April 12, 2012
We just passed our 3 year transplant anniversary on Easter Sunday and we are heading to VCU on Sunday to check into the hospitality house and get ready for a near week of lab and doctor appointments while they bring Kurt off the Teleprevir. His 12 weeks will be done~! They will keep him there so they can adjust his immuneo suppressant drugs as they wean him off the Teleprevir. We don't want any issues with rejection. I ask those of you who will, to pray for him next week as this process entails.
March 26, 2012
We met with Dr. Stravitz Monday as Kurt started week 10 of the triple tx. All levels look good and they do not want to see us back for another 3 weeks. At that time we will check into the hospitality house because they will be weaning Kurt OFF the Teleprevir over the course of several days and want to keep an eye on him so there are no complications. YAY! Finally will be off the third drug and the doctor said Kurt WILL feel better, though, Kurt says, it's the interferon that he's looking forward to getting off. The doctor said that they are really having breakthroughs with the interferonLESS treatments. Too bad Kurt couldn't have waited for them to get those treatments down pat, but, it is what it is and we are grateful that this triple tx is doing what it's suppose to do!
March 20, 2012
Kurt started week 9 of triple tx with Incevik. He feels bad, but doesn't complain much. I just look at him and my heart hurts for him. He is working 40 hour work week and even though it's "light duty" by the end of the week he is wore out and then it's time for another interferon shot :( He says he can't look too far ahead because it is overwhelming, so he stays focused on doing one thing at a time, one day at a time and here he is at week 9. Three more to go of the telepravir and then the doctors will stop that drug. Hopefully, it will bring some relief to him to be off it.
He's got a good routine down to help him. Up for first round of immuneo and treatment drugs at 7am with breakfast. (making sure he has at least 20 grams of fat with this meal as he is taking the telepravir along with everything else.) He rests for about 40 minutes while he digests and gets his thoughts ready for the day. Sometimes he reads his bible, sometimes he just listens to some uplifting music, sometimes he naps. I get his clothes ready while he is resting. We found that if he is better prepared and not looking for matching socks or that special shirt he has more time to prepare mentally for the day. A shower, a walk in the garden with our little Zoe girl and then he is off to work with a wave and a smile.
For lunch he will come home where he is also able to close his eyes for a few minutes and refocus. We are fortunate he works only a couple miles from home. He will take his 3:00 meds at work, along with an avacado or cheese and crackers as this snack requires another 20 grams of fat.
When he gets home from work he usually goes to bed for a bit before dinner. He has another round of meds at 7pm and then the telepravir at 11pm. That's how we're rolling with the schedule right now. It works for us. One thing we have laughed about is the fact that since I got laid off in November (the same month Kurt started treatment) it has worked to his advantage with me being so available to help him. Still, I sure wish Publisher's Clearinghouse would hurry up and come with my big check to pick up the slack :)
March 13, 2012
Kurt started week 8 of Incevik (Telepravir) and at his clinic appointment today was told his labs indicate no changes from last appointment. This is good news as the triple treatment is still working! However, we learned that even though he finishes the Incevik in four more weeks (it's a 12 week protocol) he will continue to take the peg/riba treatment until November. He was very disappointed to learn that as the interferon makes him feel like he has the flu all the time. But, we know we can't complain too much, because the treatment IS working! So, won't complain, just report and continue on continuing on :)
March 6, 2012
Kurt went back to work today. Dr. says light duty only for now. He has been on sick leave since starting the treatment in hopes he would have the majority of it done before returning to work. Because there was a delay of about a month in starting him on the Incevik, that wasn't the case. So, though still easily fatigued and experiencing body aches as side effects of the treatment, he has been able to "push" through and get a full day's work in. This excited him very much, feeling like a big mile stone was passed. We are more than half way through the triple tx.
MARCH 2, 2012
Week 6 on the teleprevir and got our second RNA report indicating negative viral load!!! Dr. Stravitz's exact words..."AMAZING!" He said whatever we are doing, keep doing it. When we said "prayer and faith!" he said "keep believing because it's working!" Wow, so good to hear the docs so excited. In fact, we were asked to get the word out to the media so others would know there is hope in this treatment.
WTKR news 3, (the news team with heart) interviewed us on Wednesday and put it on the local news two days in a row. The local Smithfield Times paper interview was today. We are so thankful to not only be recipients of this breakthrough treatment and want others to know of it's availability.
FEBRUARY 8, 2012
Kurt started the protocol in November with interferon/ribavirin therapy and Telaprevir was added 3 weeks ago. We stayed in Hospitality House to go to daily labs at VCU for a week. They monitored Kurt closely. We return weekly for labs and doctor visit to make sure Kurt's levels are acceptable. Side affects are taking their toll, fatique, aches, trouble sleeping, etc. but nothing he can't "push through" he says. In fact, some of the more serious sides he has not had and the doctor is very optimistic about that. Now for the GOOD news......Kurt's labs results on Monday was that the telaprevir is already doing it's job and there is no evidence of the Hep C virus in his system. Zero, negative! Dr. Stravitz was elated saying that what normally takes longer to happen, with Kurt has already and that is a great indicator that he will be a responder to this drug regiment. For now, he continues with protocol, 12 total weeks of telaprevir continuing the interferon/ribavirin afterwards. So it's not over yet, but at the end of treatment and after 6 months they re-test Kurt, if he is negative virus, then he is officially cured! Amazing! We are so humbled by God's goodness, His connectiions, His timing. We were told in 2011 that the virus was aggressively attacking Kurts new liver and already there was fibrosis. They gave him about a 2 year window before his liver would be failing. This new drug therapy was just FDA approved in May 2011, but, it hadn't been used on post transplant patients, only pre-transplant patients who were healthy enough to undergo the hard hitting drugs. God brought so many factors together for Kurt to even be considered for this therapy. We are so thankful.
Side affects from triple tx so far: fatigue, (Kurt sleeps A LOT) body aches all over, brain fog (not able to concentrate) anxiety, runny nose. ALL side affects except fatigue and body aches were gone within the second month. Kurt has learned when to schedule his rest and to take it when he has to. He rarely has to take a Tylenol for body aches but says, he still feels them.
March 13, 2012
CROI 2012: HIV/HCV Coinfection News from CROI 2012 [VIDEO]
[Liz Highleyman, Douglas Dieterich, and Kenneth Sherman, CROI 2012 interview, Seattle, March 8, 2012. Video footage courtesy of IFARA]
Provided by HIVandHepatitis.com
Published on Monday, 12 March 2012 00:00 Written by Gregory Fowler
Hepatitis C was a major topic at the 19th Conference on Retroviruses and Opportunistic Infections (CROI 2012) last week in Seattle. Liz Highleyman from HIVandHepatitis.com spoke with Douglas Dieterich and Kenneth Sherman about advances in the field, with a focus on HIV/HCV coinfected patients.
The attention this year was apt, since an estimated one-third of people with HIV are coinfected with hepatitis C virus (HCV). Dieterich and Mark Sulkowski presented the first data on sustained virological response (SVR) using the recently approved HCV protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek) plus pegylated interferon/ribavirin in HIV/HCV coinfected patients.
Researchers also discussed drug-drug interactions between HCV direct-acting antivirals (DAAs) and antiretroviral agents, as well as interferon-free combinations that may be available in the future.
3/12/12
Source
L Highleyman, D Dieterich, and K Sherman. HIV/HCV Coinfection News from CROI 2012. IFARA interview, Seattle, March 8, 2012.
Source
AHF Asks 'What's Rotten at FDA?' in New Politico Playbook Ads
PRESS RELEASE
March 13, 2012, 6:00 a.m. EDT
According to AHF, the FDA spied on its own scientists and doctors, shows little or no transparency and granted fast track review to Gilead Sciences for its application for use of its blockbuster AIDS treatment, Truvada, as a form of 'Pre-exposure Prophylaxis' (PrEP) for use as an HIV prevention pill in uninfected individuals despite dubious studies supporting the application
WASHINGTON, Mar 13, 2012 (BUSINESS WIRE) -- --In response, AHF expands advocacy campaign targeting the FDA and Gilead with a new online banner ad asking, "What's Rotten at FDA?" on the Politico.com website and Mike Allen's Politico Playbook; public is invited to send e-letters to HHS Secretary Kathleen Sebelius asking her to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA
As part of its ongoing effort to ensure that the Food and Drug Administration (FDA) does not hastily approve Gilead Sciences' controversial application for expanded use of its blockbuster AIDS treatment, Truvada, as a form of HIV prevention in uninfected individuals, AIDS Healthcare Foundation (AHF) this week expanded its media and advocacy campaign targeting the two parties with a series of pointed online text and banner ads on Mike Allen's Politico Playbook on Politico.com asking, "What's rotten at FDA?" The banner ad runs in the online version of Politico Playbook March 12 through March 16. In addition, text ads embedded into Allen's editorial content will run each of those days. The 'What's rotten...' banner ad directs people to a website where the public may send e-letters to H.H.S. Secretary Kathleen Sebelius asking her to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA.
"In January, the FDA was sued for spying on its own scientists and doctors. In February, it announced it was fast tracking consideration of expanded use of Gilead's AIDS treatment, Truvada, as a possible HIV prevention pill drug despite numerous failed clinical trials for that purpose. Overall, it has shown little or no transparency in its dealing with the public--this, in a presidential administration that has vowed to be the most transparent in history," said Michael Weinstein, President of AIDS Healthcare Foundation. "Something is certainly rotten at the FDA and through these ads and this campaign, we hope to shine a bright light on it."
On December 15, 2011, Gilead issued a press release formally announcing that it had filed an FDA application to expand use of Truvada as a form of HIV prevention; however, no date of the application was included in Gilead's statement. On February 13, 2012, Gilead announced that FDA had granted its fast track application for consideration of Truvada as a form of 'Pre-exposure Prophylaxis' (PrEP) for use as an HIV prevention pill in uninfected individuals despite dubious studies supporting the application.
AHF's What's rotten at FDA? Advocacy advertisements on Mike Allen's Politico Playbook, March 12-16
Text of Ad #1 What's Rotten at FDA? ** A message from AIDS Healthcare Foundation: What's rotten at FDA? The U.S. Food & Drug Administration refuses to release documents regarding contact with drug company Gilead Sciences about the drug Truvada for HIV prevention. The FDA is now hastily considering approving this drug despite several failed clinical trials. More info at www.nomagicpills.org . **
53 words
** A message from AIDS Healthcare Foundation: Something is rotten at the FDA when the agency is hastily considering approving an HIV prevention drug despite serious concerns about safety and effectiveness. Current studies show that patients failed to take the drug (Gilead Sciences' Truvada) daily, a precondition for effectiveness. There is also a significant risk that the people who take it haphazardly will mistakenly believe they are protected from HIV and other STDs and behave recklessly, increasing the number of new infections. The agency has refused to release documents regarding its contact with Gilead. What do they have to hide?
The mismanagement at FDA reaches beyond HIV. The Washington Post reported that the agency's own scientists are suing because the FDA secretly monitored the personal e-mail of a group of internal "whistle-blowers." Clearly, the FDA can no longer fulfill its mission to protect the public health.
What is rotten at FDA? More info at www.nomagicpills.org . **
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Text of Ad #2 What's Rotten at FDA?--No Transparency ** A message from AIDS Healthcare Foundation: AIDS advocates and doctors warn that FDA's hasty review of Gilead's Truvada for HIV prevention threatens the safety of the American public. The FDA is ignoring this warning, claiming that its drug review process "is not a participatory process," and the "premise that FDA's review of a pending drug application should be transparent is also wrong." More info at www.nomagicpills.org .
67 words
** A message from AIDS Healthcare Foundation: Something is rotten at the FDA when the agency is hastily considering approving an HIV prevention drug despite serious concerns about its safety and effectiveness. AIDS advocates and the medical community have loudly warned that this drug (Gilead Sciences' Truvada) has failed to prevent HIV in multiple clinical trials, and carries an increased risk of kidney damage for people who take it.
In response to these concerns and calls for greater transparency at FDA, the agency says that its drug review process "is not a participatory process," and that the "premise that FDA's review of a pending drug application should be transparent is also wrong." FDA has also refused to release documents regarding its close contact with Gilead. What do they have to hide?
More info at www.nomagicpills.org .
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Text of Ad #3 What's Rotten at FDA?--Spying ** A message from AIDS Healthcare Foundation: What's rotten at FDA? Spying. The 'Washington Post' reported the FDA secretly monitored personal e-mail accounts of some of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients. More info at www.nomagicpills.org .
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** A message from AIDS Healthcare Foundation: The Post said the surveillance, unearthed by six of the scientists and doctors, who then filed a federal lawsuit against the FDA, took place over two years as the group accessed their personal G-mail accounts from government computers. This behavior took place at the highest levels of the FDA during the Obama administration--which vowed to be the 'most transparent' in history. Now, FDA is considering fast track approval an HIV prevention drug despite serious concerns about its safety and effectiveness, which might actually result in MORE HIV infections. Why? People may think they are fully protected when they are not, and may not use condoms, a proven HIV prevention method 95% effective when used correctly and consistently. Something is rotten at FDA--jeopardizing the health and safety of the American people--the very people FDA is charged with protecting. More info at www.nomagicpills.org .
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Background on Gilead and the FDA
Gilead is seeking FDA approval to market the AIDS drug, Truvada, as a means of Pre-Exposure Prophylaxis, or PrEP. The idea behind PrEP is that people who do not have HIV may protect themselves against HIV infection by taking Truvada, which is already approved as a daily treatment for people infected with HIV or living with AIDS. While early studies saw some initial potential, more recent studies have been halted because the drug has shown little or no preventative effect. In addition, a study released this month found that people who take Truvada are at higher risk for kidney disease and long-term kidney damage that persists even after they stop taking the drug.
AHF strongly opposes Gilead's application because the science does not yet demonstrate that Truvada for HIV prevention is safe or effective. While some studies claim to show a limited preventive effect (only 44%), other studies have been halted because PrEP was not shown to be any more effective than a placebo. A primary reason for these poor results is the failure of study participants to take the drug daily, a precondition for PrEP to have any preventive effect. When this occurs in a "real world" setting, people will not only be at higher risk for developing drug resistance, but we will see an increase in HIV infections.
The alleged mismanagement at FDA reaches beyond HIV. In January, the Washington Post reported that the agency's own scientists are suing the agency because "the [FDA] secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients." Clearly, the FDA can no longer fulfill its mission to protect the public health by ensuring that our food, drugs and medical equipment are safe and do not cause harm to the public.
For more information, please visit www.nomagicpills.org .
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 135,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare
SOURCE: AIDS Healthcare Foundation
New finding could lead to improved treatments for liver disease
Updated: 2012-03-12 15:59:55 CST
For individuals who have received liver panel test results indicating they have serious liver disease, the only long-term solution to their problem is a transplant. However, a team of Scottish researchers may have found a way to address the condition without requiring liver transplant.
Investigators from the University of Edinburgh found that it is possible to alter the expression of certain genes in early-stage liver cells. This causes the cells to develop into hepatocytes rather than bile duct cells.
In advanced stages of liver disease, doctors have found that a person's liver is choked with bile duct cells. This is thought to be one of the main causes of the health problems that accompany the condition. On the other hand, hepatocytes play an important role in detoxifying the liver. They are known to be very scarce in a person with liver disease.
"This research helps us know how to increase numbers of cells that are needed for healthy liver function and could pave the way for finding drugs that help liver repair," said lead researcher Luke Boulter. "Understanding the process in which cells in the liver are formed is key in looking at ways to repair damaged liver tissue."
Hepatitis C Infection Increasing Among Adolescents, Young Adults
By: SHARON WORCESTER, Family Practice News Digital Network
03/13/12
ATLANTA – The incidence of hepatitis C infection is increasing among adolescents and young adults in Pennsylvania, just as it has in other areas in the United States, according to surveillance data for 2003 through 2010.
During that 7-year period, the number of reports of newly recognized confirmed or probable cases of hepatitis C past or present infection among those aged 15-34 years increased from 1,384 to 2,393, representing a near doubling of the rate of cases (from 43 to 72) per 100,000 population, Dr. Sameh W. Boktor reported in a poster at the International Conference on Emerging Infectious Diseases.
The rates in other age groups, however, declined during this time period.
For example, the overall rate of newly reported cases for all age groups combined declined from 85 to 72 per 100,000 population, and the rate of cases among those aged 45-64 years declined from 185 to 142 per 100,000 population, said Dr. Boktor of the Pennsylvania Department of Health, Harrisburg.
The increases in the adolescent and young adult age groups are likely caused by high-risk behaviors, such as intravenous drug use and unprotected sex between men – and, to a lesser degree – unprotected heterosexual sex.
"We know high-risk behaviors are common in this age group," Dr. Boktor said, noting that evidence suggests such high-risk behaviors are increasing among residents in rural areas, and the increases in cases of hepatitis C among adolescents and young adults in this study were greater in rural areas, compared with two large urban centers.
This finding, however, should be interpreted with caution because of the small population in rural counties; targeted studies may shed more light on this apparent trend.
The data for this study were derived mainly from laboratories via electronic reporting. Age-specific rates of reported cases were calculated and compared over time, as were demographic and spatial characteristic, Dr. Boktor said.
The findings, which are similar to those from Massachusetts and other areas, are of concern, because hepatitis C infection is the leading cause of advanced liver cirrhosis and liver cancer in the United States. They indicate a need for increased attention to prevention in the adolescent and young adult population.
"We need to work more on characterizing risk factors, and we need to work more on developing effective prevention strategies in this very productive age group," Dr. Boktor said.
He noted that these findings "almost certainly underestimate the real impact of viral hepatitis," because they reflect only those patients with access to testing, and whose results are reported.
Dr. Boktor said he had no relevant financial disclosures.
Medivir Announces New Studies in Phase III Program for TMC435
PRESS RELEASE
March 13, 2012, 4:02 a.m. EDT
HUDDINGE, Sweden, Mar 13, 2012 (BUSINESS WIRE) -- Regulatory News:
-- Study in previous non-responder Hepatitis C genotype-1 infected patients
-- Study in Hepatitis C genotype-4 infected patients
MedivirAB (sto:MVIRB) (omx:MVIR) a research based specialty pharmaceutical company focused on infectious diseases announces that its oral, once daily investigational protease inhibitor TMC435, developed by Janssen Pharmaceuticals for the treatment of Hepatitis C virus (HCV), has commenced patient dosing and started screening in two new phase III clinical trials, HPC3001 and HPC3011, respectively.
HPC3001
HPC3001 is a phase III efficacy, safety and tolerability study comparing TMC435 versus telaprevir, each in combination with Pegylated Interferon a-2a (PegINF) and ribavirin (RBV), in hepatitis C genotype-1 infected patients who were null or partial responders to prior PegINF/RBV therapy. The study which is a randomized, double-blind, double-dummy, two-arm study is targeted to enroll 744 patients.
The aim of the study is to demonstrate the efficacy of TMC435 based therapy compared to the approved telaprevir regimen in this difficult to treat population.
Patients will receive TMC435 150 mg once daily or telaprevir 750 mg administered every eight hours (q8h) in combination with PegINF/RBV for 12 weeks followed by 36 weeks of PegIFN/RBV alone. The primary endpoint of the study is sustained virological response at 12 weeks (SVR12).
HPC3011
HPC3011 is an open label, single arm phase III trial to explore the efficacy, safety and tolerability of TMC435 150 mg once daily, in combination with PegIFN/RBV in 100 treatment naive or treatment experienced, Hepatitis C genotype-4 infected patients.
Current standard of care treatment for chronic HCV genotype-4 infection consists of 48 weeks of PegIFN/RBV with a large proportion of patients do not achieve SVR with this treatment regimen.
All subjects will receive 12 weeks triple therapy of TMC435 150 mg once daily and PegIFN/RBV, followed by PegIFN/RBV alone. The duration of total treatment is response guided in treatment naive and prior relapser subjects and patients are eligible to stop all treatment at week 24 if predefined response-guided criteria are met. Subjects with cirrhosis will receive 48 weeks of therapy, irrespective of on-treatment virologic response and treatment history. The primary endpoint in the study is SVR12.
TMC435 - Ongoing global phase III program in brief:
-- TMC435-C208 or QUEST-1 in 375 treatment-naive genotype-1 patients
-- TMC435-C216 or QUEST-2 in 375 treatment-naive genotype-1 patients
-- TMC435-C3007 or PROMISE in 375 genotype-1 patients who have relapsed after prior interferon-based treatment
-- Phase III program in Japan, includes 417 genotype-1 treatment naive and treatment experienced patients
Charlotte Edenius, Executive VP Research and Development, of Medivir commented, "We are extremely pleased to expand the phase III program with these two new trials as we continue development of TMC435 for broad patient populations. The 744 patient HPC3001 study is aimed at further confirming the positive findings of the ASPIRE phase IIb trial in genotype-1 non-responder patient populations and in the HPC3011 study, the genotype-4 activity of TMC435 is being investigated."
About TMC435
TMC435 is an investigational HCV protease inhibitor in late phase III clinical development. It is an efficacious, safe and well-tolerated once-daily (q.d.) drug jointly developed by Janssen Pharmaceuticals to treat chronic hepatitis C virus infections.
TMC435 is in phase III clinical development in combination with PegIFN/RBV but is also being evaluated with Direct-acting Antiviral (DAA) agents in interferon-free combinations both with and without ribavirin (RBV).
For additional information please visit www.medivir.com and www.clinicaltrials.gov
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is TMC435, a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Pharmaceuticals.
In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialisation of TMC435 in the Nordic markets, once approved.
Medivir's first product, the unique cold sore product Xerese(R)/Xerclear(R), was launched on the US market in 2011. Xerese(R)/Xerclear(R), which has been approved in both the US and Europe, is being launched in collaboration with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights in North America, Canada and Mexico were sold to Meda AB in June 2011. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: www.medivir.com
This information was brought to you by Cision http://www.cisionwire.com
SOURCE: Medivir
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