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Ongoing Phase II Trial: Hepatitis C Virus Undetectable in Patients

October 9, 2013

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Boehringer Ingelheim, a leading pharmaceutical company, along with Presidio Pharmaceuticals, has developed a 12-week interferon-free program with promising results.

Investigational interferon-free regimen demonstrates undetectable hepatitis C virus in all patients reaching end of treatment in ongoing Phase II trial

08 October 2013

Ingelheim, Germany (Business Wire (Business Wire India))

Boehringer Ingelheim today announced that interim data from its Phase II hepatitis C (HCV) clinical collaboration with Presidio Pharmaceuticals have been accepted for presentation as a late breaker poster at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place 1-5 November in Washington, D.C.1 The poster presentation will be on Monday 4 November.

This ongoing study evaluates a new 12-week interferon-free regimen of Boehringer Ingelheim’s protease inhibitor, faldaprevir*, and non-nucleoside NS5B polymerase inhibitor, deleobuvir*, in combination with Presidio’s pan-genotypic HCV NS5A inhibitor, PPI-668*, with and without ribavirin.1,2 The trial is fully enrolled (36 patients) and to date, 97% of patients (28/29) have achieved undetectable levels of virus at week 4 of treatment, also known as rapid viral response (RVR). Additionally, 100% of patients who have completed treatment (13/13) achieved undetectable levels of virus at the end of treatment.

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  • Min Donald Lee Johnson

    Praise The Lord as His mercy endures forever (Psalm 118).

    • Dave

      Get a life.

      • Min Donald Lee Johnson

        I have one. Thank-you!!!!

        • Dave

          Based on a novel, created to control the weak. Good luck with that. BDS!

      • Shannon Tucker

        Praise who? How is a normal person with hepc suppose to afford this?

        • Dave

          Hi Shannon, I was referring to MDLJ and his religious banter. Hope you’re feeling good today. Peace. BDS!

    • Deborah Mand (Brown)

      no disrespect but it was earthly man who worked day/nite to find this collaboration of meds to try and help stop the virus. how can we praise the lord when so many people have died from this virus? how can we thank god that 1 person lives threw a car crash and another dies in one and both people were christians or one dies from cancer and another lives,does the lord care for one person more than he cared for thee other? you can’t answer that!

      • Deborah Mand (Brown)

        for 1 to think that the bible has not been tampered with is just nonsense. the worst judgers ive ever ran into are christians,they take things way overboard when it comes to the bible.

      • Min Donald Lee Johnson

        Deborah:
        I hear you. But who created “the earthly man” to have the intelligence, mindset (concern and maybe even care enough for humanity) and the will to create such drugs? We theologians identify that kind of vicariousness as “General revelation.” (God enabling earthy man to comprehend and create the incomprehensible).
        No God does not care for one person more than another. We can’t say that He cares more for people with Hepatitis C (so He introduced a cure) more than He does for people with AIDS (since so many have died from that disease.) But I can answer your question. Answer-God is sovereign. In another words sometimes, just sometimes things are beyond our control. Yet God decides and acts very effectually and independent of all others. Often, life emerges out of death as in the case of Christ’s resurrection!!! I’m certain it’s God all the time. Peace!!!

  • Melanie

    Long-term prognosis of the 13/13 patients? They were undetectable at the end of treatment; and I am thinking about 6 months out, 1 year out? This is still great news!

    • LFRD

      If you were undetected for 6 mo. even, your liver will regrow a healthy liver. There would still be no virus found in any given time there after. I am so glad this may be the proof in the pudd’n. Interferon, I heard is a bi%#h.

  • larry

    i am in this study no side effick just stay out of sun protect thery supply sun and lip block and eat with pills 2 x a day i am told people in early study are still virus free after 2 years also told cost was 40 50 thousin dollars its the end of this big h

    • Greg

      $40-50,000?????????

      Ouch!

  • Larry Temple

    How do I get involved in a clinical trial?

  • Robert Turnage

    In New Orleans area, how can I be involved in this trial treatment

  • carlman

    I’m hep c free from a study drug by Gilead. I have had two transplants.

  • wagih gamal eldin

    How do I get involved in a clinical trial

    • Carlos

      Go to clinicaltrials.gov to see trials and requirements.

    • droitduseigneur

      I suggest you research the top Hep C docs (I did, and found Mark Sulkowski at John Hopkins but there are many many more). Being under the care of a specialist makes it more likely you will be offered the opportunity to participate in trials.

  • phil

    I live on Nottingham England and am due to start a course of this treatment around January when my hospital will start giving out this treatment. Initially a relapser with interferon and ribiravin I am pleased and exited at this new breakthrough.

  • High maintenance

    Larry, I was offered to be in this study today @ my 4th annual liver transplant checkup. I have taken 2 interferon treatments, 1 for 36 1/2 weeks and the second two years after my transplant. Heard lots of good from the new treatment & looking forward to starting it. Baylor University Medical Hospital Dallas Tx is where I was offered the treatment. Hope you can find a spot in the trial.

  • KAT

    HI WHAT ARE THE SIDE EFFECTS