Hepatitis C: Experimental Drug is Proving Efficacy in Research Studies

Hepatitis C, or HCV, is a viral infection of the liver which has no known cure. While companies such as Merck and Vertex are developing medications called protease inhibitors for the treatment of Hepatitis C, Bristol-Myers Squibb recently published its results of the data for the Phase II trial of a medication, also to treat HCV, but does so by blocking a protein, NS5A.

Hepatitis C: Current Treatment

Current treatment for Hepatitis C is a regimen of antiviral drugs; these medications can be administered successfully to only about 50 percent of those diagnosed with HCV. Those diagnosed with genotype 1 may not see an improvement in the viral load measurements; if so, treatment would be discontinued.

A combination of interferon or peginterferon and ribivirin are the antiviral medications most commonly administered at present. These medications do not produce a cure, but can sometimes decrease a person's viral load to acceptable levels, meaning liver damage is less likely to occur secondary to Hepatitis C.

One of the concerns with the virus that causes HCV is that it is able to quickly build up a resistance to the medications that work to eliminate it. Researchers feel confident that a multiple-regimen approach is the most likely to bring the greatest success in treating this disease which has infected over 170 million people throughout the world.

Hepatitis C: Bristol-Myers Squibb Experimental Medication

Before a new medication can receive approval by the Food and Drug Administration (FDA), it must go through three study phases. During all the phases, not only in the efficacy of the drug determined, but also its safety. These studies are called clinical trials.

The new medication that Bristol-Myers Squibb is testing is called BMS-790052. The medication works by blocking a protein, NS5A, a protein essential to the hepatitis C virus being able to replicate itself.

And while the clinical trials in phase 1 and phase 2 have shown promising results, BMS-790052 is seen to be an additional weapon in the arsenal of fighting this deadly disease.

In the phase 1 study, infected patients who received one single dose of BMS-790052 saw a drop in the viral load of 99.99 percent.

Phase 2 clinical trial early results were presented in Vienna the first week of May, 2010. Seven out of eight infected patients who took the highest dose of the new compound had such low levels of the hepatitis C virus that it was undetectable. The eighth person had stopped taking the medication for a period of time; no reason was given.

A representative for the pharmaceutical company, Nicholas Meanwell, stated, "The hope is that the compound could be used in a cocktail of drugs to keep the virus from developing resistance long enough for patients to clear the disease" (Reuters.com).

BMS-790052 will not be considered for approval until phase 3 clinical trials have been done and data analyzed. Meanwhile, Vertex Pharmaceuticals expects to complete its phase 3 clinical trials for their hepatitis C treatment in 2010. It is hoped that it will receive FDA approval by mid-2011.

Sources: Reuters.com
Bristol-Myers Squibb Clinical Trials
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