A Review of the New Generation Hepatitis C Drugs Launched in India

A Review of the New Generation Hepatitis C Drugs Launched in India

By Arpita

According to the World Health Organization, more than 12 million people in India are suffering from hepatitis C. However, as the infection is primarily asymptomatic, most of these people infected with hepatitis C are unaware that they are carrying the deadly virus in their body, which is a leading cause of cirrhosis of liver, liver failure and liver cancer. Even when the infection is diagnosed, patients struggle with the high cost of the treatment.

Despite advancement in hepatitis C treatment, in the war against hepatitis C, the major obstacle is the exorbitant cost of the treatment. The new generation antivirals, although significantly more effective than the earlier interferon and ribavirin treatment with almost 90% cure rate, could be availed by a small fraction of hepatitis C patients in India. For instance, the prices of Sovaldi and Harvoni, the two blockbuster hepatitis C drugs developed by Gilhead Sciences, are more than $1000 per pill. Fortunately, a number of Indian pharmaceutical companies are striving to manufacture affordable drugs that would help in reducing the economic burden of the sufferers and improve the quality of their lives.

In the past few month new generic drugs have been introduced in the Indian market, which have significantly reduced the cost of hepatitis C treatment in the country. Here is a review of the latest hepatitis C drugs and how they will benefit patients in India.

Generic Harvoni Drugs

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New Drugs Launched: Hepcvir-L from Cipla, MyHep LIVR from Mylan, CIMIVIR-L from Biocon, Sofocruz LP from Torrent.

Hepcvir-L, manufactured by Cipla, is the first generic version of Harvoni. It has been launched in India in December 2015. It was soon followed by Mylan Pharmaceuticals' generic Harvoni drug MyHep LIVR and Biocon's CIMIVIR-L, both launched in January 2016. Several other drug makers including Hetero, Ranbaxy, Natco and Cadila have signed non-licensing agreements with Gilead Sciences and their generic versions of Harvoni are in the pipeline.

Benefits of Generic Harvoni: Harvoni is a fixed dose Ledipasvir-Sofosbuvir oral combination therapy for hepatitis C genotype 1 infection. Compared with the interferon and ribavirin therapy, the Ledipasvir-Sofosbuvir combination is more effective. It is capable of curing 90% of patients with hepatitis genotype 1 virus in just 12 weeks, whereas the ribavirin and interferon treatment could clear the virus in less than 45% cases. Ledipasvir-Sofosbuvir is well tolerated and it is devoid of side effects that are usually associated with the conventional interferon and ribavirin treatments such as mild anxiety, depression and gastrointestinal and flu-like symptoms. However, clinical trials have reported fatigue and headache as the common side effects of Ledipasvir-Sofosbuvir treatment.

Cost Benefits: Introduction of the generic versions of the Ledipasvir and Sofosbuvir combination drug has helped in slashing the price of the expensive hepatitis C treatment by almost 99%. The price of a bottle of 28 generic Harvoni tablets regardless of brand is between Rs19900 and Rs25000.

Generic Sovaldi Drugs

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New Drug Launched: Sofocruz from Torrent Pharmaceuticals

The generic version of Gilead Sciences' Sovaldi (Sofosbuvir 400) tablet was recently launched by Torrent Pharmaceuticals. However, soon Sofocruz will see new competitors when Natco, Cipla and Strides Shasun launch their generic versions of Sovaldi tablets under the brand names Hepacinat, Hepcivir and Virso respectively.

Benefits of Generic Sovaldi Drugs: Sovaldi is used in combination therapy to treat hepatitis genotypes 1, 2. 3 and 4. This is a fast acting drug and it helps in clearing the viruses in 12 to 24 weeks.

Generic Harvoni Vs. Generic Sovaldi: When it comes to treating hepatitis C genotype 1 patients, which is the most common type of hepatitis C infection, the single dose Hepcvir-L, MyHep LIVR and other similar Ledipasvir-Sofosbuvir drugs are considered a better option than Sofocruz. Although both the therapies have similar cure rate, Sofocruz is not a standalone drug and it has to be combined with interferon and ribavirin. Hence, it entails the same side effects of the ribavirin and interferon therapy. However, Ledipasvir-Sofosbuvir drugs are not approved for treating hepatitis C genotype 2, and the rare genotypes 5 and 6. Sovaldi is considered the best option for treating these three types of hepatitis C.

Cost Benefit: The new generic drug will be sold at a fraction of the price of the original Sovaldi drug. It will cost around Rs20000 per tablet.

Generic Daclatasvir

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New Drug Launched: Dclacruz from Torrent Pharmaceuticals

In addition to Torrents' new generation hepatitis C drug Dclacruz, which is a generic version of Daclatasvir, the drug developed by Bristol-Myer Squibb and available in the market under the brand name Daklinza, a number of other generic versions are waiting in the pipeline, which includes drugs of Natco Pharma, Cipla, Emcure and Hetero.

Benefits of Generic Daclatasvir: Daclatasvir is approved for treatment of hepatitis C genotypes 1, 2, 3 and 4. It is usually used in combination therapies with both interferon-free treatments as well as with interferon and ribavirin treatments. It is most effective when used in combination with Sofosbuvir for treating hepatitis C genotype 3. This combination not only boasts of a high cure rate but it is also currently the best option for treating hard-to-treat hepatitis C cases. When combined with interferon and ribavirin treatment, Daclatasvir significantly reduces the duration of the treatment.

Cost Effect: Hepatitis C patients in India will benefit immensely from the low price of the generic drug. While in the US the cost of the Daclatasvir and Sofosbuvir treatment is around $150,000 per patient, in India the availability of the generic drugs will lower the cost to about Rs 47500 per patient.