New here - considering lambda/daclatasvir study

[melish249]

Hi folks,

I'm new here and seeking support as I consider treatment for HCV genotype 2. I've had it for over 25 years and am co-infected with HIV, which is very well controlled.  
The study I'm considering is daclatasvir +lambda interferon + ribavarin for 12 weeks followed by 12 weeks lambda/riba.  

I'm so afraid that I won't be able to maintain my f/t work schedule. I feel somewhat better having found some posts by people who have fared well on the lambda vs. SOC.  Any others out there with experience on lambda/riba that can offer words of wisdom?  

Thank you all!

[melish249]

Thanks Hector and Kanarstead, for taking the time to reply.

Your point is very well taken Hector regarding waiting and settling in with a good gastroenterologist.   (I missed the Sofosbuvir study enrollment by one day last year.)  

The study doc mentioned that when Sofosbuvir is available later this year or early next, there will likely be a longer wait before its offered to those coinfected with HIV.  She also said it's unknown how insurance companies will be responding to the $100,000 estimated cost for 12 weeks of Sofosbuvir.  

Even though these issues will be likely be resolved in the (somewhat near? year or two?) future,  I've felt a strong pull to put HCV behind me any way I can, ASAP.  

I read every post I could find in every HCV support forum related to taking lambda, and people seem to have gotten by fairly well. The ribavirin is still another issue, and given that I'm not at death's door and have a favorable genotype 2, the bottom line is, I don't want anything to interfere with my work schedule or mental health which is delicately balanced.

Kanarstead, I hope you will post about your experience on the study and the affects of the lambda and daclatasvir. Wishing you full-on success in every way.

Thanks again!

[Kanarstead]

I'm in this trial and will get my first shot tomorrow.  I'm 1b so my situation is different than yours, I jumped at the chance. As Hector says you may be better off waiting.  Looking at the limited data it seems that although the side effects of Lambda are less severe, there is still a chance you will run into some nasty ones, from BMS study report,

" The most commonly reported adverse events at the Lambda 180 µg dose were fatigue (46.1%), headache (27.5%) and nausea (21.6%). Certain adverse events commonly associated with interferon alfa treatment were less frequently seen with Lambda than with alfa in this study. There was a greater than 2-fold difference in frequency between Lambda and alfa in the rate of flu-like symptoms and musculoskeletal symptoms."

http://news.bms.com/press-release/financial-news/bristol-myers-squibbs-investigational-hepatitis-c-compounds-lambda-and-

Good luck to you!

[HectorSF]

Why do a trial which has an unknown outcome and has interferon?
Why not wait for Gilead's therapy to come to market in the next few months? It has NO interferon (all oral) and very little side effects for most people and it has the highest cure rate ever for hepatitis C genotype 2s?

Genotype 2 is the easiest type of hepatitis C to treat successfully.
The data from Gilead's FUSION trial in patients that never treated their hepatitis C before had a SVR (cure rate) of 97%! As close to a cure as there has ever been! All the rest of us genotypes would love to have odds like that. There is no reason for you to do any other type of treatment IMHO and especially not any type of interferon which is what causes most of those nasty side effects as well as blood level issues we all hate.

As far as co-infection with HIV, I believe there is a trial now going on with this Gilead treatment is co-infected patients but there is no data as yet.
"A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects"
ClinicalTrials.gov Identifier: NCT01667731

You have enough to deal with being infected with HIV please look into Gilead's Sofosbuvir + Ribavirin therapy and find as gastroenterologist or better yet a Hepatologist who is knowledgeable about Hep C and HIV so you can rid yourself of hep C and then focus your energies on caring for yourself and your HIV.
-------------------------------------------------------------------------------------
"FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 8, 2013-- Gilead Sciences (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. 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."

FISSION Trial

"The sofosbuvir-based regimen was successful in 97% of patients with genotype 2 infection and 56% successful in those with genotype 3 infection compared with 78% and 63% in the standard peginterferon alfa-2a plus ribavirin group."

:About FISSION
In FISSION, treatment-naïve HCV genotype 2 and 3 patients were randomized (1:1) to receive either 12 weeks of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day) (n=256) or 24 weeks of peg-IFN (180 μg/week) plus RBV (800 mg/day) (n=243). Overall, 20 percent of patients had compensated cirrhosis (advanced liver disease) and 72 percent had genotype 3 infection.
The SVR12 rates in patients receiving sofosbuvir plus RBV were
97 percent for genotype 2 patients and
56 percent for genotype 3 patients.

The SVR12 rates in patients receiving peg-IFN plus RBV in this study were
78 percent for genotype 2 patients and 63 percent for genotype 3 patients."

(I'm so afraid that I won't be able to maintain my f/t work schedule.)
"In FISSION, just 1% of patients receiving 12 weeks of sofosbuvir plus ribavirin discontinued therapy. However, a higher rate — 11% — of patients who received 24 weeks of peginterferon plus ribavirin stopped treatment."

All the best with your treatment!
Hector