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Indian generics expected to get the green light 8 years 4 months ago #3788

DrJames
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timesofindia.indiatimes.com/home/science...cleshow/49966218.cms

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.

YMMV

The following user(s) said Thank You: LondonGirl, greyhound, mgalbrai, CJ, Lynne-Francis-facebook, honker

Indian generics expected to get the green light 8 years 4 months ago #3797

Joy
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But next door in Pakistan there is interference from interferon...

"in the process of preparing guidelines at the national level but since they still have over 0.3million vials of interferon, they have decided to wait until the stock ends."

tribune.com.pk/story/1000800/taking-on-b...-c-blocked-by-lobby/

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 4 months ago #3808

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Joy wrote: But next door in Pakistan there is interference from interferon...

"in the process of preparing guidelines at the national level but since they still have over 0.3million vials of interferon, they have decided to wait until the stock ends."

tribune.com.pk/story/1000800/taking-on-b...-c-blocked-by-lobby/

Getting rid of the "Rat Poison" first.

Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated

GT 3 - about 28 yrs with HCV

Indian generics expected to get the green light 8 years 4 months ago #3820

LondonGirl
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Sounds like NHS England, although hopefully now, this will become less and less.

GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 'In the slow lane'
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC

Indian generics expected to get the green light 8 years 4 months ago #4638

honker
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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)
Fibroscan F0
Starting Redemption Sof/Led on February 2, 2016
Thanks to Greg Jeffries, Monkmed , FixHepC and Dr. Freeman

Feb. 29
Week 5 of tx
ALT 23
Undetected

May 26
4 EOT
ALT 25
AST 28

Didn't test for viral load. Will test is July at 12 weeks EOT

August 1
Liver enzymes in normal range
HCV UNDETECTED