How Do I Make Sure I Do Not Lose Touch With Lessons Born Screaming From Hepatitis C Treatment Side Effects And All That Suffering?

I had such a powerful and unexpected experience today. I was transferring my iPhoto pics from my MacBook Pro to my new iPad, and I saw for the first time in almost two months, the extreme pictures of the rash and what happened to me. It was horrifying. I simply could not believe how truly bad it was even though it happened to me. As I heal, it is a part of me but it seems so far away as well. If I lose touch with the horror, do I lose touch with my gratitude? And it was horrific... for example, here is a pic taken on November 22, 2011 of my right leg and left foot. The treatment already had lasted two months. And it got much worse over the next ten days as the wounds became a staph infection...

I should look at these pictures every day. It might not be very appetizing, but it will be such a strong reminder of why I should be grateful and humble and happy to be alive. It is so easy to lose touch with your gratitude. I am a master at tossing it out a window as the wanting takes over and I dance with the devil, comparing myself to other people, wading in envy and jealousy, feeling either less than or more than, but never being myself. I know it is normal, but it is so careless as well. I have gone through a nightmare and I have survived; if it is to mean anything, I must truly change and transform the lessons wrought screaming from my body into everyday practices. A hard way to learn those lessons, but more valuable than I can ever express.

Here is a picture of me on September 15, 2011 in the doctor's office as I take my first dosage of Ribavirin right after I had given myself the first injection of Interferon in my stomach. I so believed that it would be a tough process, but not all that bad, and I would get through it with little damage and healed of the virus. I seriously had no idea what was coming down the pike like a runaway school bus with all the kids screaming and terrified. Okay, maybe not that awful, but it truly sucked!

Yes, it all began on that day, and I am grateful to be healed of this virus. At least, there's about an eighty to ninety percent chance that I am healed, and I will take those odds in Vegas any day. 

But, honestly, I am not the same guy anymore, and I am trying to process the changes, both negative and positive. The scars are healing, although they will always be visible on my legs. But the physical scars do not represent the change. The change is a spiritual shift into realizing the beauty and wonder of this gift of a life and truly valuing it on a daily basis. No more excuses and no more bullshit as I embrace the sometimes difficult and always challenging path of my authentic self. 

Will everything be okay in the end? I think so because I choose to live in faith and not in fear. Rather than being overwhelmed by and terrified of the question mark, I embrace the strange wonders of this mystery that lies before me. I do not know what it is right now and I am always a bit neurotic and worried, but I promise to do my best to truly walk the walk and no longer just talk the talk.

Another Rash, More Itching, New Side Effect Of HCV Treatment - You Have Got To Be Kidding!

I must admit that I cannot believe I am writing these right now. It is so absurd that I am now being hit by a whole new side effect of the Ribavirin, an itchy rash that is not nearly as bad as before, but still sucks. The rash is nothing like the raised boils and insect-bite like bumps that I experienced before. The itching is nothing in comparison, although it is quite annoying. At this moment, my back and both of my thighs are itching. Not screaming like before, not the madness that has no answer, but a nasty rash that bites the big one. 

I guess the best comparison I can come up with is a Scarlet Fever rash that I had when I was a kid. The rash is not raised and is evenly spread across the areas like a red splotch. I am shaking my head and I cannot believe that I actually have to deal with this crap and convey my frustration and anger to you. This is not a picture of me below. It is from the Internet and a mild form of a Scarlet Fever rash. The new rash is not nearly as extensive or as bad, but you get a sense of what it is like.

I mean, Jesus Christ, I have less than a month left of treatment, and this is what the universe decides to throw my way. I would say it is downright unfair, but the words of Rabbi Mark Borovitz echo in my ears. Whenever someone would complain at Beit T'Shuvah, the Jewish rehab where I originally got sober in 2003, the Rabbi would laugh, point to the door, and say: "The Fair's in Pomona." For everyone unaware of California traditions, the yearly state fair is always held in Pomona. Still, as I try to maintain a certain stillness and not erupt into anger, I am pretty damn well pissed-off. 

It is so easy to lose faith. It is so easy for me to curse God and to believe that the universe is throwing more at me than I can handle. But this is bullshit. This is the voice of my fears and my past. I can handle this and whatever else come my way because a beautiful awaits. I just need to walk my path and believe that the sun will rise tomorrow and I am already cured. I do have faith that a lovely destiny is around the next bend at the end of the road in the city of my mind.

Money Talks - If The Hepatitis C Market Is The Next Mecca For The Pharmaceutical Fat Cats, Who Will Win The Rat Race?

Is the Hepatitis C market the next Mecca for the pharmaceutical sector? If so, who will win the rat race: the millions of HCV patient with little or no resources or the pharmaceutical fat cats. It seems like the fat cats are salivating right now if we go by the flurry of activity and heightened interest in the HCV market. The Hepatitis C virus (HCV) market seems to have caught the eye of several pharma/biotech companies – as evident by the deals being signed for the development of drugs for the treatment of HCV.


Biotech rivalries are like bare knuckles boxing matches: two lone fighters battle until they are beaten and bloodied for the prize. But the hepatitis C market is turning into a battle royal that’s more wide open and unpredictable. The medical advances in hepatitis C have been dizzying this year, especially in what it means in terms of multi-billion dollar business implications. The safest thing to say is that there’s plenty of good news for patients this year, but that shareholders in the major hepatitis C drug developers had better hold on tight as a new standard of care gets established.

Pharmaceutical Companies Battling For Big HCV Profits

The Allure of the HCV Market
HCV is a hot development area which has come into the limelight with the launch of two new treatments – Vertex Pharmaceuticals’ (NASDAQ:VRTX) Incivek and Merck’s (NYSE:MRK) Victrelis. Both drugs gained approval in the US earlier this year. Incivek, which was launched in May 2011, posted a whopping $419.6 million in sales in the first full quarter of its launch.


With two new recently launched products in the market, why is the HCV market considered so attractive? Firstly, it is estimated that about 170 million people suffer from HCV infection across the world. However, the treated population is much lower. In major markets like the US, EU, Japan, Australia, Turkey, Canada, only 200,000 HCV patients out of a total of more than 12 million are estimated to receive treatment each year. This means a huge number of HCV patients go untreated, leaving the field open for new treatments. 


A 48-week course of both peg-interferon and ribavirin are the standard treatment for genotype 1 HCV infection. However, this treatment regimen is associated with significant side-effects like fatigue, flu-like symptoms, rash, depression and anemia. As we have seen with me, it is tough to say the least. However, let's not forget that my extreme side effects, the endless itching and pain of the rash, was caused by the new Protease Inhibitor and not the other drugs. Hell, in retrospect, the other drugs that I still take every week are a walk in the park in comparison. Yes, it sucks, but it is so very far from hell on earth.


With a large number of HCV patients failing to achieve a sustained viral response (SVR) on the current standard of care, there are several patients who would be open to treatment with new and potentially more effective therapies. These factors have made the HCV market an attractive commercial opportunity for pharma and biotech companies. It also has made it attractive to the millions of patients like myself with the American genotype. Suddenly we have a chance to live that has risen from about 45% to almost 80% treatment success rate.


Cocktail Therapy – The Next Big Thing in HCV
The goal is to change the treatment paradigm for HCV patients by providing them with all-oral treatment regimens. The aim is to develop a treatment which does not require the administration of interferon, thereby doing away with a whole range of side effects. The treatment duration will also be shorter. In retrospect, I wish I had waited until such treatments were available, but regrets are silly. I am powerless over the past and I cannot change it. All I can do is embrace health and happiness in the future.

The Financial Fat Cats Love The HCV Marketplace As It Opens Up

Who Will Win the Rat Race?
With several companies pursuing cocktail therapies for HCV, it will be interesting to see which of these companies will be the first to hit the market with a new treatment option. Hopefully, the rat race will help the millions of infected Americans and not just line of the pockets of the pharmaceutical fat cats.

Why The Silence? A Certain Malaise Sets In As The Hell Of The Side Effects Ends And Purgatory Is Restored But A Hero Is Reborn

I would apologize for the recent silence, but I honestly don't believe that such an apology is necessary. After going through the utter hell of six straight weeks of endless itching and intense pain, I find myself giving in to a certain malaise and ennui. Yes, purgatory is an utter pleasure when compared to the fires down below, but it is not quite a celebration and not quite an inspiration. I am tired and burned out to the bone as I struggle to retain a certain equilibrium within. It is strange because the rewards of such an experience are so much greater than the scars, but the scars and the damage of the wounds remain.

The thing about a hero, is even when it doesn't look like there's a light at the end of the tunnel, he's going to keep digging, he's going to keep trying to do right and make up for what's gone before, just because that's who he is.                                                                — Joss Whedon

I am beginning a new journey as I approach the end of treatment that I believe is successful and the Hepatitis C virus will have been eradicated from my body. But I still have another month and a half of Interferon and Ribavirin so I spend several days each week with flu-like symptoms and exhaustion. It remains difficult to eat at times and the indigestion is constant and the toilet is not my friend. But I have survived and I have learned lessons that not only cannot be taken from me, but will be maintained through practice and a loving focus. It is nice not only to see the light at the end of the tunnel, but to walk into the sunshine with the knowledge that another always awaits.

Faith Is The Realization That The Light Is The Gift Of A New Dawn

Do you recognize the hero within? Not only are you the main character of your story, but you alos have the power to define the genre of the story. It does not have to be a tragedy or a farce, it does not have to be epic or absurd. Your story is your own and you are the hero of its creation. Welcome to the freedom to define the journey of your name and your life.

Here is a new poem that I rediscovred and recently recreated... gotta love such a reenvisioning and a reawakening and a simple return because even if re is a prefix, occurring originally in  Latin, used with the meaning “again” or “again and again” to indicate repetition,or with the meaning “back” or “backward” to indicate withdrawal or backward motion, it still provides the ability to express the eternal recurrence of being a-okay. Here is that poem I mentioned above...

between

between the first step taken

and lying down on a leather couch,

between the opening of a door

and the turning of the bedroom lock,

between putting pen to paper

and checking out what’s in the fridge

fall the sunken eyes of ennui.

between the biting of a nail

and the opening of a fist,

between the twitching of a palm

and the raising of a thumb,

between the flapping of tongues

and the calmness of silence

stands the bright shadow of courage.

Night 145 - Innovations In Hepatitis C Treatment Definitely One Of The Major Medical And Financial Breakthroughs Of 011

Several other Protease Inhibitors are being developed as well, including the nightmare experience I had with the Protease Inhibitor by BI. Still, I believe I will be cured so it does work, and my side effects were more extreme than anyone else in the clinical trials. Lucky boy!

Drug Research Is Big Business: 4-6 Million HCV Infected Adults In The US

Overall, the innovation in the Hepatitis C treatment arena and thus the overall marketplace are nothing less than stunning. Within a few years, it looks like Interferon and Ribavirin will be removed from the treatment regimen, replaced by a Protease Inhibitor that covers all the bases. How great is that!

But let me be clear about my response to these incredible innovations. Despite the severity of my side effects, I am not bitter about my decision to enter the clinical trial and get treatment now. It was the right decision to make at the time, and my bad luck in regards to the side effects was just that - simple bad luck with no dark magic or evil curses. Hey, sometimes we roll the bones and we come up aces and sometimes we just crap out.

Such is life, and I choose to free myself from the burden of bitterness and regret. What's the point?! It's not like I was playing with loaded dice and got screwed. Sometimes the universe works for you and sometimes you work hard for the universe.
             I wish we had more control, but, as the French say, C'est La Vie!

If you choose to hold tight and carry the bitter weight of your regrets, do not ask why their no fluidity or rhythm to your life. What the hell do you expect when you are so overwhelmed by the horrors of the past that you sacrifice the freedom to live in the present.

Here is the article below about some of the new Hep C innovations:

2011 has brought patients with hepatitis C not one but two new groundbreaking medicines to treat the condition. Merck’s Victrelis (boceprevir) and Johnson & Johnson/Vertex’s Incivek (telaprevir) were both launched in the US in May. 

The drugs are both oral protease inhibitors, and promise to significantly improve treatment when added to the current standard treatments for the disease. An estimated 270-300 million people throughout the world have the disease.

Analysts predict Incivek will prevail because it has shown a higher cure rate, and a simpler and faster simpler dosing regimen. But Vertex, which has never launched a drug before, will have to overcome the might of Merck and its new US marketing partner Roche. 

Vertex’s belief in the superiority of its product is reflected in its price, which is $49,200 for a 12-week course. This cost is much higher than Victrelis, and is equivalent to the price of a whole 48-week treatment with Merck’s drug. 

Incivek has had the best start, earning $420 million between May to October, while the same period saw Victrelis earn a more modest $31 million.

Night 136 - Long Silence As Ennui Sets In + The Side Effects Added To Warning Label Of Peg Interferon - Depression and Suicidal Ideation

I know I have been silent for almost ten days which is the longest gap since I started treatment. It is strange because you would think I would have been silent during he nightmare and living hell of the constant itch and pain of the rash and staph infection. But the blog was my life preserver during that six weeks of hell, and it provided me with a sense of value and faith. Now things have shifted as I slowly recover from the trauma while remaining on the Interferon and the Ribavirin. 

Although I See The Way Out, I Remain In The Dark Tunnel At Essence

Although I see the light at the end of the tunnel I am still in the tunnel, still nursing my wounds, and, in the stillness of the cold night, facing the weight of the consequences. I have shifted into the doldrums of ennui as my burned-out body sags to the floor, and I fall on the couch and surrender to the banality of just being uncomfortable. Mind you, being consistently uncomfortable 24-7 is so much better than being in the thick of hell on earth. I am grateful, but being out of the flames and the fire, you begin to register the price and the traumatic effects of the wounds and damage. It is a bit overwhelming as I give in to being a couchaholic once again and find refuge in the arms of my old brown leather couch.

At the same time, I am writing beautiful poetry, and I shall publish a few newly rewritten and completely revised poems in the next blog. Right now, I am healing from the most extreme trauma of my life, and I must be gentle with myself. It is hard and brutal at times, and I must realize the toll taken in terms of the extremity of my survival. Yes, I survived and even did well in the face of a such a living nightmare, but there was damage and there was a lasting price. Although the long-term consequences have turned out to be both negative and positive, I must recognize that the negative cannot be ignored and must be treated with the respect of the price and the necessity of healing and recovering slowly.

Finally, I am still on the Ribavirin and Peg Interferon for another 2.5 months. The traditional side effects of these two drugs is what you always heard about when people mentioned how awful and difficult the process of going through Hepatitis C treatment. The worst side effects I experienced was due to the new Protease Inhibitor, but I am in a clinical trial, the drug is completely new, and my side effects won the gold medal for the worst in the entire country, if not, the entire world of clinical trials. Nevertheless, the side effects of the other two drugs continues to be a challenge.

The Ribavirin and Peg Inteferon Side Effects Continue To Be A Challenge

Here is a recent article about side effects officially added to the Interferon warning label:

FDA Hepatitis Update - Important Updates to PegIntron Warning Labeling

On December 22, 2011, the Food and Drug Administration approved revisions to the product labeling for PegIntron to include the use of PegIntron with hepatitis C virus (HCV) NS3/4A protease inhibitors for the treatment of genotype 1, chronic hepatitis C (CHC) infection. Additionally, the product labeling was update to include revisions to the text regarding the use of PegIntron in patients with neuropsychiatric disorders. Changes were made to the Medication Guide for consistency. The following changes were made to the warning and precaution sections of the product labeling.

Warning and Precaution section was revised as follows:

Neuropsychiatric Events

Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.

PegIntron should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.

Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate. In severe cases, PegIntron should be stopped immediately and psychiatric intervention instituted. Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of PegIntron.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Not Very Helpful: Medical Sites On BI 201335 And Bad Rashes, But Good Ideas From Real Patients Suffering Like Me!

Basically, all I have learned is that they have no answer to the severity of my particular rash, and such severity has caused 4% of patients to discontinue treatment. Not very helpful. Man, this is really wearing me to the bone! Thank God for fellow patients in other Protease Inhibitors treatment with bad rashes. Maybe something they suggested below might just work.

Here is the list: Prednisone, Zertec, Elocon steroid cream, Atarax, Triamcinolone Acetonide Cream, Solumedrol

You Would Think There Would Be An Answer Readily Available!

Here are some possible treatments recommended by patients with similar side effects with other Hep C Protease Inhibitors that I need to investigate:


The only thing that did stop the itching was a pill called Atarax.  Its not a over the counter drug and your doctor has to write a prescription.  The itching was so bad I wanted to stop tx until I started the Atarax and it was the only thing that worked.  


triamcinolone acetonide cream usp. this is my rx, It is 1lb, and I have 6 refills


finally getting the rash under control with the solumedrol


Some parts looked like eczema.  Other parts like my neck just went a uniform angry red and I had to put ice packs on day and night to make the burning bearable. I got really wore out and fed up inspecting it every day and seeing one part die down just to see another part start to flare up. It was a total bummer. Lasted the whole month of July, then gradually the inflammation died down.  I had to treat with Elocon steroid cream the whole time.   


 I had some of the common riba rash issues during tx, but Lidex cream and Zertec antihistimine cleared it up in a few days. Wish I had that treatment earlier, because the itching was hellish! 


At that point, my dermatologist told me this was one of the most extreme allergic reactions she had ever seen.  The rash had converged, if you will, into one large continuous red area that covered, as she said, 90% of my body.  The term she used was confluent.  If you didn't touch it, it looked just as a really bad sunburn would.  There were no longer any indivdual bumps, they had all joined together at this point.  It caused extreme chills and fever and was hot to the touch, as an extremely bad sunburn would be.  I was always cold and taking a shower was excrutiating.  It zapped my strength and the itching was like nothing I've ever experienced before. 

Derm  prescribed Prednisone with a taper schedule of 21 days, however, my study doctor allowed me to stay on all meds for an additional day or two to see if the prednisone would work.  He was very clear that if the prednisone didn't clear it up quickly, I had to completely come off of the study, including SOC drugs. 


THIS IS WHERE I WILL NOT GO:


 But this rash is soo bad I hardly recognize myself. I'm covered fromhead to toe. I bath,shower 10 times a day, have tried every lotion, potion and perscription pill known to man. I lay in bed with up to six bags of ice at a time. I have never experienced so much pain  in all my life. It has now traveled to myface as well as other places too sensitive to discuss. I AM DONE! 12 weeks of torture.


For three weeks the rash kept increasing in area and intensity of pain.  I was panicking about what was going on.  The Hep Service nurse said it is common to have itch and rash so I kept on taking the treatment.   I finally couldn't take it any more so I stopped after taking with my family doctor and the Hep nurse.  After I stopped, I talked with a  dermatologist, and the Hep Specialist who said I was having an adverse reaction to the medication and it was a good thing that I stopped as it could have become life threatening.   It took about 10 days for the rash to clear but I still feel itchy at night.  Hopefully that will stop as well.  The side effects I was having until week 15 were not that bad to manage but the rash was too much.  Now I am waiting to see if the treatment cleared the virus.  The Hep specialist is doubtful but I am keeping up hope.


And something more...

Skin Care:
The dry skin from the interferon and the Riba-rash can be potentially very big sides from treatment.  It seems to affect fair skinned people the most.  Many describe the feeling as being like little bugs crawling all over your body.  Your skin is also dry and very sensitive from the interferon.  Freyja is sure that the Princess from the Princess and the Pea must have been on interferon treatment!

Your skin is your largest organ, and skin integrity is very important to your overall health.  Spend time on it, do some preventative maintenance on it - before it gets bad.   Your skin will heal slower due to low platelet counts and lower white blood cell counts (WBCs) which can make fighting infections more difficult and slow the healing process. The human body is an incredibly complex entity, when you are on interferon, your body is told that the a number one task is to fight viral infections. Unfortunately this leaves you open to bacterial and fungal infections, so use common sense.   also see Infection

Winter is also a drying season, run a humidifier, take warm, not hot showers, don't take baths (soaking can be very drying and irritate your skin), tap water contains a lot of chlorine.  Chlorine is a bleaching and color oxidizer which dries and strips your hair and skin of natural oils and color during a hot shower or bath.   Chlorine also absorbs into your skin through your pores.  This can aggravate sinuses, irritate eyes, and cause rashes.  Try to get a Chlorine filter for your shower head.

When showering, try to use a mild non-perfumed bath soap or gel.  Deodorant soaps may contain chemicals that could be hard on your delicate skin.  Use a soft cloth, no hard rubbing or scraping!  Do not pick at your blemishes!

Try to put only soft natural fibers next to your skin.  If you wear a bra (not occasionally but every day), get an all cotton one to reduce the irritation from the elastic.  Victoria's Secret has a wonderful line of soft stretch bras, or get an all cotton sports bra.  Carefully cut out those scratchy plastic tags in the back of your clothing.  Do not violently rip them out with your teeth as Lacey and Freyja did, it will leave holes in the back of your clothes.

Here is an overview on three approaches to skin care while on combo:

Over the counter:  To help preserve your skin integrity use a good lotion on your skin every day, am and p.m.-especially when getting out of the shower.   This stuff is excellent! Call your pharmacy and ask if they carry Aveeno lotion (made with colloidal oatmeal), if not, they can order it for you. Does not require a prescription.  Good to keep the itching at bay, good overall moisturizing lotion to use everywhere before dry patches, cracks and sores form.  Bag Balm (also known as Udder Cream) is also a good moisturizer (if you can stand the smell!). Eucerin Lotion is also inexpensive and great for dry skin.

For the face, I like PX Prescriptives-Flight Cream - "Instant Help for Dehydrated Skin" for the "Mummy Skin" on your face (your face will be as soft as a baby's butt, but your wallet will be hurtin'-$36 for a 1.7 Fl. oz tube that lasts about 2 months). Full of aloe, eucalyptus , and other great stuff, can slap it over makeup-sinks right in, no smearing.

If you start to get the "Riba-Rash" (small blister like eruptions that itch like hell-look like flea bites and leave oozing sores when scratched) get a hydrocortisone cream or Benadryl or Gold Bond lotion-they seem to help somewhat.  Downside: If you've got it bad, they usually don't last more than 4-5 hours at best.  Not enough for a good nights sleep.   Hot showers seem to aggravate them.

Homeopathic: Calendula lotion (made from Marigold flowers) helps sooth skin, aides in healing.  Here is a link I wrote about it with a place to get it on the web:http://my.webmd.com/roundtable_message/221527.

Prescription: If all else does not provide you with consistent relief, and you are tearing your skin up- then ask your doctor to  prescribe a good antihistamine.  You are having a severe allergic reaction to the Ribavirin, it's not uncommon at all.  I use Zyrtec, it goes right to the skin, does not make me drowsy. I’ve also heard good things about Claritin (also by Schering) and Allegra.  Also, ask your doctor forFluocinonide Cream USP 0.05, even doctors use it for their cracked skin from all the hand washing.

Freyja gets Elocon from her primary care physician. Can you guess who sells it? If you guessed Schering you get 100 points!

If you must scratch your itches, Pier One has excellent bamboo back scratcher for about .80-get many and put them around your house, they work much better than steak knives or screwdrivers!  Scratch gently!  Do not tear or rip your skin.

Lotion applicator- apply lotion to your back, if you don't have someone to do it for you, order a lotion applicator from a senior catalog -try Dr. Leonards-1-800-785-0880 - ask for #921 its $5.99.

 Info About Boehringer Ingelheim 201335


 The side effects attributed to BI 201335 were jaundice (no severe cases) and rash (severe cases–0.7 to 5.8%) and were found to be dose dependent. 
The PegIFN sparing treatment was well tolerated. Investigators reported that the most common adverse events observed in the study were mild gastro-intestinal effects (diarrhea, nausea, vomiting), rash or photosensitivity. 


Skin rash or photosensitivity reactions (mostly mild-to-moderate): 33%, 40%, and 59%, respectively; 1.3%, 0.7%, and 6%, respectively, developed severe rash. 4% of patients discontinued treatment prematurely due to adverse events (rash, photosensitivity, or jaundice) in the 2 once-daily groups, compared with 24% in the twice-daily group.


The most common side effect was rash and it was observed in 59% of the patients who received the 400 mg dose. 


The company reported potential side effects from the two oral compounds including itchiness, rash, photosensitivity, jaundice, nausea, vomiting and diarrhea.


Weakness, itching, rash, hypersensitivity to sun exposure, yellowing of the skin and eyes, nausea, vomiting and diarrhea were the most common side effects in the study, occurring in more than 25 percent of patients. Between 6 percent and 12 percent of volunteers have discontinued treatment because of side effects, with most dropouts occurring among those receiving once-daily BI 201335, three-times daily BI 207127 plus ribavirin. 


Adverse Effects with Protease Inhibitors

 A sudden and severe cutaneous[outer skin]–mucous[inner skin]hypersensitivity reaction occurred, characterized by a diffuse, maculo[blemish-]papular[pimples]-orticarioid[irritation] rash accompanied by intense itching...  During the subsequent week of intensive care, including fluid-electrolyte management, steroid-albumin administration, and erythrocyte transfusion, the skin rash evolved into a desquamative phase with extensive epidermal detachment, whereas a normalization of all liver–kidney–myelopoietic parameters became almost complete 16 days after HAART interruption, and did not show relapses during the subsequent follow-up... In [treatment group 1] 1 individual withdrew from the study with rash...in [treatment group 2] 2 participants withdrew from the study, 2 due to rash...

 Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with STOCRIN. The incidence of erythema multiforme or Stevens-Johnson Syndrome was 0.14%. STOCRIN should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever... Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with STOCRIN...

Rash

Rashes often appear as a side effect of antiretroviral treatment. These may be itchy but are usually harmless and short-lived. However, severe rashes can occur with nevirapine, and more rarely with some other drugs. Any rash occurring during the first few weeks of treatment should be reported to a doctor immediately, as should any rash accompanied by fever, blistering, facial swelling or aches. A rash occurring with abacavir may indicate a very dangerous hypersensitivity reaction, as described later in this page.

Tips for coping with rashes include:

• Avoiding hot showers or baths
• Using milder toiletries and laundry detergents
• Wearing cool fibres such as cotton, and avoiding wool
• Humidifying the air
• Trying moisturizers/emollients or calamine lotion

Antihistamine tablets can sooth rashes and are generally available without a prescription. However, because these may interact with antiretroviral medications, patients should check with their doctors before using them. More severe skin problems may be treated with steroids.