Generic Harvoni | Harvoni Cost | Gilead Hep C Drug

While much, if not most, of the discussion on Hepatitis C community pertains to interferon and the various topics surrounding it, I am concerned about so much that is not being talked about, that is generic Harvoni.

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Only if they knew about generic Harvoni or Gilead had released its $24,000 Asegua Generic Hepatitis C Treatment.


As you see from reading the article on the fake or black market Harvoni, safety issues are of paramount concern due to the hardiness of the HCV virus in fluids and on environmental surfaces.

In 2001 an article was published called “Risk of a Haircut” in which a couple of doctors took it upon themselves to study the viability of the HCV virus in  all FDA approved “viricides” used in the cosmetic industry., new ones and old ones.

I was engaged in a concern regarding a product called New Skin recently and I want to share those concerns with readers here.

As some of you know, I participate on (and others) because HCOP has chosen not to have  message board. “Tom” asked about this product (New Skin) after he used it on a fishing trip. His brother in law is positive for HCV and Tom noticed that he, the brother in law, had used the new skin prior to his using it on a cut he had.

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People, this is serious. As a result of a lot of personal investigation I have found that the EPA and FDA regulations about viricides, like Cidex and others, do not require PCR technology used on them to determine efficacy against the hepatitis C virus. What they do is use markers. The logic goes that if it kills hepB, TB, etc , it kills hepC. But that is not necessarily so.

Using bovine feces to test hepB is not at all the same as using PCR technology in the fluid itself. But, that is all that regulations currently  require. Additionally, many of these products were approved as “viricides” under old EPA guidelines and that approval followed into the FDA at a point when the FDA took over jurisdiction.

This is appalling! Once approved (prior to our knowledge and the current testing techjnology of PCR and TMA) always approved. There is no surveillance and no requirement to re-validate claims of efficacy based on new science and/or technology.

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So, when “Tom” contacted me I began an investigation and, sure enough, New Skin has been around long enough that it was approved prior to knowledge of HCV and the technology that would validate it. I contacted the CEO of the company on Friday, July 30,2004 who promised to get back to me  after speaking with the scientists at the manufacturing company. They market the product all over the country but they are not the manufacturers.

DO NOT BUY OR USE THIS PRODUCT OR ANY LIKE IT.  Only Buy Generic Harvoni from Sunny Pharma.

I contacted the FDA on Friday also and expressed my concern. I received a call back today . While the person returning my call does not have jurisdiction, she promised to follow up  within the FDA and to make sure this information gets to the right person.

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New Skin comes in a spray also. I believe it is a spray can. If not, don’t buy it, either. The container should be sealed to protect against any possible contamination.

I am aware that Johnson and Johnson has a similar product. I cannot vouch for it at this time simply because I have had no opportunity to pursue the nature of that product.

Here is my email to the FDA outlining this concern. I will post the progress of this investigation as new information is available.

“Thank you for your efforts to follow up on this matter. I undstand from our converstion this morning that this is not a matter that is under your jurisdiction but that you are willing to make the appropriate referral within the FDA. Please update me on who you refer this matter to.
New Skin liquid bandages have come to my attention as a potential vector for the transmission of the hepatitis C virus.
We have been contacted by a person who used this product after it was used by a HCV positive relative. It occurred to him later that this was not prudent and contacted us for information and guidance.
This product is packaged in two forms: a spray on and a bottled liquid with an applicator attached to the cap, which screws on leaving the applicator  inside the fluid.
It is the liquid with applicator that is of high concern. The applicator is attached to the cap of the bottle and it is applied to a wound and then replaced into the bottle (think nail polish) for use on the next person.
According to the CDC the virus can be viable from 16 hours to 4 days on a surface at room temperature. In studies of fluids in tubes and containers, this has been extended to 7 days in some studies of fluids (see bottom of this message).
I have personally spoken to (name withheld), CEO of Medtech  who promised to speak with the scientific staff at his company and report back to me on what scientific studies have been done on this product with respect to the safety issues raised by Hepatitis C Outreach Project.

Thank you for your attention to this matter. I look forward to hearing from you soon.”

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To the Editor: Hepatitis C virus (HCV) infection has a prevalence of 1.8% in the United States. The mode of acquisition of HCV is unclear in nearly 40% of patients with chronic HCV infection.

Various social practices are currently under scrutiny, including sharing razors, snorting cocaine through the same straw another person has used, and sexual practices (1).

We questioned whether a haircut that includes a trim of the sideburns and back of the neck using a straight razor might lacerate the skin and thereby spread hepatitis C. We obtained the fluid used in five different male hairdresser salons to “sterilize” the cutthroat blade after its use to trim the neck hairs and sideburns.

The five fluids were negative for HCV RNA by reverse transcription polymerase chain reaction (RT-PCR) (2). The fluids were then deliberately “spiked” with 0.1 ml of 1:10 diluted serum that contained HCV.

The serum had been obtained from a patient who had chronic HCV infection, as determined by a positive result on PCR testing for HCV RNA.

This qualitative test was considered to be more sensitive (it detects >100 viral equivalents/mL) than the HCV branched-DNA quantitative assay (which detects >200,000 viral equivalents/mL). By use of RT-PCR, HCV RNA was detected at 6 and 24 hours and at 7 days.

The antiseptic fluids used to clean the razor did not destroy the viral RNA. We wonder whether the routine male haircut may be a risk factor for HCV infection. Norman Gitlin, MD Frederick S. Nolte, MD

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