New to the forum – have been reading and following the activity here with great interest.
Contracted HCV (genotype 1a) back in the late 60’s – diagnosed some 20 years later. Went through over 28 months of pre-pegylated interferon therapies including ribavirin – no success.
Two biopsies and recent FibroSure results show a score holding at the upper edge of F1-F2 – I am very fortunate. AST/ALT scores historically ranged in the 100/140 range or higher. With these numbers – I was able to wait for availability of the new DAA treatments.
Tried to get my insurance carrier to cover Harvoni when it was released – no dice – numerous attempts and paths tried. Was waiting for the generics overseas when my GI called and informed me that AbbVie had a coupon for their Viekira Pak – a free 12 week trial. Can’t really explain in words how it felt when I got the news.
Followed the directions to the letter – had a contract nurse from AbbVie checking my progress. Started with a low VL of 500k (guess my immune system has been waging a decent battle over the years – was in the millions). Went to undetected at two weeks – and held throughout treatment. AST/ALT dropped to 13 and 11 - the best I have seen in some forty years. It was looking good.
Had my blood drawn for the SVR12 near the holidays and shortly received the sad news that my VL had returned – to multiples of the start point. Sad news indeed. Curious to note that when my previous INF/RBV therapies failed – the suppressed VL also rebounded with a vengeance.
Using the AASLD/IDSA guidelines for retreatment – "deferral of treatment" is indicated in my case (due to minimal liver damage). If cost/price were not an issue – there would likely be a recommendation for retreatment.
What the lab tests do not show is the debilitating fatigue that has worsened over the years. The impact on my quality of like is driving me to look for alternatives.
I had the HCV Drug Resistance Testing performed by LabCorp (Monogram Biosciences). There are three separate tests covering NS3/4A, NS5A and NS5B with currently approved DAA medications. Some detail on their site here:
Since my insurance may not cover this, I checked ahead on the self-pay price. The three tests required are each priced at $690 USD here in California. A bargain really at less than two days of retail Harvoni or Viekira treatment expense (I was expecting a number in the thousands).
Test results were available in three weeks – and mine confirmed an NS5A resistance to both ledipasvir (Harvoni component) and ombitasvir (Viekira component). The drug resistant associated variant (RAV) detected for both was Q30R (a somewhat common RAV for GT 1a patients that have failed current DAA therapy from my reading).
The good news in my case is that no RAVs were detected for NS3/4A or NS5B – most importantly for the former. According to the AASLD guidelines – this allows for the possibility of my retreatment with currently approved drugs – specifically simeprevir (Olysio) and sofosbuvir (Sovaldi) with the probable addition of ribavirin.
However – the price here is breathtaking.
The recommendation “for patients with cirrhosis or other patients who require retreatment urgently” calls for a 24 week regiment with ribavirin. I did a quick check on retail prices.
Olysio (150 mg capsules) Qty. 28 $23,000
Sovaldi (400 mg tablets) Qty. 28 $28,000
Combined price of treatment (24 weeks – excluding ribavirin) $306,000
Fortunately – since I haven’t progressed to cirrhosis – I might be able to get by with 12 weeks of therapy according to my gastroenterologist. However – there is no doubt that my health insurance provider would deny such retreatment (even at the reduced prices they pay for these drugs).
This leaves me a few options:
Deferral of treatment (watchful waiting).
Enrollment in Clinical Trials.
Medical Tourism. Have just begun to look into this seriously. Availability of sofosbuvir seems well documented. Simeprevir appears to be more difficult to obtain from my reading. Have done a search here but have not yet made any inquiries.
My hope is to acquire a 24 week supply of these medications in the near future. If need be – I can travel abroad. I do have some past understanding of the U.S. FDA/DEA/Customs regulations regarding importation (was trying to acquire Roche’s Pegasys before the FDA approved it here – different issues to be sure). Need to do some more reading on this I suppose.
Would appreciate any thoughts here in developing a plan.
Thanks in advance for your help – and for all the good work you folks are doing to make these life saving medicines available to those who suffer.