Telaprevir for Hepatitis C, soooon...

We did know that Telaprevir (VX-950), is a member of a class of antiviral drugs known as 'Protease Inhibitors' was an experimental treatment for Hepatitis and two companies Vertex and Johnson & Johnson jointly developed and phase II clinical trials were being done. Now thanx, to Dr. Ira M. Jacobson chief of the Division of Gastroenterology and Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Clinical Medicine at Weill Cornell Medical College, who has come up with the results of Phase IIb clinical trial.

Th results are really encouraging and as per the author, "the findings point the way to a new era in the treatment of hepatitis C". The most significant part of the research lies in the fact that, by adding Telaprevir the treatment was more effective and quicker and there by reducing the therapy to half (from 48 weeks to 24 weeks).

Results showed that 67 percent of patients taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 36 weeks were cured; and 61 percent of those taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 12 weeks were cured. This is compared to 41 percent cure rate in the 48-week control group. And more over the study also showed that the percentage of patients who relapsed in the 24-week and 48-week telaprevir-based groups (2 percent and 6 percent, respectively) was much lower than the control group (23 percent). Also the authors found that it can be used alongwith Ribavirin, for those with HIV & Hepatitis C. Congratulations for this achievement. Phase III clinical trials are currently underway at the NewYork-Presbyterian/Weill Cornell and centers worldwide will attempt to confirm the results, potentially leading to FDA approval of telaprevir and hope there will be a relief to the sufferers very soooon......

Ref : http://news.med.cornell.edu/wcmc/wcmc_2009/06_04_09.shtml

Positive Phase 2 results of Telaprevir...

I did mention about telaprevir (structure) in my earlier blog, and following other developments for hepatitis C (blogs). Now Vertex Pharmaceuticals has announced the results of Phase 2.

The results are really encouraging and as per the claim by the company "more than 80 percent of hepatitis C patients in each arm of the Phase 2 Study C208 achieved a sustained viral response (SVR) with a telaprevir-based regimen according to results of an intent-to-treat (ITT) analysis".

Across the four arms, SVR rates were 82 and 83 percent in patients treated with the every 12 hour telaprevir-based regimen (PEGINTRON and PEGASYS, respectively) and 81 and 85 percent in patients treated with the every 8 hour regimen (PEGINTRON and PEGASYS, respectively). For the majority of patients, these SVR rates were obtained with a 24-week telaprevir-based regimen.

Ref : http://investors.vrtx.com/releasedetail.cfm?ReleaseID=420611

Telaprevir-based regimens increase rates of SVR in patients with genotype 1 HCV infection

In continuation of my update on telaprevir-based regimens, I found this article interesting to share with.....

In a clinical trial known as PROVE 3 published in this week's New England Journal of Medicine, treatment with telaprevir-based regimens significantly increased rates of sustained viral response (SVR) in patients with genotype 1 hepatitis C virus (HCV) infection who did not achieve SVR with at least one prior course of pegylated-interferon and ribavirin therapy. In the trial, 51 percent and 53 percent of patients who received telaprevir in combination with pegylated-interferon and ribavirin as part of a 24-week or 48-week regimen, respectively, achieved SVR.   More...

Telaprevir drug shows promise in curing hepatitis C infection

In continuation of my update on Telaprevir...............

Telaprevir drug shows promise in curing hepatitis C infection

Survey Concludes Telaprevir a Winner for HCV Genotype 1 | Hepatitis Central News, Updates and Commentary

I did mention in my earlier blog about this drug and one person did (Dawn - Blog Name) mention she was happy about the info. I am sure the following update will help her. All the best...(Dawn, U can mail me at dr.umesh1969@gmail.com-if u find this info useful). I am happy something I did blog and that helped a needy & this encourages me to do spend more time with my blog.....

Survey Concludes Telaprevir a Winner for HCV Genotype 1 | Hepatitis Central News, Updates and Commentary

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Incivek Approved for Hepatitis C

In continuation of my update on telaprevir...
Incivek Approved for Hepatitis C: "MONDAY, May 23 -- Incivek (telaprevir) has been approved by the U.S. Food and Drug Administration for adults with chronic hepatitis C infection who either haven't received standard interferon therapy or haven't responded to it.

New drugs (Victrelis and Incivek ) encouraging for African Americans with hepatitis C

Current standard of treatment of interferon and ribavirun has only been effective in curing 38 to 40 percent of patients with chronic hepatitis C genotype 1. In clinical trials, Victrelis and Incivek, when working in concert with interferon and ribavirun, cured 65 to 75 percent of people with chronic disease and Victrelis-alone doubled the previous cure rate among African Americans......

Victrelis (Boceprevir)             

                                                                                                                                                                                                                                      Incivek (Telaprevir)


News Release Archives > New drugs encouraging for African Americans with hepatitis C

FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients

The U.S. Food and Drug Administration today approved Mavyret (telaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017.

   Pibrentasvir

                                  Glecaprevir

“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Jeffrey Murray, M.D., M.P.H., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”

HCV is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the U.S. Centers for Disease Control and Prevention, an estimated 2.7 to 3.9 million people in the U.S. have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection. It is estimated that there are 23,000 to 46,000 children in the U.S. with HCV infection.

With today’s approval, dosing information is provided for Mavyret for the treatment of adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of six identified HCV genotypes either without cirrhosis or with compensated cirrhosis.

The safety and efficacy of Mavyret in pediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 100 percent of patients who received Mavyret for eight or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured. In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or genotype 5 or 6 HCV infection, the safety and efficacy of Mavyret are supported by previous studies observed in glecaprevir and pibrentasvir in adults. The adverse reactions observed were consistent with those observed in clinical studies of Mavyret in adults.

Treatment duration with Mavyret differs depending on treatment history, viral genotype and cirrhosis status. The most common adverse reactions in patients taking Mavyret were headache and fatigue. Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret.

https://www.drugbank.ca/drugs/DB13879

https://pubchem.ncbi.nlm.nih.gov/compound/Glecaprevir#section=Structures

https://en.wikipedia.org/wiki/Pibrentasvir

https://pubchem.ncbi.nlm.nih.gov/compound/Pibrentasvir

FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients