Hepatits C New Hope With Harvoni Treatment
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Hepatitis C New hope with Harvoni treatment. If you have hepatitis C, you’ve no doubt heard of the drug harvoni. Gilead Sciences' Harvoni is one pill containing two drugs. Both are direct-acting antivirals (DAAs) which means they directly interfere with the hepatitis C virus replication. One drug, sofosbuvir (brand name Sovaldi), has been on the market since late 2013. It is a polymerase inhibitor. The second drug is ledipasvir, this drug is a NS5A inhibitor.
Those being treated for hepatitis C qualify for first day life insurance coverage at the standard rate. We also talk about this topic in our article here.
Hepatitis C New Hope with harvoni treatment. Twelve weeks of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) plus ribavirin cured 73 percent to 89 percent of people with genotype 3 of hepatitis C virus (HCV), while 96 percent of people with genotype 6 were cured without ribavirin in a recent trial, the National AIDS Treatment Advocacy Project (NATAP) reports. Researchers conducted a Phase II study of the once-daily fixed-dose combination tablet of the NS5A inhibitor ledipasvir plus the nucleotide analog polymerase inhibitor sofosbuvir, which was given with ribavirin for 12 weeks to 50 cirrhotic and noncirrhotic treatment-experienced people with genotype 3 of the virus, and without ribavirin for 12 weeks to 25 treatment-naive and treatment-experienced people with genotype 6. They presented their findings at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston.
Whether you are currently in a treatment program or have already completed it, you qualify for life insurance with first day coverage.
Overall, 82 percent (41 out of 50) of the participants with genotype 3 achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), including 73 percent (16/22) of those with cirrhosis and 89 percent (25/28) of those without. Ninety-six percent (24/25) of those with genotype 6 were cured.
Among the genotype 3 participants, 90 percent (45/50) experienced at least one adverse side effect. Two percent (1/50) experienced serious side effects that led to discontinuation of therapy. Among those with genotype 6, 84 percent (21/25) experienced at least one adverse side effect and 4 percent (1/25) experienced serious side effects that let to discontinuation.
The most common side effects (affecting at least 10 percent of participants) reported by the genotype 3 group were fatigue, headache, upper respiratory tract infection, insomnia, rash and nausea. The most common side effects (affecting at least 10 percent of participants) reported by the genotype 6 group were fatigue, upper respiratory tract infection and diarrhea.
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Here is a brief summary of Harvoni:
• Harvoni is approved for treatment of genotype 1 HCV infection in adults.
• Cure rates range from 94% to 99%.
• It is a single pill taken daily, with or without food.
• Patients who have never been treated for HCV, whether they have cirrhosis or not, take Harvoni for 12 weeks.
• Treatment-naïve patients without cirrhosis whose pre-treatment viral load (HCV RNA) is less than 6 million IU/mL may be considered for 8 weeks of treatment. This is about 40% of eligible patients.
• Patients without cirrhosis who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin, take Harvoni for 12 weeks.
• Patients with cirrhosis who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin, take Harvoni for 24 weeks.
• Harvoni was not approved for HIV/HCV co-infection despite high cure rates in clinical trials.
Drug Interactions
Harvoni interferes with some other drugs. Let your doctor and pharmacist know all the drugs (prescription and nonprescription) and supplements that you are taking.
• Do not take Harvoni with drugs/herbs that are P-gp inducers (e.g., rifampin, St. John's wort).
• Other drugs that may interact: antacids and other acid-reducing drugs, digoxin, anti-seizure medications, simeprevir (Olysio), rosuvastatin, HIV and TB drugs
Although some herbs and drugs have the potential to interact with Harvoni, this doesn't mean you can't take drugs that may potentially interact. It usually means that your doctor or pharmacist will advise you on how to space out the timing of your medications.
Adverse Events (Side Effects)
The majority of reported side effects were mild. Fatigue (13 to 18 %) and headache (11 to 17%) were the most common. Nausea (6 to 9%), diarrhea (3 to 7%), and insomnia (3 to 6%) were also reported. The discontinuation rate due to side effects was very low (0 to 1 %).
Increases in bilirubin, lipase, and creatine kinase were observed.
Here is a huge change: HARVONI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This is big change from ribavirin's dire Black Box warnings of potential fetal damage.
How effective is Harvoni? Harvoni's efficacy rates are excellent, ranging from 94 to 99%. Harvoni has a high barrier to drug resistance.
Hepatitis C – New Hope with harvoni treatment. Harvoni is expensive. The wholesale acquisition cost of twelve weeks of Harvoni is $94,000, or $1125 a pill. Approximately 40% of patients will have 8 weeks of treatment at the bargain price of $63,000. Patients with cirrhosis who failed prior treatment will need 24 weeks of treatment, with a price tag of $188,000.
Will insurance cover Harvoni? Probably, but not for everyone. My guess is that there will be push back from state Medicaid programs, and some insurers. This past year, more than 30 states instituted stringent preauthorization regulations. For example, some states force patients to qualify for HCV treatment by proving they have cirrhosis.
Also take a look at - Qualify for a Burial Plan with Hepatitis C.
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Last Updated on October 13, 2017 by lifepolicyshopper