Hep C Discussion Forum

Lizzy · Member

RE: FDA Approves Gilead’s Sovaldi (Sofosbuvir)

Tig · Admin

Thanks Jim! Very interesting and it pleases me to see groups of people letting their feelings be known. I also noticed a rather poor description of the methods of transmission. Very incomplete for a scientific report. That kind of reporting adds to the stigma... We need better accuracy by these editors.

JIme · Guru

More via Vicky, The attachment didn't come through, I will try to link to it separately.

Science 13 December 2013:

Advocates Protest the Cost of a Hepatitis C Cure

Jon Cohen

For disease advocates, the U.S. Food and Drug Administration's 6 December approval of what promises to become a blockbuster drug against the hepatitis C virus (HCV) was bittersweet news. Sofosbuvir, made by Gilead Sciences of Foster City, California, works better than anything on the market: It's effective against most HCV variants and will help rid the body of this liver-damaging virus more quickly and safely than existing drugs. What rankles advocates is its priceeach pill costs $1000, and the drug must be used for at least 12 weekswhich will put it out of reach of most of the more than 100 million people in resource-limited countries who need it. "It doesn't matter how great these drugs are if no one can have them," says Tracy Swan, who works with the Treatment Action Group, a New York City nonprofit whose members successfully battled big pharma as leading AIDS activists in ACT UP.

In an unusual move, Swan and other HCV advocates have been imploring Gilead to offer a lower price to cash-strapped countries right from the start. They want to avoid a repeat of what happened during the early days of the AIDS epidemic, when it took yearsand many protests and lawsuitsbefore the poor had access to lifesaving antiretroviral drugs. "We want the drug nownot in 15 years," says Isabelle Meyer-Andrieux, a clinician based in Geneva, Switzerland, who works for the Campaign for Access to Essential Medicines run by Doctors Without Borders (Médecins Sans Frontières [MSF]). "We are really convinced that this drug can revolutionize the way we treat HCV in low- and middle-income countries."

Meyer-Andrieux says that Gilead seems receptive to differential pricing, a strategy the company uses for its anti-HIV drugs. Gregg Alton, Gilead's executive vice president for corporate and medical affairs, wrote in an e-mail to Science that the company hopes "to develop an appropriate access and pricing strategy" and "greatly values" input from advocates. "Providing treatment in resource-limited settings presents complex challenges and we understand the concerns that have been raised," he wrote.

HCV, which can cause life-threatening cirrhosis and liver cancer, infects an estimated 130 million to 185 million peopleand 90% of them live in poorer countries (see map). It is mainly transmitted through contaminated blood transfusions or syringes shared by injecting drug users, but sexual transmission can occur, too. There are six main viral variants, called genotypes, which respond differently to treatments. New drugs are desperately needed.

Until 2011, the only treatment was an unpopular 48-week regimen that combined injections of interferon with ribavirin pills, which boosted the immune system and had some nonspecific antiviral effect but didn't directly attack HCV. The treatment often had severe side effects and cured fewer than 50% of those with genotype 1, which infects about 70% of the estimated 3 million people in the United States with hepatitis C. In the past 3 years, three drugs have come to market that directly attack HCV and reduce treatment regimens to 12 to 28 weeks, but they are approved only to treat genotype 1, some have serious side effects, and cure rates are, at best, 80%.

Gilead's sofosbuvir cripples an HCV enzyme, polymerase, that the virus needs to copy itself. The drug cures roughly 90% of genotype 1, 2, and 4 infections in 12 weeks with relatively minor side effects, when given with ribavirin and, for genotypes 1 and 4, interferon injections. It's also approved for use in combination with ribavirin for genotype 3, although efficacy is slightly lower and treatment takes 24 weeks.

The drug's performance in early studies led Gilead in January 2012 to pay a staggering $11.2 billion to purchase the small company that first made it. But Meyer-Andrieux argues that the full-price sales of the drug in wealthy countries will offer the company ample profit. "They don't have to treat so many patients to reimburse the $11 billion," she says. A 20 November investor report from Credit Suisse bank, subtitled "The HCV Revolution," suggests sofosbuvir's sales in wealthy countries in 2014 alone could total $3 billion.

"The drugs are extremely cheap to make," contends Andrew Hill, a pharmacologist at the University of Liverpool in the United Kingdom. Based on the raw ingredients, the steps in the chemical synthesis, and molecular similarities to anti-HIV drugs, Hill and his colleagues concluded that it costs $68 to $136 to manufacture enough sofosbuvir to treat a person for 12 weeks. MSF suggests that diagnosing and curing an HCV infection should cost developing countries no more than $500.

Hoping to pave the way for an inexpensive generic version of sofosbuvir, another nonprofit is challenging Gilead over its Indian patent application, a strategy that also proved successful with anti-HIV drugs. The Initiative for Medicines, Access & Knowledge (I-MAK) in New York City led an "opposition" to the Indian sofosbuvir patent application on 21 November, contending that sofosbuvir is a slight variation on an earlier patented drug that had activity against HCV and thus is not novel. Gilead did not respond to Science's question about the I-MAK opposition.

Many expect that sofosbuvir will prove even more powerful when combined with one of several other anti-HCV drugs in late-stage development. Meyer-Andrieux of MSF says the group is also trying to establish differential pricing for those drugs, and ultimately hopes to convince companies to coformulate one pill that works against all genotypes. "We would very much like to take the best drugs and combine them and escape from big pharma monopoly strategies," Meyer-Andrieux says.

When a short course of pills can cure all HCV infections, demand for treatment will intensify further, says David Thomas, who treats hepatitis C at Johns Hopkins University in Baltimore, Maryland. Says Thomas: "I can't imagine anyone who won't want the cure."

Tig · Admin

Thanks for sharing that release Matt. I would love to see something like this. It's interesting when you consider how these situations work sometimes. First you have the big company (read GILD) and then let's put everyone else in a second group. Big company jumps out of the starting gate with their entry named Greed that is the odds on favorite. Then as the race runs and the lead appears to be waning, Entry 2 starts to pull ahead. When Greed's owner sees the possibility of coming in 2nd, they order the rider to drop weight and start using the whip. They made the mistake of disregarding the longshot on the field and are now in a race they hadn't planned for. It's kind of similar to the playground bully. Once he sees that he may be losing his status, he quickly resorts to befriending those he had previously hurt or disregarded. Now it's up to the rest of playground to decide if they want to play. I love it!

I'm on my way to the store to get some popcorn. Plain, salted or extra butter? This game is going to be good!

Matt Chris · Guru

Hey all

The entire financial world has taken notice of Gilead's $1,000 per pill price on its HCV drug

Check out this mention from Germanys CMO very large investment group.

Deutsche downplays alleged "price war" for Gilead, AbbVie HCV drugs

Wednesday, December 11, 2:47 PM ET | GILD, ABBV

"The biggest U.S. drug benefits manager plans to start a price war over a new generation of hepatitis C treatments that will cost $1,000 a pill, in a bid to drive down spending on the medicines," Bloomberg said Tuesday, tying comments made by Express Scripts (ESRX -0.5%) CMO Steven Miller to pricing for Gilead's (GILD -2.1%) sofosbuvir and upcoming HCV treatments from AbbVie (ABBV +1.2%).
Deutsche's Robyn Karnauskas thinks the comments might have been taken out of context given that "the CMO did not mention GILD or any other company/drug."
Other takeaways from Deutsche's conversation with ESRX: The company says it "spoke about various formulary changes and [while] HCV might be one of them, this is not something new [as it] works on formularies everyday."
Also: ESRX says it does not "comment on drug/companies specifically. For Gilead drug, the internal committee still has to vote."
Let the price war start, yes!

Loopy Lisa · Guru

I think with all the new drugs coming out the price will bottom out after a year, they are going to try and get a fast return quickly. It will be interesting to see how long it will be for the FDA and EU to approve other drug companies?

I am with you on that Bill, the fact that the life line for many people are there, it is the start of the end for this terrible disease.

I only hope that every country gets these drugs in a reasonable time scale with a realistic price as we all know that other countries do not have the luxury that most of the West can afford. This is what angers me the most, one life is not more valuable than another due to geography!

I am getting in the Christmas spirit, especially knowing that this may be the last one I ever have with these viruses playing breading games in my RNA.

:D

-- Edited by Loopy Lisa on Thursday 12th of December 2013 12:16:20 AM

Bills · Guru

This is the longest thread I ever seen on here and only a few days old.

I don't have time to read it all yet I'm just overwhelmed with relief that it's here and hope the other drugs BMS etc are coming up fast. I just keep breathing relief to the hope it comes quick for all of us and all geno types just taking a pill. In a short time it will be forgotten what we went through. I'll get technical later but for now I'm just happy and excited for all of us.

BillS

Matt Chris · Guru

Hey All HepCFriends

This forum rocks, we can express our opinions, feelings, viewpoints and get things off our minds and chest to our member that can relate to the topic.

Keep it up Zlikster, Karen, Suziq, Biggy, Darkstar, Tig, JIme, Loopy and everyone else

Their is no movement without talk and their is no talk without thought and their is no thought without people who care.

matt

Zlikster · Guru

we got estimation how much sofosbuvir production might cost, check this, imho, very valuable pdf:

http://freepdfhosting.com/d4a7e2bba6.pdf

estimated production cost of 68-138$ for 12week (84 pills). This is not an "internet" estimation. I have showed it to my hepa too and then she told me sad news for GT1 folks and Vertex pricing for Incivek for Bosnia...

include usual costs of R&D, marketing, clinical trials, etc... but lets for "fun" exclude 10.4 bil $ for acquisition of Pharmasset. Add possible market share (hcv infected in mid and upper income countries) and i doubt it would be, least to say, reasonable to price 1k $ per pill. I am really keen to hear is this a new fact: is Sovaldi most expensive pill ever??? (all other on that forbes most expensive drugs list are injections for rare diseases)

check also for how much Gilead could have bought Pharmasset for back in 2004:

http://www.reuters.com/article/2011/11/22/us-pharmasset-founder-idUSTRE7AL2ES20111122

so the cost of acquisition could have been 30 times less?

I do realise there are problems with QOC with cheap generic drugs made in India and China, but i presume there are variable sources, some more reliable, some with real QOC problems. So getting a generic drug from India/China is indeed a risky biz, but i hope there will be, if that happens with Sovaldi, a reliable source.

I am not against high priced meds, but there is always a line to be crossed in overpricing. I think that 1k $ per pill crossed it by far...

now where is my anti rant 1$ happy pill? ;)

cheers

Biggyb · Guru

Karen wrote:
Hey Zlikster (someone please send me some extra patience spray and some antirant pills ;) )
Lol!!! Coming your way

Lol,,send some my way too will ya ?

Also need some heat here in Michigan,,right Karen?

darkstar · Senior Member

Zlikster wrote:
hit me with Riba anytime :) i would go with interferon again too, if it didn't attacked my hearing :/ The question is also about long term consequence of interferon based therapy.

darkstar, you are absolutely right in the economic aspect...on the moral aspect (is there a such thing anymore on this planet?) it's just evil to have 2000% times price of the production cost considering the majority of infected are in low income/no insurance group. It's well known fact Gilead could have bought Pharmasset for much less $ and then could have priced SOF much less with same ROI time frame . Not to mention that young chemist and inventor of PSI-7977 molecule is broke(n) and without job. I don't expect to big pharmas in brutal market race to be altruistic, but fair pricing/adjusting to low income countries/markets should be considered as ethical and, i guess, smart market move. Re India making cheaper meds, it's quite (morally) normal to me what their government is doing to protect/help their own citizens. Of course there is omnipresent problem of fake drugs, but i know people who got their meds/intervention from India who couldn't otherwise afford it.

Malcolm, cheers! You know my default mode is "impatience" ;) I can't find Merck any clinical study nor hint that MK-5172 and MK-8742 will be for GT3s. I will keep my eyes on Merck for sure. Waiting to see results from Gilead's LDV/SOF combo trial for GT3s (only ongoing in NZ?). Does Ledipasvir as NS5A inhibitor has pangenomic properties/effect?

it's gonna be interesting (2014) year for sure!

all the best

Zilkster,

Neither you or I know if it is 2000 times there cost. As I tried to point out, manufacturing cost is only a small part of the issue. Again, not trying to defend pharma, but realistically, the cost of acquisition, the manufacturing cost but also the cost of clinical trials, failed drug efforts all go into the final cost of the drug. Even considering that the pharmaceutical industry expects an ROI that is unreasonable. But it is not as unreasonable as some of the comments suggest.

In regards to India, I think that you are misinformed. The issue is not fake drugs, it is GMP (good manufacturing practices). Generic versions of drugs are produced where their process and quality control are poor. This results in a different drug that may have completely different effects. That is the concern. For some chemo drugs there are over 50 generic products, much cheaper, but based on effect, clearly not the same product.

suziq · Senior Member

Zlikster and others.

I do understand the outrage. I just posted in rant the other day about paying for my liver scan. I don't know if other clinical trials pay for scans (except in screening process). Then I realized that my liver is NOT the issue. Stopping the Hep C virus and getting FDA approval is the only issue--at least for now.

I am very grateful for the new meds and my clinical trial. That does not mean that I don't see the flaws in the system. Born in 1934, I have seen the changes in how the world works--or at least the monetary system. The change can be clearly seen if You read about President Truman and when he left office in 1948 or 1949. He drove his own car home and went back to his modest family home. He lived on some small pension from previous employment. It has all changed. CEO's lay off workers and add to their pensions and stock options. That is enough--my riba seems to be kicking in.

Hopefully some of the other drug companies will be more reasonable in their "need" to recoup money. Think I'll take a nap now.

-- Edited by suziq on Wednesday 11th of December 2013 06:59:48 PM

Karen · Senior Member

Hey Zlikster (someone please send me some extra patience spray and some antirant pills ;) )

Lol!!! Coming your way

Zlikster · Guru

that support program is only for US patients that have private or state insurance and can't (read their insurance won't) afford full price.

@SuziQ, thanx! please let me know if you hear any clinical trials for GT3 from Merck! :)

as for Gilead's miracle cure, as i mentioned, molecule itself (PSI-7977) was developed by young chemist Jeremy L Clark then employed by Pharmasset. It's development was partially government funded (!!!), then when the potential of it were realized by the owner of Pharmasset, he nicked/striped patents from original inventor(s) and sold Pharmasset to Gilead for incredible amount of 10.4 bil $ (as i mentioned all other Gilead acquisitions sum to 6.5bil $). Even the owner of Pharmasset who pocketed 400mil $ from that transaction said Gilead overpaid it (they could have bought it for 3-4bil $ just few months earlier), while Mr.Clark got fired and is mostly without a job last 3 years. Strange story is (if i heard well), PSI-7977 was first licensed to Roche to try n make prodrug of it and they failed? Gilead didn't spent all that money just cause of a good will to help the world cure hcv infection. It's plain be first, grab as much as you can in brutal market race. They (biz managers) do not see patients/infected as living beings, yet as financial units. I think Sovaldi is the most expensive drug in (one) pill form ever?

read this (older) article about most expensive drugs...
http://www.forbes.com/2010/02/19/expensive-drugs-cost-business-healthcare-rare-diseases.html

considering that number of hcv infected ain't low at all, as justification for those high priced drugs mentioned in forbes article is small number of patients. I do not share any sympathy for Gilead and it's biz plan. I can only share my gratefulness to all hard working people in labs making these miracle molecules/prodrugs and doctors fighting for their patients.

I do not mind when big pharma companies profit from drugs. They have to return their R&D, marketing, complex production investments and at the end profit, but this is just plain wrong in my eyes. It's not just Gilead, other companies are doing same things, cause we (governments) allowed them to race in the free market without any moral/ethical lines. System is broken and have wrong moral values.

I earn 15-30k $ per year (i am freelancer) and i live in a country where until 3-4 years ago Peg and Riba was not on the essential drugs list (one year for GT1 patients was round 30k $). While on tx I had to pay for Neupogen shots and most of the diagnostic tests (PCRs,etc). Bank won't give me credit loan cause freelance doesn't counts as steady income source. I pay annually for one private health insurance (just diagnostics i get for 50% off the price) and i pay monthly for state owned insurance which strangely covered Riba&Peg (i had a tip that they got Riba almost free and Peg was subsidized from EU IPA fonds). My hepa jokes Sofosbuvir will arrive in 2057 year over here ;) but i could see how sad she was telling me Vertex asked for 55k$ for triple tx (Incivek+Riba+Peg), which i doubt it will be covered by any insurance over here. I am only F1/A1 with my liver, but i can only imagine if my liver was in such a bad condition from hcv (pre transplantation condition) and didn't respond to SoC tx, i would break in in first Gilead's (or whatever big pharma lab was there) and risk it all (SUE ME!).

For years i have been reading about overpriced anti hiv meds and was appalled by it, but now i am feeling it bit (less severe tho) on my skin and i now i can be just a tiny bit in skin of all those desperate people.

i have few mates with phd in microbiology and in R&D meds departments, who work really hard and at the end they get frustrated by chasing grants and working for really not that great salaries thayt now they want to move to sales (less work, bigger money) :(

sorry about this long rant...i just can't get over this "1000$ per pill" story with ease. Hopefully competition will bring price down of these amazing new anti hcv drugs. If not China and India are best bet!

someone please send me some extra patience spray and some antirant pills ;)

much love

Tig · Admin

Hi Karen, I'm in complete agreement with you. It would be a splendid bit of news to read the headline, "Hepatitis C Virus cure found"!! It would be hard to believe anyone wouldn't. Perhaps Big Pharm would like to see it happen next year or the year after or.... I suppose society owes them the right to earn their R&D money back and make a tidy profit. That would be selfish to want otherwise, or would it? I want everyone to regain their health and understand it takes R&D $$$$$ to do that. My question is what are the limits? When is enough, enough? If an individual wants a product and can afford to pay its cost + 2000% profit, more power to them. But a seriously ill third world HCV patient that makes $4.00 per month is going to both find a 12 or 24 week course of treatment with a drug costing $1000 dollars per pill ($84,000/$168,000) inaccessible and likely the last person on earth that will be considered a candidate for a well meaning but still internally developed support path program that satisfies the questions on price gouging from those on Capitol Hill.

I'm optimistic that Big Pharm has made great progress toward finding a cure for this disease and thankful that they have the intelligence and resources to do it. But there must be a limit to it. It has been reported in medical journals already that there are other pharmaceutical companies that can make the same 12 week course of the medication available for approximately $200 dollars. I believe Gilead should be able to recoup their costs and profit from it, they've earned it and the kudos that come with the development of this treatment. However, I hope that wiser minds will decide to limit their seemingly endless desire to profit off the backs of the ill. There are limits to everything but happiness and pain. I think these corporations would serve themselves and the global community well to learn that.

suziq · Senior Member

Someone on a different forum said she has contacted the program www.MySuppportPath.com that jime just posted. She said they were very nice and responsive. They said they will be contacting her doctor to set it up. It never hurts to look into it and check it out if you need it. That is how I got into my clinical trial--by checking out every option I saw.

Thanks for the posting of a financial support program.

Karen · Senior Member

Last evening I had a long discussion with a friend. We were talking about the high cost of health care/drugs etc. We also touched on how people think about their bodies-human life in general-how we set our priorities. My friend is a diabetic and her drugs necessary to sustain her life are outrageously expensive and her treatment never ends. She has managed to figure out how to pay her monthly-life long medical bills because without these drugs her life would end quickly.

Once or twice I have heard the old adage, where there's a will, there's a way. I believe we too can figure out how to pay or get the funding we need when the time comes (the blessing-12-24 weeks). Whatever Gileads intent, their job was to find a possible cure for HVC (which I pray they have)-let us take on the challenge of finding away to fund treatment by thinking outside the box. Maybe it is time to set-up a non-profit for those who do not have the means or support...any takers? I have also been in touch with the liver foundation to see how to expand on their efforts.

Greed or no greed on behalf of the drug companies, it will be nice to see Hep C wiped from the face of the earth. Where is the optimism.

Tig · Admin

Until I see it happen, with Gilead's history of greed, I think any "support path" provided by them will probably be both narrow and short. I hope they prove otherwise, but I won't be holding my breath. Let's call it the $84,000 dollar question... (Deductible?)

suziq · Senior Member

Zlitster,

I'll ask my coordinator if she knows anything about Merck and G3 when I get my week 12 results--should have been yesterday--or you might email her.

JIme · Guru

More details from Vicky. Thanks Vicky!!!!!

www.natap.org

Sofosbuvir (Sovaldi) Gilead U.S. Patient Assistance Program

Gilead is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path (www.MySupportPath.com) to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for the medicine. The program consists of an integrated offering of support services for patients and providers, including:

· Access to dedicated case managers to help patients and their providers with insurance-related needs, including identifying alternative coverage options such as federally-insured programs (e.g., Medicaid, Medicare) and health exchanges. · Education and support, including a 24/7 nursing support service line and the ability to schedule an onsite visit from a clinical educator.

· The Sovaldi Co-pay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per co-pay. Co-pay assistance can also be applied toward deductibles and co-insurance obligations.

· Gilead will provide support to the Patient Access Network (PAN) Foundation, an independent non-profit organization that provides assistance for eligible federally-insured and privately-insured patients who need help covering out-of-pocket medication costs.

· The Support Path Patient Assistance Program will provide Sovaldi at no charge for eligible patients with no other insurance options.

Information about how to apply for any of these forms of assistance can be found at www.MySupportPath.com or by calling 1-855-7MyPath (1-855-769-7284) between 9 a.m. - 8 p.m. EST.

Global Availability Gilead is committed to helping ensure access to Sovaldi in resource-limited settings. The company is developing a hepatitis C treatment access program, focusing on those countries with the greatest HCV burden. Full program details will be announced in the coming months.

Karen · Senior Member

Zlikster...smile, help is on the way!

In yesterday news: Sovaldi will come with a copay assistance program that will make the copay less than $5 for eligible patients.

Zlikster · Guru

hit me with Riba anytime :) i would go with interferon again too, if it didn't attacked my hearing :/ The question is also about long term consequence of interferon based therapy.

darkstar, you are absolutely right in the economic aspect...on the moral aspect (is there a such thing anymore on this planet?) it's just evil to have 2000% times price of the production cost considering the majority of infected are in low income/no insurance group. It's well known fact Gilead could have bought Pharmasset for much less $ and then could have priced SOF much less with same ROI time frame . Not to mention that young chemist and inventor of PSI-7977 molecule is broke(n) and without job. I don't expect to big pharmas in brutal market race to be altruistic, but fair pricing/adjusting to low income countries/markets should be considered as ethical and, i guess, smart market move. Re India making cheaper meds, it's quite (morally) normal to me what their government is doing to protect/help their own citizens. Of course there is omnipresent problem of fake drugs, but i know people who got their meds/intervention from India who couldn't otherwise afford it.

Malcolm, cheers! You know my default mode is "impatience" ;) I can't find Merck any clinical study nor hint that MK-5172 and MK-8742 will be for GT3s. I will keep my eyes on Merck for sure. Waiting to see results from Gilead's LDV/SOF combo trial for GT3s (only ongoing in NZ?). Does Ledipasvir as NS5A inhibitor has pangenomic properties/effect?

it's gonna be interesting (2014) year for sure!

all the best

Loopy Lisa · Guru

JIme wrote:
If I could wait, I would try and skip both riba and interferon.

I would too if it wasn;t for other things, but 1 extra year is too long :S

Loopy Lisa · Guru

Matt Chris wrote:
Hey Tig
How is your recovery going?
I too appreciate Malcolm simplified explanation of how these DAA's work.
Here is an article that explains in the same language what Malcom was talking about.
'New therapeutic strategies in HCV: polymerase inhibitors'
Link- http://onlinelibrary.wiley.com/store/10.1111/liv.12068/asset/liv12068.pdf?v=1&t=hp19yeil&s=1aae227485ae6b0a1614830440641a69081b1d93
BTW this is one of the fun weeks of the year because of the ground breaking difference that Sofosbuvir will usher in for millions of patients.
matt

Hi Matt, this link doesn;t open to anything? Please can you check? :)

JIme · Guru

If I could wait, I would try and skip both riba and interferon.

Biggyb · Guru

I think the majority of us hepc patients see that a drug has to be taken with interferon, most of us just think,,hell no. Not that crap again.

But 12 weeks might be tolerable. For me, i say no thanks.

suziq · Senior Member

Hi

The FDA approval of Sovaldi is just the beginning of approval of several very good meds --most without interferon. This is such exciting news and I believe there will be more approvals during the coming year.

I am on the Merck trial with MK-5172 and MK-8742 that Mallani referred to in his post. I got the arm with riba for 18 weeks. I am starting week 14 today, Don't have my VL back for week 12 due to ice storm here, but other labs showed my enzymes are best yet (and normal) and my Hgb is going back up. Had a scan that showed my liver and spleen are shrinking. So the coordinator expects UND from week 12 labs. Just waiting for a phone call.

The previous trial had 97 out of 98 SVR. And there was no difference between the arms with/without riba. However, it was an early phase 2 trial for Geno 1. I am in 2nd part of phase 2 trial with cirrhotics and null responders. EOT date is 1/14/2014. Some arms ended last week. And one arm for treatment naïve (no cirrhosis) was only 8 weeks.

And, since Merck (and others) need to do more clinical trials for FDA approval, there will be an opportunity to treat free. The approval of Sovaldi moved it out of the free area.

Matt Chris · Guru

Hey Tig

How is your recovery going?

I too appreciate Malcolm simplified explanation of how these DAA's work.

Here is an article that explains in the same language what Malcom was talking about.

'New therapeutic strategies in HCV: polymerase inhibitors'

Link- http://onlinelibrary.wiley.com/store/10.1111/liv.12068/asset/liv12068.pdf?v=1&t=hp19yeil&s=1aae227485ae6b0a1614830440641a69081b1d93

BTW this is one of the fun weeks of the year because of the ground breaking difference that Sofosbuvir will usher in for millions of patients.

matt

Loopy Lisa · Guru

I thought this was easy to read:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm377920.htm

-- Edited by Loopy Lisa on Tuesday 10th of December 2013 05:14:55 PM

Tig · Admin

mallani wrote:
Tig: I just re-read my post. Sorry, it isn't easy to read. I spend too much time reading Virology Journals. Basicly, all that is important is that nucleoside polymerase inhibitors are good, mutation resistant and cause few side effects.

Malcolm, No apology necessary! I wanted to express my admiration for your ability to commit such detailed information to memory and instant recall. There are many here that are able to do that and it's just plain impressive! My thanks to all of you.

darkstar · Senior Member

IMHO the best bet for genotype I is based on the COSMOS trial looking at a combo of simeprevir and sofosbuvir.

Loopy Lisa · Guru

mallani wrote:
Guys,
As Jill said, we have discussed Alisporivir (DEB025) previously. It is not a DAA, and one of our members (Bill) was pulled off a Trial last year. There are safety concerns, and personally I would avoid it at this stage.
Tig: I just re-read my post. Sorry, it isn't easy to read. I spend too much time reading Virology Journals. Basicly, all that is important is that nucleoside polymerase inhibitors are good, mutation resistant and cause few side effects.
Zlikster: Mate, I know you're impatient, but you can afford to wait for a while. You probably should avoid Riba, after your previous experience. Wait for Merck to get MK-5172 and MK-8742 approved. If the Victrelis pricing was anything to go by, Merck should put a reasonable price on their combo. Obviously Sovaldi/Ledispavir will be available first, and, for Geno 3's, almost certainly without Riba. For those who can afford it, this will be almost 100% SVR. Merck should be pretty similar. For the AbbVie drugs, ABT-450 and ABT-333 will probably not be effective for Geno 3's.
I will go on reading. I can't understand why Sovaldi isn't 100% effective. All articles comment about the NS5B active complex being stable, pan-genomic and present in all mutations. As nucleoside antipolymerases block this site, why can't Sovaldi be used as monotherapy? It's driving me nuts.....
PS: I've studied the structure of the S282T mutation, and can see why it could be a problem. However, Gilead insist that S282T has not been found in Sovaldi relapsers. If you want some light reading, try this......
http://aac.asm.org/content/56/6/3359.full

-- Edited by mallani on Tuesday 10th of December 2013 02:59:40 AM

The trial I listed is also is DEB205. I don't want problems I never had previously. Back to Sofosbuvir!

darkstar · Senior Member

Guys, I am probably going to get a lot of $hit for what I am about to say, but does anyone think that companies invest billions of dollars because of altruism. That used to be the role of the National Institutes of Health, they stopped long ago. If a company pays billions for a drug, they then have to invest additional megabucks for clinical trials that meet FDA standards and frankly your standards and my standards not just for efficacy but also for safety. Why has sofosbuvir been FDA approved as quickly as it has? It's not because anyone is worried about you or me, it is because of profit motive. So criticize Gilead, BMS etc all that you want but these drugs are going to be available because of potential profits. Is the price reasonable, not if you can't get the drug and I do not believe that insurance will pay today for genotype I.

India, what a great idea, let's go there....not. You get what you pay for. Although there are generic manufacturers in India that do a good job, many do not. There are many reports of patients receiving one of the many generic versions of a drug, all of whom have different side effect profiles. That means they are not the same drug and GMP is not adhered to. Simply not safe and I would never put that in my body.

Don't forget when you are talking about the economics of a drug that the company may have bought three other drugs for billions that failed. The economic are not simple and although the companies milk it for all that they can, the profit motive does improve care.

mallani · Guru

Guys,

As Jill said, we have discussed Alisporivir (DEB025) previously. It is not a DAA, and one of our members (Bill) was pulled off a Trial last year. There are safety concerns, and personally I would avoid it at this stage.

Tig: I just re-read my post. Sorry, it isn't easy to read. I spend too much time reading Virology Journals. Basicly, all that is important is that nucleoside polymerase inhibitors are good, mutation resistant and cause few side effects.

Zlikster: Mate, I know you're impatient, but you can afford to wait for a while. You probably should avoid Riba, after your previous experience. Wait for Merck to get MK-5172 and MK-8742 approved. If the Victrelis pricing was anything to go by, Merck should put a reasonable price on their combo. Obviously Sovaldi/Ledispavir will be available first, and, for Geno 3's, almost certainly without Riba. For those who can afford it, this will be almost 100% SVR. Merck should be pretty similar. For the AbbVie drugs, ABT-450 and ABT-333 will probably not be effective for Geno 3's.

I will go on reading. I can't understand why Sovaldi isn't 100% effective. All articles comment about the NS5B active complex being stable, pan-genomic and present in all mutations. As nucleoside antipolymerases block this site, why can't Sovaldi be used as monotherapy? It's driving me nuts.....

PS: I've studied the structure of the S282T mutation, and can see why it could be a problem. However, Gilead insist that S282T has not been found in Sovaldi relapsers. If you want some light reading, try this......

http://aac.asm.org/content/56/6/3359.full

-- Edited by mallani on Tuesday 10th of December 2013 02:59:40 AM

Loopy Lisa · Guru

Zlikster wrote:
i knew i should have stayed in .nl for good last time i was there :)

My dentist told me today he got connection with indian supplier and he will hook me up with him when the time comes. He thinks Sofosbuvir knockoff will be made there next year (if the production process is easy) as he knows they are producing cheap anti hiv meds there. Also told me a really nasty story about oral surgeon/dentist infected with hcv, who is avoiding hcv test/inspections by sending his asisstant's blood sample...now i am even more suspicious about my possible infection source.

Be careful as it is known to sell chalk pills too! I think that is utterly terrible, I love the Balkans as you know, but it breaks my heart seeing people unable to treat problems that are easily treated here! :/

Loopy Lisa · Guru

Cinnamon Girl wrote:
Zlikster wrote:
meh, treatment naive only (i am off) ;S

all 3 arms in this trial include Ribavirin and i do not have much information on Alisporivir, maybe Malcolm knows bit more info on it?

Hi Zlikster, as far as I know, alisporivir by Novartis is an oral host-targeting antiviral that inhibits cyclophilin, a host protein that HCV needs for replication. Not to put anyone off, but earlier trials, with a peg/riba combo, were put on hold in April 2012 by the FDA because of concerns about pancreatitis which 3 people developed. There was also one death but it wasn`t proved to be definitely linked to alisporivir.

I was just reading about it on th web, it is certainly something to seriously consider! :/

Zlikster · Guru

i knew i should have stayed in .nl for good last time i was there :)

My dentist told me today he got connection with indian supplier and he will hook me up with him when the time comes. He thinks Sofosbuvir knockoff will be made there next year (if the production process is easy) as he knows they are producing cheap anti hiv meds there. Also told me a really nasty story about oral surgeon/dentist infected with hcv, who is avoiding hcv test/inspections by sending his asisstant's blood sample...now i am even more suspicious about my possible infection source.

Loopy Lisa · Guru

suziq wrote:
Hi Zlikster and Lisa,

I don't know anything about this study you just found, but my coordinator called this morning and we chatted about Sovaldi. She said she was not impressed with Sovaldi SVR rates for Geno3---That there are better meds doing clinical trials for Geno 3. Maybe she was talking about this study you just found. Can't remember if Merck is doing a Geno 3 study, but probably not in Europe. Hope Mallani can shed some light on this new study. I am in the second part of a phase 2 study that started before any info was released. My coordinator had participated in the earlier part of the same study and assured me it was a good study. it sounds like a wonderful opportunity for both of you.

Wish both of you lots of luck!!!

SuziQ

Hi Suziq, they addressed this problem and changed type 3 from 12/16 weeks til 24 weeks - 24 being is now accepted as the duration of treatment as the odds became slightly higher than previous treatment to cure. :) Good luck on your trial, I will keep fingers crossed. Thank you for thinking of us. I'm afraid our genotype is a low percentage in the West so they are not too concerned with us lol. :)

-- Edited by Loopy Lisa on Monday 9th of December 2013 06:32:14 PM

-- Edited by Loopy Lisa on Monday 9th of December 2013 06:33:28 PM

Loopy Lisa · Guru

rebeca wrote:
Loopy Lisa wrote:

Thanks Karen, I was waiting to hear it had been approved in the US, I suspect january in Europe. I do believe the trail off drugs that follow in the next few years will eradicate Hep C. The real battle is people testing and having access to the drugs. Soon the toxic levels off drugs will be so short that they will have little effect in comparison to the warrier horse amount currently in use.
:D

Hi Loopy Lisa,
How does social security work in Netherlands?
Do you talk to your hepatologist to treat when approved in January?

Good luck and thank you !

Hi Rebeca, we have a different system than the US, we pay very high taxes in the netherlands and this is spread over many sectors - medical, education etc etc. We all pay insurance for medical whether working or non working. If we lose our job, we receive 70% of our previous income for one to two years on average, then it reduces over time. But we are always covered for medical insurance and basic living costs as it is a legal requirement. Even if you are married and your partner has an income, you are still entitiled to your unemployment benefit, it is based on an individual criteria. Most people do not remain unemployed for very long as people prefer to work for pension etc, etc.

I already discussed for Sofosbuvir on my previous chat with my infectious disease specialist, and if it is cleared for perscription I can have it when it becomes available. We have a very effiecent system. I hope this answered your question? :)

-- Edited by Loopy Lisa on Monday 9th of December 2013 06:16:58 PM

-- Edited by Loopy Lisa on Monday 9th of December 2013 06:23:18 PM

Zlikster · Guru

Hi SuziQ :) thanks for info. Hope Merck puts out some GT3 clinical trial, i can't find any atm?

Sofosbuvir results after 24w for GT3s doesn't sound that bad, for 12w were dissapointing tho...

Hows your trial going on? next pcr @ 12w? (btw, congrats on 4 n 8w UND!)

thanks!

suziq · Senior Member

Hi Zlikster and Lisa,

I don't know anything about this study you just found, but my coordinator called this morning and we chatted about Sovaldi. She said she was not impressed with Sovaldi SVR rates for Geno3---That there are better meds doing clinical trials for Geno 3. Maybe she was talking about this study you just found. Can't remember if Merck is doing a Geno 3 study, but probably not in Europe. Hope Mallani can shed some light on this new study. I am in the second part of a phase 2 study that started before any info was released. My coordinator had participated in the earlier part of the same study and assured me it was a good study. it sounds like a wonderful opportunity for both of you.

Wish both of you lots of luck!!!

SuziQ

rebeca · Veteran Member

Loopy Lisa wrote:

Thanks Karen, I was waiting to hear it had been approved in the US, I suspect january in Europe. I do believe the trail off drugs that follow in the next few years will eradicate Hep C. The real battle is people testing and having access to the drugs. Soon the toxic levels off drugs will be so short that they will have little effect in comparison to the warrier horse amount currently in use.
:D

Hi Loopy Lisa,
How does social security work in Netherlands?
Do you talk to your hepatologist to treat when approved in January?

Good luck and thank you !

Cinnamon Girl · Guru

Zlikster wrote:
meh, treatment naive only (i am off) ;S

all 3 arms in this trial include Ribavirin and i do not have much information on Alisporivir, maybe Malcolm knows bit more info on it?

Hi Zlikster, as far as I know, alisporivir by Novartis is an oral host-targeting antiviral that inhibits cyclophilin, a host protein that HCV needs for replication. Not to put anyone off, but earlier trials, with a peg/riba combo, were put on hold in April 2012 by the FDA because of concerns about pancreatitis which 3 people developed. There was also one death but it wasn`t proved to be definitely linked to alisporivir.

Loopy Lisa · Guru

Zlikster wrote:
oh, which one? :) do share!...i have just sent (another) email asking for participation in Sof+Rbv clinical trial in UK http://www.clinicaltrials.gov/ct2/show/study/NCT01962441

Looks good too :)

AngieV123 · Senior Member

I see my doctor on January 13th to hopefully get the ball rolling to get started on this new treatment. I was disappointed to find that I would still need to use interferon ...but the 12 week duration sounds good to me. I read just now that people that have issues with interferon that are type 1 can be considered for just the sofosbuvir and ribovarin for 24 weeks instead.

Zlikster · Guru

meh, treatment naive only (i am off) ;S

all 3 arms in this trial include Ribavirin and i do not have much information on Alisporivir, maybe Malcolm knows bit more info on it?

Karen · Senior Member

As mentioned in the article-the cost of the disease far weights out the price of treatment. I have not been on many allopathic drugs in my life but from people I know they are bloody expensive. Somehow they manage to get them covered or assistance. Give this time, don't jump the gun...there will be a way! For now...let's be grateful that we have a solution.

Loopy Lisa · Guru

This one Zlikster:

http://www.clinicaltrials.gov/ct2/show/NCT01970904?term=novartis+hepatitis+c&rank=2

Phase two is safe enough for me . If I can't get on it or fail, plan B. :D

-- Edited by Loopy Lisa on Monday 9th of December 2013 05:13:21 PM

-- Edited by Loopy Lisa on Monday 9th of December 2013 05:40:17 PM

Zlikster · Guru

oh, which one? :) do share!...i have just sent (another) email asking for participation in Sof+Rbv clinical trial in UK http://www.clinicaltrials.gov/ct2/show/study/NCT01962441

Loopy Lisa · Guru

I doubt it will be anywhere near that in Europe. They can't refuse treatment on price in the Netherlands, so they will have to suck it up as it is for the welfare of the patient.... I am considering enerting the trial coming in Germany, one is not too far from me anyway, 12 week! ;)

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