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The current drugs to treat hepatitis C have high cure rates and minimal side effects (compared to the older therapies). This has created a dilemma for drug developers who must develop new drugs that somehow improve upon the current drugs. This is a difficult task, but not impossible. Probably the biggest achievement will be shorter treatment duration and lower cost. There is a percentage of patients who are the more difficult to treat, such as those with genotype 3 who have cirrhosis and have not achieved a cure with a previous course of therapy. The race is on for new, better and cheaper therapies -- this is very good news for people living with chronic hepatitis C.
You will see below that the need for these new therapies has narrowed the pharmaceutical companies to a number that you can count on your fingers! As a result I have decided to rework our pipeline and list it by the pharmaceutical company. I am also just listing the major studies. This is also a new pipeline that will grow as information is released. The pipeline is a brief overview. More extensive information is listed in our newsletters and in our blog.
A brief overview of how this pipeline is laid out:
Date: The Pipeline will be updated on a monthly basis and will be included with the HCV Advocate Newsletter
Genotype(s): This lists the drugs or combination of drugs and the particular gentoype or genotypes that the drug is active against.
Comments: This section will list the study results. Within this section, I will list the genotype(s) being studied and the phase of the study with a brief recap of the study.
You will note that many of the drugs or combinations of drugs are pan-genotypic -- that is they work on many or most of the HCV genotypes.
Note: Many of the drugs listed below have been updated with the latest information from the Liver Meeting 2015 and and the International Liver Congress 2016. More detailed information about drugs in development is available in our blog and reported in the HCV Advocate newsletters.
Genotype(s): 1, 2, 3, 4, 5, 6 (Pan-genotypic)
Genotype 1 -- Phase 2 Study: Information from the International Liver Congress 2016: AbbVie's once-daily therapy of ABT-493 (protease inhibitor) and ABT-530 (NS5A inhibitor).
Non-cirrhotic patients Treatment period -- 8 weeks:
Treatment period 12 weeks:
Cirrhotic treatment-naive patients, genotype 3 -- cure rate -- 100% (24 of 24 patients) Non-cirrhotic treatment-navie patients (85%), PEG/RBV (15%); genotype 4 (22 pts), genotype 5 (1 pt), genotype 6 (11 pts) -- cure rate -- 100% (34 of 34 pts)
Bottom line: cure rates were 97% to 100%.
Genotype 1,2,3,4,5,6, (Pan-genotypic)
In another study to treat people who are treatment experienced genotype 1 through 6 and who had been treated with a previous course treatment -- prior NS5A-experienced (27%); non-NS5A-experienced (52%), direct-acting antiviral-experienced (DAA (52%), and 21% that failed an interferon-based therapy without a DAA. The cure rate was 99% (127 of 128 pts).
In yet another study GS-9857 with sofosbuvir/velpatasvir was tested to treat DAA experienced genotype 1 patients with cirrhosis. The treatment period was 12 weeks. The cure rate was 100% (24 of 24 pts).
The bottom line: the cure rates were in the 79% to 100% in people treated 6 to 12 weeks.
The combination of sofosbuvir, velpatasvir and GS-9857 is currently in phase 3 clinical trial (POLARIS 1,2,3 and 4). The Food and Drug Administration (FDA) has granted the combination as Breakthrough Therapy for those who have previously failed an NS5A Inhibitor-containing regimen.
Genotype 1,2,3,4,5,6 (Pan-genotypic)
Genotype 1, 2, 3, 4, 5, 6 (Pan-genotypic)
Twenty-four percent of genotype 1 patients had resistant associated variants (RAVs): 59% had NS3 (protease) RAVs and 21% had NS5B (polymerase) RAVs.
The overall cure rates were 91 to 100% in the genotype 1 groups; 60 to 94% in the genotype 2, and 86 to 91% in genotype 3. The drugs were well-tolerated with no treatment discontinuations.
Part B of C-CREST 1 and 2 will evaluate the most effective dose to treat prior treatment failures, cirrhotic patients and treatment in people with HIV/HCV coinfection.
Bottom line: The most effective dose was associated with cure rates in the 90 to 100%.
Genotype 1, 2, 3, 4, 6
The study included 79 treatment-naive genotype 1 and 4 patients. RG-101 is a GalNAc-conjugated anti-miR targeting miR-122, a host factor for HCV infection. It is an injectable medication given at Day 1 and Day 29 plus 4 weeks of a once-a-day direct-acting antiviral medication -- Harvoni (27 patients), Olysio (27 patients), Daklinza (25 patients). Sixty-four of the patients were evaluated through week 8 of follow-up, 41 reached 12 weeks post treatment.
The cure rate was 97% (40 of 41 pts).
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