Acute infection, Genotype 4

[newguy1]

I've just been diagnosed with acute hepatitis C, genotype 4. For all it's worth I'm gay and HIV positive as well and this is 99% likely to be sexual transmission. No iv drug use or any sort of contact involving the blood of another person.

I asked my doctor to test for HCV viral load since I was feeling tired and itchy for ~3 weeks. He did not suspect it and the antibody test was still negative. It is amazing to me that doctors are still not aware of what some are calling a sexually transmitted epidemic among gay men. It is reminiscent of the early days if HIV.

Curious if there's anyone else with genotype 4 out there who has been trying to get Harvoni through insurance. The clinical trials show almost 100% cure rates but it's not FDA approved in the US. My doctor said he will fight them until they approve it, as it is in the AASLD guidelines. Any insights welcome! 

[KimInTheForest]

Hi newguy, and welcome to the forums!

I see you are in the US. If you were in UK or Germany, this clinical trial of Harvoni sounds like it was made-to-order for you:
https://clinicaltrials.gov/ct2/show/NCT02457611

Still recruiting for people in those countries. Must be acute HCV, Genotype 1 or 4, with chronic HIV co-infection.

I have a feeling the only way you will get Harvoni in the US as a Geno 4 is through a clinical trial. Same for me here in Canada as  Geno 3. I am in the final 10 days of my Harvoni trial, and I expect to be cured.

You can search for relevant clinical trials by going to https://clinicaltrials.gov/

and typing "Genotype 4 Harvoni" in the search box top left. You will get a list of trials. It says which are still recruiting and which aren't. Then you have to look at the country, and of course other criteria. But it is all there.

Best of luck, and keep us posted!
kim

[newguy1]

Very interesting! Thank you for bringing this to my attention. My doctor in New York has been involved in a lot of the work on acute HCV infection and HIV; too bad there is no trial in the US right now. But I am their ideal candidate so we'll see what we can do.

Also interesting that they are trying out only 6 weeks of treatment. With a one month coupon from Gilead, it almost becomes a drug one can afford to pay for.  There is a growing epidemic of HCV among HIV infected gay men,  and somewhat less in HIV negative MSM who take Truvada for Prep (also a Gilead drug!). We all get tested for liver enzymes every 3-6 months anyway, and acute HCV usually gets picked up this way. This could be very commercially viable for Gilead. They certainly know what they're doing.

[KimInTheForest]

I noticed the 6-week period of the trial too and thought that was interesting. Perhaps acute HCV infection can be cleared more quickly than chronic because it is less deeply embedded in the body? Just a guess. But interesting.

There may be similar trials like that one I mentioned, but in the US. I did not look far down the list.

kim

[newguy1]

Re: acute infection. It appears that during the first 6 months of infection there is an immune response- that's why some people clear it. And my doctor said the symptoms I am experiencing are largely the immune response to the virus. So perhaps the antivirals work more effectively while the immune system is also activated, which wouldn't happen in chronically infected patients. The concern is that there is no way to know exactly when the immune system "gives up"- it could be 3 months or it could be a year after being infected. That's why it's not certain that a shorter treatment course would work, and Gilead had the cutoff for the trial at 6 months.

In my case, doctor thinks we'll be able to get it through insurance on appeal. I'll post what happens here since there may be others in a similar predicament. He says it is all about building a convincing case and fighting the insurance company until they give up...

[melke123]

My mom is also genotype 4. Although harvoni is not approved by the FDA she was still able to get it. Her insurance agreed to pay for it instead of the 6 month solvaldi, which is the standard for geno 4

[newguy1]

Hi guys! I am happy to report my insurance approved 12 weeks of Harvoni with lightning speed. Acute infection shows high inflammation markers of the liver, so my doctor used that and what looked like a very convincing letter to get approval.

The mail order pharmacy sent the drugs to the wrong address, but that's to be expected of them. I'm just happy to have the bottle in my hands and start treatment!

If anyone else is wondering- genotype 4 made no difference since the AASDL guidelines still ask for Harvoni, and acute infection is still a murky area. I am of the strong opinion that anyone who has HCV should get treated asap and waiting 6 months for the virus to clear is irresponsible.

[KimInTheForest]

Congrats on getting your harvoni, newguy! and good luck on your treatment.

kim

[Tig56]

Hey Newguy,

Congrats on the quick approval! Lets hope the next round of approvals are as fast as the recent denials have been. I'm glad your doc went to bat for you. I have this update on GT 4 from the U of W that you might find interesting. Won't be long and you'll be doing the SVR happy dance, good luck...

http://www.hepatitisc.uw.edu/pdf/treatment-infection/treatment-genotype-4/core-concept/all

[Cure4life]

Hi guys! I am happy to report my insurance approved 12 weeks of Harvoni with lightning speed. Acute infection shows high inflammation markers of the liver, so my doctor used that and what looked like a very convincing letter to get approval.

The mail order pharmacy sent the drugs to the wrong address, but that's to be expected of them. I'm just happy to have the bottle in my hands and start treatment!

If anyone else is wondering- genotype 4 made no difference since the AASDL guidelines still ask for Harvoni, and acute infection is still a murky area. I am of the strong opinion that anyone who has HCV should get treated asap and waiting 6 months for the virus to clear is irresponsible.

Hi newguy that is great news. I am also genotype  4  and I finished 16 weeks of harvoni 9 weeks ago so waiting for my 12 weeks eot to see it it works. Keep us posted on your  progress.  Best  wishes

[Cure4life]

My mom is also genotype 4. Although harvoni is not approved by the FDA she was still able to get it. Her insurance agreed to pay for it instead of the 6 month solvaldi, which is the standard for geno 4

Hi I am interested to  hear on your mom's treatment  as I am also  genotype  4 and I finished 16 weeks  of  harvoni  9 weeks  ago. I am not in the US though. Cheers

[slats1056]

Tig56 bouncing around the forums & saw Your avatar, Love it man. I'm a dragon freak. Ironic isn't it?