simeprevir + sofosbuvir

[Alef1]

Just saw very promising preliminary results of combination of sofosbuvir + simeprevir (around 96% SVR4).  since both drugs should be approved by the FDA around December this year, does anyone know if it would be possible to use this combination?  will the combination require approval? how long will it take?

Thanks

[LiliChen]

As I have posted here on other threads, I am set to go to Duke Medical Center for my first appointment (straightaway they make it known on their site that one might enter a clinical trial). I will gather all the information and data I can to post as soon as possible on what is doing on at Duke re. HVC.

[Alef1]

Thanks. I read this and I think the results are not that good Probably becsuse there is no protease inhibitor. The preliminary results of Sofosbuvir + Simeprevir seem much more convincing and on theory this combination may be available at the beginning of 2014.

[Shyrlgame]

Last paragragh states Gilead ready to launch all oral, by end of 2014, for genotype 1


http://hepatitiscnewdrugs.blogspot.ca/2013/08/hepatitis-c-gileads-experimental-drug.html?spref=fb

Hepatitis C: Gilead's experimental drug could flip current treatment paradigm on its head

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Friday, August 30, 2013
Posted by New HCV Drugs
FILE UNDER GS-7977 NOW SOFOSBUVIR, HCV NEWS
Gilead's sofosbuvir clears another HCV hurdle

Full Text Available at NATAP
Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients With Unfavorable Treatment Characteristics: A Randomized Clinical Trial
Or Download the PDF here  
Related: Gilead's Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 shows promise in NIH trial

Evidence continues to mount suggesting Gilead's experimental drug for hepatitis C virus could flip the current HCV treatment paradigm on its head.

Results of the Phase II trial, sponsored and led by the National Institutes of Health, suggest that a regimen of sofosbuvir and ribavirin was highly effective in clearing the virus and well tolerated in two difficult-to-treat groups—patients with severe liver damage and African Americans. Both groups were comprised of those with genotype-1 HCV, which accounts for 70% of all HCV infections.

The findings among patients with genotype 1, which appear in the current issue of JAMA, come on top of data showing strong efficacy for sofosbuvir in cohorts with genotypes 2 and 3. As such, analysts say the drug is poised to take the lion's share of the HCV market. A recent forecast from FactSet Research Systems put annual sales of sofosbuvir at $6.4 billion by 2017.

In the current study, of the 60 enrolled volunteers, 50 were African American (88% of whom suffer from genotype 1 and are known to be harder to treat with interferon-based therapies).

The bifurcated study broke out one group of 10 people with liver fibrosis. Fibrosis is part of the scarring process and represents the liver's response to injury.They received sofosbuvir and ribavirin. After 12 weeks of therapy, HCV was no longer present in all volunteers who completed therapy (nine out of 10).

The other group consisted of 50 volunteers, including 13 with serious liver damage. They received sofousbuvir and either a dose of ribavirin based on weight or a low-dose ribavirin. From that group, 17 patients had no detectable levels of the virus 24 weeks after treatment stopped. Of the 22 volunteers who received the low-dose ribavirin, 12 were considered cured after the end of treatment.  

In an NIH press release, researcher Dr. Shyam Kottilil summed up the findings, saying, “We saw an overall cure rate of about 70% using regimens that did not include interferon. This is an encouraging result, especially considering the proportion of volunteers who had characteristics…that are recognized as predictors of poor response to treatment.”

The findings could make it harder for other prospective all-oral treatment regimens. Boehringer Ingelheim unveiled Phase II data earlier this month of its HCV combo of faldaprevir and deleobuvir, reporting high efficacy rates—85% in genotype 1b—but the sample did not include African Americans.

Gilead's new drug application for sofosbuvir was filed in April. This initial application, under priority review, is for use in genotypes 2 and 3, and in the treatment-naïve for types 1, 4, 5 and 6.

FDA expects to review the application by December 8, the agency said. The European Medicines Association, too, has given sofosbuvir an “accelerated assessment,” and if approved the drug could become available by the first half of next year.

ISI Group analyst Mark Schoenebaum, in an investor note issued around the time of the FDA filing, wrote that “Gilead should be ready to launch an oral genotype 1 regime around the end of 2014.”

[Alef1]

Thanks a lot!  It's good to know that there will be another option which is interferon free.  Good luck with treatment.

[can-do-man]

My bad, scratch this part...." as for them two drugs ever teaming up again, not going to happen"

As the two drugs I was thinking about were daclatasvir and sofosbuvir combo, sorry to many drugs in the pipeline.

[can-do-man]

While it could be possible it would be very unlikely as you would have to get a doctor to do this off label. Then the huge problem would be the cost involved as both drugs will be very expensive and getting your insurance to pay for both might be next to impossible.

There is other all oral treatments in trials now for genotype 1 that are having very good results and could be here in 2 years, maybe even a little less then that, as for them two drugs ever teaming up again, not going to happen.......... Good luck