Hep C Discussion Forum

pl1952 · Senior Member

RE: Who's waiting for treatment with ledipasvir and sofosbuvir?

Isiscat2011 · Guru

Groupergetter wrote:
Not sure if my doc wants this combo or another coming in December. Guess I'll find out in October

I wouldn't be surprised if your doc wants you to wait for the ABBVie combo since you relapsed on Sovaldi.

Gracie · Guru

Yes, your right. I won't do RIBA Inteferon again. I'll wait (patiently maybe) for the pill combos. Hope the wait isn't too long!

Groupergetter · Guru

Not sure if my doc wants this combo or another coming in December. Guess I'll find out in October confuse

pl1952 · Senior Member

Well, it looks like, for me anyways, it will be mid November for starting this treatment, assuming all goes well with insurance coverage too. I was told its going to take them a few weeks in the beginning to "work out the bugs and by mid November the office will be a well-oiled machine in order to get the drugs a bit more expeditously"... Ahhh, what's a few more weeks, huh... oh well! :)

Isiscat2011 · Guru

Thank you for the update, Colin. So glad you were able to get on this tx and wishing you the very best results! :)

col135 · Member

Hello there im now just short of three weeks of tx and my viral load is going in the right direction down from 465.000 to 325.00 so im pleased with those figures.Im back at the royal london on the 2nd september i did not have to attend on the 26th for bloods so a week off.As for side effects im definitly suffering from being extremely tired and very lethargic.My eating habits are just as poor as before tx and that still applies to my sleeping pattern as well can stay in bed for quite a while.Ive suffered with a few headaches but to be honest they do not seem to last long im looking forward to see at the end of tx how im going to feel.Wishing everybody the best with tx.Colin.

Isiscat2011 · Guru

I hope you get the all orals soon, Gracie. smile

They aren't going to try to put you on Sovaldi with Interferon/Riba are they? That probably would not be advisable since you have had viral breakthroughs both times before using Interferon. Time to get something new that works for you.

Gracie · Guru

Well I was prescribed Incevik in December 2013 so that tells you how far behind we are. I asked my doctor around week 5 when I found out that with a viral load of 22, that I would have to do 48 weeks, why he never prescribed the sovaldi combo. He said it wasn't available in New Brunswick. I have the impression that I could have and thus should have convinced him to try to get me approved through my private insurance companies for the sovaldi combo, but I was deep in anemia by then and didn't have the energy to argue with him. I was still convinced I was being cured so didn't want to muddy the waters. I'm waiting the six months and then am going to contact my insurance companies myself to see if I'm covered. He can't say no of I go in to see him armed. It's a bad situation here, not enough doctors and thousands that don't even have family physicians. I think he was just too busy. Hope I'm wrong, but I'm going to take my next treatment into my own hands, even if I have to travel to Quebec or Ontario. My life, my choice!

pl1952 · Senior Member

The exhaustion is debilitating most times. Just no energy to do anything -- its as if life is passing me by. Oh, Isis, I forgot the brain fog. This has been for years as well. I can't remember a damn thing. I can read something....don't ask me 2 minutes later to explain what I read. Years ago I attributed all of this to just getting old...but I know for damn sure now the fatigue is a direct result of the hep c. The brain fog...oh well...I'm not as confident that's ALL from HEP C! LOL In any event, I know all of us here and looking forward to getting rid of this thing and living life without this disease! :) And thanks for the good wishes for hubby!

-- Edited by pl1952 on Monday 25th of August 2014 12:03:32 AM

Isiscat2011 · Guru

So glad your husband is doing well. You will get there, pl1952.

Fatigue is my biggest symptom too. It isn't even comparable to being tired; it is like total exhaustion sometimes. I have felt like I must have narcolepsy, because I sometimes get so exhausted that I can't stay awake, and I have to sleep for a few minutes. It feels more like passing out than sleeping. My doc said I don't have hepatic encephalopathy, which I was concerned about, so I guess it is just extreme fatigue.

It will be so good to be rid of this!!

pl1952 · Senior Member

My husband feels really good and we're both hopeful he'll still be undetected. I on the other hand have the worst fatigue ever, my biggest symptom. I've seen the change in him and it gives me hope that I'll get there too.....

Isiscat2011 · Guru

pl1952 wrote:
I'm excited Isis! I feel like I've been waiting forever....I'm still going on 9/23...We'll see if my husband reached SVR 12...Hoping and praying! But damn, I'm excited, yes I am!!! :)

Wow, Sept.23rd will be a big day for both of you! How are you both feeling?

pl1952 · Senior Member

Hi Colin, How are you coming along?

pl1952 · Senior Member

I'm excited Isis! I feel like I've been waiting forever....I'm still going on 9/23...We'll see if my husband reached SVR 12...Hoping and praying! But damn, I'm excited, yes I am!!! :)

Isiscat2011 · Guru

Any idea on when you might get it, Gracie?

Gracie · Guru

I am... Even though I'll have to wait longer... biggrin

Isiscat2011 · Guru

Hi Anon4This:

If you make your appointment for before October 10th the doc can't prescribe it yet. So, you will just end up having to make a second appointment!

My doc said it should be on the specialty pharmacy shelves right away post approval on October 10th. Most insurance will require preauthorization, and they can't preauthorize till after Oct 10th, so that process could take a while.

Is everybody excited? biggrin biggrin biggrin

pl1952 · Senior Member

My NP said I should reschedule my 9/23 appt. for end of October or November, that "9/23 is a bit too early for the new stuff". My husband goes 9/23 to see if he has reached SVR 12 at that time. An important appointment...So there's no cancellation of appts., but it will give me an opportunity to find out more info to see if they know when S/L will actually start to be dispensed and share it here....

Anon4This · Member

Mine is on September 30th at Mass General in Boston...Can't wait. Keep us posted about your progress.

pl1952 · Senior Member

Can't wait! We're getting there....my appt. is 9/23

Cinnamon Girl · Guru

col135 wrote:
Hello and thanks for the support obviously im very fortunate to be recieving the tx but i am aware that when i signed all the paperwork that some of the drugs are not licensed in the uk.Although for me i was told that waiting maybe another year would not be to my advantage so i decided to sign up,prof foster is very excited that he can be part of hopefully curing so many people.Mallani im sure we have spoken already when i was struggling it was quiet a while ago,and thank you Tig56 i will keep you all updated.Problems that i endured on tx before was low white cell count and low platelets and being anemic.Im hoping this time that its going to be plain sailing yeah right!!!All the best to everyone Colin.

Hello again Colin, great to hear your good news and I`m so pleased your doctors have put you on the compassionate access scheme which allows you to get these drugs over here in the UK where they are not yet approved for general use. With your medical and tx history though I would have been very surprised if you hadn`t been selected and I wish you all the very best of luck!

I`m glad you`ve posted your update on the forum and I know you can count on getting plenty of support here!

Keep us posted and I`ll be following your progress.

(Ps - Thanks for your message, I`ll reply shortly.)

Gator Man · Senior Member

Hi Colin,

I will join the others and welcome you back to the forum. As you can see from this thread, there are members eagerly awaiting tx approval for Sovaldi/Ledispasvir in the U.S. Some are tx naive, but many are like yourself who have been non responders or relapsers with prior Hep C combos. I'm sure they will value updates on your own tx experience as a sneak preview of what's in store with this latest DAA combo.

I expect that this go around with tx will be a lot easier for you, and hopefully "plain sailing". Good luck and we look forward to your posts.

col135 · Member

Hello and thanks for the support obviously im very fortunate to be recieving the tx but i am aware that when i signed all the paperwork that some of the drugs are not licensed in the uk.Although for me i was told that waiting maybe another year would not be to my advantage so i decided to sign up,prof foster is very excited that he can be part of hopefully curing so many people.Mallani im sure we have spoken already when i was struggling it was quiet a while ago,and thank you Tig56 i will keep you all updated.Problems that i endured on tx before was low white cell count and low platelets and being anemic.Im hoping this time that its going to be plain sailing yeah right!!!All the best to everyone Colin.

Tig · Admin

Hi Colin,

I'd like to welcome you to the forum too! Sounds like you've had quite a ride so far and I'm thrilled that you are able to participate in this excellent treatment protocol in London. You've got an impressive group of professionals taking care of you. I see nothing but great results in your future!

I'm anxious to hear about your treatment and how you feel during the initial weeks of administration. You're on a blockbuster combination and should respond very well. Good luck buddy, hang in there!

Tig

Groupergetter · Guru

Isiscat2011 wrote:
Only 8 weeks (63 days to be exact) till Sovaldi/Ledipasvir is approved in the US! Time goes by so fast. I hope everybody has their doctor appointments scheduled! :)

My appointment is scheduled the 15th, hoping my insurance will cover meds. After S/O relapse not certain my doc will prescribe this? I still wondering what the best tx would be for me at this point?

mallani · Guru

Hi Colin,

Welcome to the Forum and it's good that you managed to get on that powerhouse of a drug combination. Keep us informed of your progress. Cheers.

col135 · Member

Hello there ive just started tx on ribavirin/ledispavir/sofosbuvir i started on 6/8/2014 im in the u.k.Its on the expanded access scheme for only 500 people at present, im under the care of prof,graham foster and his team at the royal london hospital england.Im taking 1200mgs of ribavirin 600 at a time split into am/pm and 400mg of sofosbuvir which is combined with 90mgs of ledispavir in the morning at present no side effects that ive noticed early days though.I have been waiting 4 yrs for this tx after i was a total non responder in 2010 whilst using ribavirin/interferon im genotype 1a with varices in my throat ascites of the stomach and cirrhotic liver and a swollen spleen.Just thought id reply incase you was interested in being informed of my progress etc.All the best Colin.

Mugsy · Senior Member

I had scheduled my every 6 months appt for October 1st. Just got a call that they want to move it back to October 15th. First time I have been happy for a cancelled appt!

Isiscat2011 · Guru

Only 8 weeks (63 days to be exact) till Sovaldi/Ledipasvir is approved in the US! Time goes by so fast. I hope everybody has their doctor appointments scheduled! :)

Isiscat2011 · Guru

pl1952 wrote:
Hoping and praying for the best.

I hear you, pl1952, and Hubby definitely has some good things going for him. As I recall he is tx naive and he is also a 1b-- both very good things. Fingers crossed.

Isiscat2011 · Guru

Turnsit wrote:
I am on s/o as i have mentioned and have a feeling next i am on s/l. I am one of the more ill ones so no riba or interferon, did t work anyway the first go and did a year! I have not cleared the virus on s/o but my platelet level became 4x's as high, it was low low low and my liver profile readings are very nice and they were off the charts! Really this disease for me is like being stuck on a spinning wheel so i just live...

Hi Turnsit:

Hopefully not, but if you do need to treat with S/L, the side effects are reportedly less than S/O. I know how much you enjoy your cycling, and the Olysio has put a cramp in your being outdoors during the day, but that shouldn't be a problem with the S/L combo.

Good news about your increased platelets and liver readings. As someone who also has low platelets and abnormal liver readings I'm sure it must be a good feeling just to see those in a better range. Take care.

Beacon · Senior Member

Isis-

"I'm thinking that Interferon will become a thing of the past (at least in the US market) come October."

Let's keep our fingers crossed :)

pl1952 · Senior Member

Isis, last time my husband saw the Dr. (he's my Dr. too), I reminded him about me waiting for October to treat and the Dr. responded "oh, that's right you're waiting for the 'good stuff' "....so I think you may be right about Ledipasvir being superior to Olysio. My husband just made 4 weeks EOT on S/O. Next week he visits the Dr. I just emailed to see about getting a VL test done at this time. All throughout treatment he had VL tests pretty much every 2 weeks. Wish I saw more EOT responses on this protocol, but I guess the info is starting to come in little by little. He's cirrhotic, so we have our concerns. Hoping and praying for the best. And I'll definitely post here to keep the info coming!

Turnsit · Veteran Member

I am on s/o as i have mentioned and have a feeling next i am on s/l. I am one of the more ill ones so no riba or interferon, did t work anyway the first go and did a year! I have not cleared the virus on s/o but my platelet level became 4x's as high, it was low low low and my liver profile readings are very nice and they were off the charts! Really this disease for me is like being stuck on a spinning wheel so i just live...

Turnsit · Veteran Member

Just happened to view this, thanks, this is the boat i sail in, its tough alright to keep things flowing so i just take it as it comes and live one day at a time. I use strenuous exercise to keep the oxygen and blood flowing...

Isiscat2011 · Guru

Thanks for posting this valuable information, Suziq. Substantial relapse rate for 8 weeks tx time, and that is just for the non-cirrhotic, tx naive, who also included Riba.

suziq · Senior Member

Hi all,

Pulled up a chart from my Merck trial that I am posting, primarily in response to longer vs shorter treatment times. It is only for the treatment naive non-cirrhotic patients in the trial, but it does indicate that longer treatment--at least with their drug and that group--is better. I had 18 weeks with Riba in my arm of the trial. Looks like the Riba caused more to dis-continue treatment. I am EOT+24= SVR just last week.

Although shorter treatment time seems nice, since the newer drugs have so few side effects, I would really prefer better outcome to shorter time. As the drugs get out in to general population, we will know more about response hopefully. Problem is that there will be no documentation of the results as with the trials. On forums like this one (lots of intelligent info and great people) we will be able to learn more about how well people are doing outside of the trial info that we originally had.. It is important that those on the newer drugs continue to post during and after treatment so there is information about the new FDA approved drugs--not just trial information. For instance, I had a lot of stomach pain during end of trial, as did another patient that I corresponded with, which is not listed as side effect. There are also ongoing trials relating to length of treatment.

-WORTHy Study Design

C-WORTHy is a two-part, parallel-group, randomized (within group) clinical trial evaluating a range of subpopulations of patients with HCV GT1 infection. The study evaluated different treatment durations of MK-5172 (100 mg once daily) plus MK-8742 (50 mg once daily), with or without RBV. A total of 471 patients with HCV GT1 RNA levels of 10,000 IU/mL were enrolled in C-WORTHy across 16 arms.

Key Findings for MK-5172/MK-8742

The interim results presented were from treatment-naïve, non-cirrhotic patients who received one of 3 regimens: A) MK-5172/MK-8742 + RBV for 8 weeks (N=30), B) MK-5172/MK-8742 + RBV for 12 weeks (N=85), and C) MK-5172/MK-8742 (without RBV) for 12 weeks (N=44), (see table 1).

Table 1 Interim Results from the C-WORTHy Trial Showing Treatment-Naïve, Non-Cirrhotic Patients with HCV GT1 Infection (Intention-to-Treat (ITT) Analysis)


Parameter	MK-5172 + MK-8742 (NO RBV) (12 Weeks) (N =44)	MK-5172 + MK-8742 + RBV (12 Weeks) (N = 85)	MK-5172 + MK-8742 + RBV (8 Weeks) (N =30)
SVR4-24, % (n)	98% (43)	94% (80)	83% (25)
No SVR, % (n)
Breakthrough	0	1% (1)	0
Relapse	2% (1)	1% (1)	17% (5)
Non-virologic Discontinuation	0	4% (3)	0
By Sub-genotype
GT1a	97% (29)	94% (49)	83% (25)
GT1b^§	100% (14)	94% (31)	--
Part A: 100% of patients completed Follow-up week (FU)24; Part B: 8 week arm: 93% have completed FU8; 12 week arm: 100% of patients have completed FU4; 2 patients (Part A) and 1 patient (Part B) discontinued early and are counted as failures. § Two patients with GT1 (non-a, non-b) were enrolled; these are analyzed with GT1b.

Among the five patients who relapsed in the eight-week regime

mallani · Guru

Hi Matt,

It's off-topic again, but just to try to answer your question.

Liver blood supply is complex. About 25% of the blood supply comes from the hepatic artery which brings oxygen rich (95% saturation) blood from the heart. The remaining 75% comes via the portal vein. This is formed by the junction of the splenic and superior mesenteric veins. This brings all the absorbed drugs from the small intestine. It also carries oxygen but in reduced saturation ranging from 50% after a meal to about 85% fasting. The portal vein supplies about half the liver's oxygen requirements.

I need to explain how blood reaches hepatocytes. The hepatic artery and portal vein branch and empty into thin-lined sinusoids that are lined by hepatocytes. Oxygen reaches the hepatocytes by the usual passive diffusion ( high concentration to low concentration). Same deal for drugs ( eg the DAA's). Blood drains from hepatocytes into venous sinusoids, that join to form the central veins that coalesce to form the hepatic veins.

In cirrhosis, the liver tries to protect itself from portal blood flow (too much work!). Fibrous tissue forms around the portal vein branches narrowing the lumen. The portal vein pressure rises. Blood starts to bypass the liver by collaterals that join the portal and systemic circulation and blood is shunted to avoid the sinusoids. The varices in the lower oesophagus and stomach are an extreme example of this. Eventually this leads to decreased portal flow in the liver, meaning less oxygen and drugs. The hepatic artery tries to compensate by increased flow (more oxygen)- this is only partially successful. A cirrhotic liver shows many areas of low oxygen saturation.

Another problem for cirrhotics is the regenerating nodule or lobule. This is the feature of cirrhosis. For a lobule to function, it needs a portal vein branch, an hepatic artery branch, a draining vein branch and a bile duct sinus to drain bile. This fine architecture of a lobule is often missing or incomplete. These contain hepatocytes that may be filled with virus but with little drug exposure. These are the viruses that can 'hide', unaffected by adequate DAA levels in peripheral blood.

This is greatly simplified. It's enough to know the liver blood supply is very complex and different from other organs. The DAA's have trouble reaching parts of a compromised liver.

If Talal is saying this also applies to patients that are less than F2, I have no answer.

Isiscat2011 · Guru

Beacon wrote:
Pl- No matter what happens it looks like Solvaldi combined with "something" is going to be the standard treatment. So in October it's going to be LDV/SOF, or SOF/OLY, or SOF/RBV/INF, etc. As things are changing very quickly, I see INF dropping out of the picture before long. I was diagnosed in Sept of 2013 and my specialist doctor said because I have cirrhosis that I shouldn't wait but wait I have and tried not to panic. That was pre-Sofosbuvir approval so the treatment would have been the old "triple therapy". I keep an eye on my albumin, platelets, bilirubin, etc. to make sure my liver is functioning well (I would hate to see what it looks like), do some aerobic exercise, drink lemon juice daily, and try to eat healthier while I wait and hope and pray for the best for my future.

Good call, Beacon. My brother also opted not to do the triple tx and for him the decision has paid off. While my liver damage actually accelerated during tx his has increased very little and he has not become cirrhotic. He also doesn't have the PI RAVs, and should be much easier to treat, for which I am very thankful.

I'm sure you are right about Sovaldi being the backbone of any tx come October, but come December, the Abbvie tx should be FDA approved. Then the tx one receives comes down to cost for most people. Obviously, whatever costs less is what insurance companies will want to pay for. That is probably why Gilead is now hot to sell the 8 week tx plan--to remain cost competitive. It is all upside for them because if the reduced tx time doesn't work as well they will have repeat customers. Cynical, I know; but that's the game they play. I'm thinking that Interferon will become a thing of the past (at least in the US market) come October.

Matt Chris · Guru

For myself the waiting for LPV & SOF has been a marathon, keeping my mind off it has been the goal but easier said than done.

A recept article examining why HCV patients relapse found a pretty much obvious conclusion about why, but the conclusion seems to point to duration of treatment to be important.

Here's an excerpt from http://hepatitiscnewdrugs.blogspot.com/2014/07/study-begins-to-define-how-long-hcv.html

RNA Decay in Liver Lags Behind That in Blood

Findings regarding the rate of decay for viral ribonucleic acid (RNA) an indicator of how quickly the virus is being eradicated are of particular interest.

We found that HCV RNA decay in the liver lagged behind that in the peripheral blood, which has implications for how long the virus may persist in the body and the possible duration of treatment needed, Talal says.

Researchers also found higher levels of telaprevir in blood than in the liver.

These findings can affect the duration of therapy, said Talal, adding that they can also help identify when drug-resistant variants of the virus emerge in the blood and liver.

The longer treatments have a higher SVR percentage in every DAA trial I have every studied with cirrhotics and previous treatment patients. So untill they figure how to have the DAA's or other drugs reach the hard to reach areas of a cirrhotic liver in a faster and in a more complete manner, the longer treatment duration will be the norm.

Malcolm help me understand the term "perfusion " as it pertains to the blood reaching the cirrhotic areas of the liver. The saturation level of the DAA and Ribavirin in the blood plasma is also part of the puzzle as this is carried to the liver and every other area of the body.

matt

-- Edited by Matt Chris on Wednesday 9th of July 2014 06:01:33 AM

Beacon · Senior Member

Pl- No matter what happens it looks like Solvaldi combined with "something" is going to be the standard treatment. So in October it's going to be LDV/SOF, or SOF/OLY, or SOF/RBV/INF, etc. As things are changing very quickly, I see INF dropping out of the picture before long. I was diagnosed in Sept of 2013 and my specialist doctor said because I have cirrhosis that I shouldn't wait but wait I have and tried not to panic. That was pre-Sofosbuvir approval so the treatment would have been the old "triple therapy". I keep an eye on my albumin, platelets, bilirubin, etc. to make sure my liver is functioning well (I would hate to see what it looks like), do some aerobic exercise, drink lemon juice daily, and try to eat healthier while I wait and hope and pray for the best for my future.

mallani · Guru

Dropping treatment times to 8 weeks sounds good, but remember these are trials of Rx-naive patients with little liver damage.

It'll be interesting to see how that translates into the real world. The Sx of Sovaldi/ Ledipasvir sound almost non-existent. The Insurance Co's will be keen to see this length of treatment, as it will reduce cost. I hope exceptions will be made for the previous treatment-failures and cirrhotics.

Isiscat2011 · Guru

Marypetrecz wrote:
why do you think the S/L would work better? Or adding another med produces better results?

Because I think Ledipasvir is superior to Olysio at least for my particular situation. I treated with Incivek, am cirrhotic, and am 1a genotype. Adding a 3rd DAA or increasing tx time to may be necessary for harder to treat people such as myself. My opinion is based on what I have read and conversations with doctors.

Gracie · Guru

I'm still waiting... Haven't even got a call back from my hepologist since he called me at the beginning of April to tell me of my breakthrough. "We will get you in to see me very soon" he said. "The doctor will be calling you shortly to set up an appointment to see you" his nurse said. His definition of real soon and my definition of real soon are two different things....lol. I feel like a woman scorned, like I was dropped like a hot potato. But.... Since I am seeing a couple of relapses in the new protocol, am thinking waiting for the ledispasvir sofosbuvir might just be my best option, so maybe this is a good thing.

Since I stopped treatment, I had liver pain for a long time. Better now, but was a long flair-up. Also am losing hair.... Like really??? Now I'm losing hair... Geesh! My joint pain has all gone away and I sleep most nights like a baby. Feeling pretty good I guess. Gearing up for the next round and trying to keep positive thoughts and exercise regularly. The food though... After twelve weeks of eating whatever and seeking out extra fatty foods, I developed some bad habits. Trying to break those is hard... Darn ice cream is addicting. Slowly shifting back to healthy eating. Taking it day by day.

.... So yes... I'm also playing the waiting game.... patiently... Most of the time...

Tig · Admin

Mary,

The way it has been explained to me and has been discussed here many times, is that while they are using the word "CURE" to describe SVR, the fact remains that the possibility of relapse remains, even if it is a chance well under 1%. The use of 100% cured hasn't been used in any documentation I've read. My personal concern is that while we have such a low risk of relapse, the possibility remains. If there is a single virus particle floating around somewhere, and your body's own immune system is capable of keeping the virus "undetectable", be it below 5, 7, 15 or 43 IU/ml, then the chance of your immune system failing for whatever reason and then allowing the virus to reestablish itself exists. That topic has come up at times particularly when we've discussed the possibility of starting drinking alcohol again. Whatever we can do to keep our systems at peak performance, which includes paying attention to the same things that were dangerous while we were still actively infected. I hope that with time, the chances of relapse reduce even further. But until I read it from the proper source, I'm going to consider it a possibility...

Tig

Marypetrecz · Senior Member

I just read your other post on the question of S/O relapse and why. It is concerning but i guess well roll with what we get. I'll ask my doc on thursday about q80k . ... And how their people are doing after the 12 weeks. I was told they have a 100% cure in their office right now......so I'm still very hopefull.

Tig · Admin

True, and Gilead seems to have relied on more than these small participant studies to support the 8 week protocols. Even the CROI in Boston this years discussed the possibility of 6 week courses of treatment. I believe you mentioned that possibility yourself in a separate thread. So I think the chances are high that we'll see reduced treatment lengths in the very near future. I certainly hope so and if given the opportunity to participate in an abbreviated study like that, I'd jump on the chance to do so! The hope is always there...

Tig

Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

"The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis. - See more at: http://www.gilead.com/news/press-releases/2014/2/gilead-files-for-us-approval-of-ledipasvirsofosbuvir-fixeddose-combination-tablet-for-genotype-1-hepatitis-c#sthash.buSFevof.dpuf"

Marypetrecz · Senior Member

I'm not good at navigating the long ago past posts but after reading your concerns isiscat, I'm wondering how many people have been thru the S/O and how long is the longest still clear of hep c? I was under the assumption that once we were clear, we were clear. If there's no hep c cells.....there's no more hep c.....end of story. Is this wrong? Does hep c hide better than I think it does? I've seen some people relapse on this med combo...and it has raised concerns for me, and why do you think the S/L would work better? Or adding another med produces better results?

Isiscat2011 · Guru

Interesting topic, Tig. The reduction in tx time sounds wonderful but the direction this is taking also concerns me. Is 8 weeks (or perhaps 12 for cirrhotics) really benefiting the patients or are there other interests at work here? Like financial interests.

We already know that Sovaldi can bring almost anyone to UND. The question is for how long? Small clinical trials mean very little in real world terms.

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