Three Weeks to Cure!
There was a news story on October 30, 2015, about a study that will be presented at the upcoming Liver Conference this month in San Francisco, CA about curing hepatitis C in as little as three weeks! It sounds too good to be true, but, in this case, it just might be true. The study included 18 genotype 1b patients treated with a combination of drugs—everyone received sofosbuvir (HCV polymerase) as the backbone of therapy. Sofosbuvir was either combined with ledipasvir or daclatasvir—both NS5A Inhibitors. The third drug was either simeprevir or asunaprevir—both protease inhibitors. The result is that you are inhibiting the virus at muliple viral entry sites. Also, the patients enrolled in the study had the lowest viral loads. Originally 26 patients were enrolled in the study. After two weeks, those patients who had the steepest decline in viral load—HCV RNA—were allowed to stay in the 3-week trial. The others were treated for 12 weeks. Taken together this was actually a response-guided therapy trial on steroids. Still, it is pretty impressive, and all 18 patients achieved a cure.
More studies are needed to understand if this approach can be used in a larger population of people with hepatitis C. There are also questions regarding this approach about harder to treat genotypes such as genotype 3 and genotype 1a.
As far-fetched as a 3-week treatment to cure sounds I believe this will come to pass. Soon many drugs will be available to pick and choose from to create a drug cocktail to treat patients based on a patient’s characteristics. The only roadblock will be the business practice by some pharmaceutical companies that combines two drugs into one pill.
Source: Article: Study suggests unprecedented 3- week hepatitis C cure.
Viekira Pak and Technivie: Safety Warning
On October 22, 2015, The Food and Drug Administration (FDA) issued a warning on Viekira Pak and Technivie that “can cause serious liver injury mostly in patients with underlying advanced liver disease.” The liver injury occurred within 1 to 4 weeks of starting therapy. As a result, the package prescribing label has been updated for Viekira Pak and Technivie. We have posted the updated labels on our website: Technivie - Viekira Pak.
Just to be clear—the warning was for people who had had underlying advanced liver disease, and the liver injury happened after starting treatment within the first week through the 4th week. The best thing to do if you have concerns about your treatment – talk with your medical provider.
Source: FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie.
Achillion/Janssen – Starts New Trial
On October 16, 2015, Achillion and Janssen announced the initiation of a Phase 2a clinical trial of AL-335, odalasvir (formerly ACH-3102) and simeprevir to treat HCV genotype 1a/b. There will be three treatment arms with three treatment durations—four, six or eight weeks. Sixty treatment-naive patients will be enrolled. This study is not yet enrolling.
Source: Company Press Release. See clinicaltrials.gov. Study identifier: NCT02569710 for more information about the study.
It is probably not a big surprise that many drugs have originated from common herbs or other sources. However, at first glance the headlines “Scientists ‘go bananas’ for a new application of fruit protein as a method for treating viruses” made me think it was a joke. However, it was not a joke! The reality--scientists have been able to extract a substance found in bananas—banana lectin or BanLec—that can read the sugars on the surface of cells and viruses. The scientists were able to adjust Banlec to work against certain viruses such as HIV, hepatitis C and influenza. The scientist used a certain type of the BanLec to protect mice from getting a certain type of the flu. This could a VERY, VERY, BIG discovery.
Source: Article: Scientists ‘go bananas’ for new application of fruit protein as method for treating viruses.
Labels: achillion, banana lectin, BanLec, drug development pipeline, Janssen, Safety Warning, Technivie, Viekira Pak