Hepatitis C Commercial Game Theory

[OdinLovesLife]

Interesting analysis on how big pharma pricing strategy. The HCV drug price wars we are hoping for may not happen as soon as we would like.

http://www.xconomy.com/national/2015/01/01/hepatitis-c-commercial-game-theory/

[HopeInPA]

sorry, wrong article above (had too many things open). Here is what I meant:  "Antiviral Drug Miravirsen: Final Phase 2a results show dose-dependent, prolonged antiviral activity in Hepatitis C patients", 2013  

http://mirnablog.com/antiviral-drug-miravirsen-final-phase-2a-results-show-dose-dependent-prolonged-antiviral-activity-in-hepatitis-c-patients/

The problem with these miR-122 inhibitors is that they pose at least theoretical risk of hepatocellular carcinoma.  

[HopeInPA]

That's a very interesting study. Thanks for posting this. I'm looking into an earlier version of it, another Co., using miR122 inhibitor -- also monthly subcutaneous injections, with somewhat less impressive results: Miravirsen (SPC3649) can inhibit the biogenesis of miR-122, 2014  

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874169/

My question:

if miR-122 is highly conserved in all vertebrates and if HCV is dependent on miR-122 for its replication, then why HCV does not infect other vertebrates, but only humans (and some other primates)?

There must be something else as well at play, no?

anyway, I feel lazy digging and wish someone could explain this to me -- as well as what's going on with these new miR-based drugs, and how they differ from, say, Sovaldi or Olysio.

Thank you very much whoever can shed even a bit light on these questions, much appreciated :)

[OdinLovesLife]

Late-Breaking Oral Presentation at The International Liver Congress™ (ILC 2015) Highlights RG-101's Potent, Durable and Pan-Genotypic Effects in Diverse HCV Population

http://ir.regulusrx.com/releasedetail.cfm?ReleaseID=908586

Extended follow-up results evaluating a single subcutaneous administration of either 2 mg/kg or 4 mg/kg of RG-101 as monotherapy in HCV patients with varied genotypes, liver fibrosis status and treatment history showed that 10/22 patients had HCV RNA levels below the limit of quantification ("BLOQ") at 12 weeks and 70 percent of those patients remained BLOQ at 20 weeks (7/10)

Oh yeah! NO MORE RIBAVIRIN! Just one or two shots of RG-101 and maybe a DAA added for extra punch.

[OdinLovesLife]

Watch out for Regulus RG101
http://ir.regulusrx.com/releasedetail.cfm?ReleaseID=877462

Interim results from the ongoing clinical study are summarized below:

In the first dose cohort of part IV of the ongoing study, 16 HCV patients were enrolled with multiple genotypes, 10 GT1s, 5 GT3s, and 1 GT4. 14 patients, 8 naïve and 6 patients who experienced viral relapse after a prior IFN-containing regimen, received a single subcutaneous dose of 2 mg/kg of RG-101 as monotherapy while 2 patients received placebo.

- In the 14 HCV treated patients, there was a mean viral load reduction of 4.1 log10 at day 29 (range -5.8 log10 to -2.3 log10).
- 6 out of 14 patients had HCV RNA levels below the limit of quantification at day 29 and the 3 patients from this group who have reached day 57 still have HCV RNA levels below the limit of quantification.
- Viral load reduction occurs within the first 96 hours and virologic response is not influenced by IL-28 genotype.
- Due to the long-lasting and sustained virologic effect seen, the ongoing study protocol has been amended to follow patients for up to six months after dosing to evaluate the possibility for certain patients to achieve viral cure after a single dose of RG-101.
- There were no drug-drug interactions from part III of the ongoing study in which RG-101 was combined with simeprevir (OLYSIO™), an approved oral DAA (protease inhibitor), and the combination had no effect on the pharmacokinetic profile of RG-101 or simeprevir (OLYSIO™).
- RG-101 is safe and well tolerated with no serious adverse events reported to date.