FAQ

Genefron kit is for prediction of Hepatitis C patient response to Peg IFNα treatment what about the new drugs – DAA?

Four new DAA (direct antiviral agents) were approved by the FDA: Victrelis (boceprevir) and Incivek (telaprevir) in 2011,   Olysio   (simeprevir)  and  Sovaldi (Sofosbuvir)  in 2013 for treatment of HCV patients. The first three new DAA  are protease inhibitors and sofosbuvir  is polymerase inhibitor. They  can be prescribed only in combination with Interferon + Ribavirin (triple therapy) for treatment of HCV type 1.

Can protease or polymerase inhibitors (PI) be used as mono therapy replacement to Interferon/Ribavirin treatment?

PI’s can never be given without concomitant Peg Interferon and Ribavirin, as monotherapy leads to rapid emergence of virus resistance. Because of the high replication rate and error-prone nature of the hepatitis C virus (HCV) RNA polymerase, in theory, every possible single and double mutation across the HCV genome is produced every day in an infected, untreated person. As a result, protease inhibitor (PI)–resistant virus exists before patients are exposed to therapy. PI’s select for resistant viruses; they do not create resistant viruses. Therefore, the triple therapy of Peg-IFNα+Ribavirin +DAA is recommended treatment.

Can the responsiveness to Interferon predict the efficacy of DAA?

Recent clinical study revealed that the strongest predictor of viral resistance to new DAA treatment is poor interferon responsiveness. The corollary is also true—improved interferon response decreases the emergence of viral resistance on DAA therapy. The reason is that interferon activates the innate response of an individual to the virus.

Is prediction of responsiveness to Interferon treatment is  still relevant with the expected launching of new DAA ?

The current situation is that about 50% of the HCV patients are responders to Peg interferon treatment. The cost of interferon treatment is about $20,000-25,000, whereas the expected cost of the new triple treatment: Peg IFN+Ribaverin+DAA is $ 60,000-90,000, about double or triple of the current interferon treatment. The associated  side effects of the triple treatment are sever and worse than the side effects of the double treatment . Therefore, the Interferon treatment will be the first line choice and only the non-responders will be treated with combination of DAA. The  use of Genefron’s companion diagnostic kits is the solution to distinguish  between Responders and Non responders in order to fit the suitable and optimal treatment.

Can the responsiveness to Interferon predict the efficacy of DAA?

Recent clinical study revealed that the strongest predictor of viral resistance to new DAA treatment is poor interferon responsiveness. The corollary is also true—improved interferon response decreases the emergence of viral resistance on DAA therapy. The reason is that interferon activates the innate response of an individual to the virus.

Is there further application to the interferon prediction kit?

The kit we have developed, together with the algorithmic simulation based on its measurements, is able to predict if the IFN innate response of an individual  ,is sufficient to overcome the challenge that is presented by the hepatitis C virus. By calculating the personal coefficients of the IFN response, it can provide physicians with the following

treatment possibilities:
In case of a predicted rapid viral response (RVR) – IFN alone can be used for treatment
In case of a predicted rapid viral response (RVR) – IFN alone can be used for treatment.
Predicted slow viral response (SVR) – An optimal calculated dose and frequency of IFN, matching the individuals’ parameters is figured out.
For predicted poor response or non-response- The optimal combination of DAA with IFN
with regard to quantities and dosing, is calculated to achieve the best results.

Personal Treatment Adjustment Using the PGE of a patient and a second  novel algorithm we are developing a new method for adjustment of Personal Treatment (PT) including Interferon with/without combination of the new DAA medications. This approach will give the physician a new tool to tailor a specific treatment course base on the genomic information of the patient.

How the kit is used?

IFR 10– Only for  patients that  must pass liver biopsy procedure for clinical evaluation. Small portion of the biopsy is used for the diagnosis.   The results of RT PCR test  are sent to Genefron for analysis. Genefron within 24 hours will sent the prediction answer to the  original laboratory.

IFR 20– You will be requested to give a blood sample for the diagnosis. The results of RT PCR test  are sent to Genefron for analysis. Genefron within 24 hours will sent the prediction answer to the  original laboratory

 

 

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