NEW DELHI: In a move that comes as a huge relief to patients of chronic Hepatitis C, the apex committee of the Central Drugs Standard Control Organisation (CDSCO) has granted a waiver of local trials for crucial new direct-acting antiviral drugs treating the disease.
The waiver for sofosbuvir and ledipasvir co-formulation and for daclatasvir is expected to bring the generic version of these drugs, which cost a fraction of the branded versions, into the Indian market within weeks. Some patients facing a threat to life currently import these drugs at a huge cost.
According to the World Health Organisation, about 12 million people are infected with Hepatitis C in India. India is now one of the few countries where generics are available for interferon-free treatment. Pegylated interferon is an old, expensive, injectable chemotherapy drug with serious side effects used to treat Hep C in combination with sofosbuvir and ribavirin.
NSW Australia. Genotype 1b 30+ years, F0-F1, VL 91,000 Feb 2015 (740,000 in 2010), Tx naive.
Ordered Sof/Dac from Buyers Club 21 Sept, received 14 Oct.
Virus UNDETECTED at 3 weeks AND 12 weeks (EOT) AND SVR4 AND SVR12 AND SVR24.
A thousand thankyous to Dr James and the amazing FixHepC team.
Indian generics expected to get the green light
8 years 5 days ago #3808
We have a very similar Hep C profile. It is encouraging to know of your success. All the best to you.
Diagnosed in 2000, Genotype 1(b), no previous treatment,
Viral Load 90,700, ALT 86, AST 56 (as of Novemeber 15, 2015)
Starting Redemption Sof/Led on February 2, 2016
Thanks to Greg Jeffries, Monkmed , FixHepC and Dr. Freeman
Week 5 of tx
Didn't test for viral load. Will test is July at 12 weeks EOT
Liver enzymes in normal range