Letter to the Editor and Response

Article taken from pages 10-11 of September/October Newsletter 2016

Letter by Alice Fox

Response by Adrianne Fugh-Berman and Charlea Massion

Dear Editor,

I am writing as a health care provider, a public health professional and a patient who has been treated (on four separate occasions over decades) for chronic Hepatitis C infection. Drs. Fugh-Berman and Massion are incorrect in conflating the very real and inequitable profit motives of the drug industry with the effectiveness of the newer treatments for Hepatitis C. These are two distinct issues and, while anger over the cost of the newer drugs is valid, putting forth opinions about the newer combination treatments with antiviral therapies, without properly referencing the latest study results is not responsible. Statements about the lack of effectiveness of the newer drugs are not supported by current research, and commenting that the previous response rates of 40-80% is “a good success rate!” is just no longer true.

A number of studies presented at the 66th Annual Meeting of the American Association for the Study of Liver Diseases in Boston Nov 13-17, 2015, demonstrate a sustained clearing of the virus with all newer combination antiviral treatments, averaging above 95%.  Anyone would choose those chances for a cure. These are new treatments for sure and only time will reveal long-term results, which may be a reason for some to wait to treat their disease, but this is an individual choice for a woman to make.

Older treatments for Hepatitis C generally included interferon, which had to be injected, required treatment for up to 11 months, and had significantly more toxicity. My own experience with interferon-based regimens (3 separate treatment protocols) was very challenging, requiring transfusions, medical leave from work for 3 months and major infections.  In each case, the drugs didn’t work; the virus returned within one month of completing treatment.

The last treatment I undertook was 2 years ago with a simple combination of simeprevir and sofosbuvir (Sovaldi), two pills per day for 3 months. The treatment was rapidly successful and with virtually no side effects. I remain, thankfully, free of virus.

The question is: what are women to take away from this article? How is this information helpful? Should a woman decide not to treat her disease because the drug companies are making money from promoting these newer treatments? Should she choose not to treat, hoping her disease will clear on its own, or at least not go on to cause cirrhosis or liver cancer?

It is important in reporting about current scientific and clinical research to advocate for women by providing accurate information and thoughtfulness about treatments, and not to allow a political perspective to obscure recognition of the very significant scientific and clinical progress in the treatment of Hepatitis C infection.

Alice Fox, DrPH, PA-C

NYC, NY

Rx for Change Response

Dr. Fox mischaracterizes our article. We never said Sovaldi and other new hepatitis drugs were ineffective; we said they are too expensive, are not the only treatment, and should not be called a cure when long-term relapse rates are unknown. Short-term studies can’t detect long-term results, a fact that Dr. Fox does not dispute.

Prescribing stunningly expensive drugs to every person with Hepatitis  C certainly benefits drug manufacturers. However, it’s societally and medically irresponsible to waste public health dollars by providing an $84,000 treatment to every patient with Hepatitis C when a quarter of patients will clear the virus entirely on their own, and many others won’t have any ill effects from the virus. Sovaldi and its relatives will bankrupt the healthcare system; it would be less expensive to provide liver transplants to those who needed it rather than provide Sovaldi to all Hepatitis C patients. Sure, interferon treatments are inconvenient and have a lot of side effects, but an 80% response rate is an excellent response rate for any drug.

Unfortunately, studies presented at meetings are not reliable sources of evidence, especially if they are industry-funded. Also, industry regularly releases preliminary results of studies they like at abstract and poster sessions at meetings – these studies are often incomplete, selectively reported, non-peer-reviewed, unpublished and thus unreliable.

In any case, short-term studies showing relapse rates of less than five percent can’t tell us what long-term relapse rates are  if participants weren’t followed long term We know that Hepatitis C virions remain in the hepatocytes of at least some patients after Solvaldi treatments, so we know there will be recurrences — we just don’t know what the percentages are yet.

Drug company-funded studies — and commentaries, reviews, letters, etc. — are not a “problem in theory;” they are a problem, period. Industry-funded studies are more likely to find positive results and suppress negative results. Our article was not a clinical guideline but a commentary raising questions that deserve discussion. It bears noting that Dr. Fox has identified no inaccuracies in our article. We stand by what we said.