Aa
24 weeks
Not a question but a comment about hep C. Am at 24 weeks and just got results back...virus undetectable. I'm genotype 1, over 60, and long term. Dr. has me on peginterferon + ribavirin. At 12 weeks, just barely 2 log drop. Then started daily Vitamin D supplements (5000mg) after reading latest studies. Doc was hesitant but agreed. Now says was good idea. I hope this helps someone out their. Just hoping no relapse for next 24 weeks. Have had gradually increasing neutropenia but still over the <500 limit and still asymptomatic. Good luck, I sure feel I have been so far.
Romark Announces Data From Clinical Trial of Nitazoxanide in Treatment-Naive Patients with Genotype 1 Chronic Hepatitis C
Study Presented at the International Liver Congress(TM) Shows Improvement in Virologic Response Rates 12 Weeks after End of Treatment and Favorable Safety Profile
TAMPA, Fla., April 15 /PRNewswire/ -- Romark Laboratories announced results from its STEALTH C-3 clinical trial, a phase 2 clinical study of nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C. Study results were presented as a late breaking communication at the International Liver Congress™ 2010, the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The study was a randomized, double-blind, placebo controlled trial conducted at thirteen centers in the United States in patients with genotype 1 chronic hepatitis C, 35% of whom had advanced stage 3 or 4 fibrosis. A sustained virologic response (undetectable HCV RNA) twelve weeks after the end of treatment (SVR12) occurred in 44% of patients treated with nitazoxanide (500 mg twice daily) plus standard therapy (Pegasys® and Copegus®, F. Hoffman LaRoche) for 48 weeks versus 32% of patients treated with placebo plus standard therapy. SVR12 rates were consistently higher in subsets of patients with high baseline viral load (41% vs. 29%) and in African Americans (38% vs. 20%). Safety analyses showed no adverse events attributable to nitazoxanide, with the exception of mild to moderate intermittent diarrhea and discolored urine. Final results of this study will be presented at a late breaking forum of the American Gastroenterological Association Institute during Digestive Disease Week in May of this year.
Results of the STEALTH C-3 study are consistent with previously reported data from studies of nitazoxanide plus Pegasys® and Copegus® in treatment-naive patients with genotype 4 chronic hepatitis C.(1,2,3) The STEALTH C-3 study is the first trial of nitazoxanide in treatment-naïve patients with genotype 1 chronic hepatitis C.
"We are pleased to achieve these results in a population representative of the broad range of hepatitis C patients in the United States, including 35% with advanced fibrosis," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark and inventor of the drug. "We plan to initiate phase 3 clinical trials of nitazoxanide using our 675 mg controlled release tablets in combination with peginterferon with or without ribavirin later this year. The 675 mg controlled release tablets deliver a higher dose of nitazoxanide with a better pharmacokinetic profile. Additional clinical trials using the 675 mg controlled release tablets in genotype 1 and 4 patients are underway and include reduction of the duration of peginterferon to 24 weeks with and without ribavirin. We also plan to investigate combinations with direct acting antiviral drugs. Because of its novel mechanism and very favorable safety profile, we expect nitazoxanide to play an important role in a broad range of patients with chronic hepatitis C."
Nitazoxanide is the first of a new class of broad spectrum antiviral drugs called the thiazolides.(3,4,5) It is a potent inhibitor of hepatitis C virus in replicon studies,(4) and studies have shown that it does not induce viral mutations that confer drug resistance.(5) Nitazoxanide is synergistic with interferon and direct acting antivirals.(4,6) In patients with chronic hepatitis C, the addition of nitazoxanide has not resulted in an increase in the toxicity associated with peginterferon and ribavirin. Studies in patients with genotype 4 chronic hepatitis C suggest that nitazoxanide can be used to replace ribavirin.(1,2) The AIDS Clinical Trials Group (ACTG) in the United States is studying nitazoxanide plus peginterferon and ribavirin for treating chronic hepatitis C in patients coinfected with HIV.
"Patients with chronic hepatitis C are diverse in many respects with patient and virus characteristics that affect treatment outcomes (HCV genotype, viral load, stage of liver disease, IL28B genotype, race, body weight, coinfection with HIV or hepatitis B virus, and ability to tolerate treatment)," said Emmet B. Keeffe, Chief Medical Officer of Romark Laboratories. "The trend in therapy of chronic hepatitis C has been toward individualized therapy with combinations of antiviral drugs. There is a need for a new class of safe drugs with novel mechanism that can be used in combination with current standard therapy or with other new classes of drugs to improve treatment outcomes. We believe nitazoxanide can play an important role in these combinations."
Another communication of late-breaking data related to use of nitazoxanide plus standard therapy in patients with genotype 1 chronic hepatitis C who previously failed to respond to peginterferon plus ribavirin is scheduled for Saturday, April 17. In keeping with the embargo policy of the conference, the title and authors of the abstract on the nonresponder study are as follows:
Title: Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide with Peginterferon Alfa-2a and Ribavirin in Nonresponders with Chronic HCV Genotype 1: Final Report
Study Presented at the International Liver Congress(TM) Shows Improvement in Virologic Response Rates 12 Weeks after End of Treatment and Favorable Safety Profile
TAMPA, Fla., April 15 /PRNewswire/ -- Romark Laboratories announced results from its STEALTH C-3 clinical trial, a phase 2 clinical study of nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C. Study results were presented as a late breaking communication at the International Liver Congress™ 2010, the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The study was a randomized, double-blind, placebo controlled trial conducted at thirteen centers in the United States in patients with genotype 1 chronic hepatitis C, 35% of whom had advanced stage 3 or 4 fibrosis. A sustained virologic response (undetectable HCV RNA) twelve weeks after the end of treatment (SVR12) occurred in 44% of patients treated with nitazoxanide (500 mg twice daily) plus standard therapy (Pegasys® and Copegus®, F. Hoffman LaRoche) for 48 weeks versus 32% of patients treated with placebo plus standard therapy. SVR12 rates were consistently higher in subsets of patients with high baseline viral load (41% vs. 29%) and in African Americans (38% vs. 20%). Safety analyses showed no adverse events attributable to nitazoxanide, with the exception of mild to moderate intermittent diarrhea and discolored urine. Final results of this study will be presented at a late breaking forum of the American Gastroenterological Association Institute during Digestive Disease Week in May of this year.
Results of the STEALTH C-3 study are consistent with previously reported data from studies of nitazoxanide plus Pegasys® and Copegus® in treatment-naive patients with genotype 4 chronic hepatitis C.(1,2,3) The STEALTH C-3 study is the first trial of nitazoxanide in treatment-naïve patients with genotype 1 chronic hepatitis C.
"We are pleased to achieve these results in a population representative of the broad range of hepatitis C patients in the United States, including 35% with advanced fibrosis," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark and inventor of the drug. "We plan to initiate phase 3 clinical trials of nitazoxanide using our 675 mg controlled release tablets in combination with peginterferon with or without ribavirin later this year. The 675 mg controlled release tablets deliver a higher dose of nitazoxanide with a better pharmacokinetic profile. Additional clinical trials using the 675 mg controlled release tablets in genotype 1 and 4 patients are underway and include reduction of the duration of peginterferon to 24 weeks with and without ribavirin. We also plan to investigate combinations with direct acting antiviral drugs. Because of its novel mechanism and very favorable safety profile, we expect nitazoxanide to play an important role in a broad range of patients with chronic hepatitis C."
Nitazoxanide is the first of a new class of broad spectrum antiviral drugs called the thiazolides.(3,4,5) It is a potent inhibitor of hepatitis C virus in replicon studies,(4) and studies have shown that it does not induce viral mutations that confer drug resistance.(5) Nitazoxanide is synergistic with interferon and direct acting antivirals.(4,6) In patients with chronic hepatitis C, the addition of nitazoxanide has not resulted in an increase in the toxicity associated with peginterferon and ribavirin. Studies in patients with genotype 4 chronic hepatitis C suggest that nitazoxanide can be used to replace ribavirin.(1,2) The AIDS Clinical Trials Group (ACTG) in the United States is studying nitazoxanide plus peginterferon and ribavirin for treating chronic hepatitis C in patients coinfected with HIV.
"Patients with chronic hepatitis C are diverse in many respects with patient and virus characteristics that affect treatment outcomes (HCV genotype, viral load, stage of liver disease, IL28B genotype, race, body weight, coinfection with HIV or hepatitis B virus, and ability to tolerate treatment)," said Emmet B. Keeffe, Chief Medical Officer of Romark Laboratories. "The trend in therapy of chronic hepatitis C has been toward individualized therapy with combinations of antiviral drugs. There is a need for a new class of safe drugs with novel mechanism that can be used in combination with current standard therapy or with other new classes of drugs to improve treatment outcomes. We believe nitazoxanide can play an important role in these combinations."
Another communication of late-breaking data related to use of nitazoxanide plus standard therapy in patients with genotype 1 chronic hepatitis C who previously failed to respond to peginterferon plus ribavirin is scheduled for Saturday, April 17. In keeping with the embargo policy of the conference, the title and authors of the abstract on the nonresponder study are as follows:
Title: Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide with Peginterferon Alfa-2a and Ribavirin in Nonresponders with Chronic HCV Genotype 1: Final Report
Good idea indeed about Vit D. There is a simple way to make sure you take the right
dosage . Get tested !
Watch out for new results coming out for Alinia in naive geno 1 phase 2 trial.
I would add that to your regimen it might just help prevent relapse and it has
next to no side effects.
How much Riba are you on ?
Congrats to UND !
dosage . Get tested !
Watch out for new results coming out for Alinia in naive geno 1 phase 2 trial.
I would add that to your regimen it might just help prevent relapse and it has
next to no side effects.
How much Riba are you on ?
Congrats to UND !
My doctor put me on vitamin D also.
Have you spoken to your doctor about extending tx to 72 weeks, since you did not clear until week 24 or thereabouts? When was your last PCR, did you start having them weekly after not clearing at week 12? It would be good to know exactly which week you cleared. The trend is to go to 72 weeks for those who responded late. We have many members in the "72 Week Club" and a great many of them have achieved SVR.
Best of luck to you.
jd
Have you spoken to your doctor about extending tx to 72 weeks, since you did not clear until week 24 or thereabouts? When was your last PCR, did you start having them weekly after not clearing at week 12? It would be good to know exactly which week you cleared. The trend is to go to 72 weeks for those who responded late. We have many members in the "72 Week Club" and a great many of them have achieved SVR.
Best of luck to you.
jd
Congrats for reaching UND!!!! I agree about extending treatment. I have read that the farther we get past 50, the harder it is to clear the virus, so if extending the tx may keep you from having to start over again from scratch, I'd sure talk to the doctor about it.
I believe the vit D is a good thing too.
I believe the vit D is a good thing too.
Congrats on getting to undetectable! I would talk to your doctor about extending your treatment. If it takes you until week 24 to get to undetectable, it's often advised to treat for longer, for a better shot at SVR.
Many people on here are more knowledgeable than I about this, so I advise you to make a new post asking a question about extending treatment. Good luck!
Many people on here are more knowledgeable than I about this, so I advise you to make a new post asking a question about extending treatment. Good luck!
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