Natco Pharma Limited announced that it is the first company in India to launch under its brand Hepcinat Plus, the generic fixed dose combination of Sofosbuvir 400 mg and Daclatasvir 60mg Tablet, for the treatment of patients with chronic hepatitis C virus (HCV) infection. Natco has launched Hepcinat Plus at an MRP of INR 17,500/-, for a bottle of 28 tablets.
Hepatitis C is a liver disease caused by the hepatitis C virus: the virus can cause both acute and chronic hepatitis, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness.
The hepatitis C virus is a bloodborne virus and the most common modes of infection are through exposure to small quantities of blood. This may happen through injection drug use, unsafe injection practices, unsafe health care, and the transfusion of unscreened blood and blood products.
Globally, an estimated 71 million people have chronic hepatitis C infection.
A significant number of those who are chronically infected will develop cirrhosis or liver cancer.
Approximately 399 000 people die each year from hepatitis C, mostly from cirrhosis and hepatocellular carcinoma.
Antiviral medicines can cure more than 95% of persons with hepatitis C infection, thereby reducing the risk of death from liver cancer and cirrhosis, but access to diagnosis and treatment is low.
There is currently no vaccine for hepatitis C; however research in this area is ongoing.
Hepatitis C virus (HCV) causes both acute and chronic infection. Acute HCV infection is usually asymptomatic, and is only very rarely (if ever) associated with life-threatening disease. About 15–45% of infected persons spontaneously clear the virus within 6 months of infection without any treatment.
The remaining 60–80% of persons will develop chronic HCV infection. Of those with chronic HCV infection, the risk of cirrhosis of the liver is between 15–30% within 20 years.
Early diagnosis can prevent health problems that may result from infection and prevent transmission of the virus. WHO recommends screening for people who may be at increased risk of infection.
Treatment Hepatitis C does not always require treatment as the immune response in some people will clear the infection, and some people with chronic infection do not develop liver damage. When treatment is necessary, the goal of hepatitis C treatment is cure. The cure rate depends on several factors including the strain of the virus and the type of treatment given.
The standard of care for hepatitis C is changing rapidly. Sofosbuvir, daclatasvir and the sofosbuvir/ledipasvir combination are part of the preferred regimens in the WHO guidelines, and can achieve cure rates above 95%. These medicines are much more effective, safer and better-tolerated than the older therapies. Therapy with DAAs can cure most persons with HCV infection and treatment is shorter (usually 12 weeks). WHO is currently updating its treatment guidelines to include pangenotypic DAA regimens and simplified laboratory monitoring. Meanwhile, there remains a very limited role for pegylated interferon and ribavirin in certain scenarios. Although the production cost of DAAs is low, these medicines remain very expensive in many high- and upper middle-income countries. Prices have dropped dramatically in some countries (primarily low-income) due to the introduction of generic versions of these medicines.
Access to HCV treatment is improving, but remains limited. In 2015, of the 71 million persons living with HCV infection globally, 20% (14 million) knew their diagnosis. 7.4% of those diagnosed (1.1 million) were started on treatment in 2015. In 2016, 1.76 million people were additionally treated in bringing the global coverage of hepatitis C curative treatment to 13%. Much needs to be done in order for the world to achieve the 80% treatment target by 2030.