December 6, 2013
FDA OKs Major New Hepatitis C Drug, Sovaldi (Sofosbuvir)
The U.S. Food and Drug Administration has approved Gilead Sciences’ hotly anticipated Sovaldi (sofosbuvir), a once-daily oral nucleotide analog polymerase inhibitor to treat people with hepatitis C virus (HCV), including those coinfected with HIV and those who have liver cancer and are awaiting a transplant. For those with genotypes 2 and 3 of the virus, Sovaldi offers the first-ever opportunity for treatment with an interferon-free drug regimen. Those with genotypes 1 and 4, however, will in most cases still require the injectable interferon, which causes flu-like side effects.
Sovaldi must be taken in combination with ribavirin regardless of genotype. The recommended treatment duration is 12 weeks for genotypes 1, 2 and 4, and 24 weeks for genotype 3.
Gilead also states that those with genotype 1 who are ineligible to take interferon "can be considered" to receive Sovaldi and ribavirin for 24 weeks of treatment. Also, for those awaiting a liver transplant, the same combination should be given for up to 48 weeks before transplantation to prevent post-transplant infection with the virus.
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s center for drug evaluation and research, said in a release.
A four-week supply of Sovaldi will cost $28,000. For the same supply, the price tag for Janssen’s NS3/4A protease inhibitor Olysio (simeprevir), which the FDA approved on November 22, will be $22,120.
Sovaldi leads the pack in the race for highly effective all-oral, interferon- and even ribavirin-free hep C therapies, and many expect the drug to become a major blockbuster. The release of Sovaldi and Olysio, however, is really only a warm-up round. The real clincher won’t come until late 2014 when the crucial NS5A inhibitors will likely hit the market. Gilead is hoping to gain approval for a single, coformulated pill of Sovaldi and the company’s NS5A inhibitor ledipasvir, which has boasted near-perfect cure results in recent trials.
In the meantime, physicians may choose to prescribe Sovaldi off-label in combination with Olysio. Phase II studies of the pair, given both with and without ribavirin, have yielded cure rates in the mid-90 percent range.
“Today marks a landmark advance in the treatment of hepatitis C, opening up new opportunities to stop the spread of this virus and the ravages of this disease,” John Ward, MD, director of the Centers for Disease Control and Prevention’s (CDC) division of viral hepatitis, said in a release. “However, new therapies only work if people receive treatment—the potential of these and other treatment advances hinges entirely on our ability to get more people screened and into care. Right now, most Americans with hepatitis C don’t access treatment because they have no idea they’re infected.”
The FDA’s approval of Sovaldi was based on data from four Phase III studies, NEUTRINO, FISSION, POSITRON and FUSION. Between 50 and 90 percent of study participants taking Sovaldi-based treatments achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).
Sovaldi has proved well tolerated, with typically mild adverse events among study participants and few treatment discontinuations because of side effects. The most common adverse side effects, found in at least one in five of participants taking Sovaldi with ribavirin and interferon, were fatigue, headache, nausea, insomnia and anemia.
To read the Gilead release, click here.
To read the FDA release, click here.
To read a recent HepMag.com feature on the hep C treatment landscape, which includes greater detail on research mentioned in this article, click here.
Search: Hepatitis C virus, hepatitis C, hep C, HCV, Gilead Sciences, sofosbuvir, Sovaldi, HIV, transplant, liver cancer, interferon, ribavirin, Edward Cox, U.S. Food and Drug Administration, FDA, approval, Olysio, simeprevir, cost, ledipasvir, John Ward, NEUTRINO, FISSION, POSITRON, FUSION, cure.
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comments 1 - 15 (of 21 total) next
steph, fort, 2014-07-22 19:21:35
just found out 2 months ago i have hep c my viral load is 14441 and genotype 2 i was just approved for the 2 pills taken daily but i don't know if i should wait for the new medication. my doctor is pushing for me to take the 2 pills but other doctors say wait
Saad Jabran, Saudi Arabia, 2014-06-02 03:10:15
would you please advice how i can get Sovaldi (sofosbuvir)drug in to my place in Saudi Arabia. my mam have hepatitis C virus (HCV). so i need your replay as soon sa you can please.
Richard Randazza, Gloucester 01930, 2014-06-01 21:50:35
I'm in desperate need of this new drug I have Medicare part A B and tufts Medicare preferred real sick and working with doctors like to know where I stand please help Rick
Linda, St. Petersburg, 2014-05-30 19:36:55
Hi this is my 3rd try at a cure since 2010. I am really looking forward to this one. I have all of the side effect but not so bad so far for I am taking the riba/peg also. Others have said it will ease up. Thank u I really hope and pray that it will be my turn this time. I am looking for support groups, can anyone help? Again Thank u so very much for this and may God Bless us all.
Kevin, Bolder, 2014-05-28 22:54:19
I have Genotype 1, 2nd time around treatment was Interfereon, ribiviran, victrelus...18 weeks relapsed...I completed 12 weeks treatment sovaldi,ribiviran and interfereon...2 monthes later virus free..will retest in 1 month. cant wait for SVR results...there is hope so hang in there....what are the chances of relapse if no virus detected 1 month after treatment?
Tamara. Abramova, Glendale, 2014-05-24 19:01:44
In order to start taking this medicine do I have to do biopsy? How much will be the whole treatment if my Medicare advantage plan doesn't cover cost of it?
nancy, orlando, 2014-04-23 21:45:19
I'm taking Sovaldi and Ribavirin ,this s my 3rd time in treatment .Prior treatments were interferon. Solavaldi has in 2 wks.put my enzyme levels in normal range and in 4 wks no viral load detected.I'm a geno type 3 with liver stage 4.This is the 1st time in 27 years that my AlT's are in a normal range.I finish treatment in Aug.2014.Praise God this time is looking like the miracle I'm praying and expecting. Faith, without it it is impossible to please God.
Bill, , 2014-04-23 09:02:10
What is the cost in South Africa, Mexico, and Canada? Thanks.
John Weaver, Eureka, 2014-04-03 15:48:58
Hello, I have genotype 1 and am ineligible to take interferon. Could I please be considered to receive Sovaldi and ribavirin for 24 weeks of treatment? My Dr. is Wakil Adil SF CA.
Hep Editors, New York, NY, 2014-03-19 09:27:36
Check out the Hep page "Patient Assistance and Co-Pay Programs for Viral Hepatitis Drugs" for help with paying for your drugs.
william burgess, phoenix, 2014-03-19 00:54:46
I have been diagnosed with hepatitis c genotype 3 and do not have the $1000 per pill it will take for my treatment. Please guide me to someone who can help save my life i have private insurance but no medicare as i am.only 63. Thank you.
M. Kordulak, Plainfield NJ USA, 2014-02-11 08:57:15
Is their any financial help or discounts I can receive for participating in any case studies. I'm a 30 month post liver transplant recipient with Hep C with genotype 3a looking to take Sovaldi strongly recommended by my doctor. Can u please help me.
Dr Erum Rehman, Dubai, 2014-02-05 02:54:29
i want to use this for a female pt age 59 with diabetes wellc ontrolled genotype 4 failed 2 previous courses can u tell me the correct regimen with ribavarin and interferon dosing and duration
Jenn, , 2014-01-15 04:33:06
The fact that they're charging $1,000 per tablet due to what they think the "value to market" is, is ridiuculous. Not only that, but they offer a $5 coupon card on their website! If you can offer a $5 coupon card for your own product, but charge insurance $28,000 there is something very wrong
robert belanger, laval, 2014-01-11 21:06:23
comments 1 - 15 (of 21 total) next
I had a transplant of my liver 2 years ago. right the doctor tell me that the desease is back in my liver and I am stage 2. it is great news BUT who can afford the cost of $84000.00
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