The Eagle has landed. The magic bullet has been fired. The cure for hepatitis C, genotype 1, the most difficult to cure, has at last arrived, and wow, it is expensive. The new drug, Harvoni, from Gilead Sciences costs $96,000 for 12 weeks of therapy, or around $1,100 a pill. (Don’t try and swallow this pill near the sink!) The price is less for those without treatment experience and without cirrhosis: about $65,000 for just 8 weeks of therapy. Why so expensive? Most pharma companies with new and costly drugs cite billions in R&D costs that must be recouped. Not so in this case. NPR interviewed Greg Alton, a Gilead executive. According to Alton, “We didn’t really say ‘We want to charge $1,000 a pill.’ We’re just looking at what we think was a fair price for the value we’re bringing into the health care system and to the patient.” In other words, what the market will bear – but don’t panic yet – Gilead Sciences, has a compassionate side. Their Harvoni website, mysupportpath.com, guides the consumer through the maze of acquiring this life-saving drug. For qualified candidates, they offer co-pay assistance, and zero-cost solutions for folks who meet financial and clinical requirements. This means great hope for those of us who failed the grueling 48-week regimen of the evil interferon and its bastard companion, ribavirin. I made four futile attempts with these awful drugs, and finally beat the virus with a combination of Sovaldi (a component of Harvoni) and Olysio – at least for now. I have one more viral load test in March to make certain I haven’t relapsed. If I do relapse, Harvoni awaits.
Harvoni is a combination of two drugs in one pill: Sovaldi and Ledipasvir. One drug stops the virus from replicating. The other mops up sub-microscopic fragments – replicons – that contain information for rebuilding the virus – like the war against the Cylons in Battlestar Galactica. Speed is Harvoni’s main weapon. One of the biggest problems with HCV is rapid mutation, which results in resistant virions that quickly overwhelm any possible cure. This is called viral kinetics. Harvoni kills fast – most patients are clear by week 4 of therapy.
When my dear friend, Sue Simon, over at the Hepatitis C Association, asked me if I’d ever heard of Harvoni, I thought it was some Italian cuisine. You know: Harvoni marinara, Harvoni with clam sauce – I mean really – someone should lead the charge to change the name of this drug: maybe Killavir, or Hepadeadavir. As benign as it sounds, Harvoni is serious medicine, curing about 96% of the geno-1 population, with hardly any side effects. With interferon, I had to worry about growing extra limbs and the effects of what we used to call Riba-rage – the propensity to growl and threaten to bite people in the grocery line.
The dispensing of Harvoni is not without policy issues. Already, because of its cost, some insurances are delaying approval of Harvoni until advanced disease sets in. This seems dumfoundingly counter-intuitive to me. Harvoni is clearly meant to be a first-line drug – not a last resort. While waiting for Harvoni, a patient may develop all kinds of secondary problems: insulin resistance, non-hereditary hemochromatosis, and porphyrias (a group of blistering diseases).
There are ethical considerations as well. For the first time ever, we’re seeing a drug that not only cures hepC, but also improves histology – liver health – something once believed impossible. I experienced this myself. Within three months after my transplant, the virus had damaged my new liver all the way to stage 3 – I was already in real trouble. Treatment with Sovaldi was an emergency for me. By the time I finished treatment, I was back at stage 0 – no perceivable damage. Now, this doesn’t mean that a person awaiting transplant will experience that kind of improvement, but the drug is known to lower MELD score, possibly just enough to remove a patient from the transplant list, creating a potentially dangerous situation, because the patient probably still needs the transplant anyway, and the improvement may not be enough to affect quality of life. In other words, you’re free of the virus, but still very sick – not an acceptable outcome. Treatment with interferon meant a single standard-of-care, but the bioethics of Harvoni are all over the place. This may change over time.
A solution is surely on its way: curing hepC is a highly competitive market. As more drugs like this become available, prices will drop, and availability will increase. Who knows? Maybe someday, hepC drugs will be available over-the-counter, maybe in a display next to the Dr. Scholl’s gel inserts. We could waltz into the drug store with coupon in hand: $10 off any purchase of Hepadeadavir.