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Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients
Another article from AASLD...
Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients
Saturday, November 01, 2008 11:00 AM
http://www.istockanalyst.com/article/viewiStockNews+articleid_2759119.html
Interim results of HCV SPRINT-1 study presented at AASLD annual meeting
Pivotal Phase III studies ongoing in treatment naive patients and those who failed prior treatment
SAN FRANCISCO, Nov. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that a planned interim analysis of a Phase II study showed that boceprevir, its investigational oral hepatitis C protease inhibitor, in combination with peginterferon and ribavirin markedly increased sustained virologic response (SVR) rates with 28 weeks of therapy and nearly doubled SVR with 48 weeks of therapy compared to current standard of care, peginterferon and ribavirin (control group) for 48 weeks. These results from the HCV SPRINT-1 study in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 were presented at the 59th American Association for the Study of Liver Diseases (AASLD) Annual Meeting.(1)
In a 48-week boceprevir regimen, the SVR rate was 74 percent at 12 weeks after the end of treatment (SVR 12) in patients who received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) prior to the addition of boceprevir (800 mg TID) (P/R lead-in). In a 28-week boceprevir regimen, the SVR rate was 56 percent at 24 weeks after the end of treatment (SVR 24) in patients who received the P/R lead-in. These results compared to a 38 percent SVR rate (SVR 12) for patients in the control group receiving 48-weeks of PEGINTRON and REBETOL alone (ITT).(2-4)
Importantly, predictability of attaining SVR 12 or 24 based on rapid virologic response (RVR) was greater for boceprevir patients in the lead-in arms compared to the no lead-in arms. In addition, fewer patients in the lead-in arms discontinued treatment due to viral breakthrough. RVR is defined as undetectable virus (HCV-RNA) in plasma on or before week 4 of boceprevir treatment.
'The high response rates seen with boceprevir in this study are very exciting, especially given that genotype 1 is the most common and hardest to treat form of hepatitis C,' said Paul Kwo, M.D., associate professor of medicine and medical director, liver transplantation, Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, and lead investigator of the study. 'Boceprevir was well tolerated by patients in this study, and the use of the 4-week lead-in prior to the addition of boceprevir appears to reduce the incidence of viral breakthrough regardless of treatment duration and may improve SVR over a 48-week treatment period.'
The rationale for this novel lead-in treatment regimen is based on the fact that both PEGINTRON and REBETOL reach steady-state concentrations by week 4, so patients have the protease inhibitor added at a time when the backbone drug levels have been optimized. In addition, the patient's immune system will have been activated and primed by PEGINTRON at the time that boceprevir is added to the regimen. This approach may minimize the period of time when there is a 'functional monotherapy' with a direct antiviral, potentially reducing the likelihood for the development of resistance.
Safety data from the study showed that the most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea and headache. No increase in skin adverse events (rash or pruritus) was observed in the boceprevir arms beyond what was seen in the PEGINTRON and REBETOL control arm.
Treatment discontinuations due to adverse events were between 9 and 19 percent for patients in the boceprevir arms, compared to 8 percent for the control arm. Treatment discontinuations for boceprevir patients due to viral breakthrough were fewer in the 28- and 48-week lead-in arms (4 and 5 percent, respectively) compared to the no lead-in arms (7 and 11 percent, respectively).
About the HCV SPRINT-1 Study
Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients
Saturday, November 01, 2008 11:00 AM
http://www.istockanalyst.com/article/viewiStockNews+articleid_2759119.html
Interim results of HCV SPRINT-1 study presented at AASLD annual meeting
Pivotal Phase III studies ongoing in treatment naive patients and those who failed prior treatment
SAN FRANCISCO, Nov. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that a planned interim analysis of a Phase II study showed that boceprevir, its investigational oral hepatitis C protease inhibitor, in combination with peginterferon and ribavirin markedly increased sustained virologic response (SVR) rates with 28 weeks of therapy and nearly doubled SVR with 48 weeks of therapy compared to current standard of care, peginterferon and ribavirin (control group) for 48 weeks. These results from the HCV SPRINT-1 study in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 were presented at the 59th American Association for the Study of Liver Diseases (AASLD) Annual Meeting.(1)
In a 48-week boceprevir regimen, the SVR rate was 74 percent at 12 weeks after the end of treatment (SVR 12) in patients who received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) prior to the addition of boceprevir (800 mg TID) (P/R lead-in). In a 28-week boceprevir regimen, the SVR rate was 56 percent at 24 weeks after the end of treatment (SVR 24) in patients who received the P/R lead-in. These results compared to a 38 percent SVR rate (SVR 12) for patients in the control group receiving 48-weeks of PEGINTRON and REBETOL alone (ITT).(2-4)
Importantly, predictability of attaining SVR 12 or 24 based on rapid virologic response (RVR) was greater for boceprevir patients in the lead-in arms compared to the no lead-in arms. In addition, fewer patients in the lead-in arms discontinued treatment due to viral breakthrough. RVR is defined as undetectable virus (HCV-RNA) in plasma on or before week 4 of boceprevir treatment.
'The high response rates seen with boceprevir in this study are very exciting, especially given that genotype 1 is the most common and hardest to treat form of hepatitis C,' said Paul Kwo, M.D., associate professor of medicine and medical director, liver transplantation, Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, and lead investigator of the study. 'Boceprevir was well tolerated by patients in this study, and the use of the 4-week lead-in prior to the addition of boceprevir appears to reduce the incidence of viral breakthrough regardless of treatment duration and may improve SVR over a 48-week treatment period.'
The rationale for this novel lead-in treatment regimen is based on the fact that both PEGINTRON and REBETOL reach steady-state concentrations by week 4, so patients have the protease inhibitor added at a time when the backbone drug levels have been optimized. In addition, the patient's immune system will have been activated and primed by PEGINTRON at the time that boceprevir is added to the regimen. This approach may minimize the period of time when there is a 'functional monotherapy' with a direct antiviral, potentially reducing the likelihood for the development of resistance.
Safety data from the study showed that the most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea and headache. No increase in skin adverse events (rash or pruritus) was observed in the boceprevir arms beyond what was seen in the PEGINTRON and REBETOL control arm.
Treatment discontinuations due to adverse events were between 9 and 19 percent for patients in the boceprevir arms, compared to 8 percent for the control arm. Treatment discontinuations for boceprevir patients due to viral breakthrough were fewer in the 28- and 48-week lead-in arms (4 and 5 percent, respectively) compared to the no lead-in arms (7 and 11 percent, respectively).
About the HCV SPRINT-1 Study
i would like more info on the aspects of the trial what where and why u are going throu with them.My mom was diagnose two years ago she is not doing so well.she get very irritable and depress and anxiaty attacks that takes a toll on her health.can any one help.
Matter of fact, I just tried the google "news" method, and there's a new one on top "SciClone Hepatitis C drug fails late stage study" that's fresh 7 hours ago. So it's a good way to get to new articles for anyone who wants to cut right to it.
This is one of the many press releases that were coming out over the weekend. They're scattered about now, but at the time, and anytime, you can google Hepatitis C news, and at the bottom of the index page will be the new "news" articles that came out.
I saved that Nov 1st list page to favorites, because the news articles are so much easier for me to read than abstracts, but the url is so long that I could never put it in here! I don't know enough about computers to do it an easier way, but the above suggestion is an easy way to get up-to-date articles I think.
c.
I saved that Nov 1st list page to favorites, because the news articles are so much easier for me to read than abstracts, but the url is so long that I could never put it in here! I don't know enough about computers to do it an easier way, but the above suggestion is an easy way to get up-to-date articles I think.
c.
I am to start the Boceprevir trial in the next 3 or 4 weeks. I am just waiting for a retinal eye exam to take place. I will be watching all of you who are about to start. Hopefully we can all clear this virus with the lest amount of side effects. The Boceprevir trials look promising.
Keith
Keith
Rocker,
I have as many sides as everybody else, as you can imagine. But, I also SO want to be done with this dumb virus. I'm tired of even having it be an issue in my life. There's the school of thought, 'oh just practice the healthy living and ''living w/Hepatitis C" ideology', but I just simply can't do that. It seems like with every biopsy that I've had an increase, or no improvement in my fibrosis. After 7 years of having bridging fibrosis, I get a bit nervous about crossing over into cirrhosis. Once you hit cirrhosis, it greatly narrows your ability to have various treatment options and then, if a new drug did come along for me, it might be too late at that point to do any good. SO, I guess I'm just stubbornly fighting it with as much as I can muster. I feel like if God allows me to, then, I will participate in another treatment, but it's up to Him on whether or not that door will be opened to me. Take care. Susan400
I have as many sides as everybody else, as you can imagine. But, I also SO want to be done with this dumb virus. I'm tired of even having it be an issue in my life. There's the school of thought, 'oh just practice the healthy living and ''living w/Hepatitis C" ideology', but I just simply can't do that. It seems like with every biopsy that I've had an increase, or no improvement in my fibrosis. After 7 years of having bridging fibrosis, I get a bit nervous about crossing over into cirrhosis. Once you hit cirrhosis, it greatly narrows your ability to have various treatment options and then, if a new drug did come along for me, it might be too late at that point to do any good. SO, I guess I'm just stubbornly fighting it with as much as I can muster. I feel like if God allows me to, then, I will participate in another treatment, but it's up to Him on whether or not that door will be opened to me. Take care. Susan400
Rocker... I saw on another post that you will be starting this Friday and wanted to wish you the best of luck in your journey. Take care....
Fret... Don't have a definate start date, but should have one by the end of the week. It will be within the next two to four weeks. I am also looking forward to the start, but with much apprehension. I think it's a given that we will all experience sx's, but how mild or severe is the question, this is where the fear comes in. Good luck to you also. I'm sure we will be keeping each other posted on our progress.
Susan...i wish i was a tough as you.....you talk about this TREATMENT like it dont even fizz on you...my God...i think if i did as much as you did i would be ,well i waont say...LOL...more power to ya my Dear.
Thanks for the information. I'm seriously thinking about the Boceprevir with this lead-in for my next treatment down the road. Not sure if I want to participate in a trial...., too many things to consider. Do I really want to go through the additional headaches of a trial? Will it even be offered at one of the trial sites that I'm already linked up with? Would I even be accepted into another trial as I am not really a good risk for their stats, you know? I really couldn't believe that the idea of trying to treat again with the Telaprevir would turn out any differently for me as, I've already been exposed to the Telaprevir and have resistance-probably and there's the bad rash that I had before. I'm not ruling out trying it again down the road..., but I like the idea of Boceprevir better. Also, I also had a better response on the Peg-Intron regimens than on the Pegasys. The Pegasys may have less sides, but it also doesn't work as well in my body. I'd also be interested in having the opportunity to try something like Infergen along with Riba and one of these inhibitor drugs-either Boceprevir or Telaprevir - but that would not be able to happen without doing it outside of the trial regimens because each company would rather use their own type of interferon. Now see, if I were to wait until one of them was FDA approved AND-(this is a BIG AND), I'd even have insurance willing to pay for them, then it would be worth looking into it. I just hope my body can hold out while these drugs are fine tuning all this process!!
Susan400
Susan400
I still like telaprevir because it shows similar results with just 24 weeks of treatment.
Good information, especially since I got my start date. I start in 10 days and I'm totally looking forward to it, right now anyways, and I don't expect that to change. lol I hope the sx nazi's are good to me. lol Are you starting soon? good luck
Continues... Follow link for more.
In this Phase II study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) was evaluated in three treatment regimens: 4 weeks of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment), boceprevir in combination with PEGINTRON and REBETOL at the doses described above for 28 or 48 weeks, and, in Part II of the study, boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily based on patient weight) for 48 weeks, compared to a control of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is SVR after 24 weeks of follow up (SVR 24). This is an ongoing study and SVR 24 rates are not yet available for patients in the 48-week boceprevir arms or the 48-week control arm of the study. In addition, SVR rates are not yet available and consequently results are not being reported for the boceprevir arm with low-dose REBETOL (n=59) compared to contemporaneous control (n=16) as described above.
Sustained Virologic Response (ITT)*
Treatment Arm All patients
No P/R Lead-in 28 Weeks 55% (59/107)
P/R Lead-in 28 Weeks 56% (58/103)
No P/R Lead-in 48 Weeks 66% (68/103)
P/R Lead-in 48 Weeks 74% (76/103)
P/R Control 48 Weeks 38% (39/104)
P/R Lead-in = PEGINTRON and REBETOL for 4 weeks prior to the addition of boceprevir
P/R Control = PEGINTRON and REBETOL alone for 48 weeks
* SVR 12 for 48 week arms; SVR 24 for 28 week arms(2-4)
In the study, predictability of attaining SVR (12 or 24) based on rapid virologic response (RVR) following 28 or 48 weeks of the boceprevir regimen was greater for patients in the lead-in arms (82 and 92 percent respectively) compared to the no lead-in arms (74 and 82 percent, respectively).
The HCV SPRINT-1 study was conducted at sites across the United States, Canada and Europe. Overall, 77 percent of the 595 patients in the study were enrolled in the United States. African-Americans represent 16 percent of the patients enrolled and 7 percent of patients in the study are cirrhotic.
Update on Boceprevir Phase III Studies
Schering-Plough is conducting two large ongoing pivotal Phase III studies of boceprevir in patients chronically infected with HCV genotype 1. One study is in treatment-naive patients and the other in patients who failed prior treatment (relapsers and nonresponders). The two randomized, double-blind, placebo-controlled studies evaluate the efficacy of boceprevir in combination with PEGINTRON and REBETOL compared to standard of care with PEGINTRON and REBETOL alone.
The study in treatment-naive patients is known as HCV SPRINT-2 and the study in patients who failed prior treatment is known as HCV RESPOND-2. The two studies are expected to enroll a total of more than 1,400 patients at U.S. and international sites.
In this Phase II study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) was evaluated in three treatment regimens: 4 weeks of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment), boceprevir in combination with PEGINTRON and REBETOL at the doses described above for 28 or 48 weeks, and, in Part II of the study, boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily based on patient weight) for 48 weeks, compared to a control of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is SVR after 24 weeks of follow up (SVR 24). This is an ongoing study and SVR 24 rates are not yet available for patients in the 48-week boceprevir arms or the 48-week control arm of the study. In addition, SVR rates are not yet available and consequently results are not being reported for the boceprevir arm with low-dose REBETOL (n=59) compared to contemporaneous control (n=16) as described above.
Sustained Virologic Response (ITT)*
Treatment Arm All patients
No P/R Lead-in 28 Weeks 55% (59/107)
P/R Lead-in 28 Weeks 56% (58/103)
No P/R Lead-in 48 Weeks 66% (68/103)
P/R Lead-in 48 Weeks 74% (76/103)
P/R Control 48 Weeks 38% (39/104)
P/R Lead-in = PEGINTRON and REBETOL for 4 weeks prior to the addition of boceprevir
P/R Control = PEGINTRON and REBETOL alone for 48 weeks
* SVR 12 for 48 week arms; SVR 24 for 28 week arms(2-4)
In the study, predictability of attaining SVR (12 or 24) based on rapid virologic response (RVR) following 28 or 48 weeks of the boceprevir regimen was greater for patients in the lead-in arms (82 and 92 percent respectively) compared to the no lead-in arms (74 and 82 percent, respectively).
The HCV SPRINT-1 study was conducted at sites across the United States, Canada and Europe. Overall, 77 percent of the 595 patients in the study were enrolled in the United States. African-Americans represent 16 percent of the patients enrolled and 7 percent of patients in the study are cirrhotic.
Update on Boceprevir Phase III Studies
Schering-Plough is conducting two large ongoing pivotal Phase III studies of boceprevir in patients chronically infected with HCV genotype 1. One study is in treatment-naive patients and the other in patients who failed prior treatment (relapsers and nonresponders). The two randomized, double-blind, placebo-controlled studies evaluate the efficacy of boceprevir in combination with PEGINTRON and REBETOL compared to standard of care with PEGINTRON and REBETOL alone.
The study in treatment-naive patients is known as HCV SPRINT-2 and the study in patients who failed prior treatment is known as HCV RESPOND-2. The two studies are expected to enroll a total of more than 1,400 patients at U.S. and international sites.
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