Sunday, August 2, 2015

Harvoni - FDA Side Effects Reported

I started this post a couple of weeks ago but was struggling to upload the FDA report - at any rate, I was able to find a link to the "FDA Adverse Event Reporting System" posted at the bottom.



Awhile back, I read somewhere about a newly released FDA publication that listed Harvoni side effects reported by consumers taking it.    This has recently become available, thanks to being sued by a couple of Patient Advocacy groups.  I have included the link to the FDA file below  - very large - contains over 700 reports of Harvoni Side effects from October 2014 - March 2015.

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD +2.45%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.
As far as the health groups are concerned, the accelerated process “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” according to the lawsuit. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”
Specifically, the groups hope to learn about different responses that different patients experienced during clinical trials. Tracy Swan of Treatment Action Group points to relapses in a Harvoni clinical trial that occurred only among African-Americans. The groups also want to perform an independent analysis of poor prognostic factors among people who were not cured in order to identify a patient profile.

The rest of the article is here:

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data


Back in January of this year, when my doctor first approached me about Harvoni, I was definitely in no rush to be on it.  I told the doctor that and he was almost stunned - "You'd turn down over $60,000 in drugs?"    Yes, I would, at this point.  The stuff hasn't been out long enough to know all of the side effects and long term side effects, etc.  I told him.   However, before I knew it, the pharmacy was contacting me, and would be sending me the Harvoni on this date.   So I went ahead and drank the Kool Aid.

I completed the my last Harvoni of an 8 week treatment on June 2nd.  Both 4 and 10 week labs were Undetectable - No Virus found.    I did have some sides, which I've detailed in earlier posts.

Currently, I do feel better than I did for the first 3 weeks after completing Harvoni.  I do worry about relapse as there does seem to be more in the real world than there was reported in the trials.


 I have included the link to the FDA file below -- very large - contains over 700 reports of Harvoni Side effects from October 2014 - March 2015.  Lord knows how many there have been since then:


FDA Adverse Event Reports 10-2014 thru 3-2015

18 comments:

carolc said...

I took harvoni last summer 2015 and had all the regular side effects, fatigue, headache insomnia, but after have felt sick ever since. Chronic tiredness, dizzyness, bowel problems as well as joint issues and an increase in cholesteral. What happened? I was told i'd feel better. I feel terrible most of the time.

Nola Chris said...

So sorry that you feel so bad!..

I'm going in this week for one year post-Harvoni viral load test. Yeah, I don't really feel any different. But some folks do feel better while others feel much, much worse. ...perhaps nutritional deficiencies? I know that digestive enzymes and acidophilus helped my stomach issues big time post treatment. ..have heard others test way deficient for D3 and B vitamins. Wish all docs would test for deficiencies post treatment..

Kim Goldberg said...

I am now 9 months post-treatment (from 12 weeks of Harvoni+ribavirin for Genotype 3). It cured me of the Hep C. But my health is a mess. I am so ill and weak most of the time I can scarcely leave the house. High fever, drenching night sweats, enlarged lymph nodes, low iron (which no amount of supplements can elevate) low hemoglobin, dry cough...

This is all AFTER finishing treatment. My health was fine going in to treatment. Ribavirin doesn't explain these symptoms. I have blood tests monthly to monitor my mystery malaise since finishing treatment 9 months ago, but no improvement. Many things have been investigated in my case, but no conclusive diagnosis for why I, and so many others cured by the new DAAs (direct-acting antivirals), are essentially disabled afterwards.

My health was fine before starting treatment. Yes I had Hep C, but I was functioning, happy, earning a living as a writer for last 40 years, could go where I want when I want. I had a life, in other words. As do many people with Hep C. It is not necessarily disabling, and the majority of cases do not lead to liver cancer. Now I can scarcely make it to the grocery store many days. And this has been going on with no end in sight (and no diagnosis) for 9 months.

The new drugs are indeed a miracle for curing Hepatitis C. But there is much we do not yet know about their long-term effects. Here is a thread on the Hep Forums with nearly 500 comments about Post-Treatment Syndrome: forums.hepmag.com/index.php?topic=2053.0


Kim

jeff said...

It has been a year since I finished Harvoni. My liver enzymes are normal now, but I get the worst mig headaches every day. Shooting pain from my neck and up through to my sinus area. Ibuprophine always knocks it out. I have had a brain scan searching for any tumors or blood clots and they found nothing. I hope this don't last forever....

Anonymous said...

I just got my 24 week post treatment lab results back last night, and as I suspected, I am SVR, not viral particles found. However, ever since I started taking Harvoni I felt poorly. I have brain fog, am fatigued, have hot flashes, and have been losing weight. 20 lbs from a starting weight of 190. All of my regular blood tests are normal. I'm 55 and had HCV for at least 25 years. My last biopsy showed stage 3 liver disease with bridging fibrosis but not cirrhosis. The thing is I didn't have any symptoms other than loose stools. I lead a normal life. Now I am struggling to be an effective family member and productive at work, where I was always very high performing. My cognitive skills are diminished. In typing this note I have had to make dozens of typing corrections. At least one or two for each sentence! Two years ago there would have been one or two. Are there any studies tracking this?

carolc said...

I still have loose stools 8 months after treatment and feel like dog meat. It's terrible. Sometimes the brain fog is so bad I'm afraid to leave the house. I felt so much better before and that was after having a triple heart bypass. My daughter says all this can be explained as the drug being toxic to the body so the body is having a toxic reaction .

Anonymous said...

jerry said Itook the 12 weeks the middle 4 where bad no more hep C but my cholesterol went from 180 to over 400,also my testorone droped from 450 to 190 Iwasnt able to heal from normal everyday physical things needed to be done around the house, if I do anything stenuous it takes 3 daysto recover

Anonymous said...

Anonymous, I started the treatment in April of this year. Had no side effects thru the fort bottle. Upon starting the second bottle about fourteen pills in my lower legs started to become numb. As I continued it seamed to be getting more intended. Second bottle down bottle three to go. At this point my lower legs were getting to the point of complete numbnes. On pill number eight my Doctor took me off the regime. Blood work has revealed that there is no HepC virus in my system. Now I face numbness from the knee down to the tip of my toes. I have no balance because I cannot feel my feet. Cat scan and MRI have been done and it shows a narrowing in my lower spine squeezing the nerves that controls sensory and muscle function. I am basically walking like Herman Munster. Hope no one else is experiencing this numbness side effect of harvoni

Nola Chris said...

I had that numbness on the second month..I was able to take daily walks in heavy sand.
Alpha-Lipoic acid can help as well as chiropractic manipulation.

It's a shame your doc took you off of treatment. ..bit I'd still give you an excellent chance of achieving SVR!

Unknown said...

I finished 24 weeks yep 6 months of Harvoni 3/5/16. I'm post liver transplant was again in stage 3 with high alt/ast a failed resonder to old tx's before transplant and after with Pegasus. While on harvoni I started having severe fatigue with muscle weakness and pain. It continued after finishing tx became worse to this day. I was just dx'ed this week by scans of cervical neck disc degeration and lumbar disc all lower back too with muscle atrophy loss. I did not have this or spinal or disc nerve problems before Harvoni with routine check ups and every 6 weeks full labs being post liver transplant. Yes I am now hcv geno 1a in remission but I'm in constant pain and having trouble just moving around. I refer to my successful Harvoni tx as in remission instead of a sure cure because I do not agree by the terms of tx. A hcv cure to me is not hcv free below 12 by labs for only 3 months. I believe I am in remission.
I asked my transplant team who perscribed it if harvoni was safe post liver transplant and being on strong anti rejection meds for so long with a very weakened immune system. I was told we really don't know yet but if it works it may stop or slow down your liver disease progression. It has so far but now I'm feeling worse than ever but trying like he'll to make the best of it.
Anyone else having muscle loss - spine - disc - nerve problems?
Thank You
Deb

Roger M said...

There was a new update about the side effects. In October 2016 FDA gave a warning about the Hep B reactivation. Apparently some patients on Harvoni who previously had Hep B got it again. Its quite a serious Harvoni side effect, I think it should be included - in the bottom of this article something like this is mentioned so I'm adding it here - https://goo.gl/R1WhFE

Anonymous said...

Still Fighting every day to hang on after Harvoni treatment a year and a half ago. (Severe Nerve Pain)), (Spinal Pain)
, memory loss worse, loss of balance and falling, blurred vision comes and goes, stomach pain increased, Increased depression and anxiety, Severe fatigue, muscle weakness, hair loss and brain fog. I had hip c before but I never felt this sick and unable to function. Now I use a Shower chair, walker, back brace and a electric cart. I pray every day it will stop and my body will get back to where it was before. We ( the patience's)know our bodies and what they where like before the treatment. Doctors ether don't know where our symptoms are coming from (or maybe they do know) or blame it on medication side effects or other medical problems. I know if you where not in pain, a wheel chair, could walk and not falling, I think you would remember that!!!!!!! :(:(:(:(

Anonymous said...

I am a year out of SVR and from Harvoni and my labs are better but I am still feeling bad. I don't have much of a baseline to compare before and after to. I decompensated in a spectacular manner with a brain abscess requiring surgical intervention. My Liver guy saw me after a GI bleed and told me I was not a candidate for a transplant because the surgery would probably kill me. I achieved SVR from Sovaldi and ribaviran early on and felt great until I relapsed. I have never felt that well since. Everyday above ground is a good one. I have a grandson who was born when all this started and he will be 4 this summer. BTW I am on a 5 year longitudinal study for Gilead so maybe I can give something back and my life will not be for naught.

Anonymous said...

Had Harvoni treatment in 2015. Ended treatment in August 2015. In October 2016 diagnoised with the liver cancer the treatment was to protect me from. Given less than six months to live. I think I was better off with Hep C.

Marjorie said...

I took Harvoni for 24 weeks. started in October of 2015,by end of Oct. I was crippled,I was severely fatigued, weak,could not think,had short term memory loss to the max. During the treatment I developed increased joint pain,elevated ammonia levels and liver failure. I had nausea and vomiting insomnia and more that I can't remember because most often symptoms continue still today.Along with anxiety and depression. I only stayed on the therapy because my MD insisted all would be back to normal when I completed the course of med. Oh and he added ribavarin against my wishes I too drank the Kool-aid and now my life is destroyed, I can't work ( I was a well respected Emergency and surgical RN. I have lost my job,long term disability cut me off because the doctor insists there is no research that backs up the con the continued symptoms I am having. So my life is in the toilet and I will probably lose my home. So yeah, my titres say air am Hep C free but at what cost...if anyone out there has any suggestions to help me..please contact me at Oneharleyrn@aol.com I need help, or something to show the MD he's wrong.

Jo said...

I to had HepC and was on 24 weeks of Harvoni. I also participated in 4 trials including Interferon and riboveron plus various trial drugs.
I am now cured but, within 5 months of the Harvoni cure, I developed mycrocardial cardiac disease and now I'm having venial problems in my legs.
Having never had any cardiac nor vein drainage problems I can only name one change in my health routine. Harvoni.
I've gone from an active, limber, Zumba dancing woman to a person with elephant like legs and heart palpitations, chest pain and shortness of breath. I now take 5 different meds and wrar compression stockings, thigh high 24 hours a day.
I believe that this is too much of a coincidence.

Anonymous said...

Hello Allc,
I took Harvoni for 3 months last year. I do not have a mental health issue , but whilst on Harvoni I became , manic , almost bi polar . Unable to filter my thoughts . I almost lost my job as a senior manager. I was barely fibrosis 1 . Am not sure is I was symptomatic prior to treatment. I work in the medical industry , so accesss became availble easily . Did anyone have a similar issue . I feel it took until now for the drug to leave my system .
M

James Politz JOANNE pOLITZ said...

I just went to doctor today after post 3mths of Harvoni,and I wish I never took it.I have no Hep C but I have no energy and my bones in my body feel like I have bone cancer!I am in my late fifties and should not feel this bad,I never thought of reactions after taking it only while on it,I hope we are not the generation that finds out it has side effects after the fact!May God bless us for trying to do the right thing!