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. This drug has so much upside that a different pharmaceutical company, Gilead Sciences, has purchased Pharmasset for 11 billion dollars even though they have no drugs on the market. Gilead Sciences have renamed this compound GS-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 GS-7977, GS-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.
GS-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. GS-7977 has a brother drug GS-7976. They both convert to the same active triphosphate once in liver cells. GS-7977 is getting more attention as it is easier to manufacture. Studies with the GS-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.
A recent study of Genotype 1 non-responders to interferon/ribavirin has been a setback as all 8 of the patients cleared the virus using GS-7977 and ribavirin for 12 weeks, but 6 of the 8 relapsed. This is the hardest group of HCV patients to treat. Trials using GS-7977 as a monotherapy also faced a higher incident of HCV returning. A new round of studies is trying to find the ideal length of time as well as finding the ideal pairing for GS-7977 to prevent patients from relapsing.
PSI-7977 is the first drug that we at Alchemist Lab have ever recommended. For patients without health insurance or riches we recommend enrolling in the next round of studies as when the GS-7977 hits the market the company is going to have charge a high price just to recoup its investment.