Sovaldi (sofosbuvir) is a direct-acting antiviral medication indicated for the treatment of chronic hepatitis C (CHC) infection. On the World Health Organization’s List of Essential Medicines, It is the most effective and safe medicines needed in a health system. Sofosbuvir has a number of ideal properties, including pan-genotypic activity, once daily dosing, no meal restrictions, few adverse effects, minimal drug-drug interactions, high genetic barrier to resistance, good safety and efficacy in patients with advanced liver disease, and excellent sustained virologic response rates in patients with unfavorable baseline characteristics; due to all these properties it is of special interest among the directly acting antiviral drugs under development.
In 2007; Michael Sofia, a scientist at Pharmasset, a pharmaceutical exporter for hospitals discovered Sofosbuvir.
In 2010: It was first tested in people.
In December 2013: Sofosbuvir was approved by the FDA for treatment of HCV genotypes.
In January 2014: it obtained marketing authorization from the European Commission (EC) as a single agent once-daily oral drug for the treatment of CHC genotypes.
Sofosbuvir was recommended as first-line therapy in combination with other antivirals for all six genotypes of Hepatitis C by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) in 2016. Generally, it is indicated for
Depending on the genotype, sofosbuvir is often used in combination with other antivirals to cure, or achieve a sustained virologic response ; antivirals that are used in these combinations include Ledipasvir, Velpatasvir, Daclatasvir, Simeprevir, Elbasvir, Grazoprevir, Ribavirin, Peginterferon alfa-2a, or Peginterferon alfa-2b with the intent, after 12 weeks of daily therapy.
With the development of Direct-Acting Antivirals (DAAs) such as sofosbuvir, treatment options for chronic Hepatitis C have advanced significantly since 2011. sofosbuvir molecule prevents Hepatitis C virus (HCV) to replicate itself. The RNA molecule of the virus is one of the necessary components for replication. A virus uses an enzyme called RNA polymerase to replicate RNA in order to make a copy of RNA for the new virus formation. Sofosbuvir inhibits enzyme RNA polymerase – the cellular worker that performs the replication process. The existing Hepatitis C viruses could not make new viruses due to sofosbuvir mechanism of action.
Among all the types of hepatitis, Hepatitis C is the most dangerous one. Around 150 million people are infected with hepatitis C around the world and 350,000 people die every year. It is estimated that about 215,000 people in the UK chronically be infected with hepatitis C.
In the market for Hepatitis C, Gilead Sciences launched a couple of drugs, Harvoni ((ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) which captured maximum market share and has a cure rate of more than 95%. It is expected that the hepatitis C drug market witness strong growth in the coming years.
Rise in injection drug users, increase in awareness, the presence of unmet need, and the anticipated launch of new drugs are expected factors that drive the market growth. The markets in India, Brazil, China, and Russia, Africa, Middle East, Asia Pacific, and Latin are also expected to grow at a rapid pace as the prevalence of hepatitis in these countries is high.
It is expected that the global demand for Hepatitis C drug Market reaches 27.63 billion USD in 2021 at a CAGR of 17% between 2016 and 2021, which was 11.81 billion USD in 2015. Key applications of the hepatitis C drug market are hospitals, private labs, public health labs, blood banks, and physician offices. Elements like the prevalence of the infection, new productive treatments, rising government subsidizing and relatively lesser time of treatment drive the Hepatitis C drug market. It can also be influenced by treatment costs, lack of awareness and information about HCV disease.
According to the Zion research, global demand for hepatitis C drug market valued at USD 11.81 billion in 2015 will reach USD 27.63 billion in 2021 and It is anticipated to grow at a CAGR of 17% between 2016 and 2021. The global hepatitis C treatment market valued at US$ 25.02 Bn in 2016 will reach US$ 65.48 Bn by 2025, expanding at a CAGR of 11.3% from 2017 to 2025.
One of the fastest growing hepatitis C drug markets across the world with more than 40% share of the total revenue generated in 2015 was North America. the largest revenue contributor for the worldwide Hepatitis C market is the U. S. Government funding for drug development will be the essential elements in the growth of U.S. HCV treatment market. The second major market for Hepatitis C in 2015 was Europe. Asia Pacific would show significant hepatitis C treatment market growth due to increasing healthcare awareness and developing the economic condition. It is expected that ongoing research and development in the pharmaceutical industry for hepatitis C drug development propel the market growth in the coming years.
Other medications available for the treatment of chronic hepatitis C are Incivek developed by Vertex Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation and Tibotec BVBA, and Victrelis (boceprevir) manufactured by Schering-Plough and Merck. Gilead Sciences makes hepatitis C drugs – Sovaldi and Harvoni; it is the main medicine wholesale for hospitals. Siemens AG, MedMira Inc., Inovio Pharmaceuticals, Inc. and Abbott Laboratories are key players involved in the development of hepatitis diagnostics.
Sovaldi price is about $1,000 a pill in the U.S., but a generic version costs only $4 a pill in India. Dano Health as a drug supplier for hospitals can supply Sovaldi for all hospitals and health care clinics.