Harvoni Research Papers

This research paper is going to review today’s silent killer, the Hepatitis C virus. This paper will talk about the description of the disease, the signs and symptoms, the etiology and risk factors, diagnostic studies, treatments and prognosis of this disease. I had lived with this disease for over ten years before diagnosed so it is important to understand the signs and symptoms so the disease can be identified and a treatment plan can be identified as the sooner it is treated the more likely it will eradicate the disease.

Treatment is varied. There are several drugs used to treat hepatitis in the United States. Intron A, Epivir-HBV, Pegasys, Baraclude, Hepsera, Viread, and Tyzeka are the only FDA approved drugs that have been shown to slow the virus and decrease liver damage and in some cases the virus is killed completely ("Hepatitis Treatments," n.d.). Ultimately vaccination is the best way to prevent HBV. The vaccine has been found to be effective and safe. Administration is given over a 6 month time and consists of 3-4 shots ("Hepatitis B," n.d.) and is estimated to be 95% effective. Everyone should be vaccinated but the

Hepatitis C virus (HCV) is from the virus family Flaviviridae with an RNA envelope serving as it's genetic material. The genetic material (RNA) is HCV's pathogenic structure. The genome is positive sense single stranded RNA, which is very similar to mRNA and can be translated quickly to the host cell (Bauman 2012). Hepatitis C is an enveloped virus, and the RNA also lacks a proofreading ability after replication, which results in mutations coding for many genotypes within the host. This genetic variability makes it difficult for the host immune system to clear all the HCV infections. As one infection clears, another strain is being produced (Bauman 2012). The HCV antibody detected by ELISA(Wilkinson

Do you recall hearing about a single medication pill that costs about $1000 each pill? Well, it exists. Sovaldi was a newly approved drug in 2015 designed to treat hepatitis C with an estimated cost of $84,000 for a standard 12-week treatment course. In addition to Sovaldi, the list price of Harvoni, another hepatitis C medication, is estimated to be $95,000 for the 12-week treatment course.

A review of the records reveals the member to be an adult male with a birth date of 01/29/1976. The member has a diagnosis of chronic hepatitis C, genotype 1a. The member’s treating provider, Michael Cohen, MD recommended the member be treated with Harvoni.

Until 2011, the main therapy against the infection was Pegylated-interferon (Peg-IFN) and the ribavirin (RBV) treatment (11). Interferon is a type of protein that stimulates the immune system and helps halt the virus from spreading throughout the body. Pegylated-interferon is a combination of three types of interferon, including polyethylene (PEG), which helps the treatment remain in the body for a longer time period. Ribavirin is a medication that helps stop the HCV virus from replicating. It is commonly used in combination with interferon, which is referred to as the “Peg/riba therapy.” This combination therapy is more effective than the interferon itself. However, these medications do not have a one hundred percent cure rate and it was reported

If someone is getting tested for Hepatitis C, they will first take an antibody test. This test will detect if antibodies are present in the blood, which will tell if the person has ever had Hepatitis C, not if they currently possess it (“Who Should”). If the antibody test comes back positive, a qualitative test will then be run. This test declares tells if someone is currently infected with Hepatitis C. A quantitative test can also be run, which shows the amount of Hepatitis C that is in the blood (“Who Should”). There are two main medications that are used to treat Hepatitis C. The first being Pegylated Interferon and another being Ribavirin. Both medications are used for the treatment of adult patients with chronic liver disease (FDA). These medications are used in place of the vaccine that has not been created for Hepatitis C. Therefore, Hepatitis C can be detected easily and is treatable.

Medicaid officials across the country are pushing for the access to the new hepatitis C drugs to be widened by state Medicaid programs because the guidelines are unreasonably strict and these medications can cost up to $1,000 per pill. The Food and Drug Administration approved the new hepatitis C drugs, Sovaldi and Harvoni, on July 24 of this year. These expenses can cost up to $84,000 for the recommended treatment period of 12 weeks. The hepatitis C drugs can help cure thousands of people with hepatitis C, which is why Federal and State officials are pushing for access to these drugs to be widened.

Compared to the general population HCV patients have higher morbidity and mortality rates (Neal et

Chronic Hepatitis B is an infection that affects the liver, and if these disease is allow in it progression. It can cause fibrosis, cirrhosis, liver failure and hepatocellular carcinoma. It is a worldwide problem that does not have a cured. These virus has affected an estimated 400 billion people and these number is growing in a rapid rate. It will kill 25% of people who does not get treatment. In China, there are approximately 60% of the people have history of HBV infection, and about 7% to 10% of the population have the disease. They are in a high risk situation to have liver disease. Currently, there are few available drugs that can manage this epidemic, such drugs are interferon-alfa, nucleos(t)ide analogue polymerase inhibitors, but other drugs can be combined to help

Daclatasvir displayed potent inhibitory activity against all HCV genotypes tested (genotypes 1-6) [18, 19]. In replicon assays, the half~maximal effective concentration (EC5O) values of daclatasvir against HCV genotypes 1a, lb, 2a,3a, 4a and 5a were 50, 9, 71-103, 146, 12 and 33 pmol/L, respectively [28]. Daclatasvir displayed additive or syneregistic inhibitory activity in replicn assays when used in combination with peginterferon-a and ribavirin, NS3/4A inhibitors (danoprevir or asunaprevir) or NSSB inhibitors [EMS-791325 (beclabuvir) or NM-107] [28, 30]

Harvoni is a new drug used for treating Hep C that was approved by FDA in October 2014. Harvoni is a combination of sofosbuvir (Sovaldi) and ledipasvir. Harvoni is used to treat Hep C genotype one. The recommended dose of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg, I tab daily for 12 weeks.The medication can be taken with or without food and patients can follow the usual missed-dose instructions (Gritsenko, Hughes). During a phase III clinical trial Harvoni cured more than 97 percent after 12 weeks of treatment. Some patients who have not taken antiviral drugs before were cured in eight weeks of treatemnt (Gritsenko, Hughes). Harvoni has less side effects are compared to other hep c drugs. The most common adverse events reported

Pharmaceutical companies that make HIV and HCV companies have sustained competitive advantage. Epclusa is the new HCV medication that is launched Jun 2016 by Gilead. Gilead carries the four attributes of sustained competitive advantages: strategically equivalent substitutes, valuable, rare, and imperfectly imitable. The indication for Epclusa is for HCV patient with every genotype. HCV has different genotype (1-6), and each genotype has different treatment. Harvoni is the most common HCV medication, but it only covers HCV genotype 1, 4, 5 and 6. Epclusa is the only medication can treat any type of HCV patients. Also, all HCV medication is expensive. Harvoni is the cheapest HCV medication, but it costs $40,000 for 12 weeks treatment with 340B

-Ledipasvir is an antiviral agent which targets a specific HCV protein which is called NS5A by which it can prevent the replication of the hepatitis c virus. Although the mechanism of action is not fully understood but all the data showed that it inhibits the NS5A which has a main role in the prevention of the replication Ngo, H., (2014).

Based on the research made by the World Health Organization or WHO, every year 3 to 4 million people are infected by hepatitis C virus or HCV and more than 350,000 die every year because of this chronic disease. Fortunately, due to the introduction of direct-acting antivirals, treatment for HCV has been improved dramatically. Some of these medications have troublesome side effects that can interfere with the normal daily activities. Here are simple and practical tips that can help in managing and reducing these side effects: