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New treatments?

Hi all,
I was diagnosed with HCV nearly 4 years ago and 3 years ago underwent 72 weeks of interferon/ribavirin treatment. Prior to treatment I had stage 1 fibrosis and a second biopsy 18 months ago a second biopsy indicated stage 3. So 72 weeks of treatment, which failed and a deteriorating liver. My question is does anyone know of any new developments in treatment for GT 3a?
Best Answer
446474 tn?1446347682
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 7, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options. Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013.

The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.
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FUSION TRIAL - Genotype 2/3 treatment-experienced:

In the second study, known as the FUSION trial, patients who had not had a response to prior interferon therapy received sofosbuvir and ribavirin for 12 or 16 weeks.

The rates of sustained virologic response achieved with sofosbuvir and ribavirin in the population of patients with prior treatment were superior to the historical control rate of 25% (using peg-INF and RBV), with rates of 50% in the 12-week group and 73% in the 16-week group (P < .001).

The secondary analysis comparing rates of sustained virologic response between the groups showed that patients receiving 16 weeks of treatment had a significantly higher rate of sustained virologic response than patients receiving 12 weeks of treatment.

The most common adverse events were again headache, fatigue, nausea, and insomnia, but the overall discontinuation rate was low at 1% to 2%.

* Higher SVR12 rates higher in patients infected with genotype 2 vs genotype 3 HCV
* Higher SVR12 rates with 16-week therapy vs 12-week therapy in patients with genotype 3 HCV (62% vs 30%; P < .001), including in patients with or without cirrhosis
* Higher SVR12 rates with 16-week therapy vs 12-week therapy in cirrhotic patients infected with genotype 2 HCV

Genotype 3 SVR rates:

12 week treatment = 30 (19/64)
16 week treatment = 62* (39/63)

No cirrhosis
12 week treatment = 37 (14/38)
16 week treatment = 63 (25/40)

Cirrhosis
12 week treatment = 19 (5/26)
16 week treatment = 61 (14/23)
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Hector
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Avatar universal
Thank you so much for your responses to my question.
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Avatar universal
Thanks HectorSF,
So if I have read this correctly (laymans terms), for gen3 the results are good, better for 16 weeks than 12 weeks.
It also looks as though the side effects aren't as heavy as the Ribivin/Interferon (from which I had a large number)
I'm in the UK and whether NICE will approve the treatment or not is another matter.
To be honest this is the best news I've heard in a long time. There is light at the end of the tunnel.
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Avatar universal
Thanks Rivil,
I will take all the information I can get from here with me next week when I have an appointment with my consultant.
Helpful - 0
4705307 tn?1447970322
Help me understand...
Genotype 3 SVR rates:

12 week treatment = 30 (19/64)
16 week treatment = 62* (39/63)

No cirrhosis
12 week treatment = 37 (14/38)
16 week treatment = 63 (25/40)

Cirrhosis
12 week treatment = 19 (5/26)
16 week treatment = 61 (14/23)
These are the % rates regarding those who have not achieved SVR. And moved on to the next step, as it would be. So if I am reading this right it means, breaking it down to the original group, lets say of 100, with 16 weeks in this treatment the SVR is 75% none cirrhosis.
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Avatar universal
Sofosbuvir/Ribavirin will be on the market in 2014 and I remember reading that it had decent results for geno 3.
I will look for the link to the clinical studies and post it unless someone else gets to it first.
Hang in there, your chances of beating the virus are improving.
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Avatar universal
Sorry it was 48 weeks not 72
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