A report in the Journal of the American Medical Association on August 28, 2013 offered exciting news for patients with Hepatitis C. A phase 2 trial of the drugs Sofosbuvir and Ribavirin revealed that this curing combination gives patients with Hepatitis C a viable treatment that is tolerable and effectively clears the virus. The study of this oral only regimen was led by both the NIH Clinical Center and the National Institute of Allergy and Infectious Diseases, and was broken down into two main parts. All total there were 60 participants who had the active Hepatitis C Virus, with the specific volunteers having the genotype-1 virus. This genotype is often less responsive to interferon-based medications and treatment. Of the 60 clinical trial patients 50 were of African American descent. A staggering 22 percent of patients with Hepatitis C are African American, and the majority of this patient population has lower cure rates with traditional interferon treatments. All of the patients in this landmark phase 2 study also had liver damage, ranging from mild to severe.
The aforementioned two part study initially began by enrolling 10 patients who had either mild or moderate liver fibrosis. These 10 patients then received Ribavirin dosages based on their weight, alongside the experimental medication Sofosbuvir. This oral treatment continued for exactly six months. There were approximately 9 participants who completed the study in full, demonstrating an undetectable Hepatitis C Virus at both the culmination of the trial and when evaluated 24 weeks after concluding therapy. As the Hepatitis C Virus does not integrate in human DNA, the patients who were virus-free after the trial were effectively labeled cured. There were 50 clinical trial participants enrolled in the second half of this phase 2 study, who also received Ribavirin dosages based on their weight. However, 25 of these patients were administered a low dose of Ribavirin, regardless of the weight requirement, which was exactly 600 milligrams daily. All of the patients also received daily oral doses of Sofosbuvir.
The second part of the trial enrolled 50 volunteers, 13 of whom had liver damage rated as serious. Twenty-five received Ribavirin based on their weight, and 25 received a low dose (600 milligrams per day). All participants received Sofosbuvir. The total cure rate from both of these studies was 70 percent, which is amazing for this group of patients who did not previously respond to traditional interferon-based treatments.
Continued trials are currently underway to develop precise and efficacious pharmaceutical interventions to foster a 100 percent cure rate. A complete cure for all patients with Hepatitis C would be quite a feat for the more than 3 million Americans suffering from this chronic disease.
LGM Pharma provides both API Sofosbuvir, CAS number 1190307-88-0 and Ribavirin, CAS number 36791-04-5 for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.
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