HCMSG - Hepatitis C Mentor & Support Group, Inc.
Search
  • About Us
    • Our Mission
    • Board of Directors
    • Medical Advisors
  • Resources
    • Corona Virus
    • Hep C Facts & Stats
    • Medications and Treatments >
      • Patient Assistance Programs
    • Reading
    • Links
  • Programs/Training
    • The Circle Model >
      • THE CIRCLE Registration
      • Group and Facilitator Guide
    • Hepatitis C Online Training
    • The Hepatitis C Education and Support Group Assistance Program
    • Healthcare Provider Training
  • Newsletter
  • Blog
  • Support Us
    • Holiday 2020
  • Contact Us

NEW HEPATITIS C DRUGS: DISAPPOINTMENT OR HOPE ??

2/8/2014

53 Comments

 
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:

  • 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
Here is a brief summary of Sovaldi. I’ve provided the Sovaldi Prescribing Information for those who want to read more.

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)
Cons

  • 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)
Sovaldi with ribavirin for the treatment of adults with genotypes 2 or 3

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
Treat or Wait  

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
Here is some information to help you make your decision. In a small study, 60 participants received sofosbuvir and ribavirin for 24 weeks. The highest response rate was 68%. The most common side effects were headache, anemia, fatigue, and nausea. (Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients with Unfavorable Treatment Characteristics: A Randomized Clinical Trial – A. Osinusi, et al. JAMA August 2013)   

 

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


 

 

53 Comments
Friv link
2/13/2014 11:24:41 am

It is an important topic, and will need more time to analyze

Reply
machines a sous link
10/17/2014 07:55:06 pm

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.

Reply
Kizi link
2/13/2014 11:26:15 am

I hope to learn from much more from your site, thanks for the article

Reply
wwe games link
7/6/2014 03:23:21 am

A study presented at the 2013 Liver Meeting showing that a virological cure for patients who had previously developed significant fibrosis

Reply
Friv Jogos Online link
5/23/2014 10:15:02 pm

Exelente articulo, gracias por la ayuda los seguire de cerca, saluidos..

Reply
Pou Games link
10/17/2014 07:54:29 pm

When clinical trial results showed high cure rates using interferon-free regimens, hepatitis C patients began to hope.

Reply
Kizi 12 link
5/28/2014 08:00:02 pm

Hi, The child is the greatest happiness for each of us, thank your story

Reply
friv link
5/28/2014 08:00:34 pm

Thanks, i have recently been searching for info about this topic for a while and yours is the greatest...

Reply
Kizi 8 link
5/30/2014 04:10:23 pm

Thank you so much for sharing

Reply
Kizi 1000 link
5/30/2014 04:11:14 pm

Excellent Blog!

Reply
Friv 1000 link
5/30/2014 04:11:56 pm

Excellent Blog! I would like to thank for the efforts you have made in writing this post.

Reply
Friv link
6/11/2014 11:22:01 am

I will share with you their references. Many thanks.

Reply
pou games link
9/20/2014 05:04:10 am

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.

Reply
Friv 3 link
6/11/2014 11:22:36 am

Many thanks for sharing this,

Reply
Kizi 9 link
6/11/2014 11:23:09 am

I am delighted to be a visitant of this website!

Reply
Jogos Friv link
6/18/2014 11:54:02 pm

Excelente el articulo, gracias x compartir, os dejo mi web de jogos de friv, saludos..

Reply
Friv 10 link
6/30/2014 03:39:52 pm

i like it.Thank you so much for sharing

Reply
mr bean games link
7/6/2014 03:22:08 am

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.

Reply
Didi games link
7/18/2014 10:52:20 am

I would like to thank for the efforts you have made in writing this post.

Reply
friv 2 link
7/28/2014 05:39:07 am

I enjoyed your post. I think emotions play a massive part in building inspiring and effective teams and I recently blogged on the secret sauce of team work. Rather than repeat it here I thought I'd post the link and I'd be very interested in your thoughts.

Reply
friv 1000 link
7/28/2014 05:39:42 am

I hope you never stop to convey information that is very attractive to his readers , because we will always be waiting for information like this very quality

Reply
Yepi link
8/15/2014 01:46:28 pm

Rather than repeat it here I thought I'd post the link and I'd be very interested in your thoughts.

Reply
girlsgogames link
8/20/2014 07:05:18 pm

i have recently been searching for info about this topic for a while and yours is the greatest...thank you

Reply
Kizi link
8/27/2014 11:47:39 pm

good post . thank for sharing

Reply
Huz link
8/28/2014 12:28:07 am

I hope all good things will come to those patients get the right medicine sick. good luck

Reply
kizi games link
9/1/2014 12:24:49 am

I liked your article because it contains a lot of useful information. thank you

Reply
y9 link
9/7/2014 05:01:11 pm

I love to read this type of material Good and attractive information I take from it..Thank you for posting such a good article.

Reply
Y2 link
9/10/2014 05:06:32 pm

thanks for share, i like it today

Reply
Friv link
9/20/2014 10:27:23 am

I agree that it is very interesting and helpful, thanks

Reply
yepi online link
10/21/2014 05:57:52 pm

The article you have shared here very awesome. I really like and appreciated your work. I read deeply your article, the points you have mentioned in this article are useful. I must try to follow these points and also share others.

Reply
friv 2 link
12/25/2014 06:43:57 am

Excellent with useful information, I would expect the same good information

Reply
friv link
1/25/2015 01:11:50 am

Posts with more useful information, I like them. Thank you

Reply
juegos de autos gratis link
2/24/2015 04:20:38 pm

Hopefully soon have drugs

Reply
Friv 100 link
4/20/2015 09:41:39 am

Thanks for the best blog.<a href="http://www.friv20games.net/" title="Friv 2">Friv 2</a>.it was very useful for me.keep sharing such ideas in the future as well.<a href="http://www.friv4com.com/" title="Friv 4">Friv 4</a>.this was actually what i was looking for,and i am glad to came here!

Reply
Friv link
5/19/2015 12:36:43 pm

What a wonderfull post! thank you... read with pleasure!
http://www.friv100gamesxl.com/

Reply
Yepi 12 link
6/3/2015 02:53:53 am

Do not know what to say, I liked your article and I hope you will have many entries or more.

Reply
Friv4school link
6/8/2015 08:48:39 am

I am fulfilled to find this post very useful for me, as it contains lot of information. I always want to research the amazing content and this factor I found in you post.

Reply
Friv 45 link
8/17/2015 08:55:36 pm

Thank you for sharing information.

Reply
Kizi link
8/24/2015 12:16:08 pm

yes. Your article is very good. this is a new and user-friendly information. Your article is very useful to me. Thanks for the article.

Reply
Play Tennis Games link
9/14/2015 01:59:34 am

The Food and Drug Administration (FDA) approved the newest hepatitis C drug was really great news.

Reply
dora link
9/15/2015 08:14:58 am

Your information is good and friendly. Your article is very useful to me. Thank you for allowing me is on this blog. you are the winner, regularly update new information of you.

Reply
G9G link
3/8/2016 08:31:44 pm

Very good. Thank so much.

Reply
G9G link
3/8/2016 08:32:54 pm

I just wanted to say thank you for sharing a great information and useful. it really necessary and timely for me at this time. I've read a lot of blogs and visit but they made me feel boring. Your article made me feel strange and fascinating it attracted me. I wanted to share this information with my friends on the social network facebook.

Reply
G9G link
3/8/2016 09:24:57 pm

Very good. Thank so much.!

Reply
Kizi link
3/25/2016 03:08:42 am

Thank you so much! Really rich content and very useful information

Reply
kizi link
8/26/2016 06:41:05 pm

Thanks so much! I like this!

Reply
zoxy link
12/4/2016 11:09:15 pm

Thank you so much! Really rich content and very useful information

Reply
facebooklite.com.br link
9/26/2017 08:46:13 pm


I was very impressed by this post, this site has always been pleasant news. Thank you very much for such an interesting post. Keep working, great job!

Reply
www.happywheelsy8.com link
10/25/2017 09:12:44 pm

I understand what you bring it very meaningful and useful, thanks.

Reply
b612az.com link
1/8/2018 12:25:07 am

Alot of blogs I see these days don't really provide anything that I'm interested in, but I'm most definately interested in this one. Just thought that I would post and let you know. Nice! thank you so much! Thank you for sharing.

Reply
potaca link
1/12/2018 07:59:10 pm

Thanks for sharing the information. It is very useful for my future. keep sharing

Reply
http://pocatravel.com link
1/26/2018 12:04:26 am

I have read your article, the information you give is very interesting.

Reply
minecraft2.com.br link
2/4/2018 07:11:53 pm

I like your all post. You have done really good work. Thank you for the information you provide, it helped me a lot. I hope to have many more entries or so from you.
Very interesting blog.

Reply

Your comment will be posted after it is approved.


Leave a Reply.

    Archives

    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    February 2020
    January 2020
    December 2019
    November 2019
    October 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    July 2018
    June 2018
    May 2018
    April 2018
    March 2018
    February 2018
    January 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    July 2017
    June 2017
    May 2017
    April 2017
    March 2017
    February 2017
    January 2017
    December 2016
    November 2016
    October 2016
    September 2016
    August 2016
    July 2016
    June 2016
    May 2016
    April 2016
    March 2016
    February 2016
    January 2016
    December 2015
    November 2015
    October 2015
    September 2015
    August 2015
    July 2015
    June 2015
    May 2015
    April 2015
    March 2015
    February 2015
    January 2015
    December 2014
    November 2014
    October 2014
    September 2014
    August 2014
    July 2014
    June 2014
    May 2014
    April 2014
    March 2014
    February 2014
    January 2014
    December 2013
    November 2013
    October 2013
    September 2013
    August 2013
    July 2013
    June 2013
    May 2013
    April 2013
    March 2013
    February 2013
    January 2013
    December 2012
    November 2012
    October 2012
    September 2012
    August 2012
    July 2012
    June 2012
    May 2012
    April 2012
    March 2012
    February 2012
    January 2012
    December 2011
    November 2011
    October 2011
    September 2011
    August 2011
    July 2011
    June 2011
    May 2011

    Categories

    All

    RSS Feed

Privacy Policy