From the Guidelines
The treatment for hepatitis B should prioritize the use of potent nucleos(t)ide analogues with a high barrier to resistance, such as entecavir, tenofovir disoproxil, or tenofovir alafenamide, as recommended by the most recent guidelines 1. The goal of therapy is to improve survival and quality of life by preventing disease progression and hepatocellular carcinoma (HCC) development. Key considerations for treatment include:
- HBV DNA levels ≥ 2,000 IU/ml
- Elevated ALT
- At least moderate histological lesions
- Cirrhotic patients with detectable HBV DNA should be treated
- Prevention of mother to child transmission in pregnant women with high viremia
- Prevention of HBV reactivation in patients requiring immunosuppression or chemotherapy Pegylated interferon-alfa treatment can also be considered in mild to moderate chronic hepatitis B patients, but combination therapies are not generally recommended 1. Regular monitoring of liver function and HBV DNA levels is essential to track treatment effectiveness and disease progression, as HCC remains a major concern for treated chronic hepatitis B patients 1. More recent guidelines also emphasize the importance of using antiviral therapies with high potency and a high viral resistance barrier, such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide, for the prophylaxis or treatment of HBV reactivation in patients with cancer prior to therapy 1.
From the FDA Drug Label
At Week 384, HBsAg loss and seroconversion were 11% and 8%, respectively, in subjects initially randomized to tenofovir disoproxil fumarate and 12% and 10%, respectively, in subjects initially randomized to HEPSERA Among the 328 subjects evaluated, the observed histological response rates were 80% and 88% at Week 48 and Week 240, respectively In the subjects without cirrhosis at baseline (Ishak fibrosis score 0 to 4), 92% (216/235) and 95% (223/235) had either improvement or no change in Ishak fibrosis score at Week 48 and Week 240, respectively In subjects with cirrhosis at baseline (Ishak fibrosis score 5 to 6), 97% (90/93) and 99% (92/93) had either improvement or no change in Ishak fibrosis score at Week 48 and Week 240, respectively Twenty-nine percent (27/93) and 72% (67/93) of subjects with cirrhosis at baseline experienced regression of cirrhosis by Week 48 and Week 240, respectively, with a reduction in Ishak fibrosis score of at least 2 points.
The treatment for hepatitis, specifically chronic hepatitis B, is tenofovir disoproxil fumarate.
- Key benefits of tenofovir disoproxil fumarate include:
- Histological response rates of 80% and 88% at Week 48 and Week 240, respectively
- Improvement or no change in Ishak fibrosis score in 92% and 95% of subjects without cirrhosis at baseline at Week 48 and Week 240, respectively
- Improvement or no change in Ishak fibrosis score in 97% and 99% of subjects with cirrhosis at baseline at Week 48 and Week 240, respectively
- Regression of cirrhosis in 29% and 72% of subjects with cirrhosis at baseline by Week 48 and Week 240, respectively
- Important considerations:
- Tenofovir disoproxil fumarate should be used with caution in patients with renal impairment or those at risk for osteopenia
- Patients should be monitored for signs and symptoms of inflammation from previous infections soon after anti-HIV treatment is started
- The optimal duration of treatment is unknown, and the relationship between response and long-term prevention of outcomes such as hepatocellular carcinoma is not known 2 2 2
From the Research
Treatment Options for Hepatitis
The treatment for hepatitis depends on the type of hepatitis virus. For hepatitis B, current therapy includes:
- Antiviral agents that directly act on viral replication, such as reverse transcriptase inhibitors, which are nucleoside or nucleotide analogues that can profoundly suppress HBV replication but require long-term maintenance therapy 3
- Immunomodulators, such as interferon therapy 3
- Novel compounds are being actively investigated to achieve the goal of HBV surface antigen seroclearance (functional cure) 3
Comparison of Antiviral Agents
Studies have compared the efficacy of different antiviral agents in treating hepatitis B, including:
- Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) 4
- ETV, TDF, and tenofovir alafenamide (TAF) 5 These studies found that the treatment outcomes of these antiviral agents were similar in terms of reducing the risk of hepatocellular carcinoma (HCC) development and orthotopic liver transplantation (OLT) or mortality 4, 5
Treatment for Hepatitis C
For hepatitis C, new, simpler therapeutics using direct-acting antivirals that target various stages of the HCV life cycle are in development to eradicate HCV without concomitant interferon 6 The treatment recommendations for hepatitis C include:
- Sofosbuvir + pegylated interferon + ribavirin for patients with HCV genotype 1 6
- Simeprevir + pegylated interferon + ribavirin as an alternative for patients with HCV genotype 1 6
- Sofosbuvir + ribavirin alone for patients with HCV genotypes 2 and 3 6
Future Treatment Options
Future treatment options for hepatitis B include targeted antiviral drugs against HBV (immunomodulatory therapies and gene silencing technologies) 7 Novel therapeutic options targeting HDV life cycle are currently under clinical investigation 7