NICE opens door to Gilead’s Viread for Hepatitis B

The National Health Service’s cost watchdog has granted patients with hepatitis B routine access to Gilead’s HIV drug Viread in England and Wales.

The National Institute for Health and Clinical Excellence has this morning published a Final Appraisal Determination recommending the drug as an option for patients with chronic HBeAg-positive or HBeAg-negative hepatitis B who are eligible for antiviral treatment.

Liver disease due to chronic hepatitis B virus infection claims around 600,000 lives around the globe every year, and it is hoped that new treatments will help to prevent the liver inflammation in patients that ultimately leads to cirrhosis or cancer.

Viread (tenofovir disoproxil) is a nucleotide analogue that works by blocking reverse transcriptase, the enzyme responsible for hepatitis B virus (HBV) replication. Clinical trials of the drug have clearly demonstrated its ability to prevent viral replication, with 72-week data presented last year showing that 91% of HBeAg-negative and 79% of HBeAg-positive patients had a viral load in the blood of less than 400 copies/mL, as well as a low risk of viral resistance.

Explaining the rationale behind its decision to endorse the treatment on the NHS, NICE said that its Expert Review Group recognised the importance of having a diverse range of therapies available to help address the problem of viral resistance, particularly as HBV has a high-degree of mutability.

Effective and cheaper
In addition, it noted that Viread is at least as effective as other currently recommended options for the disease, notably Bristol-Myers Squibb's Baraclude (entecavir), and that, at £255 for a 30-tablet pack, it has a lower price tag than Baraclude’s net price of £363 per pack. Furthermore, the drug seems to be well tolerated with few side-effects reported by patients.

Therefore, NICE’s committee concluded that Viread is a cost-effective use of NHS resources for the treatment of HBeAg positive and HBeAg-negative chronic hepatitis B, and consequently primary care trusts now have three months to ensure that funding is in place for the drug.