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Drug Development

Posted by: Alchemist Lab    Tags:      Posted date:  October 25, 2011  |  No comment



The most effective drug that we have witnessed to date for treating hepatitis C is in Phase 2b trials (Phase 1 – safety, Phase 2a – Dosing Requirements, Phase 2b – Effectiveness).  It is made by a company called Pharmasset and it is called PSI-7977.

We’ve had 4 patients enrolled in studies and all 4 have been undetectable after only 2 weeks of treatment.  One of our patients started with a 12.8 million viral load, after 1 week of this drug plus interferon/ribavirin her viral load was 21, on week 2 it was undetectable.  The second patient who has decompensated cirrhosis also cleared the virus in one week on a combination of PSI-7977, PSI-7976, and ribavirin.  The doctors that are funneling patients into these studies have in both San Francisco and Florida told patients that this drug is clearing every patient they have watched go through these trials.

It is clear that interferon in not needed along with the PSI-7977. At this point it appears that in the trial arms where PSI-7977 was used as monotherapy, the drug was just as effective in initially clearing the virus, but it had more of a tendency to return.  Whereas the patients who used ribavirin along with the PSI-7977 stayed undetectable in follow-up studies.  Viruses can remain hidden inside lymphocytes, even when undetectable in the blood.

PSI-7977 is a nucleotide analog.  Nucleotides joined together make RNA & DNA,  basic building blocks of life.  A nucleotide analog is similar enough to the nucleotides for viruses to incorporate into its strands, but then terminates these daisy chains of life. Typically these drugs do impact bone marrow.

Isomers are molecules with the same chemistry, but different structures.  PSI-7977 has a brother drug PSI-7976.  They both convert to the same active triphosphate once in liver cells.  PSI-7977 is getting more attention as it is easier to manufacture.  Studies with the PSI-7976 have been terminated as it caused a rise in liver enzymes.

Different arms that included the PSI-7976 were stopped at different junctures.  For the patients who had only 4 weeks of therapy, HCV mounted a comeback.  Though the patients whose study arm was discontinued after 8 weeks were still clear after re-testing.

PSI-7977 is the first drug that we at Alchemist Lab have ever recommended.  This drug is so effective that another drug company bought Pharmasset for 11 billion dollars, even though Pharmasset had no drugs on the market yet.  For patients without health insurance or riches we recommend enrolling in the next round of studies as when the PSI-7977 hits the market the company is going to have charge a high price just to recoup its investment.







 

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