The Texas HCV Coalition for the Cure is working on a publication to include Treatment Histories for the following:
Patients who Treated with GS-7977 (formerly PSI-7977) + Daclatasvir (formerly BMS-790052)
Patients who Treated with GS-7977 + Daclatasvir + Ribavirin
Patients who Treated with Incivek or Victrellis with Interferon + Ribavirin
If you are interested in sharing your story, it would help if you submitted it in following format. We hope to use this data to urge further Phase III collaboration between Gilead Sciences and Bristol-Myers Squibb with GS-7977 + daclatasvir.
Name: (can be First Name + Initial...or your Medhelp log-in name) Sex: Age: Location:
Genotype: Stage: Grade:
Treatment History: (List all treatment regimens past and current)
Treatment Issues / Side effects: (side effects during treatment and any you may still be experiencing after completing treatment) and any additional drugs you had to take for side effects during treatment or continue to take after treatment completed.
General Comments: (Anything and everything you wish to add about your experiences with treatment and life with HCV in general)
Your current status: Currently UND (undetectable),SVR4, 12, 24, etc., relapser, null-responder
We appreciate your participation and any ideas or suggestions about additional information you feel we should include. We have approximately eight to ten people who are participating and we would like add at least five or more for each type of treatment.
Thank you in advance for your help and we need this info as soon as possible. You can either post it here or send it to me in a private message.
Treatment History: treatment naive/treated with triple therapy with incivek; completed treatment almost three weeks ago.
Treatment Issues / Side effects: had rash twice (I was taken off riba for 9 days and then treated with fluocininide the second time); nausea, mild to severe, used gingerale and sea bands for mild/moderate and zofran for severe; severe anorexia (lost nearly 30 lbs during incivek, went away after completing incivek), anemia (later in treatment), no procrit or riba reduction; developed joint/muscle pain and near constant headaches 3 weeks before ending treatment, headaches have disappeared but continue to have joint/muscle pain (I have to say, I had issues with joint pain before treatment but it went away two weeks into treatment). Other than the joint pain which is mild to more severe while trying to sleep as well as some mild fatigue when I overdo my daily activities, I feel fantastic. My liver emzymes are normal, at my 24 week labs my hgb and rbc were near normal (and probably are right now), but my wbc were low and my anc was down to 0.6.
General Comments: I have no experience with life with HCV I found out I had HCV in Dec of 2011 and started treatment 1.5 months later. As near as I can figure I had to be infected at the age of 16 through drug use.
For me, if I had had more experience, I would have chosen a Dr. more wisely. I believe my Dr, although a good GI, was not at all experienced with treating HCV or treating side effects.
My treatment in a sense has taught me something about myself (I know this is cliche') but I learned how strong I really am going through this treatment. I look forward to SVR and living a healthy life. I have come across so many wonderful, caring, innovative, and inspiring people that I would have never had the pleasure of coming across if not for HCV, which is the only good (did I really write that?) thing that came from having HCV.
Your current status: I was und at weeks 4, 12, and 24
Thank you for taking the time to share your treatment/experience with me. If you think of anything else you may want to add, then please do so. And funny you mentioned the 'good thing with HCV' because I posted almost the exact same thoughts in another thread yesterday.
Most of all congratulations on your status and hoping to hear SVR all the way!
Treatment Naive before starting current treatment .
Current Treatment: Pegasys 180 weekly, Ribavirin 600 mg twice a day, Incivek 750 mg twice a day
Completed 48 weeks of treatment on Saturday August 26, 2012
Undetectable since week 8.
Treatment Issues / Side effects:
*Severe internal rectal pain (probably from fissures caused by the burning diarrhea) (felt like crapping shards of glass) ...the only thing that stopped this pain was to keep the stools very firm with Loperimide.
*Hemorrhoids ... Preparation H cream and suppositories, Xylocaine with hydrocortizone cream, many showers (Anusol suppositories would have helped if I had had them)
*Excoriated skin around anus (large area) ... Cleansed with a shower often and/or Huggies Baby wipes, Desitin cream, A&D ointment,
*Zofran 8 mg every 8 hours.
Unfortunately the nausea and bloating and some vomiting appeared the first week of treatment and snow balled out of control before I could convince my doctor to prescribe treatment for it (at week 9). Additional symptoms were swollen ankles and feet, high blood pressure, runs of supraventricular tachycardia, numerous premature heart beats, reeling dizziness, light headedness, inability to stay upright for any length of time, inability to eat except for Greek Gods Yogurt and eggnog and crackers or toast. All of these side effects disappeared after I got on Zofran 8 mg every 8 hours. (I am sure they were all related.)
Bad Rash with severe Itching:
Appeared about week 10 and took up residence.
Started on forearms with confluent bright red hives from the wrist to 2/3ds up the forearm. Then multiple types of rashes appeared. Small red bumps on chest. Red skin on abdomen accompanied by multiple small red bumps. Hives on buttocks and hips. On my legs and thighs I had all of the following: hives, red macules, red papules, pin point sized red bumps, flat red-purple lesions the size of a dime. On my feet and hands I had pinpoint sized red bumps and also the large flat red-purple lesions. My face got a dry flaking rash, below eyes and on forehead. My scalp had bumps like large mosquito bites. All of these lesions/bumps/spots itched all of the time. Over the counter medications (Benadryl, zyrtec, hydrocortizone cream, claritin) were totally useless. They did absolutely nothing to decrease the reaction. The only things that helped me were prescription Hydroxyzine 50 mg every 6 hours, fluocinonide ointment, and clobetesol solution. The topical ointments and lotions helped with itching but they did not get rid of the underlying rash and reaction. Only the hydroxyzine finally controlled the rash.
The rash is still a problem. It is fairly controlled with the hydroxyzine but it blossoms if I forget to take the hydroxyzine or if I get too hot.
Other side effects which were frequent and annoying, but not really treatable, and certainly not game changers, were severe fatigue, malaise, no energy, no motivation, overwhelming weakness, light headedness, heavy feet and legs (like walking through 2 feet of mud in lead boots), headaches, muscle and joint aches, brain fog and poor memory.
On the other hand, the rash, the several rectal pain, the nausea and vomiting were very debilitating and I am not sure how much longer I would have been able to tolerate them (had I not finally demanded and received treatment for them.) Both the nausea/vomiting and the rash made me systemically ill. They were not just isolated side effects.
General Comments: (Anything and everything you wish to add about your experiences with treatment and life with HCV in general)
Infected probably in 1975 via Gamma Globulin inj. OR via occupational exposure while working in the critical care unit and ER.
1993 I had systemic Vasulitis with hemolytic anemia, pleuritis, pleural effusions, pericarditis, pericardial efffusions. Off work 7 months. On steroids for a year. Despite multiple tests by an immunologist/rheumatologist, no specific cause could be found. But he told me it was almost certainly viral. They just could not pinpoint the virus.
I had always been thin (5' 7" and 118 pounds) and very active and fit before I got systemic vasculitis in 1993. After that, I never felt the same as I did before the vasculitis. I never regained my pep and vigor.
I also started to gain weight and my blood sugar started to slowly creep up (to high normal).
As the years passed I had increasing fatigue, muscle and joint aches, dry eyes (felt like sand in them), dry itchy skin, and generally not feeling well for several years. Also some peripheral neuropathy, mainly in my feet and toes.
Slightly elevated liver enzyme (ALT) Aug. 2009.
Liver enzyme elevation (ALT and AST) March 2011.
Repeat enzymes in July showed liver enzymes still elevated. Hep panel run and Hep C came back as positive for antibodies. HCV RNA test showed detectable virus and the VL was 14,000,000.
Saw Gastroenterologist late August 2011
Biopsy early Sept.
Started treatment Sept. 26, 2011
Detectable <43 at week 4.
Undetectable at weeks 8, 12, 16, 20, 24, 28, 32, 36.
Just did my EOT VL draw today. I expect it to be UND.
If I had known more about Hepatitis C last year before starting treatment, I would have chosen a more experienced and more knowledgeable treating MD. But I did not know and I was in shock from the diagnosis. I went to the GI my PCP referred me to. They drew frequent labs and that was good. However, they knew virtually nothing about the side effects and how to assess them and treat them even though they assured me they had treated hundreds of patients and treated the side effects. I started out trusting them to know when to intervene and prescribe side effect relief. Big mistake. Eventually I realized they were going to do nothing about the side effects and I began demanding relief for the nausea and vomiting. But this was after 2 months of nausea with increasing systemic symptoms. Then the rash appeared and it took them 3 months to get the meds and the doses right. In the meantime I could barely sleep due to itching and I was miserable. I had to keep demanding treatment for the side effects. They also filled out the paperwork incorrectly for the Pegasys preapproval (the last 24 weeks). Then when my Hemoglobin started to drop, I asked about getting the paperwork ready for Procrit if I needed it. Contrary to what I had been told in the beginning, they said they did not give Procit. They said they cut the Riba dose in half. That was the last straw and I went home that day and found a new doctor (hepatologist in St. Paul). I have been seeing him since the beginning of June. He is wonderful. I should have gotten him to begin with but, when I started treatment, I did not know what I now know.
It is my belief that there are many experienced and knowledgeable doctors treating Hepatitis C. Unfortunately, there also seem to be quite a few inexperienced doctors treating Hepatitis C, especially when it comes to managing side effects. This is most unfortunate. Hepatitis C treatment is very grueling and debilitating. It is even more debilitating when the side effects are not taken seriously, are not treated proactively and aggressively, and are not managed properly with the correct medications and correct dosages. Not managing the side effects appropriately can and does result in people having to stop treatment.
Had my side effects been managed properly, I would have had a much easier treatment. As it was, I was miserable for the first 6 months of my treatment simply because my doctor and case manager did not know how to manage side effects properly.
Since about mid April, I have gradually improved. I feel fairly good now. I still have fatigue and some muscle weakness, but in many ways I feel better now than I did before treatment. Many of those general symptoms that I had before treatment seem to have disappeared.
In many respects this experience and treatment has been a nightmare for me. I completely lost confidence and trust in doctors (until I got my new hepatologist in June). However, I have also learned a great deal. This experience has taught me to be very well educated about my health status and any diseases that I may have. This experience has taught me to research proper treatments and protocols and to be proactive and assertive in my own care and treatment.
This forum and the people on it have been a God-send. There are caring, supportive, and knowledgeable people on this forum and I don't know if I would have made it without them. I look forward to attaining SVR, recuperating, and living a healthy Hepatitis C free life.
Undetectable at weeks 8, 12, 16, 20, 24, 28, 32, 36.
Just did my 48 week EOT VL draw today. I expect it to be UND.
Previous treatment 2005-2006 for 56 weeks SOC - Pegasys and Ribavirin, 1200 mg. Not undetectable at week 12 (I had 40 IU/mL), first UND by sensitive testing was at week 20, and relapsed within 3 months post. 99% compliant.
Current treatment completed on 7/26/2012, with PegIntron, Ribavirin (1200mg) and Victrelis -- 4 week lead in with SOC and 44 weeks with Victrelis. Probably 99.5% compliant.
My worst side effect was the anemia. My hemoglobin was under 10 for 27 weeks out of 48. It dipped to 8.9 twice. I used procrit for 8 weeks but it was interrupted by insurance issues. I dropped ribavirin from 1200 to 1000 to 800 until I got the procrit re prescribed (40,000 units, every 5 days). It helped for about 6 weeks, then the hemoglobin dropped again and stayed in the 9s. I reduced the ribavirin for the last month of treatment to 1000. I worked throughout treatment (desk job) but was probably 60% productive.
Other sx were ankle and feet edema, itching on the ankles and calves, awful metal taste, hair loss, some memory loss or dysfunction -- not thinking as clearly as I used to. The PegIntron was hard on my system too - flu like symptoms and so on.
ANC hovered around .6 to 1 throughout tx. I used neupogen a few times, but as little as possible because of the body aches it produces.
My VL at week 4 of the lead in ws 3920. I was UND at week 6 (after 2 weeks of Victrelis) and at weeks 4, 12, 24, and 48. Completed treatment 7/26 and after 4 weeks, ALT and AST were 17 & 9 .
Addendum: List of all of the side effects that I had either throughout the entire 48 weeks of treatment or for several days or weeks of the treatment. I am sure I forgot some of them. I am including this addendum so people can see the vast array of side effects these drugs have.
Side effects that lasted during the entire 48 week treatment but which were worse the first few months:
Fatigue (the fatigue was severe and overwhelming while taking Incivek)
Unable to concentrate and focus (mentally)
Inability to read a book (concentration problem and blurred vision)
Fine hand and finger tremors
Weakness (the weakness was severe while taking Incivek)
Flu like symptoms (worse while on Incivek)
Some hair loss and thinning (no bald spots)
Tinnitus … this started the first week and is actually worse than it was when it started)
Side effects that lasted the majority of the treatment but which lessened considerably over the last 3 months of treatment.
Muscle and joint aches
Anemia (but not below 10)
Cold sweats and feeling like I would pass out
Side effects which occurred mainly while I was on Incivek:
Frequent episodes of supraventricular tachycardia (fast heart rate of 180 beats per minute)
Frequent premature heart beats
High blood pressure
Swollen feet and ankles
Nausea/Vomiting/Severe Gastrointestinal Bloating
Episodes of profound dizziness and inability to walk or sit (lurching to the side)
Severe internal rectal pain (like crapping shards of glass). Occurred with soft or loose stools.
Excoriated rectal/anal area
Taste changes (everything tasted like cardboard)
Heavy legs like I was walking through 2 feet of mud with lead boots on
Legs did not want to go where I wanted them to go … had to consciously think about stepping one foot in front of the other
Constant dry cough
Other side effects:
Gum receding front lower right … red and painful. Started about week 40.
Dry mouth and thirst (entire treatment)
Sensation of a mosquito or deer fly biting the skin (but nothing is there). Sensation that something is crawling on the skin (but nothing is there). These started about week 10 or 12 and have continued throughout treatment.
Bad Rash with severe Itching: Appeared about week 10 and stayed throughout the rest of treatment. Started on forearms with confluent bright red hives from the wrist to 2/3ds up the forearm. Then multiple types of rashes appeared. Small red bumps on chest. Red skin on abdomen accompanied by multiple small red bumps. Hives on buttocks and hips. On my legs and thighs I had all of the following: hives, red macules, red papules, pin point sized red bumps, flat red-purple lesions the size of a dime. On my feet and hands I had pinpoint sized red bumps and also the large flat red-purple lesions. My face got a dry flaking rash, below eyes and on forehead. My scalp had bumps like large mosquito bites. All of these lesions/bumps/spots itched all of the time.
More recent problems starting in May and June:
Since March or April I have had weird sensations in my chest and abdomen, like the feeling you get when going down hill on a roller coaster.
In May I noticed some dizziness and that my balance was off when I closed my eyes. I felt like I would fall over and had to open my eyes or hang onto or lean against something solid.
In June I started developing very weird unpleasant sensations that felt like mild electric current sensations were coursing through my legs (mostly just above the knees to the ankles). They would wake me up from a deep sleep and it was virtually impossible to go back to sleep. The only way to stop it was to move my legs or get up. Plus I noticed some muscle twitching of the lower legs. (Restless Leg Syndrome)
Wow pooh you put me to shame with your details LOL, guess I better elaborate more on the side effects. I have to add pooh, you are one strong woman to go through what you have/are. Ok Maragret, here are my something elses I want to add.
My first four weeks of treatment were the worse. I was so sick and had to call off work every Monday (that was my worse day for some reason). After four weeks the nausea settled down a bit; then I had periods of mild, to moderate, to severe nausea.
So for the anorexia and yes I call it anorexia not loss of appetite. I not only couldn't eat I had an aversion to food, it made me sick to smell it or look at it. I litteraly ate nothing except my 20 grams of fat with incivek and applesauce to take my afternoon riba, and I gagged and cried while eating it. This began on day 1 of treatment.
For the rash: The first time I got it, the only places it didn't cover was the bottoms of my feet, palms of my hand, face, and upper back. The itching was fairly bad. I had to take oatmeal baths and showers constantly to reapply lotions, hydrocortozone, etc...My Dr's nurse wouldn't believe I needed to se the Dr, he obviously didn't feel the need to see me; I was told to use lotion it was a common side effect. It finally subsided after 4 weeks. The second time I got the rash, the itching was out of control. This rash was also associated with pimple like sores and now have scars all over. I averaged abot 2-3 hours of sleep a night (not straight through) and had to work in the morning. Most of the time I couldn't wear clothes or have anything touching my skin. Again I took constant showers and oatmeal baths to reapply lotions to get a little bit of temporary relief. Nothing helped this time, so I called the Dr and insisted I see him. He called me back and told me to discontinue riba, without even seeing my rash. He didn't give me an appointment for 9 days and told me he refuses to give me anything steroidal for the rash, told me to use lotion. When I saw him after 9 days, I told him if he didn't prescribe fluocininide for me I was ending treatment. By then I was so despondent from lack of sleep and being plain miserable. My Dr. didn't even know what fluocininide was, and I had to spell it for him so he could look it up. The rash subsided after 2 more weeks; had that rash a total of 6 weeks all together.
For the hemmroids: they were so bad that they bled to the point I had to wear maxi pads; and they were extremely itchy and painful. I called the Dr and his nurse told me to use preperation H, and of course said it was a commom side effect. After a few days I just called back and said they were even worse. She finally agreed to give me an appointment.
Then I have to add to the list: The constant fatigue, or as I called it, feeling like a rag doll. I eventually got to the point that I couldn't muster up enough energy to do anything except go to work (don't even know to this day how I did that), I couldn't even go for walks after a while.
My fiance pretty much took over doing everything in the house because I couldn't.
For the hemolytic anemia: My hgb fell into the 9's where it stayed for several weeks, with the lowest at 9. The symptoms of the hemolytic anemia, in addition to fatigue, were brutal, such as shortness of breath, occasional chest pains, and I would get winded walking down my hallway. I really just felt like I had weights in my feet and was wading through quick sand.
I didn't get depression, but was very emotional (still am), had bouts of insomnia, which has worsened since eot. My skin is so dry and itchy, even with constant application of lotions. I have a fungal infection at the corners of my mouth that still plagues me if I stop using tinactin. I also lost quite a bit of my hair.
Thank you all for sharing this with us. This is EXACTLY what we were looking for. It is not our intention to discourage people from current treatment, rather our hopes are that with your stories we can convince and persuade Gilead Sciences to reconsider their current stance on collaboration with Bristol-Myers. Why in God's name, should people be subjected to the above brutal side effects, when the combination of 7977/daclatasvir with/without ribavirin CURED 100% of the people (88) in the Phase II trials with minimal or NO side effects. Some in the arm with RBV experienced anemia (of course) but RBV had NO impact on viral response.
I spoke with one of trial researchers (my doctor) and all 88 still remain UND to this day. Some already have their SVR24 and others are on their way. We have "treatment experiences" from some who were in these trials, but the more we can collect, the better.
Thank you again for taking the time to write the above. And if any others would consider adding their experiences, we would be most grateful and your efforts might benefit the WORLD! God bless you all and hope you have a happy and safe Labor Day weekend.
I am on Triple Tx with Vict Riv and Inerferon-
28 weeks with 4 shots left to go.
Side Effects: Brain Fog-Nausea-Tears emotional changes- shortness of breath if I try to do to much-Lobster is no longer desirable hate them for that hehe.. Anemia to the point I just want to sleep. Migraine's once in awhile. Mood Swings- Your mind never lets you forget your on treatment daily hourly!
Sounds that would normally not bother me drive me crazy such as the clown making balloons for the kids I thought the squeaking would never stop.
This treatment is like having the flu every day there is no relief. I am not trying to tell anyone not to do it because this is just how it makes you feel like its forever but it's not people have to remember why they started treatment in the beginning it will help them through it. I think the world needs more awareness and more support groups for people who arent as strong to attend and meet others that are going through what they are going through because people who arent on this treatment really dont understand.
I get weekly blood work viens and legs are so sore- My doctors office is wonderful however they need a special line just for patients on treatment because when you call on a Monday and dont get a reply till Friday to a patient it feels like life of death which again no one can understand unless you have lived it. I hope this helps others and by no means would I not do this treatment I am just being honest and telling people my story and what to expect. If your on treatment FIND A SUPPORT GROUP if you cant find one start one you will be amazed at how many people will show up.
Thank each and everyone of you for sharing this information. Hopefully, we can utilize each of your stories in a manner that will bring the "national spotlight" on this urgent situation. Thank you all again!
The HCV Coalition for "The Cure"
I keep forgetting things, and as I lie awake in the middle of the night trying to sleep...
I felt like a prisoner while taking incivek. I always had to plan ahead for work or any activity. Will I be able to get enough fat, will I get to take my fat and pills on time, if I can't bring my own fat, will ther be some there to eat. Even with family gatherings, on Easter I told my brother I had to eat by 1:30 so I could take my pills at 2:00, no such luck, I went into panic mode, and had an anxiety attack. There are more stories such as that, this was an example.
I missed so much while on treatment, because I was just too sick or too tired, or just plain sick and tired. I missed my twin grandaughters' kindergarten graduation, I missed all my grandkids sport events, I missed first touchdowns, first baskets, missed holiday/celebration gatherings, and I missed just spending time with family.
My older grandkids were so worried, they knew I was sick but didn't know why and the younger grandkids were always asking why if I was sick and when I wouls say yes, they would ask how I got sick. they didn't understand at all.
This treatment is a thief, it takes your life, your mind, and in some ways your sanity. It changes your life, and I do believe at this point, it may be forever.
to all of us-
dear friends i am a survivor of SOC twice..... but nothing was as bad as these new drugs. i am sorry i am just being honest. and i can say the old SOC almost killed me. each time i was UND after 3 weeks, but it was an illusion that didn't last after EOT.
i HOPE the the coalition can get the pharmaco's to reconsider.
i am doing all i can to help.
may God bless you and give you his healing and comfort.
and MAY you be SVR after all this.
Reading the above side effects made me cry, I had every one except for the heart palpitations.
I started tx on Sept 1st 2011, finished Feb 17 2012, I was a Geno 1A probably got it from gama globulin shot in 1977.
Tx was so horrible I can't even think about it. There were times I could not catch my breath as my HGB dropped from 14.8 to 8.7. The doc who originally said he would give me rescue drugs changed his mind when I got into trouble. I was repeatedly told to just lay down that it was the tx that was causing me to be so weak that I could barely breath. I too think that I got a doctor who had no clue what to do with me. Because I had more sx than the "flu like" symptoms he just let me suffer. If it were not for the receptionist who knew more than the doc I would never have been given the "magic mouth wash" anti nausea pills or sleeping pills.
At one point I had a lump in my lip so bad I could not eat or talk, this was in addition to the fact that my body could no longer produce saliva.
There was a point, the week after finishing Incivek that I could not talk for two days, then I realized I could not read or write. I loved to read and for over 10 days I could not do it. I kept getting the feeling that I had a bladder infection for months. Then I got a boil that 3 doctors could not diagnose until it burst and bled every where. The muscle cramps were the worst and there was no relief. The convulsive itching (with no visible rash) was terrible. The itch would move from body part to body part for hours. Anxiety was also a huge issue after finishing the Incivek.
I realize it is probably past the time that you needed information however I saw this read the above posts recognized myself and thought I should add some things.
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