Looking back at 2014, the hepatitis C community had much to celebrate. The year had already begun on a high note with the approval of Olysio and Sovaldi in late 2013; however, even better hepatitis C treatments followed. The FDA approved three treatment regimens: Harvoni (sofosbuvir/ledipasvir), Viekira Pak (ombitasvir, paritaprevir and dasabuvir, along with the previously approved drug, ritonavir), and Olysio/Sovaldi (simeprevir/sofosbuvir). Life was looking up for hepatitis C patients.
Harvoni’s approval was the high point. A single-daily pill, taken for as little as eight weeks (although more often twelve) could cure hepatitis C. The side effects were mild, and the cure rates were high. It meant no more interferon or ribavirin for genotype 1 patients, formerly the hardest to treat. Amazing.
However, this good news was derailed by some shameful practices. The price of Harvoni is exorbitant, and state Medicaid plans and private insurers severely restricted access to this drug. Patients, who had been waiting for treatment for years, sometimes decades, were denied treatment because they did not have at least stage 3 fibrosis. Still worse were the plans that only approved treatment for those with cirrhosis. Some people were denied Harvoni although they had gone through previous interferon-based treatments, including horrific triple therapy with first generation HCV protease inhibitors.
The shameful practices and lousy hepatitis C news doesn’t stop here. There is more. Here is my wall of shame, beginning with the worst:
- Michigan State Senator Roger Kahn and the Michigan Senate – Despite the fact that Senator Kahn is a physician, he introduced a bill that would make it a felony to not tell a sexual partner if you were hepatitis C-positive. It passed the Michigan Senate. In my opinion, Senator Kahn has nursed more unfounded fear about hepatitis C and increased the stigma.
- Every insurance company and state Medicaid plan that has denied treatment to hepatitis C patients because their liver disease hasn’t progressed far enough. I don’t see you holding off treating diabetics until they have lost a few toes or their eyesight, or is that down the road? I get that you need to save money. However, I think you are targeting hepatitis C because it is associated with drug use.
- Every insurance company and state Medicaid plan that requires patients to prove they are clean and sober for six months. This is wrong. It is discriminatory. Patients who have cancer aren’t denied treatment unless they can prove they are clean and sober.
- Express Scripts – You aren’t going to offer Harvoni on your formulary. Seriously? What happens to those with genotype 1a and everyone with cirrhosis who can’t take ribavirin? Do you know how awful ribavirin is? Do you think it is acceptable to force patients to endure anemia, rage, insomnia, anxiety, and so on, so you can save money? Then there is the issue of pregnancy. Is it worth risking fetal death by denying Harvoni? I do appreciate the fact that you are offering treatment to people at all stages of fibrosis (except decompensated cirrhosis), but Viekira Pak isn’t comparable to Harvoni unless you have genotype 1b without cirrhosis.
- Gilead Sciences – You began this mess with your pricing strategy. I want you to succeed; you deserve to succeed. But, did you think about what this would do to patients? Granted, you have been incredibly generous with your patient assistance plans and co-pay program, but that won’t help all the Express Script patients who can’t get your drug.
- Maine Governor Paul LePage who said, “I have been trying to get the president to pay attention to the illegals in our country because there’s been a spike in hepatitis C, tuberculosis and HIV, but it’s going on deaf ears.”
- Every legal official who arrested anyone with hepatitis C for spitting on him or her, along with every news source who reported these stories.
Honorable Mention goes to the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) – The justification for denying treatment came from your HCV Guidelines. You did try to set the record straight, but the horse was already out of the barn. I respect you, and I appreciate you trying to mend the problem, but we need a more powerful voice than this. Please step up and lead us through this crisis.
When any of these entities take action to offer more to the hepatitis C community, I will remove their names from this wall. Let’s bring the wall down in 2015!