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An increasing incidence of HIV/HBV co-infection calls for more effective treatment According to recent research the rate of hepatitis B co-infection in HIV infected individuals is increasing among the seven major markets. Although the advent of Highly Active Antiretroviral Therapy has led to increased longevity in those infected with HIV, this has consequently led to an increasing prevalence of chronic co-infections such as hepatitis B and hepatitis C. Although HBV has little impact on HIV disease progression, HIV renders HBV more aggressive and frequent, with co-infected individuals eight times more likely to die of liver damage-related mortality. The inadequate diagnosis of concurrent disease states, lack of effective HBV treatment and Highly Active Antiretroviral Therapy (HAART) hepatoxicity all have a great impact on the effective management of this niche population. The growing incidence of this co-infection has left an opportunity for companies to develop HBV antivirals, preferably with dual HIV and HBV efficacy that could address the gap in treating this co-morbid population. A two-pronged approachHBV co-infection acts as an additional economic burden to an already expensive HIV HAART regimen (approximately $10,000 per patient in the US). It is therefore more cost-effective to vaccinate the HIV/HBV co-infected population, rather than manage HBV infection with expensive antiviral and immunomodulator therapies. Although HBV vaccines have reduced efficacy in HIV-infected patients, they could still diminish co-infection prevalence. Datamonitor believes various other strategies should also be used to treat this niche population. The majority of those co-infected with HIV/HBV, i.e. HIV-infected high-risk groups such as intravenous drug users (IVDUs), should be further targeted for diagnosis, vaccination and treatment to minimize infection. This could also be extended to new immigrants in Western regions. Although immigration of HBV infected individuals from endemic countries was thought to have little impact on the general population, it is likely to affect those same high-risk groups. Western markets, such as the UK, with a high degree of immigration from sub-Saharan Africa should therefore reconsider their HBV vaccination guidelines. They should also be aware of the 'relapse' in the male homosexual population with regard to the transmission of parenteral viruses, although this is thought to be relatively rare for HBV. Developing HBV therapeuticsThe main aim of HBV mono and co-infection treatment is the suppression of viral replication, improving liver histology, and the prevention of hepatocellular carcinoma. Ultimately the goal is to achieve complete clearance or eradication of the HBV virus and induce an antibody specific immune response. Currently marketed HBV antivirals only achieve seroconversion in approximately 10% of the HBV mono-infected population and this figure will be significantly lower for the co-morbid populace. In response to this need, a number of companies including Gilead and Idenix/Novartis have recognized an emerging market for increased HBV potency but more importantly, agents capable of seamless integration with HAART regimes. This dynamic is driven further by the current unsuitability of immunomodulators and the increased product saturation of the HIV mono-infected market. The dual targeting ability of many existing HIV therapeutics such as Gilead's Viread and Emtriva provide opportunities for product lifecycle management with potential tailoring for the treatment of both HBV mono and co-infection. This strategy has been employed successfully for GlaxoSmithKline's Epivir and may be extended to MIV-310, a dual-spectrum antiviral announced as part of a recent agreement with Medivir and Boehringer Ingleheim. Idenix/Novartis are taking a different approach, focusing on the mass-HBV mono-infected population with potent developmental agents such as Telbuvidine. Aside from mono-infection, manufacturers should be increasingly aware of the co-morbid population's specific needs and that well-defined clinical studies on these groups could provide them with a competitive advantage outside mono-infected populations. A novel HBV antiviralIn conjunction with potential commercial support and advocacy of HBV vaccination, Datamonitor believes that with the advent of newer more potent HBV therapeutic agents, targeting countries where HBV is endemic could be profitable with the preparation of a vaccine-like high volume/low cost model. A large-scale production of an efficacious antiviral with eradication rates of 25-50% provided at low cost via collaborations with organizations such as the World Health Organization (WHO) could achieve this goal. "Changing HIV and HBV epidemiology through migration, a current lack of potent HBV therapeutics and early resistance development provides opportunity for those manufacturers possessing dual HBV/HIV antivirals," comments John Savopolous, lead Datamonitor healthcare analyst. "A novel potent HBV antiviral distributed at low cost and high volume may solve the problem of hepatitis B in the developing world faster than current vaccination programs. Such a model could be profitable for firms such as Novartis/Idenix and Gilead raising their profile considerably." Related research:
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