From the Guidelines
Tenofovir can be taken for an indefinite period in patients with chronic hepatitis B, especially those with cirrhosis, as it significantly reduces the risk of disease progression and complications. The duration of treatment depends on specific treatment goals, such as HBeAg seroconversion in HBeAg-positive patients or sustained viral suppression in HBeAg-negative patients, as seen in studies such as 1. Typically, treatment continues for at least 1 year after achieving these goals before considering discontinuation.
Key Considerations
- For patients with cirrhosis, tenofovir is usually continued indefinitely to prevent disease progression and complications, as recommended by current guidelines 1.
- For patients without cirrhosis, guidelines recommend continuation of NA until 1 year after confirmed HBeAg seroconversion for patients who were HBeAg-positive and until HBsAg loss for patients who were HBeAg-negative at the start of treatment, as noted in 1.
- Regular monitoring is essential during long-term treatment, including kidney function tests every 3-6 months, as tenofovir can cause renal toxicity in some patients, and bone density monitoring may also be recommended since long-term use can affect bone mineral density.
Treatment Outcomes
- Continued treatment with tenofovir for 10 years resulted in HBeAg seroconversion in 27.3% and HBsAg loss in 4.9% of HBeAg-positive and in 3.4% of HBeAg-negative patients, as reported in 1.
- Tenofovir has a high barrier to resistance, making it suitable for extended treatment periods without significant concerns about viral resistance developing, which is a key consideration in the management of chronic hepatitis B, as discussed in 1.
Clinical Decision-Making
- The decision to continue or stop therapy should always be made in consultation with a hepatologist or infectious disease specialist based on individual patient factors, including the presence of cirrhosis, treatment goals, and potential side effects, as emphasized in 1.
From the Research
Duration of Tenofovir Treatment for Hepatitis B
- The duration of tenofovir treatment for hepatitis B can vary, but studies have shown that it can be effective for up to 10 years 2, 3.
- A study published in 2015 found that long-term tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB) was associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5, with no TDF resistance through 6 years 2.
- Another study published in 2019 found that TDF treatment for up to 10 years was associated with continued maintenance of virological suppression, with no documented resistance 3.
- The efficacy and safety of tenofovir compared to entecavir in the treatment of chronic hepatitis B and HBV-related cirrhosis have also been studied, with results showing that tenofovir has a better efficacy than entecavir in the short-term treatment duration, but no significant difference in the long-term treatment duration 4.
Long-term Efficacy and Safety
- The long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues has been demonstrated, with a cumulative proportion of patients achieving HBV DNA levels <400 copies/mL of 79% after a mean treatment duration of 23 months 5.
- A prospective study published in 2018 found that effective ≥4-year entecavir or tenofovir disoproxil fumarate (TDF) therapy can be safely discontinued in non-cirrhotic HBeAg-negative CHB patients, with a cumulative probability of retreatment of 18% and 26% at 3 and 12 months, respectively 6.
Key Findings
- Tenofovir treatment can be effective for up to 10 years in patients with chronic hepatitis B.
- Long-term tenofovir treatment is associated with sustained viral suppression and regression of fibrosis and cirrhosis.
- Tenofovir has a better efficacy than entecavir in the short-term treatment duration, but no significant difference in the long-term treatment duration.
- The long-term efficacy and safety of tenofovir monotherapy have been demonstrated in patients with prior failure of nucleoside/nucleotide analogues.