The era of using pegylated interferon (PEG-IFN) and ribavirin to treat hepatitis C virus (HCV) is OVER! Or it could be ...
Those two drugs take 48 weeks to work, cost a lot, are replete with horrific and sometimes permanent side effects and are at best only marginally effective.
But in the past two weeks, the U.S. Food and Drug Administration (FDA) has approved two new drugs, simeprevir (brand name: Olysio, from Janssen) and sofosbuvir (brand name: Sovaldi, from Gilead). While the specific indications are not necessarily for these two drugs to be used together, the COSMOS study has shown that they can result in "cure" (sustained viral response) in 12 weeks of treatment in over 90 percent of patients.
These two can be combined and prescribed off label. But the bad news is: Who will cover them? Simeprevir is coming in at $66,000 for a 12-week course and sofosbuvir at around $90,000 -- for what amounts to a total of maybe $300-400 worth of drugs.
So, even though I just signed up for the Affordable Care Act, I probably won't get these drugs. Nor will most of the 150 million (or more) of us living with HCV. What these companies are doing is beyond outrageous. Add in the effects of the Trans-Pacific Partnership, if that piece of evil is passed, and you guarantee most of us will never see these drugs.
While we know other drugs from other companies are fast coming down the pike, the history is not good. When the first drugs come in at a certain price, all the other companies follow along and never significantly rock the boat (which some could argue is a form of price fixing). And there is NO rational reason for these prices (by all means, get and read Bad Pharma by Ben Goldacre).
The story starts unpleasantly enough. When studies showed Gilead's drug sofosbuvir plus a Bristol-Myers Squibb (BMS) drug, daclatasvir, cured 100 percent of genotype-1 HCV-infected individuals, instead of seeking larger, better studies, Gilead STOPPED further study to corner the market with its version of daclatasvir (which doesn't work as well).
Worse, Gilead did NOT do any of the research. It simply BOUGHT the owner/developer of sofosbuvir, Pharmasset, for $11 billion -- a company with only four drugs in its portfolio, one of which is already abandoned, while the other two are not being developed. So, Gilead basically bought ONE drug for $11 billion ... when it costs (they claim) $1 billion to bring a drug to market (it's much less, actually; that's just another pharma exaggeration).
These companies do this KNOWING the vast majority cannot afford it. They do it KNOWING that many states will not be able to sustain the rape of so many HCV patients being on Medicaid. They KNOW they will cause enormous suffering and more death around the world due to their outrageous greed. This is something I refer to as nothing short of economic genocide.
With the announcement of the FDA approval of sofosbuvir (and the laughable litany of lies from Gilead about how it'll work to get the drug to all who need it) and the previous approval of simeprevir, the era of PEG-IFN/ribavirin is over. These nasty drugs can be thrown in the trash heap (or, more politely, reserved as an extreme last resort).
There are options we can consider:
- We can demand more trials of combinations like sofosbuvir and simeprevir or daclatasvir from the NIH (National Institutes of Health), either through petitioning Griffin Rodgers at NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) or Tony Fauci at NIAID (National Institute of Allergy and Infectious Diseases), for example, among HIV/HCV coinfected individuals. There are no doubt a litany of studies that should be undertaken.
- Generics should be made immediately. Any price over $500 for the two drugs for a course of treatment is an obscenity. People with HCV in middle-income countries will be murdered. In the United States, state Medicaid and other formularies may simply refuse to permit people to use sofosbuvir if the cost per patient is approaching $90,000. It will take only ONE state to say NO to Gilead and seek to import the generics.
These are not complicated or unusual molecules nor difficult to manufacture. And indeed, there is some evidence that sofosbuvir is not even legitimately patented.
The usual polite efforts to get companies to be sane about drug pricing have failed horribly. We have to up our game if we are to break the chains of bondage that place our lives in jeopardy. The era of interferon for HCV will only end if we end this long, cruel era of greed and economic genocide. These companies will no longer listen to reason -- but they do not have the right to destroy our lives in the service of their avarice.
George M. Carter is a founder and director of the Foundation for Integrative AIDS Research (FIAR), and is the treatment information director and administrator of the New York Buyers' Club, the last U.S. buyers' club. He has been living without health insurance for most of his adult life and with hepatitis C since the early '80s.