Aa
Merc HCV trial
Wondering if anyone out there has been on a trial called "MK-7009 (Merc) there is a phase 2 trial going on over here that I'm trying to get into,any info would be great! I have HCV 1a and am a non responder from Interferon & ribo. 4 years ago. Does anyone have any info on this at all?It's all very new over here.
Thanks & good luck to all,
Ozgirl 707
Thanks & good luck to all,
Ozgirl 707
Hi again,
Could you tell me what you mean about it being better,the phase 111 trials,are the phase 11 ones more dangerous? What are the advantages of a Phase 111?Maybe i should wait? They seem to take ages to get to Australia.I guess I'm impatient to get rid of the virus....if there's a chance!! Do you have any oppinions on which trial drug seems to be the best for eradicating the type 1a HCV? I would appreciate any help as noone over here seems to know much on this subject?
Thanks,
Ozgirl x
Could you tell me what you mean about it being better,the phase 111 trials,are the phase 11 ones more dangerous? What are the advantages of a Phase 111?Maybe i should wait? They seem to take ages to get to Australia.I guess I'm impatient to get rid of the virus....if there's a chance!! Do you have any oppinions on which trial drug seems to be the best for eradicating the type 1a HCV? I would appreciate any help as noone over here seems to know much on this subject?
Thanks,
Ozgirl x
Thanks to you too,that's great info. really appreciate it.It's nice to know there are people out there who care enough to help.Thankyou,
Ozgirl x
Ozgirl x
I really appreciate your help,thanks.I want to get on something as soon as pos. because I've got Fibrosis level 3,and want to try to clear the virus before it gets worse.So I will just put up with the sides...I'm desperate,I have a little boy,I want to be well for him.
Thanks again,
Ozgirl x
Thanks again,
Ozgirl x
Phase IIb Trial Will Further Assess Efficacy, Safety And Tolerability Of MK-7009 - For Patients With Chronic Hepatitis C
Results from an ongoing Phase IIa study showed that MK-7009, Merck Sharp and Dohme's (MSD) investigational oral hepatitis C virus (HCV) protease inhibitor, in combination therapy significantly improved rapid viral response, defined as viral suppression to undetectable levels within 28 days, compared to placebo in combination therapy in previously untreated (treatment-naïve) patients infected with chronic HCV genotype 1, one of the most difficult to treat genotypes of HCV (p<0.0001). All patients received MK-7009 or placebo in combination with pegylated interferon and ribavirin (peg-IFN/RBV), the current standard of care for treatment of HCV infection. (Poster 2701) These findings were presented today at the 44th Annual European Association for the Study of the Liver (EASL) meeting in Copenhagen, Denmark.
According to the World Health Organization, an estimated 180 million people are infected with HCV worldwide, 130 million of whom are chronic HCV carriers at risk of developing liver cirrhosis and/or liver cancer. It is estimated that three to four million persons are infected each year.
"In this ongoing study, MK-7009 in combination therapy rapidly lowered and generally maintained the amount of virus in the blood to below detectable levels in previously untreated HCV patients," said Robin Isaacs, vice president and therapeutic head for Infectious Diseases, Merck Research Laboratories. "These preliminary results help us understand the efficacy and tolerability profile of MK-7009 and support the further development of MK-7009 for the treatment of HCV."
These findings are the primary analysis from an ongoing, randomized, placebo-controlled, double-blind study of MK-7009 in treatment-naïve, chronic HCV patients. In this study, 95 patients were randomized across five treatment arms with regimens of MK-7009 300 mg or 600 mg twice daily, MK-7009 600 mg or 800 mg once daily, or placebo, for 28 days. Patients in all treatment arms received standard doses of peg-IFN/RBV in combination with the MK-7009 or placebo regimens, and are continuing to receive peg-IFN/RBV for an additional 44 weeks. HCV RNA was measured by the HCV RNA PCR TaqMan 2.0 assay, which has a lower limit of detection (LLOD) of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. The primary endpoint of the study was reduction in HCV RNA to undetectable levels (<10 IU/mL) at day 28.
Suppression of viral load to undetectable levels by day 28
After 28 days of therapy, 69 to 82 percent of patients in the regimens containing MK-7009 (n= 68 included in the per-protocol analysis) versus 6 percent of patients in the placebo regimen (n=18 included in the per-protocol analysis) achieved undetectable HCV RNA levels (p<0.0001). More than 80 percent of patients in the regimens containing MK-7009 versus 11 percent of patients in the placebo regimen experienced viral suppression to below LLOQ (<25 IU/mL) on day 28.
Viral suppression continued in the majority of patients following termination of MK-7009 treatment at day 28. At day 42, HCV RNA was undetectable in 77 to 94 percent of the patients in the regimens that had contained MK-7009 versus 12 percent of patients in the regimen that had contained placebo (p<0.0001). Additionally, all subjects in the 600 mg twice daily regimen group achieved HCV RNA to below LLOQ ( 20 percent in one or more treatment arms) in patients receiving MK-7009 versus patients receiving placebo, respectively, were nausea (28 to 40 percent versus 26 percent), headache (16 to 45 percent versus 37 percent), fatigue (5 to 35 percent versus 32 percent), flu-like symptoms (20 to 26 percent versus 16 percent), anorexia (5 to 25 percent versus 11 percent), diarrhea (6 to 25 percent versus 21 percent), indigestion (0 to 22 percent versus 21 percent), rash (10 to 17 percent versus 21 percent), and vomiting (0 to 40 percent versus 5 percent). The incidence of vomiting was higher in the treatment arm containing MK-7009 600 mg twice daily (40 percent) versus the treatment arm containing placebo (5 percent); vomiting did not require anti-emetic treatment and did not lead to discontinuation or dose reduction of MK-7009.
Phase IIb study to further assess efficacy, safety and tolerability of MK-7009
A Phase IIb study has been initiated to evaluate the safety, tolerability and efficacy of MK-7009 when administered concomitantly with peg-IFN/RBV to previously treated (treatment-experienced) patients with chronic hepatitis C genotype 1 infection. Patients will receive either placebo or MK-7009 at 300 mg or 600 mg twice daily in combination with standard doses of peg-IFN/RBV. The trial is a multicenter, partially double-blind, randomized, placebo-controlled trial that aims to enroll approximately 200 patients in multiple countries.
The study will measure the safety and tolerability of MK-7009 at all dose regimens as compared to placebo through 48 weeks. Additionally, the study will evaluate the proportion of patients in the MK-7009 600 mg treatment regimens achieving sustained viral response, i.e., undetectable viral load 24 weeks after the end of all study therapy, as compared to patients in the placebo regimen.
Source
Merck & Co., Inc.
http://www.medicalnewstoday.com/articles/149544.php
Results from an ongoing Phase IIa study showed that MK-7009, Merck Sharp and Dohme's (MSD) investigational oral hepatitis C virus (HCV) protease inhibitor, in combination therapy significantly improved rapid viral response, defined as viral suppression to undetectable levels within 28 days, compared to placebo in combination therapy in previously untreated (treatment-naïve) patients infected with chronic HCV genotype 1, one of the most difficult to treat genotypes of HCV (p<0.0001). All patients received MK-7009 or placebo in combination with pegylated interferon and ribavirin (peg-IFN/RBV), the current standard of care for treatment of HCV infection. (Poster 2701) These findings were presented today at the 44th Annual European Association for the Study of the Liver (EASL) meeting in Copenhagen, Denmark.
According to the World Health Organization, an estimated 180 million people are infected with HCV worldwide, 130 million of whom are chronic HCV carriers at risk of developing liver cirrhosis and/or liver cancer. It is estimated that three to four million persons are infected each year.
"In this ongoing study, MK-7009 in combination therapy rapidly lowered and generally maintained the amount of virus in the blood to below detectable levels in previously untreated HCV patients," said Robin Isaacs, vice president and therapeutic head for Infectious Diseases, Merck Research Laboratories. "These preliminary results help us understand the efficacy and tolerability profile of MK-7009 and support the further development of MK-7009 for the treatment of HCV."
These findings are the primary analysis from an ongoing, randomized, placebo-controlled, double-blind study of MK-7009 in treatment-naïve, chronic HCV patients. In this study, 95 patients were randomized across five treatment arms with regimens of MK-7009 300 mg or 600 mg twice daily, MK-7009 600 mg or 800 mg once daily, or placebo, for 28 days. Patients in all treatment arms received standard doses of peg-IFN/RBV in combination with the MK-7009 or placebo regimens, and are continuing to receive peg-IFN/RBV for an additional 44 weeks. HCV RNA was measured by the HCV RNA PCR TaqMan 2.0 assay, which has a lower limit of detection (LLOD) of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. The primary endpoint of the study was reduction in HCV RNA to undetectable levels (<10 IU/mL) at day 28.
Suppression of viral load to undetectable levels by day 28
After 28 days of therapy, 69 to 82 percent of patients in the regimens containing MK-7009 (n= 68 included in the per-protocol analysis) versus 6 percent of patients in the placebo regimen (n=18 included in the per-protocol analysis) achieved undetectable HCV RNA levels (p<0.0001). More than 80 percent of patients in the regimens containing MK-7009 versus 11 percent of patients in the placebo regimen experienced viral suppression to below LLOQ (<25 IU/mL) on day 28.
Viral suppression continued in the majority of patients following termination of MK-7009 treatment at day 28. At day 42, HCV RNA was undetectable in 77 to 94 percent of the patients in the regimens that had contained MK-7009 versus 12 percent of patients in the regimen that had contained placebo (p<0.0001). Additionally, all subjects in the 600 mg twice daily regimen group achieved HCV RNA to below LLOQ ( 20 percent in one or more treatment arms) in patients receiving MK-7009 versus patients receiving placebo, respectively, were nausea (28 to 40 percent versus 26 percent), headache (16 to 45 percent versus 37 percent), fatigue (5 to 35 percent versus 32 percent), flu-like symptoms (20 to 26 percent versus 16 percent), anorexia (5 to 25 percent versus 11 percent), diarrhea (6 to 25 percent versus 21 percent), indigestion (0 to 22 percent versus 21 percent), rash (10 to 17 percent versus 21 percent), and vomiting (0 to 40 percent versus 5 percent). The incidence of vomiting was higher in the treatment arm containing MK-7009 600 mg twice daily (40 percent) versus the treatment arm containing placebo (5 percent); vomiting did not require anti-emetic treatment and did not lead to discontinuation or dose reduction of MK-7009.
Phase IIb study to further assess efficacy, safety and tolerability of MK-7009
A Phase IIb study has been initiated to evaluate the safety, tolerability and efficacy of MK-7009 when administered concomitantly with peg-IFN/RBV to previously treated (treatment-experienced) patients with chronic hepatitis C genotype 1 infection. Patients will receive either placebo or MK-7009 at 300 mg or 600 mg twice daily in combination with standard doses of peg-IFN/RBV. The trial is a multicenter, partially double-blind, randomized, placebo-controlled trial that aims to enroll approximately 200 patients in multiple countries.
The study will measure the safety and tolerability of MK-7009 at all dose regimens as compared to placebo through 48 weeks. Additionally, the study will evaluate the proportion of patients in the MK-7009 600 mg treatment regimens achieving sustained viral response, i.e., undetectable viral load 24 weeks after the end of all study therapy, as compared to patients in the placebo regimen.
Source
Merck & Co., Inc.
http://www.medicalnewstoday.com/articles/149544.php
If you go to hcvdrugs.com you can read about your drug there. Also, the link at the bottom will show you a graph, hit the click here to see graph. It explains the fda drug approval process etc. IMO it would be a better idea to wait until that drug is in their phase III clinical trials. More bugs will be ironed out for a phase III trial and you will possibly be better taken care of as far as rescue meds going into a phase III trial as opposed to a phase II trial. good luck to you
http://www.protomag.com/assets/drug-approval-decoded
http://www.protomag.com/assets/drug-approval-decoded
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
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.
