Zeffix, containing the active substance lamivudine, has received marketing authorization across the European Union. This antiviral medication targets chronic hepatitis B in adults, offering a vital option for those with both compensated and decompensated liver disease. The European Medicines Agency (EMA) highlighted Zeffix’s efficacy in slowing liver damage progression and reducing viral replication during its assessment.
Clinical Efficacy and Usage Guidelines
Clinical trials involving over a thousand adults demonstrated Zeffix’s superiority over placebo in mitigating liver damage, with approximately half of the patients showing biopsy-improved liver conditions compared to a quarter on placebo. For decompensated liver disease, Zeffix effectively lowered hepatitis B virus DNA and ALT levels. The recommended dosage stands at 100 mg daily, with adjustments for those with impaired kidney function. To prevent resistance, it is advised to use Zeffix in combination with another antiviral agent when necessary.
Safety Profile and Regulatory Decision
The most common side effect reported was elevated ALT levels, occurring in more than 10% of users. Despite this, the Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Zeffix outweigh the associated risks, paving the way for its approval in July 1999. Physicians are encouraged to monitor patients closely and consider alternative treatments if the hepatitis B virus persists after six months of therapy.
– Zeffix provides a critical treatment option for adults with chronic hepatitis B, especially those with resistance concerns.
– Combination therapy is essential to minimize the risk of viral resistance.
– Regular monitoring of liver enzymes and viral load is necessary to assess treatment efficacy.
Zeffix’s approval marks a significant advancement in hepatitis B management within the EU, offering a reliable treatment pathway for affected individuals. Healthcare professionals must stay informed about the latest dosage guidelines and resistance management strategies to optimize patient outcomes. As chronic hepatitis B remains a global health challenge, the availability of Zeffix enhances therapeutic options, contributing to better liver health and reduced disease progression for millions of patients.
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