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Hepatitis C Triple Therapy Response Predicted in Four Weeks

Nicole Cutler L.Ac. October 21, 2011

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Results from a newly published study reveal a way to predict who can be cured of Hepatitis C, providing motivation for affected individuals to complete treatment.

Receiving treatment for chronic Hepatitis C is not guaranteed to result in a cure. This can be devastating because of the treatment’s great expense and capability for causing misery. Thus, the medical community has gone to great strides to figure out ways of predicting the chances that a certain individual can be cured of this viral disease. Claiming to fairly accurately predict who will successfully triumph over Hepatitis C after just a month of treatment, a new study delivers good news to those who are about to begin Hepatitis C treatment.

With the approval of two new medications in 2011, treatment for chronic Hepatitis C has made great progress. Prior to the recent FDA approval of the protease inhibitors Incivek and Victrelis, the standard treatment of pegylated interferon and ribavirin only achieved a 50 percent success rate. With the addition of one of these two new drugs to the therapeutic regimen, the chances of successful treatment have risen to 75 percent or higher.

Although a dramatic improvement over the year-long regimen for pegylated interferon and ribavirin, the new triple drug treatment still lasts six months for most people. The 25 percent of individuals who are not cured of Hepatitis C within six months must still pay for the pricey medications for half a year (if their health insurance doesn’t cover it) and contend with a long list of potentially severe side effects – all for nothing. However, the results of a phase 3 study demonstrates that after just four weeks of triple drug therapy (pegylated interferon, ribavirin and Incivek), patients and their physicians should have a pretty good idea if the treatment will cure their Hepatitis C.

Incivek was approved by the FDA in May 2011 to treat chronic Hepatitis C genotype 1 in conjunction with pegylated interferon and ribavirin. This drug has been met by much excitement by the hepatitis community because it both shortens treatment duration and increases the likelihood of virus elimination. However, since this triple drug regimen relies on pegylated interferon and ribavirin, the side effects associated with these medications still apply. The most common side effects for pegylated interferon and ribavirin include:

  • fatigue
  • flu-like symptoms such as fever, headache and muscle aches
  • anxiety
  • skin rash
  • depression
  • gastrointestinal symptoms such as nausea and diarrhea
  • anemia
  • chest pain
  • hair loss

When adding Incivek to the Hepatitis C drug regimen, the following side effects are added to the list:

  • itching
  • vomiting
  • anal or rectal problems
  • taste changes

Enduring any combination of the side effects listed above can be a major challenge, and many people quit treatment prematurely. As such, encouragement to persevere through these ailments is crucial for completing the treatment and having a chance at viral eradication. According to a study published in the September 15, 2011 issue of the New England Journal of Medicine, such motivation may exist.

Conducted on individuals new to Hepatitis C treatment, this phase 3 Incivek study identified a close similarity between patients who responded to the triple drug treatment after just four weeks and those who achieved successful viral eradication. According to Kenneth Sherman, MD, PhD, Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Division of Digestive Diseases for UC Health and principal investigator of the study, “With Incivek, we know by week four how patients are initially responding and, for people who have not been treated before, we know by week 12 what their chances are of completing all therapy in 24 weeks. I believe these are important motivators for patients to start and stay on treatment.”

Since Incivek has already been approved by the FDA, this recently published study may appear to provide little new information. However, closer evaluation reveals its clinical relevance. Patients who respond to treatment with Incivek, pegylated interferon and ribavirin within the first four weeks of treatment have a significant likelihood of being cured of Hepatitis C. Thus, a positive response after one month of Hepatitis C treatment provides substantial motivation to endure the drugs’ side effects and complete another five months of triple drug therapy.

References:

http://scienceblog.com/41501/hepatitis-c-in-2011-a-predictive-marker-for-response-to-therapy/, Hepatitis C: In 2011, a predictive marker for response to therapy, Retrieved September 25, 2011, ScienceBlog.com, 2011.

http://www.drugs.com/clinical_trials/new-england-journal-medicine-publishes-data-phase-3-illuminate-study-incivek-telaprevir-hepatitis-c-12346.html, New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK(telaprevir) in Hepatitis C, Retrieved September 25, 2011, drugs.com, 2011.

http://www.hepatitis.va.gov/provider/reviews/treatment-side-effects.asp, Interferon and Ribavirin Treatment Side Effects, Retrieved September 25, 2011, United States Department of Veteran Affairs, 2011.

http://www.hepatitis-central.com/mt/archives/2006/07/understanding_h.html, Understanding Hepatitis C Interferon Therapy, Nicole Cutler, L.Ac., Retrieved September 25, 2011, Hepatitis Central, 2011.

http://www.thirdage.com/news/incivek-phase-3-study-results-published-in-new-england-journal-of-medicine_09-15-2011, INCIVEK Phase 3 Study Results Published in New England Journal of Medicine, Roberta Seldon, Retrieved September 24, 2011, ThirdAge Media LLC, 2011.

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  • Dan

    MY GIRLFRIEND JUST DIED AFTER THE FIRST 12 WKS OF THIS TRIPLE THERAPY ORDEAL. IT WAS HORRABLE! THE SCREENING PROCESS IS ENTIRELY FLAWED. IT IS KNOWN THAT HEP.C CAN CAUSE “APLASTIC INEMIA” WHICH SHE APARENTLY HAD AND STARTING THIS TREATMENT IN THIS CONDITION WAS A DEATH SENTENCE.

  • Dan

    I WOULD APPRECIATE ANY CORRESPONDENCE IN REGUARDS TO THIS “HEP C” TRIPLE THERAPY NIGHTMARE FOR ME .
    [email protected]

    • Diminico

      Dan, getting group support if you live in a city is a good thing. You can be overwhelmed with the illness and information overload. My first time on double therapy lasted 12 weeks and I decided to stop since  I had not cleared,  I am into week 21 of triple  therapy (incivek)  Incivek caused more extreme side effects low hematocrits etc.  I stopped Incivek at week 12 as prescribed and starting around week 16, my side effects were much less and my tiredness was much less.  I feel very hopeful since I cleared @ week 4, which means I have a 90% chance to sustain.  Unfortunately since I was a slow responder my Hepatologist wants me to go an additional 24 weeks?  Geno type 1 is the most virulent, I had a viral load of 5.8 m! If you have geno type 2,3,4, you should  have a six month time with a high rate of success without a third therapy.  My advice to you is to stay informed as much as you can(I have researched HCV for several years) teach yourself to read your copies of blood work(you should get a copy every time.  Now you are an informed advocate and should make a co-joint effort with your hepatologist or GI doctor, you have to be clear with your relationship with your specialists.(some can be very difficult)  I had this issue in the very beginning and made it clear to him that I am informed, I have to make life decisions here and this is my body.
         

  • Geeg

    DAN,
    I AM SO VERY SORRY TO HEAR OF YOUR GIRL FRIEND, HOW DIFFICULT IT MUST BE FOR YOU. I AM 64 AND DID MY BEST, I ONLY MADE IT 11 WEEKS BUT I KNOW FOR SURE I WOULD HAVE NOT MADE IT THROUGH. I ALSO HAVE CANCER AND IT HAS LEFT ME IN PHYSICAL RUIN. I AM FEELING BETTER IN MANY WAYS BUT I HOPE TO GET BETTER AND BETTER. IT A A GRUESOME 11 WEEKS BUT IT IS OVER. MY HEP C IS STILL NOT DETECTABLE BUT IT WOULD BE A MIRACLE BUT I MUST SAY I AM FOREVER HOPEFUL.
    I WISH YOU THE BEST AND WOULD SUGGEST ONLY YOUNGER HEALTHIER PEOPLE TRY THIS TREATMENT.
    All the best to you,
    Geeg

  • Regina

    Dan I’m sorry for your loss, I will be praying for your girlfriend and you
    But you know God bless you to be with her until the last day. My husband is a transplant patient too he is going to start this treatment but this is the only option the he has, his transplant was in Nov 2000 and medication is not working, but we Trust in God everything is going to be fine, Dan I fell like we all in transplant are one family.
    Regina

  • Barbara

    I was a non-responder to the Hep C double-therapy (Pegalated Interferon and Ribaviran). This was 1995, 1996, 1998. My new doctor told me of the new triple-therapy when it came out in 2011, and I just started the Incevek, Pegasys, and Ribaviran on Jun 1, 2012. I responded at 4 weeks, and continue to have no traces of the virus and they consider it irradicated. However, since I was a previous non-responder in the past, my doctor had me continue on the Pegasys and Ribaviran after I completed the extremely difficult 12 weeks with the Incevek…and told me I needed to do 48 weeks and not just the 24 weeks. I have tried to endure and have continued to get sicker and sicker from the side-effects. I am in week 40 right now, and this morning I made the decision to stop my treatments. What is another 8 weeks going to do when the virus has been irradicated since week 40?! Was it worth it? Absolutely 100% since I no longer have to live with the worry of when I am going to get sick from the disease – and when will I have to have a liver transplant?? It has been an incredibly difficult journey, and my husband and family have been amazing support systems. But, today I say good-bye to my treatments and I look forward to gaining “me” back (not just being known for being sick!). Best wishes to everyone.

    • jenna

      If u have genotype 1A be careful because there is still a chance that if you dont finish the full 48wks. of treatment your virus might come back.

    • Bailey Taylor

      I am quitting treatment after 14 weeks. I had been complaining about the mouth sores for 6 weeks and asking for relief. They just kept telling me to wait. I Week 12 of taking Incivek I had terrible sores in my mouth and swollen tongue and throat. Called the doctor 3 days in a row and no response from them. I was having migraines, difficulty breathing, rapid heartbeat. 5 days later I went into office to pick up monthly meds. His assistant says they tried to reach me last week to tell me to stop taking the incivek as I was having an allergic reaction. WTF? I asked for help with the sores again and the fact I was sleeping only an hour or so per night and was miserable. Nope, lets wait until next week and we take more blood, I am done.

  • Guest

    My husband completed 48 weeks of the triple therapy, after the first 4 weeks there was to detection of hep c, We were elated, he suffered tremendously, but hung in there through the whole 48 weeks. He just got home from his 6 month check up after completing the treatment, only to be kicked in the gut. His viral load is back up over 1,000,000 we are devastated.

    • richard

      OMG I am so sorry. My 6 month test is 6 weeks away. I have been feeling soooo good compared to the previous year that I cannot believe it might possibly be back. I can totally understand you guys disappointment. Is he going to try treatment again or try a new one? Best of luck to you guys regardless of what you choose.

  • Bailey Taylor

    I am in week 10 of the triple therapy, as a previous non-responder in 2004. My viral load went from 5,8 million to 43 in 4 weeks with the incivek. But I have lost my job from being so ill from side effects and social security disability is a horror show in itself. I may have to stop treatment after twelve weeks due to my dire financial situation. I am in AZ and have a chance at a free place to live in VT. I want to see if I can transfer treatment to Burlington to Dartmouth. Does anyone have info on those areas for treatment?

  • Leanne

    I am on week 37 of 48 of the triple therapy treatment. I must say that it has been horrible. I was so sick especially while on incivek. I had every side effect listed plus many others.

    A support system is a definite must. Having people around me to encourage me to keep going has been my strength. I seriously felt myself dying but kept going.

    Finally at about week 28 the side effects levelled off and I feel lots better. I’m still weak and tired and have aches and fevers. But compared to the first 16 weeks I’m doing awesome.

    I encourage anyone reading this to keep going and push through because really what are our options?

    God bless you all.

    I pray for success in all of your treatments.