TOPIC:

Are New Drugs for Hepatitis C Safe? A Report Raises Concerns
www.nytimes.com/2017/01/24/health/hepati...drug-study.html?_r=1

It's information. If it's politically in nature (I don't think it is) sorry.
I for one had not one single side effect from my 3 months on Twinvir and was undetected at week 5 on treatment.

No drugs are 100% safe. Even water (in overdose) is fatal.

When looking at new, not 100% safe medications, the quantity of risk that is "allowable" depends on disease being treated.

It is a risk benefit analysis with a heavy bias to the benefit side.

With cancer drugs, they are pretty poisonous BUT they are treating a generally fatal illness so that's accepted, although of course some patients do that analysis for themselves and decide that the benefits are not worth it.

With headache tablets, they need to be really, really safe because they are treating something non life threatening.....

Hep C is dangerous.

The old drugs were definitively more toxic than the new drugs and we observed that many patients voted with their feet and declined them.

The new drugs are much better in terms of both safety and efficacy (working-ness) and we've seen a large group of people take them (about 2 million) with the vast majority getting cure. Unfortunately a small minority have problems.

Getting out of bed is dangerous. Staying in bed is dangerous. Breakfast dangerous, but starvation is fatal.

Life is a terminal disease, and sexually transmitted at that.

The New York Times has become a worthless rag over the last few years. It's sad, they used to be amazing.

But really 1582 patients out of 250,000 had liver failure or other serious problems. That's about .6 percent. But this report does not indicate how many of these people had advanced cirrhosis where nothing could have saved or helped them.

This sounds like propaganda to the sea of denied patients.....trying to scare them to not act until their insurance approves their $80K treatment. The US media has become a sick joke.

Tommy, Twinvir cured you and me and many others.

I got to agree with everything you said greedfighter. Reminds me of that black box warning on the hep c drugs now after 24 people had there hep B activated after treatment. 24 out of millions of people who took it doesn't seem like that would require a warning.

www.nytimes.com/2017/01/24/health/hepati...core-ipad-share&_r=0

I received the above article from my brother today. It indicates that severe side effects post treatment have been reported to the FDA.
Although the numbers are rather low compared to the amount of people treated for me its still reason for concern as both sofosbuvir and dalatisvir are on the list. These were the two medications I obtained from China which resulted in a negative test in 47 days. I suspect that any damage done was to people way further along than myself. That does not mean that I will not have all my tests run again.

Moved to the other post on topic

Interesting but it looks to me that the level of deaths reported were less than 0.1% and given that a lot of Hep C patients would have been cirrhotic and elderly those deaths could have been caused by anything. Attributing them to the Hep C meds is a stretch IMHO.

Post SVR - Higher blood pressure- resolved with Lisinopril. Completely unexpected.

Shoulder problems - first left then right. Same exact symptoms. Decreased range of motion.Pain when rotating shoulders. Severe, and then resolving. Was so bad I was thinking it would be like my hips in past years - requiring replacement. Then (to my relief), it just subsided and went away.

Past experience with that kind of pain was that it was permanent, and irreversible. Not so this time - so far - fingers crossed.

At the same time went through a period where I was easily winded. Hip joints (both replaced) were clicking after walking 1/4 mile or so. That has since resolved.

Energy took a dip at 8-12 weeks post EOT. Thought I was relapsing, but tests were negative for HCV. Energy has since improved. No longer feel 'winded'.

My impression is that there may be a period of increased inflammation after completing DAA therapy. Perhaps my immune system adjusting to the 'new normal".

Whatever the cause, my impression is that it takes a while to return to normal. Even after the virus has been cleared, returning to normal is a process, rather than an 'event'.

Is anyone talking about this?

www.nytimes.com/2017/01/24/health/hepati...drug-study.html?_r=0

As the authors of the review note (please see attached PDF) there are many unanswered questions, however, liver failure and reactivation of Hep B (in those previously afflicted) are not minor issues. Although the review does not address the new pangenotypic daa's (Beacon's Sofosvel, Incepta's Panovir, etc...) the data is clearly referencing the sofosbuvir backbone meds.
In light of recognizing these issues it would seem that simple before and after lab tests (pre and post 12 or 24 week tx) might not be sufficient. For patients moving forward with treatment it might be wise to add several points of lab testing (cbc, hep b panel, iron studies, liver fxn tests, etc..) DURING treatment course. This might allow any potential adverse effects to be caught before they are fully manifested.

Moved post to the appropriate thread. Please start at the top.

As noted by others the numbers of adverse events reported in the review is relatively small in comparison to both those treated and the potential risk of non treatment. As such the level of testing before and after treatment should be appropriate to the risk factors for the individual patient and I would be surprised if monitoring doctors did not include CBC, LFT, etc during treatment.

Edit: Some further reading about this report provides additional perspective and the following comments.

Douglas Dieterich, MD, director of the Institute for Liver Medicine at the Mount Sinai Health System in New York City, downplayed the significance of the report and said the findings should not change physician practice.

"The data in this report do not conclusively prove the hepatitis C medications Sovaldi and Harvoni cause liver failure. Without clear evidence of cause and effect, we cannot risk this information deterring patients from seeking the care they need," he said in a prepared statement.....

......Even if the drugs caused the liver failure — and this report doesn't prove that — the rate "is likely much lower than that of the liver disease itself," he said. "We don't know how many of these patients were cirrhotics but even healthy cirrhotics have a 10% per year mortality rate. For decompensated, it's more like 30%."

www.medscape.com/viewarticle/875010?src=...it_tpal&uac=250627FN

Gaj-
Yes, I agree;
"As such the level of testing before and after treatment should be appropriate to the risk factors for the individual patient and I would be surprised if monitoring doctors did not include CBC, LFT, etc during treatment."
However, I think you and I both know there are MANY PEOPLE who will obtain these meds without the benefit of having monitoring docs. This is the real world and many people out there cant even afford a primary care doc. When those very people begin tx because they have enough $ to get meds from India, Bangladesh, etc....I believe they should have all the info available- including potential adverse events no matter how small the risk.
Thank you for your replies- both informative and thoughtful.

Greetings:
As noted by a major source of HCV information, in which could be biased as they sell natural liver products made to help regenerate the liver.

The natural path has told me that after a course of Harvoni the liver is unable to regenerate as before. The course of action is to assist the liver with supplements to aid in its progress.
Such as milk thistle, magnesium, a liver formula that helps remove inflammation, selenium, Vit D and a one a day vitiamin. He also believes in the active ingredient in blue berrys? Not sure. These along with plenty of water to flush the system up to 26 weeks after EOT and the liver should start to regenerate. I am a taker of some supplements and whether it is a placebo effect I am starting to feel more in control of my health, with plenty left to do.
Thx

Hi Sven,

I think your suspicions about their motives are probably 'right on the money', particularly assuming they can't point to well conducted studies that back up their claims.

Regarding supplements, IMHO for most of us a well varied, balanced diet should provide most or all of our needs so ensuring we eat well is part of taking control of our health. However age, general health and liver condition may slightly impact our ability to absorb everything we require so when I started treatment I tested for vitamin deficiencies. Vit D was very low even though I get a fair bit of sun and B12 moderately low so I took supplements at the levels recommended for me, by my doctor, to boost both of them. So I used evidenced based data to determine whether I needed "extra" over and above my diet.

- Milk Thistle is claimed to reduce inflammation although the jury is still out. In moderate doses I doubt it will cause any harm but we know that SVR reduces inflammation anyway.
- Selenium is needed at trace levels, a couple of Brazil nuts a day or a tuna/beef steak every few days should do the trick.
- Magnesium can be found in fish, nuts, leafy greens, bananas and plenty of other foods.
- Blueberries are delicious! I usually sprinkle a few on my muesli/oats for breakfast as one of the fruits I add. Like many berries and other fruit they have good levels of antioxidants plus vitamins, etc, etc. I doubt they are 'magic', just a useful and tasty part of a well balanced diet.

"a liver formula that helps remove inflammation"

Okay, this is where we are moving into uncharted territory and I would be very cautious. What does this formula contain? All the ingredients? Is there anything in there that could potentially be toxic to the liver? Or other organs? Who makes it? What are their facilities and qualitiy processes? How do they ensure there are no contaminants? Where are the documented studies that show that this formula has some positive effect on liver inflammation?

The maker of these natural supplements is various entities, I do not know them and have only heard about the supplements. The company responsible, and this NOT a plug, alternative medicine solutions. The writer Lloyd Wright has written books on killing HCV prior to any DAA's were introduced. Now do I believe the claims, no not 100%. Do I think there are "some" possibilities there, maybe. But even if it wasn't this site or that person can we verify that the liver does not regenerate as before we took DAA's? Please post any information that claims this is fiction so these sites can either be written off or can be held as a possibility. It is provocative and an answer is needed.
Thx Gaj.