Ledipasvir/sofosbuvir with the trade name of Harvoni is a medication approved for the treatment of patients with chronic hepatitis C genotype 1 infection.
This medicine is a combination of two drugs: Ledipasvir and Sofosbuvir inside (co-formulated) into one tablet. It is the first approved medicine that does not require administration with interferon or ribavirin.
Harvoni price for oral pellet (33.75 mg-150 mg) is around $32,896 for a supply of 28 pellets, depending on the pharmacy you visit.
In 2014: The FDA approved Harvoni for the treatment of chronic hepatitis C genotype 1 infection. This approval was based on three-phase III trials in 1,518 subjects with genotype 1 chronic hepatitis C with the compensated liver disease.
In March 2014: European Medicines Agency (EMA) submitted the marketing authorization application (MAA) for Harvoni. Following an accelerated review procedure in September 2014, the Committee for Medicinal Products for Human Use (CHMP) of the EMA, gave a positive response to this medication.
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This medication is indicated for the treatment of
- HCV genotypes 1, 4, 5, and 6, with or without Ribavirin depending on the level of liver damage or cirrhosis.
- HCV in patients co-infected with HIV.
Chronic Hepatitis C is a disease of the liver that is caused by the Hepatitis C Virus (HCV). HCV is a very tiny germ that makes copies of itself to survive during the replication process. This single-stranded RNA virus has at least six different strains known as genotypes. Genotype 1 is the most common genotype in the United States that affects 72% of all chronic HCV patients.
Since 2011, with the development of Direct-Acting Antivirals (DAAs) like Ledipasvir, treatment options for chronic Hepatitis C have advanced significantly.
DAAs medications directly interfere with the replication process and block the ability of the hepatitis C virus to make copies of itself. Harvoni is a combination of two DAAs: Sofosbuvir and Ledipasvir.
Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase and interferes with the reproduction of the virus’s genetic material, stopping the production of new Hep C. Ledipasvir is an NS5A inhibitor and works by interfering with a protein needed to complete the Hep C virus life cycle in the liver cell.
Ledipasvir/sofosbuvir was approved for medical use in the United States in 2014. The most effective and safe medicines needed in a health system are listed on the World Health Organization’s List of Essential Medicines; Harvoni is one of these medicines.
In 2016, The wholesale cost in the United States is about US$91,589.40 for 12 weeks and in Bangladesh, this amount costs US$1,092.00; Drugs used for the treatment of the disease from the Hepatitis C treatment market.
by the end of 2015, the value of the global hepatitis C treatment market is projected to be US$ 23.9 Bn and is further expected to reach US$ 71.13 Bn by the end of 2024, registering a CAGR of 13.1% over the forecast period of 2016-2024.
Developing countries such as India, China, and Brazil compared to other developed countries have a large patient pool. So the demand for hepatitis C treatment drugs will be increased in these countries.
Few countries and state governments have tried to control hepatitis C infection by subsidizing drugs or by giving special funds towards disease treatment programs and various private NGOs create awareness and teach the population to fight against the hepatitis C infection. So they drive the Hepatitis C treatment market.
Hepatitis C infection is prevailing at the global level because of sharing needles, unsterilized medical equipment, and a blood transfusion from an infected mother to a newborn baby. Some companies are trying to develop various hepatitis C treatment medications. So that new products will be developed which ultimately drives the market.
In 2015 and 2016, the highest market shares of the global hepatitis C treatment devoted to the:
- The combination therapy segment with 66.2% share according to the drug class,
- The hospital pharmacies segment with 42.8% share according to the distribution channel.
It should also be mentioned that the retail pharmacies segment is estimated to account for 34.2% market share in 2016.
Harvoni is the top-selling drug in Gilead Sciences (GILD) portfolio. The below chart shows revenues for the drug Harvoni over the last few quarters. Harvoni contributed ~21% of Gilead’s total revenues in 2Q17.
Revenues and Pharmaceutical Companies
According to the report of Harvoni, the revenue of $1.4 billion during 2Q17 has shown a 46% decline in revenues as compared to $2.6 billion during 2Q16.
This decline was driven by competition from other drugs due to the patent expiry of Harvoni. Sales by Harvoni sellers in the USA were $984 million during 2Q17, while for European markets they were $230 million, and for the rest of the world, sales were $168 million.
The largest market for hepatitis C treatment was North America that accounting for over 45.6% revenue share of the overall market in 2015, followed by Europe with around 19.4% share. Then there is the Asia Pacific market that will show a strong increase (2016–2024), followed by Latin America.
Key pharmaceutical companies as named-patient drug suppliers in the global hepatitis C treatment market are AbbVie Inc., Bristol-Myers Squibb Company, F Hoffmann-La Roche Ltd, Gilead Sciences, Inc., Johnson & Johnson, Kadmon Holdings, Inc., and Merck & Co., Inc.
The market is also consolidated with a few key players; In this market, Gilead Sciences, Inc. as the main Harvoni seller contributes around 80.1% of the market share, generating the majority of the revenue from the sales of drugs Harvoni and Sovaldi followed by Bristol-Myers Squibb Company and AbbVie Inc.