Increased Uptake of Hepatitis B Drugs Expected in the Coming Years

Uptake of oral nucleoside/nucleotide analogues will increase from 2011 to 2021, according to new research from Decision Resources.

The hepatitis B virus (HBV) market will flourish in the coming years, and will be driven by the increased availability of oral drugs for the treatment of the condition, according to new research from the Decision Resources report entitled, “Niche Markets and Rare Diseases: Hepatitis B.”

The market will be driven by continued use of Bristol-Myers Squibb’s Baraclude (entecavir) and Gilead’s Viread (tenofovir) as more patients gain more access to these therapies. Benjamin Guikema, PhD, brand director of Pharmacor and Niche Markets at Decision Resources, noted that generic versions of entecavir that are set to be released in 2015 and 2016 will likely cause patients to use the cheaper versions of these drugs instead.

The anticipated launch of Bristol-Myers Squibb/ZymoGenetics’ pegylated interferon lambda-1a in 2017 is expected to “help to slow the decline spurred by the entry of generics” in this therapeutic class. “In addition to the anticipated launch of a prophylactic vaccine, Dynavax’s Heplisav, pegylated interferon lambda-1a will be the only emerging therapy for HBV over the next 10 years,” noted Dr. Guikema in a press release. “But, because of patient preference for oral therapies, we do not expect widespread uptake.”

The other drugs that could potentially compete with entecavir and viread would be Roche’s Pegasys (peginterferon alfa-2a) and Epivir (lamivudine), but the latter is used mostly outside the United States and Western countries, noted Dr. Guikema. “Aside from that, we don’t forecast any other drugs will launch for hepatitis B, mainly because the genetic barrier to resistance is very high for entecavir and tenofovir and these are very good drugs,” he said. “It’s mainly a question of getting patients access to these therapies.”

“If you look at the prescribing data in the United States, entecavir and tenofovir are the preferred therapies for patients,” Dr. Guikema added. “With the older drugs, there are problems with viral resistance, so these therapies lose efficacy.”

According to Dr. Guikema, the experts don’t foresee a lot of Breakthrough Therapies being developed in the pipeline for HBV. “One thing experts want is a drug that will clear S antigen [the gene that codes for the surface antigen HBsAg], which would provide a serologic cure for the disease and allow patients to stop getting treatment —but they were pretty skeptical that any such [Breakthrough] therapies were coming along.”