Infectious Disorders

 

 

 

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VIEKIRA PAK™

December 25, 2014 by Legalized Pill P.U.S.H.A.

In January of this year I posted about a new Hepatitis C drug, SOVALDI™ manufactured by Gilead. Later in the year (October 2014) Gilead also released HARVONI™ which also treats (and according to Gilead cures Hepatitis C in the high 90 percentile).viekira Harvoni™ being a combination of ledipasvir/sofosbuvir. In other words it also contains the “Sovaldi™” component.

Just when we thought that Gilead had the Hepatitis C market all sewed up, a new product has been released, marketed by Abbvie called VIEKIRA PAK™. This product also boasts a high 90 percentile cure rate as well. All three products range from $27,000 – $31,000/month. Depending on which genotype a patient is diagnosed, therapy can be from 12 weeks to 26 weeks. All three can be taken with a Ribavirin product. Sovaldi™ and Harvoni™’s claim to fame is that they are “once” a day, one pill a day therapies. They contain no Interferon product which is most likely responsible for the flu-like symptoms, malaise, and fatigue associated with Hepatitis C therapy. The VieKira Pak™ is a 4 tablet daily dose pak with two (2) ombitasvir/paritaprevir/ritonavir tablets and two (2) dasabuvir tablets. Sovaldi™ is often times coupled with Olysio™ (which is an additional $23,000/month).

Like Sovaldi™ and Harvoni™, VieKira Pak™ also has a patient assistant program called proCeed which provides support for access to the drug, reduce financial barriers as well as track patient data (something which would be of interest to physicians and pharmacists). The great thing about is, VieKira Pak™ is, while only indicated for Genotype 1 (which happens to be the most common genotype in the United States) it contains a 4-drug combination for only one (1) price! Harvoni™ is also only indicated for genotype 1, but Sovaldi™ is indicated for genotypes 1, 2, and 3.

Being a pharmacist and this being the end of the year, we are bombarded with information regarding new changes in commercial, federal and state supported insurance plans. The pharmacy benefit managers (PBMs) are constantly updating their policies but most come at the end of the year, effective on January 1.

Now you are probably asking yourself, why did she go off on a tangent about PBMs? I did this because with the release of VieKira Pak™, ESI (Express Scripts) which happens to be a very large pharmacy benefit manager (probably one of the largest, if not the largest) just announced that they will exclude Harvoni™ and Sovaldi™ from their national preferred formulary, effective January 1, 2015. Now this doesn’t mean that you will not be able to get and/or prescribe Harvoni™ and Sovaldi™ for your patients . . . but it does mean you’ll probably have to submit and/or go through the prior authorization process (which we pharmacists lovingly call PA process) and you may (prescribers) have to prove that your patient failed on the “preferred” VieKira Pak™.

So prescribers and/or patients, if you are currently using and/or prescribing Sovaldi™ and/or Harvoni™, be aware that you may have to switch your patients to the VieKira Pak™. All three drugs report a high 90 percentile cure rate, all can have Ribavirin added to the therapy, but only one (VieKira Pak™) has a 4-drug combination for one price. Lastly, if ESI is moving to this as the “preferred” therapy for Hepatitis C, be on the lookout for CVS CAREMARK and Walgreens to follow in the near future.

Sovaldi Receives FDA Approval for HCV Treatment

January 28, 2014 by Legalized Pill P.U.S.H.A.

sovaldiRecently, (December 2013), manufactured by Gilead received FDA (Food and Drug Administration) approval for the treatment of Hepatitis C Viral (HCV) infection. So you ask yourself, what’s so different about Sovaldi™ and what is the big deal? The big deal is this, Sovaldi™ is the first drug approved for HCV (for certain genotypes) without the additional therapy of interferon.

Why is this good news? This is exciting news because many individuals infected with Hepatitis are on a combination therapy cocktail which includes: (a) a weekly interferon injection and (b) daily ribavirin oral tablet or capsule. This is not an ideal combination because 50% of the individuals on the therapy do not respond to it. In addition, those that do respond often experience debilitating side effects that can last the duration of the therapy (which is typically 24 to 48 weeks)!

Sovaldi™ is the first drug to demonstrate safety and effectiveness in the treatment of HCV genotypes 2 and 3 with oral ribavirin alone without the need for weekly pegylated interferon injections (e.g. Pegasys®, Peg-Intron®, etc.). Sovaldi™ has also been approved to be  taken with ribavirin in patients who have been diagnosed with HCV genotype 1 (the most common genotype) who cannot tolerate interferon therapy, as well as in combination with ribavirin and interferon for patients diagnosed with genotype 4 (the most difficult to treat).

What is Hepatitis C? Hepatitis C is a liver disease that results from infection with the Hepatitis C Virus. It can range in severity of mild illness lasting a few weeks to a serious life long illness. It is usually spread when the blood of an infected person enters the body of someone who is not infected. Today, most individuals become infected from Hepatitis C by sharing of needles or other equipment used to inject drugs. Before 1992, when widespread screening of blood supply began, people would commonly become infected through transfusions and organ transplants.

There is no vaccine for Hepatitis C. The best way to prevent Hepatitis C infection is to avoid behaviors that can spread the disease.

If you are on Hepatitis C therapy, or know someone who is and you or they are experiencing some challenging side effects, it is possible that you or someone you know might be a candidate for Sovaldi™. The manufacturers of Sovaldi™ feel that the cost of this medication should not be a barrier for your receiving this therapy. Gilead has a coupon that you must register for to determine if you are a candidate for this co-pay assistance. If you are, your co-pay will be $5.00 per fill for up to 6 fills. Go here to determine your eligibility for Sovaldi™ after your healthcare professional has determine if you are a candidate for Sovaldi™ therapy: https://www.sovaldi.com/copay-register.aspx

Do’s and Don’ts for this Cough, Cold and Flu Season

December 31, 2013 by Legalized Pill P.U.S.H.A.

sick_child1Just in time for cough, cold and flu season, I’d like to give parents a few tips to try and help your children and other family members avoid contracting infectious diseases this winter. Disinfecting, hand washing, safe pet keeping and vaccination are key to keeping our children and family stay healthy through the cough, cold and flu season as well as throughout the entire year.

  • Washing your Hands – Washing your hands and teaching our children to wash their hands is the single most effective way to prevent the spread of infectious diseases. Washing your hands gets rid of the germs you pick up from touching surfaces, touching other people or playing with pets!
    • When to Wash?
      • Before eating
      • Before, during and after handling food
      • After having contact with bodily fluids (after going to the bathroom)
      • After changing a diaper
      • After handling the pet’s toys
      • After touching something that could be contaminated like, trash, trash cans, cleaning cloths, drains and soil
      • Frequently when someone in the household is sick
      • Whenever they look dirty!
    • How to WashThe important thing about washing your hands is not the amount of soap and water you use, but the amount of friction applied and the length of time. How much time you say? Just imagine yourself singing the Happy Birthday song, TWICE!! Dry your hands using a paper towel or hand dryer and if all possible, use a paper towel to turn off the running water.
  • Disinfection:
    • In the kitchen – disinfect surfaces, especially where raw meat, poultry and eggs have come into contact. If using cloth towels use once then wash in hot water. Cloth towels can re-infect surfaces if not washed in between usage.  In fact use paper towels which can be thrown away to wipe up the spill or disinfect the surface. Cutting boards, especially wooden ones are harbinger of germs. Make sure your cutting boards are washed with hot soapy water in between use. Beware of cross contamination (e.g. cut your meat and/or poultry on the board, then cut up something else, like vegetables, etc).  I strongly suggest you keep two cutting boards, one for meats, poultry and fish and another for fresh fruits and vegetables. Sponges are also a great source of germs. If you desire to re-use your sponges, try microwaving them for about 30 seconds to be sure you’ve destroyed the germs.
    • In the bathroom – disinfect surfaces in your bathroom frequently, especially if someone in the house is ill  with a stomach problems, cold and/or flu. Believe it or not a common place that is often missed when we disinfect is the door knob!
  • Vaccination – The single best way to protect your children from the flu is to get them vaccinated each year. The seasonal flu vaccine protects against the influenza viruses that research indicates will be most common during the upcoming season. Children commonly need medical care because of influenza, especially if they are less than five (5) years of age. Severe influenza complications are most common in children less than two (2) years of age and children with chronic health problems like asthma, diabetes and disorders of the brain and/or nervous system are at high risk for developing serious flu complications.

TREATMENT (Common Cold)

The common cold is characterized by coughing, sneezing, stuffy and/or runny nose, sore throat, watery eyes, mild headache and body aches. There are more than 200 viruses that can cause the common cold. The rhinovirus is the most common. When a runny nose is involved clear mucus is often present. As the body begins to fight the virus, the mucus will turn white. Later, the bacteria that normally lives within the nose will grow back and the mucus will appear green. This is normal! (it’s only when that mucus has an odor that cause for concern should be raised). Antibiotics WILL NOT HELP as the cold is caused by a virus and antibiotics are useless when fighting a virus. Antibiotics are needed when it is determined that the symptoms being exhibited by your child and/or loved one is caused by bacteria. This is determined through collection of sputum (swabbing of the nose and/or throat). HOWEVER . . .

            DO:

  • See a healthcare provider if the symptoms lasts longer than 10 days
  • Temperature is greater than 100.4°F
  • Symptoms not relieved by over-the-counter (OTC) remedies.
  • Keep children and loves ones hydrated (Jello water, water, Pedialyte™ or electrolyte replacing fluids NO DAIRY if fever is present).

While many over-the-counter cough and cold preparations are not suitable for children, always read the directions and follow the dosing guidelines for children and adults. If there are no guidelines for your child (due to being younger), always contact a healthcare professional for dosing guidelines. KNOW YOUR CHILD’s WEIGHT!

TREATMENT (Influenza or Flu)

Characteristics and symptoms of the Flu are very similar to the common cold. The flu is treated with antiviral drugs. Currently there are two Food and Drug Administration (FDA) approved  and Centers for Disease Control (CDC) recommended antivirals used to treat influenza illness. These are Tamiflu® and Relenza®. Tamiflu® is available as a pill and in liquid formulation, while Relenza® is an inhaled powder. Relenza® should not be taken by anyone who has difficulty breathing or any illness characterized by difficult breathing such as asthma, Chronic Obstructive Pulmonary Disease (COPD), etc.

  • When should antiviral drugs be taken? Studies show that the best results are achieved when flu antiviral drugs are started within one to two days of getting ill. Starting them later is helpful, especially if you already have a high risk condition, e.g. Asthma, blood disorder (e.g. Sickle Cell Anemia), COPD, cystic fibrosis, congenital heart disease, kidney or liver disorders, metabolic disorders, morbid obesity, a weakened immune system (e.g. HIV, AIDS or cancer). Other individuals who are at high risk are, adults over 65 years and pregnant women.

How can you tell the difference between a cold and the flu?

Because colds and flu share many symptoms, it can be difficult (or even impossible) to tell the difference between the two based on symptoms alone. Special tests that are usually done within the first few days are needed to determine which illness you have. In general, the flu is worse than the common cold. Symptoms such as fever, body aches, extreme tiredness and dry cough are more intense. Colds are milder and are more likely to be accompanied with a runny or stuffy nose. Colds do not generally result in serious health problems such as pneumonia, bacterial infections or hospitalizations.

World AIDS Day

November 30, 2013 by Legalized Pill P.U.S.H.A.

HIV Basics – HIV stands for Human Immunodeficiency Virus. It is the virus that can lead to Acquired ImmunoDeficiency Syndrome (AIDS). Unlike some viruses that humans contract, you cannot get rid of HIV. Once contracted you have it for life. HIV is spread through the body fluids. It attacks specific cells called CD4 or T cells. Over a time the virus destroys so many of these cells (the HIV replicates so much faster than the CD4 or T cells) that the body can no longer fight off infections and disease. When this happens, the HIV infection leads to AIDS. world_aids1

Where does HIV come from? – That’s the $64,000,000 question. However, scientists identified a type of chimpanzee in West Africa as the source of HIV infection in humans. They believe that the chimpanzee version of the immunodeficiency virus (called simian immunodeficiency virus, or SIV) most likely was transmitted to humans and mutated into HIV when humans hunted these chimpanzees for meat and came into contact with their infected blood. Studies show that HIV may have jumped from apes to humans as far back as the late 1800s. Over decades, the virus slowly spread across Africa and later into other parts of the world. We know that the virus has existed in the United States since at least the mid- to late 1970s. Because this virus has the ability to constantly mutate (change), it has been a challenge to develop a vaccine.

STAGES OF HIV:

Acute Infection – Within 2 to 4 weeks after being infected an individual can feel sick, characterized by flu-like symptoms. This is called, acute retroviral syndrome or ARS (not everyone develops ARS and not everyone is symptomatic). Scary! During this time the body is mass producing the HIV and it is using the CD4 cells to replicate itself, thus destroying them in the process (the CD4 cells are cells that help to fight infection). Your CD4 cell count drops during this period. While an individual is capable of spreading the virus at anytime once infected, during this stage the probability of infection is greatest. Eventually your body’s immune response will attempt to control the amount of HIV being produced and your CD4 count will begin to rise again, but it probably will not rise above or equal to your pre-infection levels.

Clinical Latency – During this stage, the HIV is slowly being produced or dormant. The individual is still able to pass on the infection. How long this stage last is indeterminate. Individuals on anti-retroviral therapy (ART) can live for decades. Individuals who choose not to institute ART this stage may last one decade or less. Although as stated previously, this stage is indeterminate at best, and best practices recommends ART.

AIDS – This stage of the infection occurs when your immune system becomes badly damaged and you become vulnerable to infections and/or infection related cancers. Your CD4 cell counts drops again. Once the CD4 cell counts drops below 200 cells/mm3 you are considered to have progressed to AIDS. Without treatment, people diagnosed with AIDS survive about 3 years. Once someone has a dangerous opportunistic infection, life expectancy without treatment falls to about 1 year. People with AIDS need medical treatment to live.

How can you tell if you are infected with HIV? – The only way to know if you’re infected is to be tested. You cannot rely on the symptoms to tell you if you’re infected with HIV because the symptoms are common to other diseases. Some individuals do not exhibit any symptoms at all.

How can I find a testing site? – There are several ways you can find a testing site.

  • You can call 1.800.CDC.INFO (1.800.232.4636) and ask for testing sites in your area
  • You can text your zip code to: KNOWIT (566948)
  • There are two types of tests available to you in most drug stores or pharmacies:
    • One involves pricking your finger and sending off the blood sample to a lab and call in for your results
    • One test involves swabbing your mouth and using the test kit to get the results after waiting 20 minutes.
  • You can always ask your healthcare provider to order the test. ALL HIV Testing Results are CONFIDENTIAL

HIV Transmission – Only certain fluids—blood, semen (cum), pre-seminal fluid (pre-cum), rectal fluids, vaginal fluids, and breast milk—from an HIV-infected person can transmit HIV. These fluids must come in contact with a mucous membrane or damaged tissue or be directly injected into the bloodstream (from a needle or syringe) for transmission to possibly occur. Mucous membranes can be found inside the rectum, the vagina, the opening of the penis, and the mouth. This means that having unprotected sex vaginally or anal with an HIV infected person can result in you becoming infected with the virus. You can become infected with HIV if you share needles with a person who is HIV positive. Mothers who are HIV positive can pass the HIV virus to their unborn babies, if ART is not initiated as early as possible during the pregnancy.

Is there a cure for HIV? – For most people the answer is no! Others have reported a cure when they received a treatment for a cancer that would have killed them otherwise, or when tested for HIV after decades of ART there is no HIV detected. It is important for all to understand that once the virus has been detected you are infected and you can pass the infection to others.

 

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