Sofosbuvir Continues to Shine as Optimal Hepatitis C Treatment

Sofosbuvir Continues to Shine as Optimal Hepatitis C Treatment

sofosbuvirThe FDA’s approval of Sofosbuvir in December 2013 paved the way for an exciting new treatment option for patients suffering from Hepatitis C. Known as the brand name Sovaldi, which is marketed by Gilead, Sofosbuvir is a unique nucleotide analog inhibitor that is the first Hepatitis C drug to demonstrate efficacy without the co-administration of interferon. This innovative drug opens up new pathways for a greater number of patients with certain types of the Hepatitis C virus {HCV} and Sofosbuvir is currently at the forefront of clinical trials sponsored by Bristol-Myers Squibb. The most recent clinical trials include the administration of Sofosbuvir as monotherapy and as adjunctive therapy along with Daclatasvir in patients with the HCV Genotypes 1, 2 and 3 infection. These studies began recruiting adults ages 18 and older in January 2014 and positive information is hoped to be gathered by September 2014. Sustained virologic responses are expected from patients participating in these comprehensive studies, with study results and data due to be disseminated by the end of December 2014.

Hepatitis C Virus
Marc Phares via Getty Images

As a serious viral disease Hepatitis C virus can cause irreparable liver damage including liver failure. Many patients affected by the HCV virus experience cirrhosis of the liver, which often leads to chronic jaundice, fluid accumulation in the abdomen, excessive bleeding, complicated infections and liver cancer. The hepatitis C virus affects almost four million Americans, with the majority of patients being born between 1946 and 1964.

Vast numbers of clinical trials involving Sofosbuvir have been completed, including six noteworthy trials involving 1,947 patients infected with HCV. The measure of success in each of these six trials involved proof of a sustained virologic response at least twelve weeks after the completion of treatment. Sofosbuvir proved to be effectual, safe and tolerable in all six trials, including in those patients who had active liver cancer and were awaiting transplant surgery. Fatigue, headache and anemia were the most commonly reported side effects, with none of these being severe enough for any patients to withdraw from the clinical trials.

Sofosbuvir was awarded a breakthrough status from the FDA when it was introduced, as this formidable drug is the first interferon-free, oral drug designed to effectively combat the HCV virus. The Liver Meeting 2013 was the site of the latest excitement for Sofosbuvir, with physicians and research scientists revealing an upbeat attitude toward this potent HCV treatment. Sofosbuvir is coined a game changer by many experts in the R&D field, as a mere twelve weeks of treatment with this drug repeatedly elicits high cure rates in trials. One particular single-group study of Sofosbuvir offered very high rates of a sustained virologic response, with between 98 percent and 100 percent of 211 patients demonstrating a complete response.

LGM Pharma is a provider of API Sofosbuvir, CAS # 1190307-88-0 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.


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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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