Safety alert against Hepatitis C drug Sofosbuvir: IPC

IPC had earlier flagged safety alerts against drugs-- etoricoxib, torsemide and quetiapine & valproic acid interaction

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Last Updated on September 5, 2021 by The Health Master

The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has flagged a drug safety alert revealing that sofosbuvir which is used in combination with other medicinal products for the treatment of chronic hepatitis C in adults is associated with Stevens-Johnson Syndrome.

This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.

Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. Sofosbuvir used in combination with other drugs is part of all first-line treatments for HCV genotypes 1, 2, 3, 4, 5, and 6, and is also part of some second-line treatments.

Sofosbuvir in combination with velpatasvir is recommended for all genotypes with a cure rate greater than 90 per cent, and close to 100 per cent in most cases. The duration of treatment is typically 12 weeks.

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For the treatment of genotypes 1, 4, 5, and 6 hepatitis C infections, sofosbuvir is used in combination with the viral NS5A inhibitor ledipasvir. In genotype 2 and 3 HCV infections, sofosbuvir is used in combination with daclatasvir. 

For the treatment of cases with cirrhosis or liver transplant patients, weight-based ribavirin is sometimes added. Peginterferon with or without sofosbuvir is no longer recommended in an initial HCV treatment.

Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to four-fold reduced duration of therapy.

Sofosbuvir was discovered in 2007, and approved for medical use in the United States in 2013. US based Gilead Sciences bagged a patent for sofosbuvir sold under brand name Sovaldi. The company had licensing deals with 11 manufacturers in India.

In 2015 the Central Drugs Standard Control Organization (CDSCO) granted a waiver of clinical trials for direct-acting antiviral drugs to treat hepatitis C. As a result, the generic version of sofosbuvir was launched in the domestic market.

The CDSCO had granted import and marketing permission on January 13, 2015, for sofosbuvir 400mg tablet (brand name Sovaldi from Gilead Sciences), to Mylan Pharma.

Subsequently, the CDSCO also granted permission to manufacture and market sofosbuvir 400mg tablet in March, 2015 to Indian manufacturers Hetero Labs and Natco Pharma. Later Abbott also received DCGI’s approval to launch the drug in the market.

As per drug safety alert issued by IPC on August 31, 2021, sofosbuvir is associated with Stevens-Johnson Syndrome, a rare, serious disorder of the skin and mucous membranes.

Healthcare professionals and patients have been advised to closely monitor the possibility of the ADR associated with the use of sofosbuvir. If such reactions are encountered, it needs to be reported to the NCC-PvPI for suitable action.

IPC had earlier flagged safety alerts against drugs– etoricoxib, torsemide and quetiapine & valproic acid interaction.

Besides this, drug safety alerts were also flagged against drugs– clobazam, baclofen and rosuvastatin and ticagrelor interactions which are associated with risks like DRESS Syndrome, encephalopathy and rhabdomyolysis respectively.

The CDSCO had started PvPI in July 2010 across the country. Since then, IPC has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment.

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