GT 4 Sovaldi + Ribavirin 24 weeks

Infected With Genotype 4 HCV Achieve High Virologic Response Rates With Sofosbuvir Plus RBV for 12 or 24 Weeks
Date posted: 11/6/2013
Randomized, open-label, single-center study conducted in the US
Summary of Key Conclusions
Sofosbuvir plus ribavirin (RBV) for 12 weeks achieved SVR12 rates of 79% in treatment-naive and 59% in treatment-experienced patients of Egyptian ancestry with chronic genotype 4 HCV infection
Among patients treated with sofosbuvir plus RBV for 24 weeks
Treatment-naive SVR4: 100%
Treatment-experienced SVR4: 93%
SVR12 rates pending
Virologic response independent of cirrhosis, previous treatment, or other prognostic factors
Sofosbuvir plus RBV well tolerated for up to 24 weeks; safety profile consistent with RBV-containing regimens
Background
Genotype 4 HCV is most common HCV genotype in Middle East and has spread to other areas due to immigration
SVR rates with peginterferon (pegIFN)/RBV intermediate between genotype 1 and 2/3: 43% to 70%
Sofosbuvir: HCV nucleotide polymerase inhibitor
High barrier to resistance
Active against HCV genotypes 1-6
Favorable clinical pharmacology
Oral, once-daily formulation
Safe, well tolerated in more than 3000 patients to date
In vitro activity against genotype 4a HCV similar to other HCV genotypes
Phase III NEUTRINO study: 96% SVR12 rate in patients with genotype 4 HCV treated with sofosbuvir plus pegIFN/RBV for 12 weeks
Current pilot study evaluating sofosbuvir plus RBV in immigrants of full Egyptian ancestry in the US infected with genotype 4 HCV
Schematic of Study Design

Mike started to feel better almost immediately as Hep C virus left his system. It has been amazing. ML

Barry,
Just a question. Am I already out of date on my info?

I am using 5/31/2014- AASLD HCV Treatment Recommendations for treatment naive patients who are eligible to receive interferon.

GT4 - Solvaldi+ribavirin+interferon for 12 weeks.
Alternate-- Olysio 12 weeks+ribavirin+peg-interferon for 24-28 weeks.

Or, Treatment naive patients who are NOT eligible to receive interferon.

GT4 - Sovaldi+ribavirin 24 weeks --- Alternate none

The alternate for GT1 is different than GT4

Is there new information? I know you keep up to speed on the ever changing treatment recommendations :) And I have not got a re-treatment guideline. With Ledisprivir, things will change again. Big Hugs

Day 12 of 168

As I have absolutely no side effects as of yet from the tx, my next post will be when I have my 2 week blood test results.

Yesterday and today I had the energy to exercise for 1 1/2 hours each day. I have stopped waiting for the bad side effects to happen... If they do, I will handle it. If they don't, I will enjoy every single day. If there are people who are undecided about starting the treatment I hope that they can garner some positive thoughts when reading this. That is what we are here for.

I feel strongly that my diet of vegetables, fruit, and plenty of H2O, H2O, H2O and a little more H2O is helping my body better handle the meds.

Barry/Themiz,

Thanks for all the info. This forum is so educational. We will add the interferon if we do not see results in the coming weeks. If I can, I would like to avoid it.

Talk to your doc. Many use sleep aids. Some have luck with otc melatonin.

Mike is just now weaning off sleep meds after years. He has taken a number of things. Liver disease and treatments are notorious for messing up sleep cycles.

Thank you Carol and Barry.

Did have a rough night last night. Finally got to sleep around 02:30.. not good with a wake up at 05:30 to get ready for work. Took melatonin last night (contacted my DR last week about taking that) but unfortunately, it didn't have the desired effect.

Focused is my middle name.

SW

Good you have something for the side's, Willy. Some things you can not fight without a bit of help. Sleep is so important to having a good day :) Be certain to get in bed and lay down to sleep when taking Ambien.

Themister treated twice, as you know. He sleeps easily, like a rock, actually. But treatment can cause sides like this. He also was RX'd Ambien and Xanax...but just as needed, and only during treatment. The Ambien they RX'd is 5mg or 10mg for men. 10mg made him hallucinate. 5mg worked for sleep, and that was the ticket. Xanax can be tough to stop, so themister did not want to take it regularly. He took it only as needed, and not every day. That was at .25mg dose. It took about 30 minutes to work, so be aware if you are new to this drug.

You seem to have a similar treatment experience w/riba as he did. I will watch your posts and try to alert you if you post something we might suggest help with. I hope you don't, but you may get riba rage. That is when you are angry and snappy with anyone and everyone...and can not stop yourself. It is well known as a side. But some don't have that happen. Again, just a FYI. They RX'd Zoloft for that. Took 2 weeks and he had me in tears and baffled by his new crappiness until it kicked in. Poor guy was a walking drug store during treatments.

Hang in there....it is worth it to beat Hep C. Big Hugs

I'm Gen3, doctor says my cirrhosis is stage 5/6, which is basically the beginning of stage 4 using a scale of 1-4, but compensated, and was treatment naive. 1400mg/day Ribasphere (Ribavirin) and 400mg Sovaldi. Symptoms: brain fog, depression, short term memory loss, bouts of arthritis-type pain in joints/feet, slight "Riba-Rage" symptoms, massive fatigue, occasional rashes, pruritis. I'm also a Recovering Alcoholic (several years sober), and have hemochromatosis, all which contribute heavily to cirrhosis. I have one tough-*** liver which I have abused for decades which I have a new respect for and now treat with kid gloves.

I'm on my final week of a 6 month treatment regimen. I've been able (somehow) to continue working through treatment (fake it 'til you make it). I drink a killer veggie/fruit juice daily, eat lots of raw veggies/fruit, substitute beans/legumes for red meat protein, but still have occasional fish, chicken, and turkey. I 'm fortunate my insurance has covered most all of the costs with the exception of a monthly co-pay of $100.

During the first week of treatment, my viral load fell from 200,000 to 45, then was undetectable after 2 weeks (RNA Quant, PCR 2.0) and has been ever since. Iron/ferritin levels have not increased significantly, enzymes, CBC, CMP are normal except for elevated MCV and low platelet count (148 as the lowest). I'm ready to not only slay this dragon, but chop it up into bits and leave its' carcass rotting for the buzzards. I don't think I could go through this treatment again. I was fine until about 3 months in. There were days the symptoms were so bad, that I reduced Riba from 1400 to 1000, which my Hepatologist said was okay, just don't drop less than 60% of recommended dosage, and never reduce Sovaldi. The cirrhosis will remain, but it's up to me and my maker to make sure it doesn't get worse, though there is research on meds that can reverse fibrosis, like sulfasalazine.

Sometimes, it's hard to stay positive, but I have prevailed and I'll feel more confident after 12, 24, and especially 48 wk SVR. Suggestions: rest, but keep active each day by at least walking, eat, sleep, and hydrate well, stay 'regular' by juicing/diet. My juice usually contains spinach, kale, green apples, beets, ginger and tumeric root, garlic, carrots, celery, cucumber, watermelon, asparagus, squash, basil, cilantro, tomato jalapeno/serrano peppers (for a Tex-Mex zest). I make up several gallons once during the week, freeze in mason jars, then drink 32oz each day of the week. It really does make me feel so much better. It costs less than $30/week to make that much juice. I spent more than that each night when I was doing the bar scene. I repeat, juicing works. Experiment and chaqnge the flavor slightly each week by adding a different veggie. Just use minimal fruit so your glucose levels don't spike. After the juice is thawed each day, I grind 2 tablespoons of flax seeds and add them along with a tablespoon of psyllium husk, and a tablespoon of Bragg's apple cider vinegar.

Also, do research on this stuff. Get every copy of your labs and create a comparison sheet in Excel. I calculate my MELD (6) and Child-Pugh (5) scores, and most importantly: I pray once a day, every day, all day long.

Them are numbers to cry about!!!!! So glad this is working for you. Happy Dancing follows the tears. I've shed a tear for you myself this morning remembering how many milestones have been reached at our house tooooo. Hooray

Days 23-26 of 168

Doing great. For me, so far, this treatment has been pretty smooth. I have been adamant in following the advice on the 'how to eat/drink/rest/live' that people in our situation have posted on this forum and it has helped in guiding me through all of this. So far, I have not experienced any upset stomach (eat some fatty food... in my case avocado when I take the pills), never experienced any headaches (drink O2, O2, and more O2), drink and eat plenty of raw vegetables (today for lunch, I have raw cauliflower) get plenty of rest (although at times I do need some pharmaceutical assistance), and get plenty of exercise.

This Wednesday I go for my second set of blood tests. This time they will check my VL. When I started the treatment my VL was 20,400.000.00 (lotsalotsa little critters floating around inside this body)

SW

Day 28 of 168 or week 4 of 24


Went for my 2nd blood tests today and this time also to check my VL. Should have the results in about 3 days.. wish/hope/pray/fingers crossed/anxious to know results...

Asked about the reportable range of the test they use (another helpful bit of information I learned from this forum) and have been informed that they test to a reportable range of 15 to 100,000,000 IU/mL (1.18 - 8.00 Log IU/mL)

On a lighter side about possible side effects...

Has this treatment caused anybody to have excessssssss gas? I think that the inclement weather they are having in the U.S. southwest is partly my fault. I have to be destroying the ozone layer. My god...never in my life have I had soooooooooooooooo much gas....my dog even avoids me!!

SW