—Alan Franciscus, Editor-in-Chief
2014 was by far the most incredible year in hepatitis C (HCV) treatment advances, but there was a lot of bad news about treatment access. However, first let’s concentrate on the good news – all oral therapies approved to treat hepatitis C.
We started the year with the combination of Sovaldi (sofosbuvir), pegylated interferon and ribavirin that had been approved in 2013 to treat genotypes 1 and 4. The combination of Sovaldi (sofosbuvir) and ribavirin had also been approved to treat genotypes 2 and 3. The combination of Sovaldi and Olysio (simeprevir) with and without ribavirin was used off-label and later in the year was approved by the Food and Drug Administration (FDA) to treat hepatitis C genotype 1.
THE GOOD: On October 10, 2014 the FDA approved the first interferon- and ribavirin-free treatment for genotype 1—Harvoni (sofosbuvir/ledipasvir). Harvoni combines both drugs into a pill taken once daily. The majority of patients are treated for 12 weeks, patients with minimal disease are treated for 8 weeks, and patients with more severe disease can be treated for 24 weeks.
On December 19, 2014 the FDA approved the second all oral HCV treatment—AbbVie’s 3D combination, now called VIEKIRA PAK, to treat HCV genotype 1. In the “Pak” are three drugs: ombitasvir, paritaprevir, and dasabuvir. The “PAK” also includes another drug, ritonavir, that helps to increase the blood levels of paritaprevir. VIEKIRA PAK is taken with and without ribavirin. The treatment duration is 12 to 24 weeks. The cost of VIEKIRA PAK is $83,319 for a 12-week course of treatment.
These are truly miraculous drugs that in clinical trials have cured 90 – 100% of the patients treated. The high cure rates in clinical trials are being replicated in ‘real world’ settings—that is, patients in regular practice are achieving similar cure rates. The new all oral drugs work for people who have minimal disease, severe disease, pre- and post-transplant—in other words everyone with HCV. This is truly spectacular!
The price of Sovaldi and Harvoni has been a lightning rod in the news. The price is one piece of the puzzle because if you looked at the historical pricing of HCV treatment, Harvoni is actually about 10K to 20K higher (the duration of therapy is shorter), but the side effects are minimal. Why the uproar? Because insurance companies and government payers believe that there are thousands of patients waiting for these therapies. This is the reason, they think, that it will cripple Medicaid/Medicare. It has also been suggested that the price of the all oral therapies could increase insurance premiums for everyone including those without HCV.
THE HOPE: AbbVie’s recently approved combo is coming in lower than Gilead’s. Express Scripts announced a deep discount deal with AbbVie that will bring the drugs to more patients. More deals = more patients treated.
Personally, the best news I’ve heard all year was from people who have told me that they had been approved for the treatment. I heard it from people who had been approved by their insurance carrier. Approved by Medicaid. Approved by Medicare. Approved by pharmaceutical compassionate care programs. I also heard from many people who were treated and cured. I heard from people who had been waiting for these treatments for many years who were treated and cured. But I also heard from people who had not been approved—they fought back, got the medications and were treated and cured. Of course there were many people who I heard from who were denied. They had never heard of the patient assistance programs. Some I heard back from and some I didn’t hear back from. Some got approved, some gave up. I just hope that the ones who fought back got approved. The message: Fight back—you have nothing to lose!
THE BAD: Who loses in the battle between pharmaceuticals and insurers/government? It is always the people with hepatitis C who can’t get treated with these life-saving drugs. If there was a ‘Shame Award’ it would be awarded to these groups that are withholding these drugs from patients.
For those who are cured, and want to leave all memory of HCV behind, think about one last gift of advocacy: Help one person before you leave.
HCV WORLDWIDE: The interferon-free therapies are being approved in other countries around the world. Gilead has made sofosbuvir available in Egypt for a much lower cost. Gilead has also reached an agreement with India to produce it at a much lower cost. Daklinza (daclatasvir) in combination with sofosbuvir, peginterferon, and ribavirin is approved by the Committee for Medicinal Products for Human Use (CHMP) in the European Union. CHMP has recommended the approval of Harvoni and Viekirax (VIEKIRA PAK in the US). Canada has approved both Harvoni and HOLKIRA PAK (VIEKIRA PAK in the US). Japan approved the dual therapy of Daklinza plus Sunpreva (asunaprevir) to treat genotype 1. Unfortunately, insurance companies and governments have been restricting access to the new medications around the world, not only in the U.S.
In 2014, we launched a new series of fact sheets ‘HCV Around the World’ to shine light on the issues of hepatitis C in other countries. We would love to hear from others around the world about their struggles and victories.
THE IGNORED: The HCV epidemic among people who inject drugs continues to spread throughout the United States especially among people in their 20’s. There have been reports of outbreaks in Kentucky, Vermont, California, Minnesota, and Wisconsin. This is occurring in rural, suburban and urban areas. However, make no mistake this is an issue all over the country, but it is not being tracked efficiently nor is it being addressed.
THE DEPLORABLE: There is always one large outbreak of HCV due to unsafe infection control practices. This year the outbreak was in a very vulnerable population—the elderly—at a nursing home, Manor Care, in Minot, North Dakota. So far, 51 cases have been identified. The source of the infections is unknown.
I would like to end the article on a good note, saying thanks to all of our readers for their kind words. In spite of all the bad news I am optimistic that we will be able to cure everyone of hepatitis C, especially now that we have these amazing drugs; we just need to get these and the ones that are coming down the pipeline to everyone who needs and deserves them.
So BA-BAM!!! We now have two all oral therapies to treat HCV. What a year it was! And we are well on our way.
On behalf of the staff of the Hepatitis C Support Project and HCV Advocate, I would like to wish you and your loved ones a happy and healthy 2015! Alan
http://hcvadvocate.org/news/newsLetter/2015/advocate0115.html#1
