HCV New Drugs; The Trials and Tribulations/FDA Fast Track Pharmasset

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HCV New Drugs; The Trials and Tribulations/FDA Fast Track Pharmasset

Can I treat with Telaprevir Before It's FDA approved ?,,,

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Does a bear use toilet paper ? Wait, that's wrong. Does a bear fall while running in the woods ? Wait , I'll get it. .

If a bear had a computer would it read: What Is a Healthy Stool ? What Should It Look Like? n.

Sorry for mentioning this yet again folks, but this morning when I checked the stats, I found that for the last six months, this blogs most popular post is STILL about a "stool", not just any stool, but a "healthy one". Shut the front door !.

What is that ? Why are "American bears" so fascinated with that entry ? I am still amazed , confused and dazed. .

Anyhoo, lets move on to more pressing issues like treating with Telaprevir and humans. l..

Oh yes, Telaprevir, that new wonder drug. I ask you , could this drug be it ? Can this drug cure the difficult to treat ? I'm talken all those individuals with cirrhosis or relapsers, non-responders, and that pain in the liver genotype 1 ! I hope so ! It appears so ! l

The Question;,,.l

Can you treat with Telaprevir Before It's FDA approved ?

Yes, by entering into a clinical trial but unfortunately there aren't to many right now, as with any new drug once its near FDA approval most of the clinical research is done. Usually a few lingering trials can be found. However if I recall after Pegasys and Pegintron both were FDA approved additional trials followed. This may be the case with both these new drugs; Telaprevir and Boceprevir. .,l,,.

Any Benefit In Treating In A Trial ?

An obvious benefit of being in a clinical trial is the cost, its free. But, if you have insurance you may be billed for both blood work, and office visits.

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First up is this trial.........

Telaprevir With VX-222:/Some New Locations Are Now Recruiting

First Received: March 1, 2010 Last Updated: August 19, 2010 .l,

A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection. ml

Yes folks, this clinical trial is now recruiting in additional locations l

For a better understanding of this trial you may want to read this:

Trial For :Telaprevir and VX-222 .

Note: The above link/post is from July, additional locations have been added

..Telaprevir /Protease Inhibitor /VX-222 /Polymerase InhibitorVertexPhase II

, .From HCV Advocate:

Comments: On March 2, 2010

Vertex announced the initiation of a phase II trial of telaprevir/VX-222 (2 arms with and 2 arms without pegylated interferon/ribavirin). There will be 4 treatment arms with 25 patients in each arm. The treatment duration (12 weeks, 36 weeks) will be guided by response at certain time points during the trial...On July 28th, Vertex announced that it was on track to complete the telaprevir FDA application in the second half of this year.

(July 30, 2010)

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NOW recruiting in these locations listed below. ;

Condition:Chronic Hepatitis C Virus InfectionInterventions:Drug: telaprevir; Drug: VX-222; Drug: ribavirin; Biological: peginterferon-alfa-2a

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Purpose

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

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Exclusion Criteria:Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis CSubjects with any contraindications to peginterferon alfa-2a and/or ribavirinSubjects with any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, 's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosisHistologic evidence of hepatic cirrhosis ,,

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United States, CaliforniaRecruitingLa Jolla, California, United StatesNot yet recruitingSan Francisco, California, United StatesUnited States, ColoradoNot yet recruitingAurora, Colorado, United StatesUnited States, FloridaNot yet recruitingGainesville, Florida, United StatesUnited States, GeorgiaRecruitingAtlanta, Georgia, United StatesRecruitingMarietta, Georgia, United StatesUnited States, landNot yet recruitingLutherville, land, United

StatesUnited States, MinnesotaNot yet recruitingRochester, Minnesota, United StatesUnited States, MissouriNot yet recruitingSt. Louis, Missouri, United StatesUnited States, New JerseyRecruitingEgg Harbor Township, New Jersey, United StatesUnited States, New YorkNot yet recruitingNew York, New York, United StatesUnited States, North CarolinaNot yet recruitingChapel Hill, North Carolina, United StatesUnited States, OhioRecruitingCincinnati, Ohio, United StatesUnited States, Rhode IslandRecruitingProvidence, Rhode Island, United StatesUnited States, TennesseeRecruitingGermantown, Tennessee, United StatesUnited States, TexasNot yet recruitingArlington, Texas, United StatesRecruitingSan , Texas, United StatesUnited States, Virginia

Contact: Central Contact Center

877-634-VRTX

Link To Detailed Trial Information

...New Zealand Open Studies./

In New Zealand This Trial Is Not yet recruiting

A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection ,/.

New ZealandNot yet recruitingAuckland, New ZealandNot yet recruiting

Christchurch, New Zealand v.,...

Telaprevir In Co-infected with HCV/HIV

... .,RecruitingSafety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV.

Boceprevir In Co-infected with HCV/HIVRecruitingA Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM3) ,.

Clinical Trials & Medical Information:

Phone:877-634-VRTX (8789)617-444-6777

Email:Medical Information Request Formk,. o

Thats it folks, those are the only trials available with Telaprevir worth mentioning right now , the pickings are pretty slim. But not to worry, soon the drug will be FDA approved and ready for use.

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Next Up

The medical community is pretty excited about another drug called BMS-790052 a drug I mentioned a few days ago. With all the promising press on Telaprevir and Boceprevir other drugs currently in clinical development seem to get lost.

I guess in retrospect when drugs are in the early phases of devolvement there isn't a lot of data to report .

From the little information I can find on BMS-790052 its being toted as the next important drug to treat HCV, if the trials go well , then the press will be all over it.

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If I Knew Then, What I Know Now

As I list these trials, I cant help but struggle with this fact ;

The people who enter these trials have so much to gain or lose. They don't know if these drugs will work or not. These people put themselves into a vulnerable position of being human subjects for research or guinea pigs. They will either be cured or fail, in the end they are clearing the way for the rest of the population who need to treat this disease. It seems like such a risk, such a gamble, I wish there was another way.

;, .As I have written before, I participated in a clinical trial back in 2000 and successfully reached my SVR status. My genotype ? I was genotype 2 with a high viral load. As we all know genotype 2 only needs 24 weeks of treatment. However in this trial we treated for a 48 weeks. The drug was Intron A and Ribavirin, the dose was high daily injections for four months, then on to SOC, etc. .

If I knew then , what I know now, I would have skipped it and waited. I could have treated with Pegasys or PegIntron soon after it was FDA approved. For me it would have meant less of the drug, shorter treatment duration and with fewer side effects. My downfall ? I was too eager, too desperate, it was to soon to treat. Maybe because my children lost their father to this disease, I felt rushed, and thought I had to treat now, I was wrong.. .,

Personally If I needed to treat today "depending on my liver damage", and if I was insured, I would skip the trials. Especially when Boceprevir and Telaprevir are so close to hitting our shelves. I do understand the fear and desire to clear the virus, but now I also understand the wisdom of knowing how long to wait.

When its possible, of course, wait for FDA approval.

Back to the drugs at hand.... .

When will the public start hearing about BMS-790052 ?.

When the drug has a name and not just a number. Remember when Telaprevir was vx 950 ? A new drug is in clinical testing long before it acquires a name, when BMS is named and the press picks up on it , so will the public. Until then this blog will keep you updated.

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Back in July I downloaded an audio and added it to the blog, check it out ll

Conversation about New HCV Drug: BMS-790052 .

According To HCV Advocates BMS-790052 Updates as of *July 14, 2010

,lbBMS-790052 NS5A Inhibitor Bristol-Myers Squibb .Phase II.

Comments: The results from a study of 48 HCV genotype 1 treatment-naïve patients who received doses of BMS-790052 (3, 10, & 60 mg once a day) combined with pegylated interferon/ribavirin (or just pegylated interferon plus ribavirin – control arm) were released.

In the 10 mg & 60 mg groups the rapid virological response (undetectable at week 4) was 83 to 92% and the complete early virological response (undetectable at week 12) was ~83%. There were no safety concerns noted.

These were listed a on the blog a few days ago folks.

Recruiting

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of CareCondition:Chronic Hepatitis CInterventions:Drug: BMS-790052; Drug: BMS-650032; Drug: pegylated-interferon-α; Drug: ribavirin

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Study of BMS-790052 Add-On to Standard of Care in Treatment Naive SubjectsCondition:Hepatitis C VirusInterventions:Drug: BMS-790052; Drug: Placebo; Drug: peg-interferon alfa-2a; Drug: ribavirinl.lStudy of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT) This study is not yet open for participant recruitment.Verified by Bristol-Myers Squibb, July 2010 First Received: July 16, 2010 Last Updated: August 11, 2010History of Changesl.llJapanAn Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) SubjectSafety and Efficacy of BMS-790052 Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin) ,l

A few other drugs to keep an eye on :l, .TMC435Protease InhibitorMedivir/Tibotec

lPhase IIaComments: In July 2010, Medivir announced 24-week end of treatment interim data on their 5 arm (75 to 79 pts. per arm) study in 386 treatment- naïve HCV genotype 1 patients. Based on various stopping rules, 83% of patients were able to stop treatment at week 24. In the arms that received either 12 weeks or 24 weeks of TMC (all received an additional 24 weeks of pegylated interferon/ribavirin) the interim SVR12 results of those who had completed treatment (based on protocol) were 80% to 97%. No unexpected safety concerns were reported. The final study results including more SVR and safety data will be released later this year. (July 14, 2010) ,,

PSI-7977Polymerase InhibitorPharmasset

,lPhase IIaComments: On May 2, 2010 Pharmasset announced that in their 28-day treatment study (63 HCV genotype 1 treatment naïve pts) of PSI-7977 (100, 200 mg or 400 mg once-a-day) in combination with Pegasys and ribavirin that 88 to 94% were HCV RNA negative (less then 15 IU/mL) compared to 21% in the group that received placebo with Pegasys plus ribavirin. The drugs were generally well-tolerated and the adverse effects were similar to the adverse effects seen with Pegasys/ribavirin.PSI-7977 received Fast Track designation from the FDA on August 12. (August 16, 2010)

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Update; Aug 21

TODAY IN THE NEWS

'.FDA puts Pharmasset, Duke hepatitis C treatment on fast track

DURHAM – A treatment for the deadly hepatitis C virus being developed by a New Jersey pharmaceutical firm with tight ties to researchers at Duke University and at UNC-Chapel Hill has been awarded coveted fast track status by the U.S. Food and Drug Administration.Pharmasset Inc. of Princeton, N.J., maintains a small research office in Durham where two of the company’s eight top executives are based, including Chief Medical Officer Dr. Berrey and Chief Development Officer .Although the company has no immediate plans to expand its local operations, its work with Duke

Univerity’s academic research organization, Duke Clinical Research Institute, or DCRI, could grow if its drug candidate trials show favorable results.Pharmasset is developing four different treatment options for patients who have contracted hepatitis C, which can cause cirrhosis of the liver and eventually, liver failure if left untreated. The virus is a “silent infection†and can often go undetected for decades because it has few symptoms.

Read more: FDA puts Pharmasset, Duke hepatitis C treatment on fast track - Triangle Business Journal

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Aug 13 In The News

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A new hepatitis c treatment called PSI-7977 has received fast track status from the FDA. The new hepatitis c treatment is being developed by Pharmasset Inc and has recently concluded a phase 2 clinical trial. The phase 2b clinical trial should be started later this year before going through another examination by the FDA.There is a great need for hepatitis c treatments for both people newly diagnosed with the disease and those who have already been receiving treatments. This new hepatitis c treatment has shown great promise in early clinical trials by creating antiviral activity and also possesses a strong barrier to resistance. These two areas are where development of an effective hepatitis c treatment has fallen short.Hepatitis c is a serious disease that attacks the liver in the human body. It is caused by the hepatitis c virus and is contracted through blood to blood contact. More than half of those infected by the disease

will eventually be cured but the remainder must stay on hepatitis c treatment for life. s

http://www.worldsbreakingnews.com/hepatitis-c-treatment-receives-fast-track-from-fda/1617/..

A few things to remember about clinical trials :

n,A phase 2 trial is riskier then a phase 3 trial and so on../

Why ?

There are a few reasons and one is that the dosage profile is still being adjusted early on in the trial and adverse effects are still being identified.

The Policy On Dose Reductions

Ask the trial coordinator about the policy for dose reductions in order to manage any adverse effects. Will they let you adjust the dose if side effects become either a medical problem or intolerable ?.m

Do they allow Rescue Drugs ?

These drugs may be needed to complete treatment ; neupogen to bring up the low white counts and epogen for red blood counts.

Ask if they will cover the cost of any rescue drugs.

,What If You Relapse ?

Will you be offered a rollover trial ? A trial with another protocol ?

What is all this Placebo Arm Stuff ?

1-If you are in the "Placebo Group, or Arm" and receiving the placebo will they allow you to treat with the trial medications later ?

2-It is possible you may not receive the best dose, depending on what treatment Arm you have been placed in, remembering that often the optimum dose is often discovered after the trial is over. m

Consent forms

They should and must have a consent form, you should receive a copy you can review before you sign it. Most likely you will sign it in the doctors office, when you do, think of me, and tell yourself you should be taking this home to read. You are not doing your homework, never sign anything before you read it. .

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,Testing For Viral Load

Ask what PCR test will be used and at what sensitivity. They often use an in house test to save money. The viral load test should measure at least down to 50 viral copies per ml. of blood . There are ultra sensitive tests for research that can detect less than 5 copies. Find out if you are privy to the PCR results.

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Criteria For Stopping Treatment

You should know the viral response or protocol of when treatment will be discontinued.Examples : Complete early viral response (cEVR): a viral load ofless than 50 IU/mL 12 weeks into treatment.Do they want you to be virus free by the forth week, eighth, or at week twelve ?

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In Conclusion

An important factor in treating this disease is the success rate achieved

as " Treatment-Naïve ". If you enter into the wrong trial, and respond slowly, or have a break through and maybe even relapse could you be lowering your next chance at clearing this virus ? Would you have achieved SVR if the protocol were different ?, .With Telaprevir and Boceprevir being so close to FDA approval waiting might be the best scenario. I understand not everyone has the resources to wait, and a trial may be the only chance you have to treat this disease.. .If you do enter into a trial read the trial agreement and look closely at the protocol with each arm. Compare SOC or standard of care therapy with the dose of interferon and ribavirin in the said trial.How much do they differ ?How much of a risk are you taking ?Before signing on the dotted line ask yourself if you did all your homework.

http://Hepatitis Cnewdrugs.blogspot.com/2010/08/hcv-new-drugs-trials-and-tribulations.html