Aa
Aa
A
A
A
Close
179856 tn?1333547362

Bocepravir Aug 5 Announcement

Did this get posted yet I'm having a bad week and can't remember, sorry if it's a double,  I guess they were answering the tele one.:

Phase 3 study of boceprevir for the treatment of HCV
August 05, 2010  

RELATED CONDITIONSViral infections  Merck announced the completion and results of its two Phase 3 studies for boceprevir for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection.  Boceprevir, in combination with PegIntron and Rebetol, is being studied for the treatment of patients with chronic hepatitis C genotype I who have previously been treated (treatment-failure; HCV RESPOND-2) and in patients who are new to treatment (treatment-naïve; HCV SPRINT-2). PegIntron

The HCV RESPOND-2 study was conducted in 403 patients who failed prior therapy at U.S. and international sites, and patients were randomized into the three groups (48 weeks control; 48 weeks control plus boceprevir; control plus boceprevir using response-guided therapy) at a 1:2:2 ratio. In the boceprevir 48-week treatment group, 66 percent of patients achieved SVR, and in the boceprevir response-guided therapy group, 59 percent of patients achieved SVR, compared to 21 percent of patients in the control group (p<0.0001 for both, intent-to-treat analysis).

In the HCV SPRINT-2 study, 1,097 treatment-naïve patients at U.S. and international sites were enrolled in two separate cohorts, one with 938 non-African-American/Black patients and the other with 159 African-American/Black patients. Patients were randomized into the three treatment groups (48 weeks control; 48 weeks control plus boceprevir; control plus boceprevir using response-guided therapy) at a ratio of 1:1:1. In the study overall, 66 percent of patients in the boceprevir 48-week treatment group achieved SVR, and 63 percent of patients in the response-guided therapy group achieved SVR, compared to 38 percent of patients in the control group (p<0.0001 for both, intent-to-treat analysis).

Boceprevir is an investigational oral hepatitis C protease inhibitor that Merck plans to submit a New Drug Application (NDA) to the FDA on a rolling basis; it expects to complete regulatory submissions in the U. S. and E.U. in 2010.
7 Responses
Sort by: Helpful Oldest Newest
Avatar universal
Does this mean Sprint-2 participants have access to their records/or are now unblinded? Wonder how soon I will be able to find out if I was given a placebo or the real deal.
Helpful - 0
Avatar universal
I aim to shoot for the Boceprevir/Peg-Intron/Riba when it becomes approved over Telaprevir, since I don't want to deal with the rash and since I've already been exposed to the Tele.  This is all according to the ability to be able to pay for the drugs once they do get approved.  My local hepatologist agrees with my decision between the 2.

Susan400
Helpful - 0
Avatar universal
Thanks nygirl,

I think before a whole lot can be taken out of either of these studies one needs to know how much cherry picken was involved. What was the % of african americans and cirrhotics? As we know they are the hardest to gain SVR.

If one study didn't include any or very few of either compared to the other one then the numbers would be different, once doctors and not stock pickers are able to compare the results its just a guess.......... Still it looks very encouraging.

cando
Helpful - 0
446474 tn?1446347682
Telaprevir vs Boceprevir in First- and Second-Line Settings

Trial design         Setting Acronym   (SVR in best treatment arm) (SVR in control arm)

SoC ± Telaprevir  1st-line ADVANCE      *75% (n=362)           44% (n=369)      ▲31%
Soc ± Boceprevir 1st-line SPRINT-2       †66% (n=366)           38% (n=366)     ▲28%

SoC ± Telaprevir   2nd-line PROVE-3      ‡53% (n=151)           14% (n=151)     ▲39%
Soc ± Boceprevir  2nd-line RESPOND-2 †66% (n=134)            21% (n=134)    ▲45%

* ‘12+12’ arm. (SVR in ‘8+16’ arm was 73%.)

† 48w arm with 4w lead-in on SoC alone. (SVR in ‘response-guided’ arm
was 63% in SPRINT-2 and 59% in RESPOND-2.) No breakdown of patients
by response to first-line treatment is available for RESPOND-2 at this time.

‡ ’24+24’ arm. (SVR in ‘12+12’ arm was 51%.) 57% of patients were prior
non-responders, 7% were prior breakthroughs, and 36% were prior relapsers.


Hectorsf
Helpful - 0
Avatar universal
Two numbers always concern me, 1: drop out due to sx, 2: those not acheiving SVR.  I would think the drop out is higher in trials, because they are limited to what helper medications they can prescribe?  I would hope drop out is lower when the drug hits the market and doctors can do what they need to in order to help pt's with sx.  The SVR rate for both boceprevir and telaprevir are great numbers.
Helpful - 0
446474 tn?1446347682
Thanks nygirl7. I think part of this (the comparison between Bocep and Telaprevir was posted earlier but not the rest. Hectorsf

Here are more details from the studies...

About the studies

The HCV RESPOND-2 study was conducted in patients chronically infected with hepatitis C genotype 1 who failed prior therapy with peginterferon and ribavirin, including those who had experienced prior relapse or who were prior non-responders, and the HCV SPRINT-2 study was conducted in previously untreated (treatment-naïve) patients chronically infected with hepatitis C genotype 1. Approximately 25 percent of patients in each of the studies had less than a 1 log decrease in viral load after the 4-week Peg/riba lead-in period.

Sustained virologic response (SVR), the protocol-specified primary efficacy endpoint, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication (Roche TaqMan LLD=9.3 IU/mL). Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient’s 12-week post-treatment assessment was utilized.

Response-Guided Therapy - Different Treatment Durations

In the HCV RESPOND-2 study, patients in the response-guided therapy arm who had undetectable virus at treatment week 8 and week 12 received a total of 36 weeks of therapy (lead-in with Peg/riba followed by the addition of boceprevir for 32 weeks); patients with detectable virus at week 8, but undetectable virus at week 12, stopped boceprevir treatment at week 36 and continued on Peg/riba alone for an additional 12 weeks, for a total treatment duration of 48 weeks. Patients in any arm of the study who had detectable virus at week 12 were considered treatment failures and discontinued treatment.

In the HCV SPRINT-2 study, patients in the response-guided therapy group of the study who had undetectable virus at treatment week 8 through week 24 received a total of 28 weeks of therapy (lead-in with Peg/riba followed by the addition of boceprevir for 24 weeks); patients with detectable virus at week 8, but undetectable virus at week 24, stopped boceprevir treatment at week 28 and continued on Peg/riba alone for a total treatment duration of 48 weeks. Patients in any arm of the study who had detectable virus at week 24 were considered treatment failures and discontinued treatment.

“The response-guided therapy approach used in these studies enabled those patients – both treatment-failure patients and treatment-naïve patients – who had undetectable virus at certain points of the study to achieve SVR with a shorter total treatment duration than current standard therapy,” said Fred Poordad, M.D., chief of hepatology in the division of gastroenterology at Cedars-Sinai Medical Center, associate professor of medicine at the David Geffen School of Medicine, University of California, Los Angeles (UCLA), and co-principal investigator of the HCV SPRINT-2 study.

Adverse Events:

In the HCV RESPOND-2 study, the five most common treatment-emergent adverse events reported for the boceprevir 48-week treatment group, boceprevir response-guided therapy group and control group, respectively, were: fatigue (57, 54, and 50 percent), headache (40, 43 and 49 percent), nausea (42, 44 and 38 percent), anemia (47, 43 and 20 percent) and dysgeusia (bad taste) (45, 43 and 11 percent). Treatment discontinuations due to anemia were 3 percent and 0 percent for the boceprevir groups, respectively, compared to 0 percent for the control group. Treatment discontinuations due to adverse events overall were 12 percent and 8 percent for the boceprevir groups, respectively, compared to 3 percent for the control group.

In the HCV SPRINT-2 study, the five most common treatment-emergent adverse events reported for the boceprevir 48-week treatment group, boceprevir response-guided therapy group and control group, respectively, were: fatigue (57, 53 and 60 percent), headache (46, 46 and 42 percent), nausea (43, 48 and 42 percent), anemia (49, 49 and 29 percent) and pyrexia (fever) (32, 33 and 33 percent). Treatment discontinuations due to anemia were 2 percent for each of the boceprevir groups compared to 1 percent for the control group. Treatment discontinuations due to adverse events overall were 16 percent and 12 percent for the boceprevir groups, respectively, compared to 16 percent for the control group.
Helpful - 0
179856 tn?1333547362
UPDATE 4-Merck hepatitis drug works; anemia seen
Digg This  Tweet This Share on LinkedIn  Share on Facebook Related NewsUPDATE 3-Isis-Genzyme cholesterol drug works; safety weighs
Wed, Aug 4 2010
UPDATE 1-Health Net raises forecast as Q2 profit rises
Tue, Aug 3 2010
Avoid U.S. health insurers after reform, brokerage says
Mon, Aug 2 2010
White knight could be elusive for Genzyme
Mon, Aug 2 2010
UPDATE 1-Dynavax posts Q2 loss, shares fall
Fri, Jul 30 2010Related TopicsStocks »
Regulatory News »
Global Markets »
Healthcare »
Stocks  
Merck & Co., Inc.
MRK.N
$35.07
-0.12-0.34%
3:00pm EDT
Vertex Pharmaceuticals Incorporated
VRTX.O
$36.11
-0.15-0.41%
3:00pm EDT
Wed Aug 4, 2010 2:44pm EDT

* 66 pct cure rate seen with Merck's boceprevir

* Merck to seek boceprevir approval by year's end

* Side effects raise questions in one of two trials

* Merck shares rise 0.8 pct

* Shares of rival drugmaker Vertex up 3.4 pct (Adds comment from Merck research chief, updates shares)


By Ransdell Pierson and Bill Berkrot

NEW YORK, Aug 4 (Reuters) - Merck & Co (MRK.N) said its experimental hepatitis C treatment met the main effectiveness goals of two late-stage studies and it expects to seek approval for the high-profile medicine by the end of the year.

But a much higher percentage of patients taking the Merck drug, compared with those taking standard treatments, dropped out of one of the trials due to adverse events, including anemia.

The drug, boceprevir, was one of the most important experimental products gained by Merck through its acquisition of Schering-Plough Corp last year.

In the two trials, 66 percent of patients who took boceprevir plus standard drugs for a full 48 weeks were cured of the serious liver disease, a significantly higher cure rate than for standard treatment alone. But that compares with a 75 percent cure rate seen in a separate trial of a rival drug being developed by Vertex Pharmaceuticals Inc (VRTX.O).

"We have a compelling profile with boceprevir, with impressive (cure) rates across both studies," Merck research chief Peter Kim said in an interview.

Boceprevir and Vertex's telaprevir are considered possible blockbuster products because of their potential to cure far more patients and in as little as half the time of standard drugs that require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.

Vertex shares rose 3.4 percent to $36.42 as investors compared the Merck data with recently released data on the Vertex drug. Merck said it would provide more detailed clinical trial data at a meeting of the American Association for the Study of Liver Diseases that begins Oct. 29 in Boston.

Merck shares rose 28 cents, or 0.8 percent, to $35.10.

The new class of drugs, which are combined with standard treatments, work against the liver-damaging hepatitis C virus by blocking a protein called protease that the virus requires to replicate. The current standard treatments involve a combination of the injectable drug interferon and an anti-viral pill called ribavirin.

Based on today's top line data, we are maintaining our view that, while telaprevir will likely take a majority of the initial hepatitis C protease inhibitor market, boceprevir will play a role in the category," J.P. Morgan analyst Chris Schott said in a research note.

Schott said investors will get a better picture of the respective strengths and shortcomings of the two drugs when full late-stage trial data on telaprevir and boceprevir are unveiled at the upcoming Boston meeting.

Merck said boceprevir, taken in combination with the company's Pegintron brand of interferon and ribavirin, significantly increased the number of patients who achieved a sustained virologic response, or SVR -- meaning no detectable virus levels 24 weeks after the end of treatment -- compared with those who received the standard drugs plus a placebo.

Achieving SVR, in layman's terms, is considered being cured of the disease.

One of the trials, called HCV RESPOND-2, involved 403 patients with genotype 1, the most common form of hepatitis C, who had failed prior therapy with interferon and ribavirin. The other trial, called HCV SPRINT-2, enrolled 1,097 patients with genotype 1 who had not previously been treated for the virus.

In both trials, a significant number of patients received 48 full weeks of treatment. But patients with undetectable virus at week 8 and again at certain points later in the studies were able to stop all treatment at 36 weeks in the smaller trial, and at 28 weeks in the larger study.

In the HCV RESPOND-2 study, 66 percent of those receiving boceprevir for 48 weeks were cured, while cures were seen in 59 percent of those receiving shorter treatment regimens of the medicine. That compared with a 21 percent cure rate for those receiving standard treatments.

In the HCV SPRINT-2 study of previously untreated patients, 66 percent of those receiving boceprevir for 48 weeks were cured, along with 63 percent of those on shorter regimens. Cures were seen in 38 percent of those receiving standard therapy.

Telaprevir's 75 percent cure rate in its own Phase III trial tested the drug in previously untreated patients.

Vertex is expected next month to unveil data from another late-stage trial of telaprevir in tougher-to-treat patients who had failed prior treatment with standard drugs.

Sanford Bernstein analyst Tim Anderson said available data from separate trials of boceprevir and telaprevir suggest the Merck drug is less effective.

Moreover, he said boceprevir seems more likely to cause anemia -- a side effect that could require patients to take intravenous anemia medicines that boost red blood cells. The question is whether the need for an additional anemia drug on top of the three-drug regimen will greatly discourage use of boceprevir, should it be approved.

Anderson forecast boceprevir would garner sales of $330 million in 2015, far below his forecast of $4.3 billion for the Vertex drug. (Reporting by Ransdell Pierson, Lewis Krauskopf and Bill Berkrot, editing by Maureen Bavdek, Dave Zimmerman, John Wallace, Gary Hill)

StocksRegulatory NewsGlobal MarketsHealthcareAfter reading this article, people also read:UPDATE 3-Isis-Genzyme cholesterol drug works; safety weighs
Aug 4, 2010
UPDATE 1-Merck hepatitis C drug meets main study goals
Aug 4, 2010
In Pivotal Phase III Studies, Merck`s Investigational Medicine Boceprevir Helped Majority of Patients with Chronic Hepatitis C Genotype 1 Infection Achieve Sustained Virologic Response, the Primary Endpoint of the Studies
Aug 4, 2010
UPDATE 2-Dendreon says cancer vaccine launch going well
Aug 3, 2010
Cancer cells slurp up fructose, US study finds
Aug 2, 2010



  

Add a Comment*We welcome comments that advance the story directly or with relevant tangential information. We try to block comments that use offensive language or appear to be spam and review comments frequently to ensure they meet our standards. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. Ads by GoogleWhat's This?Due Diligence Data Room
Due Diligence Complimentary Guide. Download It for Free Now!
www.DataSiteDeal.com/DueDiligence

2010 Top Penny Stocks
3 Penny Stocks Could Turn $200 into $1.2 Million! -Free Report
www.agorafinancial.com/Stocks

Stocks Ready To Explode
#1 U.S Penny Stock Newsletter 1000% Gains, Join Now Free
WhisperfromWallStreet.com
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.