Anti-Viral, Drugs

Co-formulation of Ledipasvir and Sofosbuvir in one tablet: Harvoni

Harvoni tablets 400 mg


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. Some patients travel to India because Harvoni cost is lower in India. Fatigue is one of the most common harvoni side effects.

Approval  of Harvoni

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.

Medical use

This medication is indicated for the treatment of hepatitis C virus (HCV). It has been evaluated for the treatment of infection with other hepatitis C genotypes and has shown promising results in genotypes 3 and 4, making up 30% and less than 22% of HCV cases respectively.

Harvoni side effects

Harvoni compared with previous drugs causes few side effects . It is so new, so researchers are still learning about its side effects. The following are  some common harvoni side effects:

  • fatigue
  • headache
  • nausea
  • diarrhea
  • insomnia (trouble sleeping)
  • cough
  • weakness
  • muscle pain
  • dyspnea (shortness of breath)
  • irritability
  • dizziness

What is Harvoni

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.

Harvoni Market Around the World

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$1,092.00;  Drugs used for the treatment of the disease form the Hepatitis C treatment market. by the end of 2015, the value of the global hepatitis C treatment market is projected to be US$ 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 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 infected mother to 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.

Dano Health as a Named-Patient drug supplier can provide Harvoni for the companies who looking for it, too.

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 in Dano Health view- global market

Harvoni in Dano Health view- global market

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.

Harvoni in Dano Health view- revenues

Harvoni in Dano Health view- revenues

Harvoni Revenues and top seller:

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 patent expiry of Harvoni. Sales for Harvoni 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 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. Dano Health as a big Turkish pharmaceutical wholesaler is also active in this market.

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