Aa
A
A
A
Close
Hepatitis C Community
13.4k Members
Avatar universal

Clinical Trial

I have Hep C genotype 3a and stage 4 cirrhosis (compensated). I'm age 60 and have been Hep C positive most of my life, since my teens.

I failed 24 weeks of interferon/ribavirin treatment in 2003, and 28 weeks of peginteferon/ribivirin in 2012. The second time I had severe side effects and became severely depressed toward the end of treatment.

I just started on a Merck clinical trial for genotype 3a, which consists of 16 weeks of MK-3682B plus ribivirin.

The drug MK-3682B consists of three drugs: MK-5172 (aka grazoprevir), MK-3682, and a newer drug MK-8408 (some are being given MK-8742 aka elbasvir).

I see there have already been testing with the combination of grazoprevir and elbasvir (similar to MK-8408) over just 8 weeks, and results look okay.

I can't find much about MK-3682 and MK-8408, looks like these drugs are still very much in the early stages of experimentation. I've read that Merck has high hopes for MK-8408, some think it may be highly effective against genotype 3a.

I started the treatment last Monday Jan 11 and so far, even with the ribavirin, there have been barely any side effects. Hopefully I'm not on a placebo.

Does anybody here know any more about these drugs?
18 Responses
Avatar universal
The lack of side effects makes me think I may be on a placebo.

Does anyone know if placebos are used in these Merck clinical trials?
1747881 tn?1546179478
If this is the right trial, they do not have a placebo arm, only treatment arms

Efficacy and Safety of MK-3682B (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)

Purpose
This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172 (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (60 mg) for 16 weeks with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily

https://clinicaltrials.gov/ct2/show/NCT02613403?term=MK-3682B&rank=2
Avatar universal
I saw my first results from the clinical trial:

Baseline viral load was about 5,600,000  IU/mL

After two days of treatment:
4505  IU/mL

After one week of treatment, before taking the drugs that day:
227 IU/mL

After one week of treatment, two hours after taking the drugs:
181 IU/mL

It's working quickly. It will be interesting to see whether the blood tests I had today (two weeks) will result in an undetectable viral load.
Avatar universal
Sounds like you are off to a great start.  Praying that all works and that you become Hep C free
1113735 tn?1273178030
Hi, hope this will work for you! I believe yes! I'm also on a 5th day of Harvony. Geno 1, few side effects, fatigue , raised blood preadsure sometimes (140/80-90), which don't drop quickly, itching, heart pulpations,  shortness of breath sometimes, thirsty at night, ....now drinking much more water during the day, its better. Well see the results!
Avatar universal
I'm having a bit of itching from the ribavirin and my stamina is a bit less than normal. I'm somewhat more thirsty and I've been drinking more water than usual.

But these side effects are nothing compared to what I endured during the two interferon/ribavirin treatments. During those treatments, my stamina became so poor I had trouble walking a couple of blocks, and the itch during the second treatment was a horrific torment.
Avatar universal
I will be starting the same trial in 2 weeks.16 weeks with the ribo or 24 weeks without it.I asked the doctor about a placebo and he said he would not conduct the trial if there was a placebo.You should have gotten paperwork from the office you are going through that explains if there is going to be a placebo.I did get a pamphlet that explained everything so I knew there would be no sugar pills involved-good luck
Avatar universal
I am starting the same trial in 2 weeks-16 weeks with ribo or 24 weeks without it.There are no placebos.I have the Merck paperwork on the study.Good Luck
Avatar universal
Week 4 results:

Viral load: undetectable

AST: 38 (borderline normal range, lowest in decades, been elevated since the 1970s)

ALT: 35 (normal range, lowest in over 15 years)

At no time during previous my two treatments were the AST and ALT in the normal range.
2 Comments
Way to go!  You are definitely off on the right foot!  And, IF you should fail, Daklinza is now on the market and it was researched and developed to be taken with Sovaldi, just for Genotype 3 ( works well on Gt 2, I believe).

Do your part, drink 1/2 your body weight in ounces of water each day.  If you weight 160 lbs, then drink 80 oz of water.  Look on the Internet for a liver friendly diet and follow that, basically fresh fruits and veggies, good fat - yogurt, cottage cheese, cheese, nuts, peanut butter, - fish, chicken, turkey, white pork, all cooked done, reduce or cut out red mean, cut out all added sugars, reduce or cut out salt - I am sure I have forgotten something which is why I said to look it up.  Also, exercise as you can - do not overdo - just do within your limits - walking is what I do, but many Dragon Slayers, rode bikes, swam, went to the gym, some even ran - all depends on you energy/fatigue levels and side effects, if any, from the meds.stuff and what you like to do.

I know I am forgetting stuff, but others will probably remember more and add their info.

Good luck and Blessings, Pat
Thanks Pat
Avatar universal
How are you all finding out about these clinical trials?  I have acute HCV 3a and I want it gone ASAP.  I am already scared that my insurance is going to deny me coverage on the newer DAA's so a clinical trial would be a Godsend for me!
Avatar universal
https://clinicaltrials.gov/ct2/search/index

Early results of the first phases of this Merck clinical trial indicate it works better for genotypes 3a and genotype 1 than for genotype 2.

Most treatments of the past like interferon/ribavirin had less success with genotype 3a and did better with genotype 2.
Avatar universal
Just a few days to go and I've reached.

Something that worries me: I found the main label on recent bottles of MK3682b to have an expiry date of January 2016, with another label over it with a later expiry date.

The viral load dropped rapidly in January. But if the drugs are spoiled, do I have a chance of SVR?

All three drugs grazoprevir, MK3682 and especially MK8408) have been shown to be very effective against genotype 3a.

But recently I've read that my genotype is the most likely to re-surface even if I test undetectable after 4 weeks (3%) and after 12 weeks (1%). A person with genotype 3a is only definitely cured with genotype 3a if you test undetectable after 24 weeks.

(with the other genotypes 1, 2 and 4, if you test undetectable at 12 weeks you are CURED, even if you test undetectable after 4 weeks you have a 99% chance of being cured).

Avatar universal
Opening comment of above post should read: I've reached the end of treatment.
Avatar universal
Freedom, I think you are worrying needlessly. The expiration dates on just about every drug are many many months (even years) earlier than what the truth is. I have no idea why the drug manufacturers do that, but they do. I wish you the best for an SVR.
Avatar universal
I just saw the result of two weeks post treatment blood tests from May 16. It's still UNDETECTABLE!

The result of the next blood tests on May 30 (4 weeks post-treatment) are very significant. About 97% of people (with genotype 3, and about 99% of those with genotypes 1, 2 and 4) who are still undetectable 4 weeks post treatment will attain SVR 12 and SVR 24.
1 Comments
4 week post-treatment result: still undetectable!

After all I've been through with past treatments, I felt it was impossible to ever be rid of it. But now it looks like a have a really good  chance of SVR.


Avatar universal
8 week post-treatment blood test results: still undetectable!

Maybe miracles do happen?  

If this treatment works on a cirrhotic, hard-to-treat, two-time treatment failure like myself, I highly recommend it to others.
Avatar universal
12 week post treatment result: undetectable!

SVR 12

Now there's a greater than 99% chance I'm finally cured. Next blood test in October (24 week follow up).
Avatar universal
Result after 24 weeks: undetectable!

Looks like I'm finally cured.
Have an Answer?
Top Hepatitis Answerers
317787 tn?1473362051
DC
683231 tn?1467326617
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Here’s how your baby’s growing in your body each week.
These common ADD/ADHD myths could already be hurting your child
This article will tell you more about strength training at home, giving you some options that require little to no equipment.
In You Can Prevent a Stroke, Dr. Joshua Yamamoto and Dr. Kristin Thomas help us understand what we can do to prevent a stroke.
Smoking substitute may not provide such a healthy swap, after all.