When we talk about what were the greatest discoveries in the year 2013, not only in medicine, but in general science as well, we cannot but stumble upon Sofosbuvir drug Sovaldi. Because Hepatitis C is a worldwide disease with 170 million patients, the new drug treatment in the form of Sovaldi drug by Gilead is of paramount importance. With the lack of effective Hepatitis C treatments the impact Sofosbuvir has and will have in the future will have lasting positive effects.
To put it simply, Sofosbuvir drug is a great news for everybody. Where it really shows its effect is in Hepatitis C patients, especially those with most common genotype 1 Hep C. The reason is simple. Sofosbuvir drug discovery enables the best treatment out there. Till now the most effective Hep C treatment was interferon treatment, which required injections after injection for sometimes as long as a year, with flu-like side effects and the most problematic part was that even after a year of treatment the changes of getting cured were less than 50%. In addition, Interferon and boceprevir were used – Victrelis drug by Merck contains boceprevir, and interferon and telaprevir – Incivek drug by Vertex Pharmaceuticals. Boceprevir and teleprevir are protease inhibitors that help the action of interferon.
Sofosbuvir changed all that. This is the first all-oral Hepatitis C medicine with the high cure rate for genotype 2 and 3 Hep C. Right here it must be said that for genotype 1 the Sofosbuvir drug treatment includes interferon as well as ribavirin, an antiviral drug, and uses these three substances to treat Hep C. Interferon requires needles and injection procedures, with the undesired flu-like side effect. However, despite the treatment for genotype 1 Hepatitis C, the use of Sovaldi drug provides a major advantage – it is effective in curing cancer in 89%, according to clinical studies by Gilead Sciences, the company that developed Sofosbuvir containing drug Sovaldi.
9 out of 10 Hepatitis C patients are cured with Sofosbuvir drug. The treatment with interferon and ribavirin alone cures on average 5 out of 10 Hepatitis C patients.
“We're in a brave new world of hepatitis C treatments, and we're very quickly reaching all oral, interferon-free, short-duration regimens.” Dr.Kris Kowdley, MD, director of the Liver Center of Excellence at the Digestive Disease Institute at the Virginia Mason Medical Center in Seattle.
With medical experts like Dr. Kowdley hailing the new treatment – this was in October 2013 – the Sofosbuvir FDA approval was not far and Gilead Sciences sciences drug Sovaldi, that contains Sofosbuvir, was approved by FDA on 6th of December 2013 to be used in chronic Hepatitis C treatment.
SOFOSBUVIR MECHANISM OF ACTION
In this section, we will talk about the molecule of sofosbuvir itself and see how it is different than similar drugs. Mechanism of action is similar to that of acyclovir with a vital, but ingenious change to the molecule that makes Sofosbuvir drug the next step antiviral molecule for treatment of complex viral infections.
The mechanism of action is biochemical in nature and describes how the Sofosbuvir manages to inhibit the functions of Hepatitis C virus in a selective and efficient way.
SOFOSBUVIR DEVELOPMENT AND CLINICAL STUDIES
Drug research and development is a very long process that takes approximately 12 to 15 years and costs about 1 billion US dollars. Sofosbuvir molecule was patented way before the FDA approval of Sovaldi, Sofosbuvir containing medicine. The molecule was discovered by Pharmasset, a pharmaceutical company known for antiviral drugs such as HIV drug racivir, Hepatitis drug clevudine, and Hepatitis C drugs. Two years prior of sofosbuvir FDA approval, Pharmasset was acquired by Gilead Sciences for $11 billion and continued to develop Sovaldi drug.
Drug development started with Sofosbuvir discovery, followed by serious of preclinical studies. Once the Sofosbuvir was approved to take clinical studies, stage 1 clinical studies begin, followed by stage 2 and stage 3 clinical studies. We write more about the details of clinical studies.
It was a long way and we will reveal the history of Sofosbuvir drug becoming Sovaldi in order to treat Hepatitis C patients.
INTERACTIONS AND SIDE EFFECTS
Sofosbuvir has, as all drugs, some minor side effects. Sofosbuvir drug interactions are less known, but we will reveal them all in this section.
One of the most controversial things not only in Sovaldi treatment, but also in pharmaceutical industry, is the price of the drug. Different numbers from $1,000 to $200,000 are coming from the media. We discuss and reveal the numbers in Sofosbuvir cost section and talk about how Gilead is trying to reduce the price to make Sofosbuvir treatment available to as many Hepatitis C patients as possible.