HEALTHWISE: New Hepatitis C Drugs: Disappointment or Hope? —Lucinda K. Porter, RN
Last month the Food and Drug Administration (FDA) approved the newest hepatitis C drug. Sovaldi (sofosbuvir) is the first polymerase inhibitor approved for hepatitis C treatment.
Sovaldi combined with ribavirin became the first interferon-free hepatitis C treatment, but the all-oral application is for those with genotypes 2 or 3, and special cases. I’ll say more about that later. Sovaldi with peginterferon and ribavirin was approved for patients with genotypes 1 and 4.
After the FDA announced the approval, messages from upset patients arrived. “@*#! I have genotype 1 (or 4). I thought the FDA was going to approve all-oral treatments.” Tweets and facebook posts expressed similar sentiments. One patient asked if the FDA had just signed his death warrant.
I understand this reaction. For more than 15 years, interferon was the basis of hepatitis C treatment. The drugs improved in that more people were cured, but this cure had a high price with even more side effects. Some patients couldn’t or wouldn’t take interferon, or ribavirin for that matter. Patients had to make a risky choice—hope they didn’t progress to cirrhosis or endure a potentially grueling treatment that might not even work. Both are lousy options.
When clinical trial results showed high cure rates using interferon-free regimens, hepatitis C patients began to hope. The big question was—would these drugs be here soon enough? Well, one of the drugs is here, sort of. Let’s review who Sovaldi can technically be prescribed for, if one’s medical provider stuck to the label.
Sovaldi in combination with ribavirin and/or peginterferon can be prescribed to nearly everyone with hepatitis C. It doesn’t matter if you are new to treatment or a prior treatment failed to work for you. The only restrictions are the usual one, such as children, nursing mothers, pregnant women, and men with pregnant partners. Also, there are the usual warnings about ribavirin and pegylated interferon. However, the FDA opened the door for all-oral treatment for genotype 1 patients who are “interferon ineligible.”
Other special populations for whom Sovaldi may be used:
Sovaldi in combination with peginterferon and ribavirin for adults with genotype 1 or 4
Pros
Pros
Cons
Despite this progress, genotype 1 patients are still saddled with big decisions. Should they:
As for off-label use of Sovaldi and Olysio, results of a small study (COSMOS) showed excellent preliminary results. Patients with advanced liver fibrosis or cirrhosis had 96% to 100% SVR4 rates after 12 weeks of simeprevir and sofosbuvir with or without ribavirin. Note that SVR4 rates are not as meaningful as SVR12 or SVR24. The most frequent complaints were fatigue, headache, nausea and insomnia.
The sticky problems of using off-label hepatitis C drugs are: a) finding a provider who will prescribe the two, and b) getting insurance to cover it. Twelve weeks of Olysio and Sovaldi would cost more than $150,000. Insurance companies will likely want solid evidence about this treatment before forking over that kind of money. SVR12 data should be released in January.
If you are waiting, these words are for you
I am deeply concerned that patients are delaying hepatitis C treatment too long. A study presented at the 2013 Liver Meeting showing that a virological cure for patients who had previously developed significant fibrosis, could continue to be at risk for fibrosis/cirrhosis and liver cancer. In short, those that delay treatment may go through treatment, clear the virus, but still suffer some of the tragic consequences. (AASLD 2013: Long term survival of liver fibrosis after virological cure in patients with chronic hepatitis C: The avenue of the scars? by Thierry Poynard)
If you think you are immune to progressive liver disease because previous biopsies have been good, think again. Fibrosis often accelerates with age and duration of infection, and is not a linear progression. Additionally, those with hepatitis C have added risks of stroke, heart disease, diabetes, kidney problems, and cancer.
It’s a hard decision to make. Don’t let fear of side effects be the main reason for your delay. Although the current hepatitis C treatments are hard, they are doable. With support and good side effect management, twelve weeks will be over before you know it.
If you can’t or don’t want to take pegylated interferon and/or ribavirin, use this time to build your health. Commit to a plan of living the healthiest lifestyle you can. Aim to be physically active, maintain a normal weight, don’t smoke, wear your seat belts, floss your teeth, and laugh a lot.
I’ve seen far too many people die from hepatitis C, and I am sick over it. We are on the brink of changing the future for those affected by hepatitis C. Hope is here, but without action, hope is just hope.
Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com
Further Information:
Source: HCV Advocate Newsletter: January 2014
Last month the Food and Drug Administration (FDA) approved the newest hepatitis C drug. Sovaldi (sofosbuvir) is the first polymerase inhibitor approved for hepatitis C treatment.
Sovaldi combined with ribavirin became the first interferon-free hepatitis C treatment, but the all-oral application is for those with genotypes 2 or 3, and special cases. I’ll say more about that later. Sovaldi with peginterferon and ribavirin was approved for patients with genotypes 1 and 4.
After the FDA announced the approval, messages from upset patients arrived. “@*#! I have genotype 1 (or 4). I thought the FDA was going to approve all-oral treatments.” Tweets and facebook posts expressed similar sentiments. One patient asked if the FDA had just signed his death warrant.
I understand this reaction. For more than 15 years, interferon was the basis of hepatitis C treatment. The drugs improved in that more people were cured, but this cure had a high price with even more side effects. Some patients couldn’t or wouldn’t take interferon, or ribavirin for that matter. Patients had to make a risky choice—hope they didn’t progress to cirrhosis or endure a potentially grueling treatment that might not even work. Both are lousy options.
When clinical trial results showed high cure rates using interferon-free regimens, hepatitis C patients began to hope. The big question was—would these drugs be here soon enough? Well, one of the drugs is here, sort of. Let’s review who Sovaldi can technically be prescribed for, if one’s medical provider stuck to the label.
Sovaldi in combination with ribavirin and/or peginterferon can be prescribed to nearly everyone with hepatitis C. It doesn’t matter if you are new to treatment or a prior treatment failed to work for you. The only restrictions are the usual one, such as children, nursing mothers, pregnant women, and men with pregnant partners. Also, there are the usual warnings about ribavirin and pegylated interferon. However, the FDA opened the door for all-oral treatment for genotype 1 patients who are “interferon ineligible.”
Other special populations for whom Sovaldi may be used:
- Patients with hepatocellular carcinoma (liver cancer) who are waiting for a liver transplant (all-oral using Sovaldi and ribavirin/up to 48 weeks or until liver transplantation)
- Patients with cirrhosis (safety not established in patients with decompensated cirrhosis)
- HCV/HIV-1 co-infected patients
- Patients with renal impairment
- Adults age 65 and over
Sovaldi in combination with peginterferon and ribavirin for adults with genotype 1 or 4
Pros
- Short 12-week treatment duration, with limited exposure to peginterferon and ribavirin, which translates into an easier to tolerate side effect profile
- High cure rate at around 90% overall
- Genotype 1, 89%; genotype 4, 96%
- Cirrhosis 80%
- Hardest to treat (genotype 1, cirrhosis, IL28B non-C/C, high viral load) 71%
- Highest rate of response in Blacks 87% vs. Non-blacks at 91%
- Low drug-resistance profile
- Sovaldi is a once-a-day pill with no food requirements
- Fewer known drug interactions than other direct-acting antivirals (Incivek, Victrelis, and Olysio)
- Peginterferon and ribavirin side effects
- Cost ($84,000 for 12 weeks of treatment just for Sovaldi; pegylated interferon and ribavirin costs are additional)
- Too soon to know if insurance will cover it
- Treatment not approved for genotypes 5 or 6 yet (although the FDA didn’t approve this application, some providers may use it anyway)
Pros
- No peginterferon
- Short 12-week treatment duration for genotype 2, with limited exposure to ribavirin (24 weeks of treatment for genotype 3 patients)
- High cure rate at around 93-95% overall for genotype 2
- Cirrhosis 60-94%
- Improved cure rate at around 84% overall for genotype 3
- Cirrhosis 60-92%
- Easier to tolerate side effect profile
- Highest rate of response in Blacks 87% vs. Non-blacks at 91%
- Low drug-resistance profile
- Sovaldi is a once-a-day pill with no food requirements
- Fewer known drug interactions than other direct-acting antivirals (Incivek, Victrelis, and Olysio)
Cons
- Ribavirin side effects
- Cost ($84,000 for 12 weeks of treatment just for Sovaldi; ribavirin costs are additional)
- Too soon to know if insurance will cover it
Despite this progress, genotype 1 patients are still saddled with big decisions. Should they:
- Go with one of these new, shorter interferon-based treatments
- Ask their medical provider to prescribe Sovaldi and ribavirin without pegylated interferon
- Wait for all-oral, interferon-free hepatitis C treatments, which will likely be available in late 2014 or early 2015
- Wait until ribavirin-free regimens are available
- Discuss off-label options, such as combining Sovaldi and Olysio
- Look for a clinical trial
As for off-label use of Sovaldi and Olysio, results of a small study (COSMOS) showed excellent preliminary results. Patients with advanced liver fibrosis or cirrhosis had 96% to 100% SVR4 rates after 12 weeks of simeprevir and sofosbuvir with or without ribavirin. Note that SVR4 rates are not as meaningful as SVR12 or SVR24. The most frequent complaints were fatigue, headache, nausea and insomnia.
The sticky problems of using off-label hepatitis C drugs are: a) finding a provider who will prescribe the two, and b) getting insurance to cover it. Twelve weeks of Olysio and Sovaldi would cost more than $150,000. Insurance companies will likely want solid evidence about this treatment before forking over that kind of money. SVR12 data should be released in January.
If you are waiting, these words are for you
I am deeply concerned that patients are delaying hepatitis C treatment too long. A study presented at the 2013 Liver Meeting showing that a virological cure for patients who had previously developed significant fibrosis, could continue to be at risk for fibrosis/cirrhosis and liver cancer. In short, those that delay treatment may go through treatment, clear the virus, but still suffer some of the tragic consequences. (AASLD 2013: Long term survival of liver fibrosis after virological cure in patients with chronic hepatitis C: The avenue of the scars? by Thierry Poynard)
If you think you are immune to progressive liver disease because previous biopsies have been good, think again. Fibrosis often accelerates with age and duration of infection, and is not a linear progression. Additionally, those with hepatitis C have added risks of stroke, heart disease, diabetes, kidney problems, and cancer.
It’s a hard decision to make. Don’t let fear of side effects be the main reason for your delay. Although the current hepatitis C treatments are hard, they are doable. With support and good side effect management, twelve weeks will be over before you know it.
If you can’t or don’t want to take pegylated interferon and/or ribavirin, use this time to build your health. Commit to a plan of living the healthiest lifestyle you can. Aim to be physically active, maintain a normal weight, don’t smoke, wear your seat belts, floss your teeth, and laugh a lot.
I’ve seen far too many people die from hepatitis C, and I am sick over it. We are on the brink of changing the future for those affected by hepatitis C. Hope is here, but without action, hope is just hope.
Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com
Further Information:
- HCV Advocate News and Pipeline Blog (includes links to clinical trials)
- A Guide to Hepatitis C: Making Treatment Decisions
- A Guide to Hepatitis C: Preparing for Treatment
- How to Evaluate a Clinical Trial
- Making Sense of Hepatitis C: Research and Medical Literature
Source: HCV Advocate Newsletter: January 2014
RSS Feed