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“Gilead” has signed a licensing agreement with the Indian manufacturers

On 15 September it was announced that the company “Gilead” has signed a licensing agreement with seven Indian companies for the rights to produce and sell drugs sofosbuvir (“Cavaldi”) and ledipasvir for the treatment of viral hepatitis C in the territory of certain countries.

Under the agreement, the licensees will be able to supply sofosbuvir and combination drug ledipasvir/sofosbuvir in 91 markets of countries with low and middle income countries. According to preliminary data, the price for a three-month course of treatment with sofosbuvir should be around 900 USD.

According ITPCru, in the region of Eastern Europe and Central Asia the license applies only to Tajikistan, Turkmenistan, Uzbekistan and Kyrgyzstan. Russia, Ukraine, Georgia and Moldova are not included in the territory of the license.

Experts in the field of health and representatives of civil society accused of “Gilead” in that the company’s policy, oriented solely to obtain commercial gain, blocking access to the drug. Even in developed countries cannot afford to provide the drug to all those in need because of overly high prices, reaching 84000. According to some studies, the cost of production of a three-month course sofoluwe is only about 70 dollars.

Earlier, on 10 February 2014 the company Gilead has applied to the FDA food and drug administration (FDA) for registration of combination drug ledipasvir/sofosbuvir (LDV/SOF) for the treatment of viral hepatitis C and had intended to apply for registration in other countries. And in October the us FDA approved combination drug Harvoni for the treatment of viral hepatitis C with a regime of taking one tablet a day. The Committee for medicinal products for medical use European medicines Agency (EMA) also recommended for approval in the EU this drug. Harvoni will be the first combination drug for the treatment of hepatitis C in the world market. This drug is indicated for the treatment of viral hepatitis C genotype 1 in adults for 8 or 12 weeks (depending on the experience of the previous treatment and presence of cirrhosis) without having to add the current standard treatment is interferon and ribavirin. Oral drug Harvoni Gilead Sciences for once daily use contains 90 mg ladieswear and 400 mg sofoluwe. Sofosbuvir is a NS5B polymerase inhibitor of hepatitis C virus, ledipasvir – NS5A inhibitor protein, the main component of the replication complex of the virus. Clinical trials of the drug showed that the application of the combination of sofosbuvir + ledipasvir allows to obtain a sustained virologic response in 94-99% patients. The treatment is well tolerated by most patients. Widespread use of the drug may halt the epidemic of viral hepatitis C.

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