NVHR Director Speaks at FDA Hepatitis C Drug Hearing

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Public Comment: Good afternoon. My name is Martha Saly. I am the director of the National Viral Hepatitis Roundtable (NVHR), a coalition of more than 175 public and private organizations, from patient groups to medical associations, government agencies and pharmaceutical companies, dedicated to reducing the infection, morbidity and mortality from viral hepatitis in the United States.

Although NVHR’s members have been eagerly anticipating the approval of this new class of hepatitis C drugs, I am here today to speak personally as a former hepatitis C patient and as an advocate for people who have not been as fortunate as I.

It strikes me a little funny to be able to say I was treated for hepatitis C in the last century. But when I think about what a long road it has been for many of my aging baby boomer friends who are still suffering from hepatitis C, it seems totally appropriate to say it this way. I was diagnosed in late 1998. At that time there was much anticipation of pegylated interferon, but my doctors decided that I could not wait for that, so I embarked on the 48 week journey of three times weekly shots. I was told I had about a 30% chance of a sustained response – the word cure wasn’t even being used at that time – and I decided to chance it. Had I not, I have no doubt that I would be dead or on a transplant list today. As I said, I was fortunate; some would say much more than fortunate. Against the odds, I was cured. I am here today because I believe that something quite historic is happening in this room and I want to be a part of it.

For more than 10 years, I have dedicated my personal and professional life to addressing this silent epidemic. In this role, I have spoken with too many patients to count who are ill, afraid, unable to access the care they need, who were failed by earlier treatments and are waiting for something that will give them better odds. Some just want to tell me that my story inspired them to be able to take the next step. I tell these patients that treatment is not easy and that it is a personal choice, but one that might save their lives. It is for these patients that this day is of paramount importance, because for the first time I can actually tell them, although treatment may still be extremely challenging, hope for a cure should outweigh their fear that the treatment will fail them.

Yes, I believe that approval of these drugs will be the biggest thing that has happened in the years I have been doing this work, and certainly what many patients have been anxiously awaiting; However, it still concerns me that treatment will continue to be a difficult and challenging ordeal. I am hopeful that a shortened course of treatment for many patients will equate with a greater ability to tolerate the drugs and manage the side effects, but I fear that the issue of compliance with strict medication regimens might affect treatment success. And these drugs will help few if awareness of the hepatitis C epidemic is not increased, and if awareness does not go hand in hand with improved screening and affordable access to care for the people who need it. I have every hope that both Merck and Vertex will employ their considerable resources to address these concerns. Thank you.

Martha Saly