The National Institute for Health and Clinical Excellence has published final guidance endorsing the use of Gilead’s Viread for the treatment of chronic HBeAg-positive or HBeAg-negative hepatitis B on the National Health Service in England and Wales.

Hepatitis B is a disease caused by the hepatitis B virus (HBV), which is transmitted through blood or bodily fluids containing blood and infects the liver. Chronic forms of the condition ultimately lead to liver cirrhosis and liver cancer, which is generally very difficult to treat, and around 600,000 patients lose their lives to liver disease caused by HBV every year.

As the HBV virus has a high degree of mutability, a key goal in the management of the condition is combating the development of antiviral drug resistance and dealing with it effectively when it occurs. Therefore it is important that doctors have access to a diverse range of therapies to switch between should the virus become resistant to any of them.

In England, the prevalence of HBV infection is thought to be about 0.3% of the population, with around 6,400 new cases diagnosed every year. Currently, around 5% of patients are treated with antivirals and 13% are given interferon-alfa or peginterferon, but the vast majority - 87% - are treated with nucleoside/tide analogues.

Viread (tenofovir disoproxil) is a nucleotide analogue that blocks reverse transcriptase, the enzyme responsible for HBV replication. Clinical trials of the drug have proven its power in preventing viral replication, with 72-week data from one study presented last year showing that 91% of HBeAg-negative and 79% of HBeAg-positive patients had a circulating viral load of less than 400 copies/mL, and, importantly, were also found to be at low risk from viral resistance.

A competitive edge?
It is claimed that Viread is at least as effective as other currently recommended options for the disease, most notably its rival Baraclude (entecavir; Bristol-Myers Squibb), but that it comes with the added bonus of being cheaper, with a price tag of £255 for a 30-tablet pack compared to Baraclude’s net price of £363 per pack, which could give it a competitive edge particularly in the current economic climate.

Commenting on the guidance, NICE deputy chief executive Gillian Leng said: “One hundred times more infectious than HIV, Hepatitis B can have a serious impact on a person’s quality of life, and those with the disease are more likely to develop serious liver problems such as cirrhosis and cancer. This guidance means that patients with the virus will have another treatment option available to combat the problem of viral resistance to other drug therapies”.