Hepatitis is defined as the inflammation of the liver due to an infection by a virus or other causative organism or toxin. Hepatitis C on the other hand, is primarily as a result of the infection by hepatitis C virus (HCV). With a cure rate between 50%-80%, and no commercially available vaccine as of yet, hepatitis C is considered a deadly disease with a moderate to high infection rate. It is the leading cause for liver transplantation in the U.K and North America.
The transmission of this virus in a majority occurs from injectables drug abuse, as the virus can only be transmitted via blood-to-blood contact. The secondary transmission factors include tattooing, sexual contact, healthcare (blood transfusion, organ transplant) mishaps, and other rare unknown cases. HIV infected individuals and AIDS patients too are at a higher risk of infection. The diagnosis of Hepatitis C is also very tricky as there lays a risk of misdiagnosis as the virus can go undetected in a liver biopsy sample. Liver enzyme levels may remain normal for an infected person for years, in some cases an infected person may go as long as 30 years without showing any symptoms of infection.
PCR amplification of purified and centrifuged biopsy samples done at specified time intervals are the best proven method for near accurate diagnosis.
This process is done so as to remove any errors caused as a result of false negatives by antibody immunoassay testing. However since PCR testing is quite expensive, initial screening is usually done via immunoassay method, in addition, immunoassay also determines the viral load and thereby help identify the stage of infection between acute and chronic. The acute stage of disease can generally be cured in majority of the cases, in some cases spontaneous curing has also been observed. Complete cure rate cannot be a possibility as Hepatitis C virus has various strains and is found to be mutative in nature. Chronic cases are seen in a majority of infected individuals and are also curable in some cases, but again among the majority, liver cirrhosis is observed, which may then require liver transplantation. Transplantation requires to be done with continuous medication, as chances of reinfection are very high. Therapy for Hepatitis C is not definitive but is generally done with a combination of medicines, namely pegylated-interferon-alpha and ribavirin, which is an antiviral. Other medications include boceprevir, ledipasvir, telaprevir, sofosbuvir and the novel simeprevir and sovaldi. These are either given as an addition to ribavirin or as a replacement, depending upon the condition, contraindication, genotype of virus and patient history.
At present the cost of the antiviral and interferon market remains the biggest hurdle for the proliferation of Hepatitis C therapeutics market. The prices vary from few hundred dollars to hundreds of thousands of dollars for a single dose. Insurances companies generally do not cover the complete cost of drugs in standard covers, often individuals who have very high premium are the only ones able to afford the treatment. The ongoing research into vaccination may also provide as a restraint in the future, as preventive vaccination has always shown greater success versus therapeutics.
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The market for Hepatitis C therapeutics remains in billions, with new combinations being patented every year, and each having their own market segment. They are at present one of the most sought after investment segment in the healthcare drugs industry. With entry of Asian players the prices too are bound to decrease, thereby potentially increasing therapeutics market. The North American market is the highest market by volume, followed by Europe, as in these regions reported cases are high in number, and so is the affordability of drugs.
The major cause for Hepatitis C transmission in developed nations is intravenous narcotic/psychedelic drug abuse, which is common in these regions. In developing markets of Asia and South America, the leading cause for transmission is healthcare exposure and their poor standards. This along with their population size make for a large market, however unavailability of affordable drugs is often the reason why markets haven’t been proliferated as of yet. However the recent growth of market in Asia Pacific is a positive sign for potential manufacturers. The rest of the world also follows a similar pattern.