IPC flags adverse reaction linked to Hepatitis C drug Sofosbuvir

This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Sofosbuvir is a direct-acting antiviral drug used in combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by Hepatitis C Virus infection (HCV).

HCV is a single-stranded RNA virus with nine genotypes, the most prevalent of which is genotype 1, which affects 72 percent of all chronic HCV patients in the United States. Since 2011, with the introduction of Direct Acting Antivirals (DAAs) like sofosbuvir, treatment options for chronic Hepatitis C have improved significantly.

Sofosbuvir is a nucleotide analogue inhibitor that functions by inhibiting the RNA-dependent RNA polymerase of the Hepatitis C Virus (HCV), NS5B (non-structural protein 5B).

NS5B, an RNA-dependent RNA polymerase, is essential for the transcription of Hepatitis C viral RNA and for its high replicative rate and genetic diversity.

Sofosbuvir incorporates into HCV RNA by the NS5B polymerase and serves as a chain terminator. Sofosbuvir inhibits HCV viral replication by binding to the two Mg2+ ions found in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material.

Natco Pharma's Hepcinat 400mg, Abbott's Viroclear 400mg, and Mylan Pharmaceutical's Myhep 400mg are some of the brands of Sofosbuvir 400mg Tablets available in India.

However, following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, the Indian Pharmacopoeia Commission has reported that Sofosbuvir, which is indicated in combination with other medicinal products for the treatment of chronic hepatitis C in adults, is associated with Stevens-Johnson Syndrome.

Stevens-Johnson syndrome (SJS) is a rare, life-threatening skin and mucous membrane condition which is generally a drug reaction that starts with flu-like symptoms and progresses to a painful rash with blisters. Fever, sore throat, and fatigue are classic symptoms of SJS, which are frequently misdiagnosed and treated with antibiotics.

Stevens-Johnson Syndrome (SJS) is a type IV hypersensitivity reaction in which a medication or its metabolite triggers cytotoxic T cells (CD8+ T cells) and T helper cells (CD4+ T cells) to launch autoimmune responses against self-tissues.

As per the issued drug safety alert, the following suspected drug is associated with the ADR as given below:

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADR associated with the use of above suspected drug.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPI Helpline No. 1800-180-3024 (Toll Free)."

To view the official notice, click the link below:

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