Tuesday, November 29, 2011

Telaprevir-Am I Anal Or Do I Itch?

Telaprevir-Anorectal Adverse Events

Define Anorectal- Pertaining to, or associated with the anus and rectum.

In clinical trials 29% of subjects treated with INCIVEK-telaprevir combination treatment* experienced anorectal adverse events, compared to 7% of those treated with pegIFN-RBV alone.

The majority of these events- eg, hemorrhoids, anorectal discomfort, anal pruritus and rectal burning - were mild to moderate in severity. Less than 1% led to treatment discontinuation. Events resolved during or after completion of INCIVEK dosing.

Yep, the topic on the blog today is one heck of a side effect, its horrible, annoying, painful, and unrelenting. Its Telaprevirs-Unmentionable-Itch, better known as the "anorectal side effect".

In 2011 during the April FDA Advisory Committee meeting Dr. Van Dyke asked the advisory committee a question on the anal topic.

Anal Itch; Burning sensation or an itching sensation

DR. VAN DYKE: My other question is, could you give us more clinical details on the anorectal symptoms in terms of what they were, what did they look like clinically, and how long did they last, and how much of a problem really were they for the subjects? Because they were quite common, like 29 percent.

DR. KAUFFMAN: Yes. We first became aware of this in Phase 2 with increased reports of hemorrhoids. And, frankly, I don't think it was really hemorrhoids, but hemorrhoids are present very commonly, so when you take a look, you often will find hemorrhoids, even if they're not really related to the phenomenon. We have really only anecdotal reports. But I have spoken to many investigators about this phenomenon. Upon examination, there is no inflammation. Either externally or on anoscopy, there's been no inflammation. And I'll just point out parenthetically that in all of our nonclinical studies, there is no inflammation or other findings related to the colon with telaprevir.

It's described as a burning sensation or an itching sensation. It occurs relatively rapidly after the beginning of administration of telaprevir. It actually often resolves either during the period of dosing or very rapidly thereafter. And as we pointed out, it's almost never associated with treatment discontinuation. It is an annoying side effect, but it really doesn't have any serious consequences in terms of compliance with the treatment regimen.

Back in 2009 at the The European Association of the Study of Liver Disease(EASL) columnist Adam Feuerstein reported on the phase III clinical studies for Telaprevir , he mentioned the anal itching scenario in his column. Here's the quote folks;

Telaprevir was the "butt" of some negative EASL chatter due to an anecdotal report that the drug was causing severe anal itching in patient(s). One EASL attendee described the side effect as "fire in the hole."


Perhaps you're that patient, and this side effect has taken on a life of its own. This blogger has received a few emails over the last year from men and women asking for more information on this itching, burning, anal phenomenon. Although, between the two sexes, male and female, the men are a little more graphic, more concerned and very direct. Why ? In part maybe because the male gender hasn't had the pleasure of experiencing the after effects of childbirth. I think most men are probably anorectal virgins, and my heart goes out to them. The majority of women on the other hand have felt post delivery anal pain, we're talking the- "mother of all hemorrhoids". The women write asking for an informational link, then mention the discomfort. Done.

Over the last year, I've corresponded with one such colorful male character. My friend was treating with the "anal itch" magic triple therapy.

Yesterday, I wrote this lovely gentlemen and asked him if I may paraphrase in a post his description of the irritating anal itch. I told him my readers needed a smile, he quickly replied with "Yes, please carry on, my pain is your pain".

First let me share one of his favorite quotes

The more serious the illness, the more important it is for you to fight back, mobilizing all your resources — spiritual, emotional, intellectual, physical.
Your heaviest artillery will be your will to live. Keep that big gun going.
Norman Cousins -Anatomy of an Illness

This charismatic man served in the Vietnam War, which explains his description of his anal irritation;

Hell, in Nam I had boot rot, give me boot rot over butt rot any day. Tell me woman, should I call my doctor and demand a shot of "butt rot fixer", or should I call Vertex asking to be reimbursed for a broken ass.

I quickly wrote back telling him I googled the said Pharmaceutical company and proceeded directly to the site, where I clicked on the "Contact Us" forwarding his email. We're still waiting to hear back.

Yes folks, there is a happy ending to his "telap-ass-rot" story, last week my sweet friend notified me with the results of his six month post PCR .. IT was....Undetectable.

I quickly replied with;

My heart is singing, my dog is excited, but I have one question.
Did your hemorrhoids make it outta the jungle alive ?

He replied;

Yeah, they couldn't take the heat.

No doubt treatment sucks, but when the end result is successful, its so worth the battle.

The following information is from Mayo and based on general clinical practice and current recommendations. It may help get you through the itch, I hope you find it beneficial.

Managing Anal Itching and Burning

Avoid irritants.
Avoid bubble baths and genital deodorants.

Switch tissue.
The skin around your anus may be sensitive to toilet paper that contains dyes or perfumes. Use unbleached, unscented toilet paper. You may want to use toilet paper that's moistened or made extra soft for comfort, or unscented flushable bathroom wipes

Cleanse gently.
Wash the area in the morning, at night and immediately after bowel movements. But don't scrub and avoid using soap. Instead, use a wet washcloth or a small squeeze bottle of water to cleanse the area.

Dry thoroughly.
After cleansing, pat the area dry with toilet paper or a towel. Avoid any greasy products such as Vaseline, the idea is to keep the area dry, not moist.

Wear cotton underwear and loose clothing.
This helps keep the area dry. Avoid wearing pantyhose and other tight-fitting garments because these can trap moisture

Don't scratch.
Scratching further irritates your skin and leads to persistent inflammation. If you can't tolerate the itching, apply a cold compress to the area or take a lukewarm bath or sitz baths to find some immediate relief.

Treatments that may help manage symptoms

The only “natural” cleaning agent that is 100% safe and effective on the anus is water.

A protective ointment that contains zinc oxide (Desitin, Balmex) applied to the affected area may help relieve symptoms.

To relieve mild or moderate itching, try over-the counter cream or ointment that contain hydrocortisone (Cortaid, Preparation H Anti-Itch Cream). This should be used over a short period of time as prolonged usage may thin the perianal skin. Apply sparingly and as directed.

If nothing seems to relieve your symptoms alert your physician as they can prescribe an ointment, antihistamine or both.

*Antihistamines before bedtime may help relieve nocturnal itching.

Swollen veins in the rectum or anus

Mild pain, swelling and inflammation from hemorrhoids often can be managed with self-care measures.

Hydration and fiber:
Softening and bulking up stool for easier passage is helpful. Strategies include drinking six to eight glasses of water or other nonalcoholic beverages daily, eating high-fiber foods, and taking fiber supplements such as Metamucil and Citrucel.

If diet alone isn't working talk to your provider about over the counter laxatives.

For Pain

Swelling relief: Ice packs or cold compresses on the anus can relieve swelling.

Again, plain warm tub or sitz baths several times a day, for about 10 minutes.

Ask your physician which nonprescription pain relievers such as acetaminophen (Tylenol, others), you should use.

In the end having a side effect validated is medically important and reassuring. Side effects are serious and must be reported. They're also stressful and can lead to apprehension, anxiety or fear. The last thing you need is to feel bleak about the future. Please remember its only temporary, keep your eye on the end result. Stay in close contact with your doctor, never hesitate to call him/her if you experience any discomfort.
You're not overreacting, you're advocating.

Please forgive me Vertex, I owe you my gratitude. Thank you. Please start those clinical trials for the post transplant patient soon.

Please see the full Prescribing Information.

In a reply to this article is a tip from HCV Advocates own-Ms. Lucinda K. Porter, RN.

Great article. I just wrote a similar one and if you don't mind my adding one more tip, here's part of what I wrote: Physicians are concerned that patients with anal itching may not be absorbing the full dose of telaprevir. The theory is that drug is “leaking out” rather than being fully metabolized, and telaprevir goes into the gut, which passes through to the other end. Therefore, not only do patients have an itching problem, they are not getting all of their medication. You can find the rest of the article by Clicking Here

Please check out this new post on the blog

In The Spotlight-HCV Advocate and Ms. Lucinda K. Porter, RN.


  1. Great article. I just wrote a similar one and if you don't mind my adding one more tip, here's part of what I wrote: Physicians are concerned that patients with anal itching may not be absorbing the full dose of telaprevir. The theory is that drug is “leaking out” rather than being fully metabolized, and telaprevir goes into the gut, which passes through to the other end. Therefore, not only do patients have an itching problem, they are not getting all of their medication. You can find the rest of the article at:

  2. What an important fact, I added it to the post, with a link to your article. I have been a fan of yours since 1999, I am so honored you read the blog. I just finished an article of gratitude to you and HCV Advocate. Thank you for a decade of HealthWise articles Ms. Porter. Rather you realize it or not,you have helped thousands of people understand and treat hepatitis C.
    Thank you

  3. Tina,
    No pun, you are still a funny ass lady.
    Its Jen, miss the humor.
    I am still SVR.
    keep in touch and have a great christmas.