China has the greatest burden of hepatitis B and liver cancer in the world. In 2014 chronic hepatitis B virus (HBV) infection affected nearly 89.8 million people in China; we expect the total number of HBV prevalent cases will decline to approximately 86.7 million in 2019. The nationwide vaccination against HBV in infants and the stringent administration and monitoring of blood products have been successful in the control of chronic HBV infection; however, only a small percentage of carriers are diagnosed and treated. As patients with HBV infection are treated with long-term, disease-modifying therapies, the increasing rate of diagnosis and/or treatment for HBV will lead to a significant expansion of the drug-treated population.
In China, nucleoside/nucleotide analogues (NAs) are most commonly prescribed for HBV infection due to the convenience of oral formulations and good safety profiles. Lamivudine (GlaxoSmithKline’s Heptodin) and entecavir (Bristol-Myers Squibb’s Baraclude) are the leading brands in the HBV therapeutic market. Inclusion of conventional and pegylated interferons (PEG-IFN) and NAs into the national reimbursement list have increased the availability of anti-HBV therapies, thereby further decreasing the morbidity and mortality associated with chronic HBV infection. However, affordability still remains a market access barrier to premium-priced HBV treatments. Emerging therapies, such as Valeant Pharmaceuticals International pradefovir and Zymogenetics/Bristol-Myers Squibb’s PEG-IFN-lambda, must properly address the government and patients’ ability to pay for HBV treatments, in addition to the ongoing cost-containment policies in China in their launch strategy in order to optimize brand uptake in this market.