A few people mentioned joint pain as HepC related issue. I also suffer from it. During the treatment it has worsened and I'm wondering if that's because I've stoped taking fish oil and other supplements. Is it safe to take fish oil during treatment? I hope it would not interfere with the absorption of the meds.

I'm with you, guys.
20 years of depression history, sleep problems, buzzing all night and drugging my feet all day. Not anymore tho. Sleep and mood has improved from the day one of the treatment. Tinnitus is still present.

Hi Dr. Freeman, if you would like a treatment naive genotype 2B in there and if I get my meds, I would participate. Wonderful idea, let me know if you would like me in.

Can hep c cause anxiety symptoms, migrating symptoms like knot travelling from abdomen to chest. Like feeling the pulse all over the body, buzzing feeling...I am not in any treatment. I have one year with many diffrent symptoms

WILSON1 wrote: Hi Sirchinenge,
I have read Greg's blogs and did see his opinions on FDA regulations. I don't recall ever seeing where he shipped to US. Lotsa "rules" regarding legal shipping to US. It is not legal.//cut

Hi WILSON1, here is Greg's August 8th blog entry:

"USA deliveries of Sofosbuvir for personal use.
My friends from India recently successfully completed a "worst case scenario" delivery of a three month treatment of Sofosbuvir and Ribavirin tablets to the USA.
As some of you may know the way that Customs works in most countries is that there is a random sampling of goods arriving from overseas origins. In the USA this random sampling has increased due to the issues surrounding international terrorism.
In practical terms this means that, lets say, one in every ten parcels comes in for superficial scrutiny and one in every twenty comes in for close inspection.
Close inspection means that contents and documentation is thoroughly inspected.
This happened recently with a shipment of Sof/Riba to a person with Hep C in the USA. This shipment had all its documents and contents inspected by Customs. The recipient was contacted and further supporting medical documents were asked for. The parcel and documents were then brought to the attention of the FDA who also inspected them closely. The result was nearly three weeks of official inspection of this shipment by every related US government entity.
Result?
The shipment of 84 generic Sofosbuvir tablets and 504 Ribavirin tablets was delivered to the person who ordered them and that person has now begun treatment.

So much for all the nonsense being peddled around by the fear mongers that it is illegal to import medicines for personal use into the USA.

My message to you folk in the USA; don't get sucked in by the fear mongers, right now hundreds of people around the world are being cured of their Hep C by using Indian generic medicines. Despite what some people say your government does not want you to be sick or to die. If you can find a couple of grand then you can be well on the way to curing yourself of Hepatitis C."

The reality for most sufferers at the moment in the UK is no DAA-only treatment until they have significant liver damage. That's not going to change unless the price of new meds comes down drastically.

OK - So yesterday NICE approved Harvoni, DAC and the AbbVie. For restricted use on NHS England.

However, Nothing will be implemented for 3 months, rumour has it Feb/March 2016.

The details for GT3 are very vague and they have not addressed this GT properly.

Many hospitals have been devolved from central Gvt and are hugely in debt and will not have the budget.

There will be waiting lists and post-code lottery.

For GT1 Tx naive only 8 weeks Harvoni.
and not all treatments the EASL recommended duration.s.

As a treatment 'guidance' (but I believe not legally in the small print) We should all have access to the approvals as listed by NICE and they have 3 months to implement this according to the HepC Trust

A pleasing step in the right direction, but maybe not all it's cracked up to be in the headlines.

We watch, and wait? The reality for many is one - two years away.

Oh come on, give me a break. My score will be on the minus side.

Actually, I'm fighting to get 233,000 treated In the group with the highest infection rate, the lowest treatment success rate and the shittiest medical care. So I tend to be over protective.

Pee Pee

Hi all,
I wouldn't wish this disease on anyone, but since I stumbled onto this site about a week ago, I feel like I have a new family of friends, and am not feeling so alone and fearful in this big ol' maze of information, decisions, and struggles. But, knowledge is power, and I am so excited and hopeful to learn more about the generic meds. I thought that since I have already had treatment and relapsed, that my treatment options were done. Who can afford a round of Sovaldi after all? My biggest hurdle in getting meds shipped to me is going to be getting a script. I did see on another post that Dr Freeman was talking to docs in the UK about writing scripts and consulting. Am wondering if he or any one else out there has heard of a doctor or specific clinic in the US who may be willing to do the same? As always, thank you for sharing your stories and info. God bless.

Thank you for posting this. I have updated the side effects page to link back here and added some additional data to it around the ADRs and mortality risk.

fixhepc.com/getting-treated/how-to-do-it...nt-side-effects.html

One of the problems with this demographic group is age.

At the age of 65 you have over a 2% per year risk of dying, or 0.5% per 12 weeks.

What this means is that if I started a hair brushing trial, and brushed the hair of people in this age group every day for 12 week, and did it to 200 people, one would probably die (statistically) during this period.

Now intuitively we know it was probably not the hair brush that killed them, but they still died while having their hair brushed daily.

Sadly some people will die taking these medications, but when you look at the big picture 10,000 times as many people died last year (500,000) because they did not take these medications, than those who may have died because they did take them (< 50).

Hi PeePee, Thanks for responding. I haven't spoken with a soul about my situation and I suppose I was looking for a shoulder to whine on. (Bartender tired of hearing it!) I'm prescribing myself 24 weeks of treatment, cirrhotic and all. The medication by itself runs over $8000 a week x 24 is uhm, a lot. Forget about the tests, doctors etc. I figure on 3 choices: #1- steal the meds or enough money to buy them, #2- find the meds at an affordable price #3-just die. Gonna have to go with door #2 on this.. Either the pills or the API's. I think API's are gonna be best choice for me at the time. Through the brain fog I don't remember exactly where it is but it is illegal for a pharmacist in the US to compound these API's. Still gotta go with door #2.
Is curious you mention HIV. I did go to an HIV clinic several weeks ago and they said they would help but appt. would be next year. They did call yesterday with an appt for Monday. Am hoping this is behind door #4. I did mention I am cirrhotic and just feeling pressed about time on this. I am hoping to stir some things up in this country, right after SVR.

We're not shy, so we asked the FDA

"If a drug (Sofosbuvir) is approved in the USA, however, too expensive for consumers and not covered by insurance, can the patient import the drug from another country? Would affordability qualify as a reason to address availability in the USA?"

Their answer....

"Unfortunately, you cannot obtain Sofosbuvir through personal importation because the drug is approved and available in the U.S. Although I understand how the price of the drug can be an access barrier for you, affordability is not considered when the Food and Drug Administration (FDA) is determining if a medical product can be personally imported into the United States.

I hope this information is helpful. Contact me if you have any questions or concerns.

Take care,

Deb

Deborah J. Miller, Ph.D., M.P.H., M.S.N., R.N.
Health Programs Coordinator
Office of Health & Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration"

I say what are they going to do? Throw everybody who buys generics in jail? Because we have 233,000 veterans with Hepatitis C (180,000 diagnosed the rest undiagnosed) under the care of the Veterans Administration and as of June they had only treated 39,000 (only 8.000 with the new meds) and they say there's no more money to pay for treatment.

In the 1980's people with HIV started Buyers Clubs to sell supplements unapproved by the FDA in an effort to improve their conditions. The FDA finally allowed it when HIVrs held protests and had one where they laid on the floor with tombstones above their heads that said "Killed by the FDA", etc.and it made the national news.

Unfortunately, people with HCV are not as organized.

Anyway, I see why I was invited to this site. I'm known for attempting the impossible, out in the forums where my shield of "good nurse" doesn't protect me.

Mesochem is selling both sofosbuvir and Daclatasvir (both powder form) without a prescription. $1800 American dollars for both. Lots of people in the forums are using them without a doctor. That worries me. Nobody should treat on their own. Plus they're doing very creative things when they can't find a compounding pharmacy to make the capsules for them. One woman said she puts the powder in a tablespoon and adds a little water then drinks a glass of juice to get rid of the taste. Others are getting different size capsules, some add fillers, most don't.

Re side effects:
We lost one on Sovaldi+Olysio, liver and kidney failure and a post transplant patient ended up on permanent dialysis (had a GFR of 23 at baseline) and tests showed he had a heart attack during treatment with Harvoni. One forum had a heart attack (Sovaldi=Riba) and another had a man who had chest pain for the last 3 weeks of treatment and refused to stop (his doctor gave him Tramadol). He was having cardiac symptoms a few days after finishing treatment. I sent him to the cardiologist.

Plus I'm seeing quite a bit of retinal damage. Well recorded because some of the people had eye exams before and after treatment and their vision got worse (studies did eye exams and they did them for a reason). One of ours had a detached retina a few days after finishing treatment with Harvoni. So far people taking generics are complaining of only minor side effects. Some are not talking, I guess they're taking the 5th.

Pee Pee Price

It may be helpful for you to read fixhepc.com/blog/item/17-lismore-liver-c...to-see-patients.html

The Lismore Liver Clinic nurses have been given official permission to monitor patients on treatment.

It's great to see government stepping up on this.

The REDEMPTION clinical trial site is clinicaltrials.gov/ct2/show/NCT02657694?term=REDEMPTION&rank=1

REviewing
DAA
Efficacy
Managing
Patient
Treatment
In
Online
Neighbourhoods

REDEMPTION-1 is already underway and is closed but REDEMPTION-2, REDEMPTION-3 and REDEMPTION-4 are currently recruiting. The results will be have been presented at EASL and AASLD. We expect to show that generics work but don't want to pre-empt things. We now know that generics work effectively.

Update2: We were also accepted for AASLD 2016 in Boston and presented.

Update: We were accepted for EASL 2016 in Barcelona and presented. Here's the results (and they look pretty good)



You can find the full presentation here: fixhepc.com/forum/media-news/914-easl-sl...-4-svr4-overall.html or watch the video.



REDEMPTION-2 and REDEMPTION-3 will be presented in 2017. They are trials so we don't know what they will show but expect that giving generic versions of Hep C medications has predictable results.

REDEMPTION-2 is testing the efficacy of generic Sofosbuvir 400 mg / Daclatasvir 60 mg across all genotypes at full phase 3 scale and is open now.

REDEMPTION-3 is testing the efficacy of generic Sofosbuvir 400 mg / Ledipasvir 90 mg in genotypes 1, 4 and 6 only at full phase 3 scale and is open now.

REDEMPTION-4 is testing the efficacy of generic Sofosbuvir 400 mg / Velpatasvir 100 mg across all genotypes at full phase 3 scale and is open now.

The REDEMPTION trials are different:

• First everyone gets active medication at full therapeutic dose, and there is no placebo.
• Next, it is not free. Entry into the Sof/Dac trial -2 arm wil cost $1500 USD and entry into the Sof/Led trial will cost $1600 USD. This is the best price in the market right now and includes shipping.
• Finally there will be no cherry picking of entrants to bias outcome results, so we will find out what the best medications are

The REDEMPTION-2 and -3 and -4 trials will both feature REAL TIME REPORTING of side effect and on treatment viral load for complete transparency.

To get started with REDEMPTION go here: fixhepc.com/the-new-hepatitis-c-cure-is-affordable

hi,
Hope everyone is feeling well today,
I read this last night & thought it was relevant to this discussion, it's about big pharma, pricing, global access to HCV meds by Els Torreele, the Director of Access to Medicines, Public Health Program, Open Society Foundations.

Really worth reading & exploring the whole blog, a lot of good links in the body of that article, also If you would like to contribute a guest post on that blog, there is a contact details there.

from the blog:
"The unaffordability of medicines is no longer just a problem for poor people in developing countries—it is a global public health emergency. Excessive prices stand between North American and European patients and life-saving treatments. Strained health budgets lead states and insurers to delay or ration expensive medicines and increase out-of-pocket expenses. To get the drugs they need, patients must suffer serious “financial toxicity,” as cancer doctor Leonard Saltz poignantly puts it, or forego treatment altogether.
"

this is part 1:
blogs.plos.org/yoursay/2015/10/13/talkin...access-to-medicines/

part 2 is written by a Jessica Wapner, a freelance US science writer, activist, blogger, most enjoyable reading.
Here she explains how the big pharma works out their drug pricing strategy, like how do you get from $101 - the real cost of tx with Sofo to $50000 or more depending in which country you happened to live :

blogs.plos.org/yoursay/2015/10/15/talkin...-post-will-cost-you/