Daklinza Sofosbuvir Side Effects

[Tomcat]

Greetings all,
I had a recent post and decided to start a new topic.

Had my first dose 12 hours ago, decided in Australia to take my meds with dinner so that I didnt feel like rubbish during the day.
All went well and fortunately I had no allergic reaction which is a real blessing for me.
I know that daklinza and sofosbuvir are not being used heavily world wide but was wanting to know if anyone had advice, suggestions or pearls of wisdom on how to deal with side effects.

The 2 most distinctive side effects for me were extreme bloating/ gas and mad crazy dreams all night.
I have read/heard from a lot of people that drinking lots of water helps and I did that 4 times in the night.
I also acknowledge that initially the body is going through an incredible adjustment, accepting new very powerful drugs and the battle to fight off a very potent virus.

Should I be taking them at night? Thoughts? Suggestions?

Note: I take Somac in the morning and HIV ARV before bed.

Cheers and here's to Australia and a Hepatitis C free world!

[lporterrn]

I'd talk to your pharmacist about this - the night time dosing looks like it may be contributing to or causing the problem, but the water could be the issue. I wouldn't drink any water at night - that would cause all those problems for me. (Drink lots in the day) Also, I don't eat anything for at least 3 hrs before bed.   

Good luck and keep us posted.

[Tomcat]

Hello lovely Lucinda Porter.

You are the one that provided me with lots of wonderful advice 18 months ago.
Thank you!

My pharmacist wont be a lot of help as she knows very little as its a local pharmacy.
Do you think I should try to switch do day time dosing and drink lots of water during the day?
Of course keeping well clear of the Somac.

[Tomcat]

Also what are your thoughts on Milk Thistle during treatment?

[Philadelphia]

I stayed off everything during treatment as per my specialists instructions - except spiractin which I was taking for oedema. I see Greg Dore and trust him implicitly.

[Tomcat]

Hi Phily,
Yes have heard of him but not seen him. I was treated straight from Holdsworth House.
Good idea I think to stay away from supplements. I am taking probiotics though to help with my stomach.
Have reflux and IBS so my stomach is digestive system is always a problem.
Actually most of me is a problem. lol

[Gaj]

Hi Tomcat,

Also an Aussie, I'm 18 weeks into a 24 week Tx with Sof/Dac (generics). The probiotics should be fine but I've stayed away from most supplements like milk thistle during treatment as I figure my liver probably doesn't need any more help than what it is getting from these meds. The exception to that rule has been been Vitamin D and B12 which are often at low levels in people with HCV even with a good diet/sun exposure. (Having good levels of these two was shown to be beneficial to Tx response during trials of Peg/riba in the old days but has not been tested with the new DAAs.) I had my levels tested and they were quite low so have been sensibly supplementing those per doctor instructions.

I've found the sides mild although vivid dreams initially does seem to be one of them. Drinking lots of water during the day will be beneficial regardless of timing of medication. "Lots" meaning keep well hydrated so probably somewhere around 2.5-3.5 litre 'total' fluid intake per day in Oz unless heatwave.
I take my meds when I first get up and apart from a slight "lift" during the first couple of weeks really don't notice any effect from them. If you want to change just step back half a day at a time, so evening - midday - morning over consecutive days. Somac doesn't interact with either Sof or Dac but it won't hurt to seperate it from them by a couple of hours. The below link may be useful to you for checking for interactions.

http://www.hep-druginteractions.org

PS Daclatasvir can be affected by food items that are strong CYP3A4 enzyme inhibitors/inducers so a well varied diet with no large quantities of any one item is probably a good idea. Known items to avoid are grapefruit, grapes, pawpaw, starfruit, pomegranate and Taurine (as found in energy drinks).

Best wishes for a successful Tx and SVR. 

[Tomcat]

Hi Gaj,

Wow that was fantastic information, thank you so much.
So how are you doing on Sof/Dac? Your almost at the end and must be very, very excited!

I will head everyones and advice and pull the plug on all sups except 'Inner Health Plus' and B12.

Your advice on the slow transition to taking the drugs in the morning is excellent and I will just see how I go tonight and then maybe start.
Personally I cant see a problem with skipping a day (2000 day 1/zero day 2/0800 day 3) if you get my drift.

Regarding Somac my GP made it quite clear to stay away from Somac but I will look into that in more detail.

Hopefully with taking the drugs in the morning the dreams wont be so bad.

Thank you again for your wealth of advice.

[Scoutdoy]

Tomcat, be careful not to drink too much water. I read several cases on this forum where the person drank too much water and it adversely affected them. I will try to find the post and put it here. Good luck, I am sure you will do well.


Scout

[Tomcat]

Hi Scoutdoy,

Interesting I havent heard that but would be interested to know more.
I have always consumed large quantities of water plus have a weak bladder go to the bathroom some insane amount of times so there is no issue with retention.

[Scoutdoy]

It had something to do with overloading the kidneys and your sodium level dipping too low. I think you would have to drink a shitload, but it is possible. I know you are on a different treatment than me, but I was told not to take any kind of suppliments air antacids, and stay hydrated. You will do well, and get cured!


Scout

[MaryC]

Hi Tomcat,
Welcome to the HepC cure train. I am one of the fortunate ones tx'd with Sof/Dac in the U.S.  I am also GT 3.   I remain virus-free 12 weeks EOT!  I am anxiously awaiting my 24 week EOT blood work in early June.

I see that Gaj already mentioned to avoid supplements/foods that impact CYP3A4 enzymes.  I wasn't aware of this during my tx (and neither was my specialty pharmacist) and LOVE grapefruit in the morning. Fortunately I decided to avoid it during my tx since is known to interfere with other drugs. I think it is probably better to be safe and avoid most supplements if possible during tx.

I had very, very mild sides during my tx...slight headache and feeling a bit 'activated' which wasn't unpleasant.  I drank plenty of water during the day, but did not overhydrate as this can flush electrolytes and cause other issues.

Best of luck to you in your tx journey. Before you know it, the 12 weeks will be completed. We are pretty lucky to have the chance to be tx'd with these newer, better tolerated meds.

Mary

[lporterrn]

Looks like you are collecting good info here. Te only thing I'd add is that I'm not a fan of amounts for hydration goals. I think we have a marvelous feedback loop built in - if your urine is pale yellow you are on target. If it is dark yellow, too little going in. If it is clear, you may be OK but if you are peeing so much you can't leave the house without knowing where the WC is, then best to back-off.

[Tomcat]

@MaryC
Great to hear from someone in the same boat as me, I do hope everything is going well for you and that you are on the road to full recovery.

@Iporterrn
Thanks for the support Lucinda.
So far so good and symptoms seem to be subsiding a bit. Have always had a funny tummy and now will pull back to very simple, clean food.
Have been a healthy eater most of the time but just need to keep away from any spices.
Regarding urine. Its all looking very good, clear and with only a little colouring.
I have also always had issues with bladder function. Kidney function tests have come up all clear so I put it down to my fast metabolism.
In the process now of swinging med taking to day so had them last night, will take today at lunch and then tomorrow at breakfast.

Easter has been a perfect time with all my friends away and the time to go through this process on my own plus with all of you people wonderful help.

One last thing Lucinda,
Gaj has made reference to Somac (Pantoprazole) having no interaction and I have done a bit of research and seen no reference to drug interactions.
I have dropped my dose from 1 tablet a day to two halves twic a day and found a huge difference.
There is also reference in some documents that Dac/Sof need to pass the acid environment of the stomach to work best.
Do you as a RN see any problems with me taking my meds near Somac?

Cheers and thank you to all

[Tomcat]

Just noted a very interesting comment from Greg Jeffreys regarding Dac/Sof G3.

22nd March 2016

Hepatitis Genotype 3: Sofosbuvir and Daclatasvir

"This is a brief but important post about recent results examining relapse rates in people treating Hep C genotype 3 with the combination of Sofosbuvir and Daclatasvir, with or without Ribavirin.

There is a strong and growing body of evidence that people with Genotype 3 should be having a treatment period of 16 weeks minimum to clear the Hep C virus completely and avoid relapse.
Results of a survey of a large group of people treating Hep C G3 with Sofosbuvir and Daclatasvir show that for people doing only 12 weeks treatment the relapse rate is every much higher than for other genotypes.
The research suggests that people G3 and without cirrhosis should do a minimum of 16 weeks of Sof+ Dac whilst people with Hep C G3 with cirrhosis should do a full 24 weeks of treatment using Sofosbuvir 400 mg and Daclatasvir 60 mg.

The results of this research are yet to be published but it confirms my own observations based on feed back from people with G3 who had relapsed. Of the people who I know who have relapsed (total of five) 80% of all relapses were from people with G3 who did 12 weeks.

Of course I am not a doctor and you should get professional medical advice when making Hep C treatment decisions."

[Flaco]

Tomcat, it sounds like you're on it as far as I can tell.

With my doc's and nurse's blessing I take a multi-vitamin at breakfast; a B-complex, a D3, an alpha-lipoic acid (antioxidant), and a turmeric (anti-inflammatory) capsule at lunch; and nothing except a prescription muscle relaxant called Flexeril (cyclobenzaprine) with my supper, along with my Harvoni. Then an hour before bed I take a melatonin, and then generally 2 teaspoons of Benadryl (diphenhydramine) at bedtime. Hmm.. actually it looks like I take a lot of stuff, heh. If I weren't such an insomniac I could eliminate three of those things. 

What with a pint and a half or so of coffee plus about three liters of water a day I stay pretty hydrated with mild colored urine. I had borderline low sodium last bloods so maybe I'm drinking a tad much.

I take my Harvoni in the evening and thereby have missed out on the Harvoni high or boost people mention. On the other hand it may be that my dreams are more frequent and lucid. No nightmares so far, so it's good. 

Hope you sail through all this, man. Sounds like you will. 

[Tomcat]

Hi Flaco,
Thanks for your message.
So far so good fingers crossed all goes well and the drugs do what they should.

[Gaj]

Hi Tomcat,

Here you go, everything you didn't need to know about Daclatasvir:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003768/WC500172848.pdf

Without wanting to preempt any comments from Lucinda about the Somac, Daclatasvir solubility isn't effected by gastric acidity in the same way as Ledipasvir so antacids aren't the same issue. However, it does need to get past the acid environment and absorbed into your bloodstream so probably best not taken with very large and/or very high fat meals which may delay/prevent that process fully occurring.

As Greg says, the observations about gt3 are currently anecdotal but more evidence is coming in and they are in line with what we know about this genotype being more difficult to treat with DAAs. Personally I suspect that there may be a need to look at a graded approach to treatment for differing levels of fibrosis and other complications rather than just the 12/24 weeks Tx dependent on cirrhosis that we see with other genotypes. Or even better a new medication that is as successful against gt3 as in other types?

[Tomcat]

Hi Gaj,
Thanks for that it's a real bible.
Appreciate it.

[lporterrn]

I can't speak with any authority on your question Tomcat, but if it helps, I didn't see any interactions when I ran it through the hep C drug interactions checker http://www.hep-druginteractions.org/checker

[Tomcat]

So after my 5th dose really feel like I have been smacked around.  Really intense dreams and woke feeling sore and fatigued.
Here's hoping this subsides.
Lucinda if you read this then I definitely feel like there is a correlation between body size and drug reactions.

[lporterrn]

There may be, but there are also other variables that we haven't tapped yet, such as genetic components.One day we will have a simple blood test and get a readout telling us the best drugs for our genetic makeup.

[Tomcat]

Hi Ya'll,
Well it's the end of day 5 and about to take dose 6.
Have had really, really bad bloating and nausea.
Anyone have any tips on how to handle this?

Tried an 'Degas' without much success, fresh ginger minimal and my probiotics.
Am still staking a super c tablet in the morning so not sure if that is causing it.

Help!

[Philadelphia]

It's not a problem that I had so I have no advice. Any suggestions from your treating team?

[Tomcat]

I will have to check.
Have had numerous IBS related issues over the years and often they have been bought on by antibiotics. Now I know these arent even remotely the same products the symptoms feel very much the same.

I might give this a shot and my gastroenterologist had recommended some years back.
http://www.iberogast.com.au/?gclid=Cj0KEQjwz-i3BRDtn53Z5Z7t4PUBEiQA23q2ANgXPWvyPPbHah1qZLoCMOjbHaK4XcFo0i505dmc2m4aAtfI8P8HAQ

[mollythedog]

Bello Tomcat and everyone,
I finished sov dak + riba 24 weeks on Monday 28 March. Started with VL 5 million and F3/4 post transplant. Failed on sov olysio + riba 12 weeks, relapsed. S/e this time were more noticeable, dry mucous, infections of mucous membranes, cough, anemia not serious, around 10.0 , irritability, diarrhoea for a week, but all bearable. Of course I hope this time it will work for me. It took longer to become undetected, at 8 weeks <12 then undetected. I can't feel so sure this time after the disappoinment last September. Started new treatejust 4 months after first one, perhaps too soon? I have this idea that I have a lot of RAVs, which doesn't help positive thinking. However I have become very philosophical about the entire matter and put my energy into making the most of every day, enjoying the fact that I have no aparrent symptoms of a damaged liver up to now and "che sarà sarà" . I'll fight whatever comes my way and stay happy. I know so many people will be cured of this horrendous virus and I know I will be too, just don't know when. I took no inegrators, bits, minerals, ate fresh food and occasionally cheated on sugary foods, drank water normally, about 2 litres a day.  Was tested for B12, and have enough for the next 15 years. Best of luck to everyone. Oh yes, muscle weakness, now starting sport slowly again as the anemia left me short of breath.
Molly the dog

[omarcasa2016]

Hi tomcat and everyone
Plz how to take sovaldi and daklinza: on one shot or take sov and after daklinza but in the same eating time
My mother is taking sov dac for gt2 for 12 w sometimes she forger to take on oneshote  and take the drugs one after the other
The side effects she Has after one week is the gout pain.  We dont know how to deal with that
Thank you for your advises

[Tomcat]

Well now safely at week 5 and about to go get my blood work done.  Nervous as all hell and praying for good results.
Have to say that I am actually feeling better other than the minimal drug side effects.

[Tomcat]

Well apparently in Australia for blood work at 4 weeks is not required and only done at 12 weeks on completion of treatment.  Only thing being tested is liver function.
Doctor is completely convinced that there will be a full recovery.

[Philadelphia]

Your LFTs will tell the tale. I'm pleased you are feeling so well!

[Tomcat]

Well fingers and toes crossed.
I have to be honest when I say that I haven't been terribly well behaved and have partaken in the occasional glass of wine.
I know I will get shot down by everyone on here but I am slim eat extremely well and do all the right things other than that. 
So only the gods whoever they are will tell me in due course how that works out.

[Gaj]

Hi Tomcat,

In Australia HCV PCR testing requirements tend to vary by doctor/clinic. Some perform regular testing, others don't. Below are the Australian Medicare rules that state how many tests will be funded. You are on antiviral treatment so can be funded for 2 quantitative and 4 qualitative PCR tests per year. But note that funding requires the specialist to approve the test which is where the variation comes in.

Hepatitis C Virus (HCV) Genotyping
Medicare criteria (one per year):
1. The test is requested by a specialist or consulting physician managing the patient’s treatment, and
2. Patient is hepatitis C Virus (HCV) PCR positive and being evaluated for antiviral therapy of chronic HCV hepatitis.

Hepatitis C Virus (HCV) PCR: Qualitative
Medicare criteria (one per year):
1. The patient is hepatitis C seropositive, or
2. The patient’s serological status is uncertain after testing,
or
3. The test is performed for the purpose of:
a. determining the hepatitis C status of an immunosuppressed or immunocompromised patient, or
b. the detection of acute hepatitis C prior to seroconversion where considered necessary or the clinical management of the patient,

Hepatitis C Virus (HCV) PCR: Qualitative (assessment of antiviral therapy of HCV)
Medicare criteria (4 per year):

Patient is undertaking antiviral therapy for hepatitis C.

Hepatitis C Virus (HCV) PCR: Quantitative
Medicare criteria (2 per year):
1. The test is requested by a specialist or consulting physician managing the patient’s treatment, and
2. The patient has undergone pre-treatment evaluation for antiviral therapy for chronic hepatitis C.

The good news is that virtually everyone who undertakes Sofosbuvir based treatments like yourself will achieve either Undetected or below LLOQ at end of treatment before going on to hopefully achieve SVR. So testing during treatment is mostly about measuring medication compliance and/or patient confidence. i.e. Nice to have but not strictly necessary. If you must know for peace of mind then you can get your GP to order them privately too but shop around as prices can vary from about $150-600 or more depending on the lab.

Assuming it is occasional and you don't have cirrhosis then that glass of wine should be okay on treatment.