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FDA Approves New Hepatitis C Medications to Treat Genotypes 3 and 4

FDA

FDA Approves New Hepatitis C Medications to Treat Genotypes 3 and 4

Recently, I wrote on my HepMag.com blog, “In 1997, there was one hepatitis C treatment – interferon. Eventually, ribavirin was approved, and until 2011, I only had to remember the brand names of these two medications. In short, hepatitis C treatment didn’t change much. Then came all the “virs” – boceprevir (Victrelis), telaprevir (Incivek), simeprevir (Olysio), sofosbuvir (Sovaldi), and ledipisvir (when combined with sofosbuvir = Harvoni). Ombitasvir, paritaprevir, ritonavir and dasabuvir (Viekira Pak, aka PrOD) caused my brain to explode, and we are just getting started.

Yes, we are just getting started. A few days after I wrote that, the FDA approved two more drugs to treat hepatitis C:

  • Daklinza (daclatasvir) for use with sofosbuvir to treat patients with genotype 3
  • Technivie (ombitasvir, paritaprevir and ritonavir) for use with ribavirin to treat non-cirrhotic patients with genotype 4

Here is a brief summary of each:

Daklinza

  • Daklinza is used with Sovaldi (sofosbuvir) to treat hepatitis C virus genotype 3
  • It is the first drug approved for genotype 3 that does not use either peginterferon or ribavirin
  • Treatment involves taking one Daklinza and one Sovaldi daily for 12 weeks
  • Daklinza is an NS5A inhibitor
  • Daklinza is marketed by Bristol-Myers Squibb (BMS); Sovaldi is a Gilead product

Warnings: Co-administration of amiodarone with Daklinza in combination with Sovaldi is not recommended.

Adverse Events (Side Effects): The majority of reported side effects were mild, with no discontinuations due to adverse events. The most common side effects were headache (14%), fatigue (14%), nausea (8%) and diarrhea (5%).

Interactions: Daklinza is contraindicated in combination with drugs that strongly induce CYP3A, such as phenytoin, carbamazepine, rifampin, St. John’s wort

Efficacy: The ALLY-3 clinical trial enrolled 152 patients with genotype 3 and compensated liver disease (101 treatment-naïve patients and 51 treatment-experienced patients). The endpoints were sustained virologic response rates 12 weeks after completing therapy (SVR12) in each treatment group.

  • Treatment-naïve patients had 90% SVR12 rates
  • Treatment-experienced had 86% SVR12 rates
  • Genotype 3 patients without cirrhosis, regardless of treatment history had 96% SVR12 rates
  • Patients with cirrhosis had 63% SVR12 rates

Pregnancy and Breastfeeding: The safety of Daklinza during pregnancy or breastfeeding has not been established. Consider the benefits and risks of Daklinza when prescribing to a pregnant or nursing woman.

Cost: The wholesale acquisition cost of twelve weeks of Daklinza is $63,000. That would practically be a bargain if it could be prescribed without Sovaldi, which it can’t. Sovaldi costs $84,000 for a twelve-week course, so with Daklinza the total is $147,000. That is $1750 per day for two pills.

Will insurance cover Daklinza? I assume so, but I also assume that there will be the usual hurdles, denials, and nightmares that patients experience trying to get other costly hepatitis C medicines.

Patient Support and Assistance: Bristol-Myers Squibb’s Patient Support Connect Program (844) 44-CONNECT (844-442-6663)

Technivie

  • Technivie (ombitasvir, paritaprevir and ritonavir) is used with ribavirin to treat non-cirrhotic patients with genotype 4
  • Technivie is taken once daily with a meal, and co-administered with twice-daily ribavirin, also taken with food. Treatment is for 12 weeks
  • Ombitasvir is an HCV NS5A inhibitor. Paritaprevir is an HCV NS3/4A protease inhibitor. Ritonavir is a CYP3A4 inhibitor
  • Technivie is marketed by AbbVie

Warnings: People who have severe liver problems (decompensated cirrhosis) should not take Technivie

 Adverse Events (Side Effects): There were no discontinuations due to adverse events. When taken with ribavirin, the most common side effects were weakness (25-29%), fatigue (7-15%), nausea (9-14%), and insomnia (5-13%).

Interactions: Technivie is not recommended for patients who take certain medicines, such as those containing ethinyl estradiol (contraceptives). Technivie may interact with drugs such as Sustiva (efavirenz), Dilantin (phenytoin), phenobarbital, rifampin, St. John’s wort, and more.

 Efficacy: The PEARL-I clinical trial enrolled 42 treatment-naive and 49 treatment-experienced participants without cirrhosis with 100% SVR12 rates

(Another 44 treatment-naive participants took Technivie without ribavirin. Forty of them (91 percent) were cured.

Pregnancy and Breastfeeding: The safety of Technivie during pregnancy or breastfeeding has not been established. Consider the benefits and risks of Technivie when prescribing to a pregnant or nursing woman.

Cost: The wholesale acquisition cost of twelve weeks of Technivie is $76,653.

Will insurance cover Technivie? I assume so, given that the price point is less than Harvoni.

Patient Support and Assistance: AbbVie’s Patient Support Program is ProCeed 844-4VIEKIRA (844-484-3547) www.viekira.com

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{ 27 comments… add one }
  • Onefluover August 2, 2015, 1:01 PM

    Lucinda, thank you for all the info you are providing and means of accessing and interacting with it so easily. You are correct. How things have changed.

    I made my first contact for treatment about a month ago.

    Quick history. I was an immunized doner (B) in ’90-’91 and after a year of donating and the advent of the new tests was told I had hep C. My earlier Hep B vaccine was about 1984. Prior to 1991 I had no tattoos, was never a drug user let alone intravenous, and was still a virgin. No transfusions. It is a mystery to me though I suspect the HeptaVax.

    Anyway, assuming I was exposed prior to ’91, in 2007 my virus count was 700,000. A month ago it is 4,000,000. I have also learned that I am Geno 3a., AST 74, ALT 153, Hep A and B immune and HIV neg. My liver is 18.6 cm, -about 3.5 cm swollen, relatively coarse and echogenic with other diffuse hepatocellular process.

    Before my GI begins treatment we are waiting on a final test for hemochromatosis (my irons were abnormal). He told me if that test was neg. then he would put me on Harvoni and Ribavirin for 12wks. This was on July 24th… Of course the big day for Daklinza and many like myself. I am on Medicaid. He told me Utah had just negotiated a deal for Harvoni. But in light of Daklenza’s approval, I think that combo may be a better option. However, cost for Daklenza/Savaldi is $147,000 for 12wks. And there’s no telling at this time at what point Daklinza will even be covered by Medicaid let alone covered and then denied.

    My question is, would I be wise to take the Harvoni/Ribavirin if Medicaid approves it for me or hold out for what may be a more expensive but gentler treatment with higher cure rate? I’m not being cheap. I’ll gladly take the one that makes me ill for a year if the cure rate is high. In light of the costs, I’ll take whatever they give me but what if that is not necessary? What if they would of approved either treatment? Which one would you opt for? Thank you.

    • Lucinda Porter August 2, 2015, 5:08 PM

      Hi,
      You asked, “would I be wise to take the Harvoni/Ribavirin if Medicaid approves it for me or hold out for what may be a more expensive but gentler treatment with higher cure rate?” – Harvoni isn’t used for GT 3. Here are your choices: HCV Guidelines The guidelines have not be updated yet to include Daklinza. I would try to get Daklinza if you can.

  • Onefluover August 2, 2015, 6:17 PM

    Thank you. Yes, I know. Which is why I thought it a bit odd at first that my Dr mentioned Harvoni but then he later did say actually one of the two meds of Harvoni, -Sovaldi. And it was only moments prior to this conversation that he learned I was GT 3. We had been talking Harvoni. Anyway. I think my hemochromatosis test comes back tomorrow and then is when I will learn more of the Deklinza option.

  • Onefluover August 6, 2015, 12:50 PM

    Hemochromatosis was negative. That’s great news! I do have one more test though. The fibrosis staging. My Dr estimated it roughly for me as between a 1 and 3. I did my own Childs score and it was a 5. Well compensated. I don’t know if this will put me at not-far-enough-advanced to get Medicaid authorization for treatment with either Sovaldi and Ribavirin or Sovaldi and Daklinza. He did say that Gilead has a new drug coming out May of 2016 that will work on all genotypes and I may want to hold out until then. I do not. My viral load took 16 to 25 years to get to 700,000 and then 7 more years to get to 4 million. My other concern is that by then Medicaid will no longer cover any of these meds.

    • Lucinda Porter August 6, 2015, 1:39 PM

      Good news about the hemochromatosis. Fibrosis staging will be important. Childs score is irrelevant unless you have cirrhosis (stage 4). Stage 4 is when conversations about compensation matter. Viral load is completely irrelevant – doesn’t correlate to anything and those #’s are very typical. (in fact, I’d be concerned if they were very low) Best place to get info is the Hep Forum – I suggest you check them out.

  • Onefluover September 4, 2015, 8:35 PM

    Thank you. I would argue though that viral load is completely relevant in GT 3 cases. Maybe not at this time insofar as insurance approval goes but NASH presents a whole host of other problems, complications of which I have many and well before F 3 my window is closing rapidly with exponential viron replication.

    “For people with genotype 3 though, the link between steatosis and the virus has now been definitively established. Up to 80% of people with genotype 3 have moderate to severe steatosis. It seems that that there is a complex interaction between the core protein of the genotype 3 strand of the virus and liver cells that leads to steatosis. This interaction is not seen in other genotypes. It also seems that the severity of steatosis in these patients is directly related to their viral load. The higher the viral load the greater the amount of steatosis. This link has not been observed in other genotypes.”

    http://hepatitiscnewdrugresearch.com/fatty-liver-and-hcv.html

    Today I was denied Sovaldi/Daklinza treatment due to me not being F 3 or greater. That and Daklinza not yet being approved by Medicaid apparently. (My Fibrospect 2 is set at F 0-1)

    My point is that it took 18 or 25 years (only two points of possible exposure) for my viral load to climb to 700,000 but only eight more years to climb to 4,000,000. I am the highest ranked member of the worlds oldest and largest pandemic flu and everything virus forum so I know, as a layperson, a bit about exponential virus growth. This means my viral load very well may be in the tens of millions right around the corner. And as I understand from the link I posted above, aside from the added physical complications of fatty liver, this will greatly increase the odds of me loosing the ability to respond to treatment. And my point is that viral load will be an important part of my appeal.

    • Lucinda Porter September 4, 2015, 8:59 PM

      You may be correct on saying that “viral load is completely relevant in GT 3 cases.” However, I think having GT 3 in and of itself should be the critical factor. Plus, viral load is a weird thing – it tends to drop when the liver isn’t functioning as well, and it can rise independently of negative factors. Also, I’ve seen viral loads that are much, much higher. And, I’ve seen cirrhotics with barely detectable viral loads. I believe you have a strong case – I’ve seen many people win approval after a few denials. Stay strong, and if you think your viral load will help you win your case, you go for it!

  • Janet September 11, 2015, 1:11 PM

    I have been to two doctors now asking for the Sovaldi/Daklinza to treat my hep c and both have said they won’t prescribe it. They only want to give me Sovaldi/Riba. I am treatment naive with a Fibroscan of F2-3. I am opposed to taking Ribavirin and have been waiting for the Daklinza to be approved. Any suggestions on how I/we might convince doctors that the Daklinza is the superior treatment and get them to go to bat for us with the insurance companies?

  • Dennis September 12, 2015, 8:27 AM

    Help ! Also a Bit of Info.
    I,m 66 Genetype 3a with Fibroscore 80 Early F-4 Naïve. Liver functions Great.Just received Meds, 24 weeks Sovaldi & Daklinza & Ribavarin. Desperately need Help with this question ? Treatment guidelines for 24 weeks with cirrhosis are Daklinza& Sovaldi Plus or Minus Ribavarin. Would like to avoid Ribavarin, But both My doctors here in the USA and Europe are Pushing for the 3 drugs.My question is Can I do without the Ribavarin ( Terrified of it ) or how much better are my chances by adding the Ribavarin PLEASE reply . Thank you kindly.
    My Gi in Europe has been treating with Sovaldi and Daklinza without Ribavarin for close to 1 year Now and Says all is going well, Few side effects and NO drop outs.All the best

    • Lucinda Porter September 12, 2015, 5:39 PM

      I am not qualified to say – that is between you and your doctor.

      • Dennis September 13, 2015, 2:35 PM

        Hello Lucinda ,
        Thank you kindly for your quick Response.I just had a lower wisdom Tooth extracted 2 weeks ago.How long shall I wait for this to heal till I begin Ribavarin inclusive therapy ? ( Concerned about Bone & tissue Healing Properly ) Also Had 5 DES Stents Put in a year ago still on Plavix And Aspirin. Went into Afib and was corrected with Cardioversion last October. Can you direct me to a proper source as to How I can find out about oral healing time before Beginning Ribavarin ? Unfortunately Neither My Oral surgeon nor GI can Help me with this. I,m ready to start But don,t want to have to stop abruptly due to Infection or inadequate healing of wisdom tooth site. Thank you again.Do you have a blog yet for Daklinza & Sovaldi & Ribarvin ? Any info is Much appreciated.All the best to you and yours.
        Kind Regards
        Dennis

        • Lucinda Porter September 13, 2015, 4:40 PM

          There is no reason to think that at this point there would be any delay – ribavirin take a few weeks before the effects even begin. No blog on Daklinza & Sovaldi & Ribarvin – are you interested in writing one for Hep? If so, let me know.

          • Dennis September 14, 2015, 6:39 AM

            Good Day Lucinda,
            Thank s again for your insight .Yes I would be interested in getting a Daklinza&Sovaldi&Ribavarin Blog started ,Just need a few instructions as to How.I,ll await your response with instructions.
            Kind Regards

          • Lucinda Porter September 14, 2015, 7:23 PM

            Look for an email from me from my hepmag.com account – just sent

  • Dennis Hayden October 14, 2015, 7:53 AM

    Good Day Lucinda,
    Dennis Here again, I will begin My 24 Weeks with Riba-Daklinza-Sovaldi this Friday the 16th. I would like to get involved with a NEW Blog.Can you please resend your instuctions e-mail from Sept 14th ? Can,t locate. Thank you and I,ll await your reply.
    Sincerely
    Dennis

    • Lucinda Porter October 17, 2015, 2:35 PM

      I just sent your email from hep mag.com – please reply there.

  • Dennnis October 22, 2015, 3:34 PM

    Hello Lucinda,
    I,m already taking Benadryl,Was OK,D by GI, as was 20 MG of Protonix prior to treatment start BUT I,ll speak with him again.Is The Hydroxyine better than the Benadryl ? Is This the Forum where you want to communicate. Please advise. Thank you again.
    Kind Regards
    Dennis

    • Lucinda Porter October 22, 2015, 4:43 PM

      Benadryl may interact with your meds – it may be a timing issue, and your doc or pharm may be able to advise you. As for your GI meds, they don’t interact with the drugs you are on, but there has been some discussion about the timing of taking them. It’s just small stuff – nothing to sweat over, but a good pharmacist or doc might have a suggestion. I don’t know the recommendations on Daklinza, but I do know that with Harvoni, you want to take the acid-reducing med at the same time as Harvoni – you want the high acid environment to help metabolize the drug. I don’t know if this applies to Daklinza, but it shouldn’t make any difference with Sovaldi or ribavirin.

  • poppy February 10, 2016, 10:37 AM

    Hello,
    I looked for an article in your Hep mag.com, and could not find an article on the Hep c geno type 3 and the treatment.
    Thanks

    • Lucinda Porter February 10, 2016, 8:23 PM

      Here’s the text:
      Article: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection – G.R. Foster, et al. NEJM November 16, 2015
      Gist of the Study: Two phase 3 studies of untreated and previously treated subjects with chronic hep C GT 2 or 3 infection, including those with compensated cirrhosis. In one trial, hep C GT 2 subjects received a single sofosbuvir/velpatasvir (SOF/VEL) combo tablet (134 subjects) or sofosbuvir plus ribavirin (SOF/RBV 132 subjects) once daily for 12 weeks. In the other trial, hep C GT 3 subjects received either a single SOF/VEL combo tablet (277 subjects) or SOF/RBV (275 subjects) once daily for 12 weeks.

      Bottom Line: In the GT 2 study, the SVR rate in SOF/VEL group was 99 percent; SOF/RBV was 94 percent. In the GT 3 study, the SVR rate in SOF/VEL group was 95 percent; SOF/RBV was 80 percent.
      Discussion: The most common adverse events in the two studies were fatigue, headache, nausea, and insomnia. In the two studies, one participant dropped out early because of an adverse event. He reported anxiety, headache, and difficulty concentrating on the first of the study.
      In the GT 2 study, two subjects had serious adverse events in each arm. In the GT 3 study, the SOF/VEL arm had fewer serious adverse events (2 subjects) compared to the longer SOF/RBV arm (5 subjects). Two subjects died in the post-treatment follow-up in the GT 2 study SOF/VEL arm; one from complications from metastatic lung cancer nearly four months after treatment; the other from cardiac arrest more than four months post-treatment.
      In the GT 3 study, three deaths occurred in the SOF/RBV arm. During the study, one died from an unknown cause, the other from a gunshot wound. In the post-treatment phase, a third died from an unknown cause.
      Comments: Fabulous results for GT 3 patients. The death from a gunshot wound in the ribavirin arm was distressing given how many of us have taken ribavirin. Glad I didn’t have access to a gun when I was on treatment.

  • BeeGone March 6, 2016, 12:23 PM

    Hello All!
    I am a GT3 who has recently been prescribed all three Ribavirin, Daklinza and Sovaldi…in week 2. There are very few of us out there apparently so I am writing for 2 reasons…1 to get possible support from someone who IS on all 3 and to give you my feedback I know it’s still early days yet..but here goes….the first week was ok however I was experiencing the headaches and low grade fevers they tell you about…in addition I was very sick to my stomach and had diarrhea and had problems sleeping at night. Also felt like I was extremely dry my lips chapped almost instantly and the taste in my mouth was like a metallic, awful taste which makes it impossible to taste food…so needless to say I have to MAKE myself eat…taste or not. I try to have several small healthy meals a day…I can’t really smell any subtle things but I can still smell stronger things like peppermint and clove in addition to Rosemary. I am replenishing fluids all day long alternating coconut water with regular water and apple cider. I feel constantly like I am going to be sick at the stomach but have been given gabapentin to calm the wretching so now I am not getting sick anymore but feeling like I will at any moment. This all said..I can say that it is not nearly as awful as interferon was I have been through that misery twice so feel like I can talk and make comparisons with experience and intelligence. I was already on BP medication at the start of this and can feel slight palpitations but so far not freaky enough to call 911. I hope this helps and I again would love to speak to someone who is one the same regimen. According to the ALF they are few and far between….looking for a needle in a haystack….thanks. Bee

    • Lucinda Porter March 9, 2016, 7:16 PM

      Thank you- this is valuable info, and I appreciate that you took the time to share it. As for looking for others, I highly suggest you join Hep Forums– probably a greater chance of finding someone. Good luck!

    • Theresa June 4, 2016, 8:19 AM

      My husband is on all three of these pills. And he is and was feeling the same way,the diarrhea is the worst right now. He has been on this for 6 weeks. Is there any thing to do for the diarrhea? Any help would be greatly appreciated.

      • Lucinda Porter June 8, 2016, 10:52 AM

        Check out the Gastrointestinal Disorders section of HEPI also suggest you join the Hep Forum
        Wishing for the best.

  • Ironworker May 8, 2016, 9:31 PM

    Lucinda I’ve been approved and have received my 1st month of solvaldi/ribavirin. I’m nervous to take the latter. When is pangenotypic being released from FDA ? Or should I just take meds I have. I’m scared

    • Lucinda Porter May 9, 2016, 4:44 PM

      June 30th – I can’t advise you as to what to do, but I can suggest you talk to your doc. You can also get feedback from other in one of the online forums, such as Hep Forum http://forums.hepmag.com/

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