack resistance with long-term use.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
First-line nucleos(t)ide analogue therapy: EASL 2025 guideline
Preferred regimens: WHO 2024 guideline
Efficacy in HBeAg-negative immune-active chronic hepatitis B: pivotal trial summary
| Outcome (HBeAg-negative, treatment-naive adults) | Peginterferon | Entecavir | Tenofovir disoproxil fumarate | Tenofovir alafenamide |
|---|---|---|---|---|
| % HBV DNA suppression | “19 (<80 IU/mL)”View highlighted excerpt for this quote | “90–91 (<50–60 IU/mL)”View highlighted excerpt for this quote | “93 (<60 U/mL)”View highlighted excerpt for this quote | “90 (<29 IU/mL)”View highlighted excerpt for this quote |
| % Normalization ALT | “59”View highlighted excerpt for this quote | “78–88”View highlighted excerpt for this quote | “76”View highlighted excerpt for this quote | “81”View highlighted excerpt for this quote |
| % HBsAg loss | “4”View highlighted excerpt for this quote | “0–1”View highlighted excerpt for this quote | “0”View highlighted excerpt for this quote | “<1”View highlighted excerpt for this quote |
HBsAg seroclearance rate in untreated and treated cohorts: meta-analysis
“We analyzed 34 published studies (with 42,588 patients, 303,754 person-years of follow-up, and 3194 HBsAg seroclearance events), including additional and updated aggregated data from 19 studies. The pooled annual rate of HBsAg seroclearance was 1.02% (95% CI, 0.79-1.27). Cumulative incidence rates were 4.03% at 5 years (95% CI, 2.49-5.93), 8.16% at 10 years (95% CI, 5.24-11.72), and 17.99% at 15 years (95% CI, 6.18-23.24).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“HBsAg seroclearance was not associated with HBV genotype or treatment history.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“Patients with chronic HBV infection should therefore be counseled on the need for lifelong treatment, and curative therapies are needed.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
Long-term tenofovir alafenamide: 8-year suppression and HBsAg loss
“By year 8, 2%–3% of patients had achieved HBsAg loss with or without seroconversion (Table 2; Tables S1 and S2).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“Conversely, rates of HBsAg loss and seroconversion were low at 2%–3%, and quantitative HBsAg titres declined minimally over 8 years.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“No patients developed resistance to TAF.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
Long-term outcomes on entecavir or tenofovir: PAGE-B cohort beyond 10 years
“The long-term PAGE-B cohort included 1,644 Caucasian patients with CHB treated with entecavir or tenofovir.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“The 10- and 15-year cumulative incidences of HBsAg loss on NA(s) were 8.3% and 14.3%, respectively; the IR of HBsAg loss increased from 0.94 before year 10 to 1.42/100 PYs after year 10 (p = 0.025).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“NA therapy was discontinued in 125 (7.6%) patients who remained HBsAg positive.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote