In November, the US Food and Drug Administration (FDA) approved simeprevir, a new oral drug, to treat the hepatitis C virus (HCV). Olysio, manufactured by Johnson & Johnson, is a protease inhibitor that halts the progression of HCV, preventing it from reproducing. The drug is used in combination with weekly injections of pegylated interferon (peg-IFN) and a daily ribavirin (RBV) oral pill.
In May 2011, the FDA approved the first protease inhibitors, Merck’s boceprevir (brand name Victrelis™) and Vertex Pharmaceutical’s telaprevir (brand name Incivek™). At the time, these two drugs represented the first new HCV therapies in ten years.
In clinical trials, Olysio was evaluated in combination with peg-IFN and RBV. The therapy is intended for adults with compensated liver disease (diseased liver that is still functioning), including cirrhosis, who have not received treatment for their infection (treatment naïve) or for whom previous treatment has not been effective (treatment experienced).
The 2,026 patients enrolled in the five clinical trials were treated for 24 weeks. The results showed that 80% of the treatment-naïve patients who were given Olysio plus peg-IFN/RBV demonstrated sustained viral response (SVR), meaning they no longer had detectable virus in their blood. Of the treatment-experienced patients on the same regimen, 79% achieved SVR. In contrast, only 37% of the remaining group, those on peg-IFN/RBVonly, displayed SVR.
The most severe side effects from the combination of Olysio and peg-IFN/RBV were itching, nausea and a severe photosensitivity rash. Olysio will have a warning on its label about the danger of sun exposure while on the drug.
Several pharmaceutical companies are pursuing alternatives to the existing standard of treatment for HCV, the combination peg-IFN/RBV, because nearly 50% of patients do not respond to it. In addition, those who do respond often experience debilitating side effects that can last the duration of the treatment—either 24 or 48 weeks. Interferon-free regimens should eliminate some of the most severe side effects.
“Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The FDA approved sofosbuvir, an investigational HCV therapy manufactured by Gilead Sciences, Inc., on December 6, 2013. Sofosbuvir is a daily oral nucleotide analogue inhibitor composed of a small molecule compound that blocks HCV’s ability to replicate.
If approved, sofosbuvir, taken in combination with RBV, would be the first all-oral treatment for two forms of HCV, genotypes 2 and 3, representing as many as 25% of HCV patients. HCV has six genotypes. In the US, patients with genotype 1 account for about 70% of those with HCV.
In the spring of 2013, the FDA granted priority review for sofosbuvir. Priority review is to drugs that potentially offer significant advantages over existing treatments.
Sources: Bloomberg News, November 23, 2013; FDA news release.
The Hemophilia Foundation of Greater Florida and the Florida Hemophilia Association are excited to announce the formation of the Bleeding Disorder Coalition of Florida, a collaborative advocacy group comprised of the two chapters, the state’s Hemophilia Treatment Centers and the bleeding disorders community at large.
The mission of the Bleeding Disorder Coalition of Florida is to preserve access to quality and affordable health care for all Floridians affected by bleeding disorders. In order to accomplish its mission, the Bleeding Disorder Coalition of Florida will educate necessary parties about bleeding disorders; develop and maintain relationships with key decisionmakers; cultivate relationships with organizations that have similar goals; inform consumers about its resources at all levels of government; and inform decision makers of the effects of legislation on persons with bleeding disorders and their families.
Meet the co-chairs of the coalition:
Francis Aracena is an alumna of Miami-Dade College, who graduated with a degree in Political Science. She developed a passion for advocacy while serving as President of the Student Government Association. Her interest in the law, justice and equal opportunity has led her to a new venture: applying to law school! Inspired by her twelve-year-old brother Stephen (who has severe Hemophilia A with an inhibitor), she hopes to pave the way for accessible and affordable health care for those affected by bleeding disorders in the state of Florida while serving as a founding Co-Chair of the BDCF.
Sara Workman lives in the Tampa area with her husband Michael, two sons (Noah, 15 and Evan, 6) and their three dogs. Her passion for advocacy comes from her son Evan's diagnosis with severe Hemophilia A. In the last six years, she and her family have learned many important lessons about living with hemophilia, and the effects it has on her family’s lives. That has inspired her to ensure that this small community of people has a voice. She is proud to be a founding Co-Chair of the BDCF and looks forward to educating, advocating, and making a difference for the Bleeding Disorders Community.
The New Year is finally here: 2014! Last year, HFGF gave Part I & Part II informative presentations of the Affordable Care Act in Tampa, Miami, Orlando, Gainesville, Jacksonville, and Fort Myers. Program speakers from Florida Blue and Health Insurance Brokers gave important information and provided immediate enrollment in the Marketplace, thereby avoiding enrollment problems that came about during the launch of the official www.healthcare.gov website.
In the paragraphs below, there is important information for you to use to gain more understanding about the Marketplace and where the state of Florida fits in the new healthcare system.
Floridians Leading the Nation in Federal Marketplace Applications
A report from the U.S. Department of Health and Human Services (HHS) released December 10, 2013 states Floridians have signed up for federal Marketplace plans in greater numbers than in any other state. The HHS report indicates that more than 281,000 Floridians had applied for coverage by the end of November. Additionally, over 75,000 Floridians have already been determined eligible to enroll in a Marketplace plan with financial assistance, more than in any other state so far. Read more coverage about health coverage enrollment from the Associated Press in The Tampa Tribune (Published:December 11, 2013. |Updated:December 11, 2013 at 07:13 PM.)
As you know, the deadline for enrollment in the Marketplace was December 23, 2013, and the last day to pay for the 1st premium was December 31, 2013 in order for your insurance to be effective on January 1, 2014. Because of the computer glitches, the President extended the date for premium payment to January 1, 2014. Coverage will be in effect on this day.
Key Date to Remember
The Affordable Care Act Brings Improvements to the Coverage Safety Net Medicaid Program in 2014
Although the Florida Legislature has yet to expand Medicaid, stranding hundreds of thousands of low-income, uninsured Floridians with no hope for coverage, a small number of residents who didn't qualify in 2013 may still be eligible starting January 1, thanks to automatic Affordable Care Act changes that are unrelated to expansion.
These changes are part of a “No Wrong Door” system” (three Insurance Affordability Programs that will help low- and middle-income Floridians get and keep good health coverage. Eligibility for each program is determined by a different entity. This benefit is often an overlooked component of the ACA that will result in real-time eligibility determination and eliminate “falling through the cracks” between programs. Under No Wrong Door, Floridians will be enrolled in the coverage they’re eligible for (family-related Medicaid, CHIP or Premium Tax Credits in the Marketplace), even if they applied for a different program.
To implement No Wrong Door, some rules were changed in Medicaid and CHIP. For one, all programs now use (almost) identical applications; Florida’s new application debuted on December 23, 2014. Also, all three programs count and calculate income the same way, using a method called Modified Adjusted Gross Income (MAGI). Some Floridians may be newly eligible because of MAGI, including some parents who receive child support or have limited savings. Read more by going to www.fcfep.org Florida Center for Fiscal and Economic Policy or send questions and stories of your experiences with the Marketplace email@example.com. You can also call toll-free 1-855-FLCHAIN (352-4246).
Time Running Out for Health Care Expansion!
The clock is ticking, and there are only 11 days left until Florida begins losing billions of valuable federal health care expansion dollars. When the time runs out, hardworking Floridians will be left stranded with no health care option. In Florida, an estimated one million individuals would qualify for Medicaid coverage under a newly expanded program. These individuals are working, fall just above the current Medicaid eligibility, but still cannot afford private insurance.
A recent report on what states stand to gain or lose in Medicaid expansion says that while Florida is not only forfeiting $9.6 billion in federal tax dollars by rejecting Medicaid expansion, it will also be sending close to $5 billion of Florida tax revenue to subsidize health care in other states. Read more about what Florida is losing by going to HealthNewsFlorida.org.
Recall of Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks Due to Potential Bacterial Contamination
The FDA and Triad Group, Inc., a manufacturer of over-the-counter alcohol swabs, have recalled lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks that have private labels but are all manufactured by Triad Group, Inc. The products are marked as sterile and nonsterile. For a list of the third parties on the label, read the FDA release.
The reason for the recall is a potential contamination of these products with Bacillus cereus, a bacterium that causes food poisoning. Use of these products can be life threatening, especially for immune suppressed and surgical patients. If any of your alcohol swab products list the Triad Group, Inc., as the manufacturer, do not use them. Return them to the product distributor. Contact your hemophilia treatment center or healthcare provider if you have used any of these products and are experiencing any adverse side effects, such as fever or other signs of infection.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS online, please go to: http://www.patientnotificationsystem.org
This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommend that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.
The Hemophilia Foundation of Greater Florida, a Chapter of the National Hemophilia Foundation, has been helping people with bleeding disorders since 1996. We have helped the bleeding disorders community improve their quality of life by offering programs and services to support healthier and more independent lives.
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