2012 Viral Hepatitis Conference Reveals HCV Testing Guidelines For Hepatitis C Are Not Being Followed By Either Insurance Companies Or Medical Providers

A new report of an in-depth study involving more than 30 million medical claims from both a commercial insurance provider and from Medicare suggest that current recommendations for hepatitis C virus (HCV) testing are not being followed. In fact, not only are they not being followed – they are being egregiously ignored. What is astonishing in the findings is that the adult demographic with the lowest incidence of HCV infection — young women — is the most likely to be tested. These results are according to data presented at the 2012 International Conference on Viral Hepatitis.

Once again, I have to express incredible frustration about the incompetence being shown in regards to HCV testing in the United States, With over 2 million Americans unaware that they have been infected for time periods that range anywhere from yesterday to fifty years ago, an effective awareness campaign directed at both the insurance companies and the consumer has become a necessity. It is no longer a choice with more Americans dying from HCV as oppsed to HIV since 2002.

It is not only the doctors and the consumers getting involved in the outcry. With countless millions invested, the Pharmaceutical giants are on the bandwagon as well. "The CDC is looking at changing the HCV guidelines to mandate a 1-time HCV antibody test for everybody born between 1945 and 1965," said lead analyst Camilla Graham, MD, who is vice president of global medical affairs for Vertex Pharmaceuticals.

Recent studies have suggested that the 1945 to 1967 birth cohort accounts for 81% of all people diagnosed with HCV infection. "This study was done to look at who is actually getting tested for HCV in the United States under current risk-based screening recommendations." The analysis was performed using records from the Thomson Medstat MarketScan commercial database, a resource comprising medical and outpatient pharmacy claims from employer-sponsored health insurance plans and including more than 30 million commercially insured and 3 million Medicare supplemental-insured individuals.

Making sure the results were accurate, the study used only claims made from 2004 to 2008 that have been verified. People who had undergone HCV testing were identified on the basis of Current Procedural Technology codes for HCV antibody or HCV RNA testing, birth cohort, and sex. People diagnosed with HCV infection after testing were identified with International Classification of Diseases, Ninth Revision (ICD-9) codes. "Filters were also employed to find people newly identified with HCV as of 2008," said Dr. Graham, "to get a sense of diagnosis trends."

For 2008, only 1.1% of individuals in the payer population and 1.7% in the Medicare population had been tested for HCV. "This is actually an increase from 2004, and a maximum for the study period," Dr. Graham noted. By far, more women than men are being tested. Since data continuing to accrue show that men have higher exposure to HCV and a greater likelihood of having chronic HCV infection, why are women being tested more frequently? Of the currently identified 800,000 HCV-related cases of cirrhosis in the United States, 75% are men.

In addition, only 32.8% of people born from 1945 to 1964 have been tested, even though this cohort has the highest rate of infection. In contrast, 48.2% of people born from 1970 to 1989 have been tested, although their rate of HCV infection is known to be much lower. An analysis of HCV diagnosis during the study period illustrates a displaced diligence in HCV screening. "When we look at the people who were actually diagnosed, young women have a much lower prevalence than older men." The results of this study are both disturbing and strange because they do not make sense. Why do the tested populations differ so dramatically from what we know about populations at risk and the multitude of risk factors, including age and gender?

For the birth period of 1945 to 1954, 3.5% of women and 7.4% of men were diagnosed with HCV. For 1955 to 1964, 2.9% of women and 5.7% of men were diagnosed with HCV. Medicare data show that 16.1% of men and 10.4% of women in the 1945 to 1954 cohort and 19.1% of men and 13.3% of women in the 1955 to 1974 cohort are HCV-positive. Dr. Graham expressed both her analysis and surprise in her comments: "Medicare is a more complicated population," because some patients are enrolled on the basis of disability rather than age. But again, you see a shockingly high prevalence of HCV in men. Is Medicare aware of this serious HCV problem as the leading edge of the boomers are entering the program?"

Why are so many young women being tested? The most likely answer is prenatal testing because of pregnancy rates. The truth is not that the medical community is so concerned that young women have HCV, but that they are simply following medical procedures that have been instituted as safeguards. Without question, HCV awareness and testing is on the back burner of health issues. How many people have to die unnecessarily before this changes?

More Hepatitis Conferences On The Horizon Around The World

Vertex, Boehringer Ingelheim, Other Pharmaceutical Giants Racing To Get Interferon-Free Hepatitis C Treatment Through Clinical Trials And To The Marketplace

Determined to try and keep pace with rival hepatitis C treatments in the pipeline by Boehringer Ingelheim and a rash of other pharmaceutical giants, Vertex ($VRTX) today unveiled a slate of somewhat positive interim midstage results for an all-oral combo regimen that includes its game-changing drug Incivek along with the experimental VX-222--its non-nucleoside polymerase inhibitor--and ribavirin.

Cutting Edge Interferon Free Hepatitis C Treatments

The previous standard goal for new hepatitis C drugs is the sustained elimination of all signs of the virus by week 12, allowing patients to stop treatment. In my clinical trial, I was normal and clear by week 4 and this allowed me to stop the brutal treatment after six months.  Researchers and drug developers are aiming for the fastest cure rates possible.

Vertex noted that 11 of 46 treatment naïve patients with the genotype 1a and 1b virus met the criteria of having "undetectable hepatitis C virus at weeks two and eight of treatment and were therefore eligible to stop all treatment at 12 weeks. " Data showed that viral loads were below the "lower limit of quantification" for 83% of the patients at week 12.

Based on the data, Vertex says it will push ahead with a Phase IIb study of the interferon-free combo, anticipating that investigators can nail late-stage data for an NDA to the FDA as early as late 2014--keeping on an ambitious development schedule. "Our ultimate goal is to develop well-tolerated, interferon-free treatment regimens with high viral cure rates and short treatment durations for people with hepatitis C," said Vertex CSO Peter Mueller. 

It is so essential for people to know about this and get tested for the virus. Over two million Americans have Hepatitis C and do not know it. Their livers are ticking time bombs that are so easy to defuse given the new medical developments. But in the general population, particularly in America, nobody knows what the hell is going on. The awareness level is close to zero and a major Act Up-like campaign that proved so effective in combating HIV is desperately needed.

 Science and health researchers have the Hepatitis C virus on the ropes. It is our job to deliver the knockout punch!

This Is So Important - Egyptians Design 'Faster, Cheaper' Hepatitis C Test

This is so important because over 2 million American citizens have Hepatitis C and do not know it. Given HCV's 20 to 30 year potential incubation period, the results of this lack of awareness are nothing less than deadly. When people experience such advanced symptoms of the effects of the virus on their livers because they have not been aware of their HCV infection, it already can be too late. And it is not easy to get a liver transplant in this country. Who possibly wants to experience such extreme health risks when it is not necessary? 

The problem is that the current Hepatitis C blood test is so expensive that insurance companies deny it more often than not. I was in the hospital for two and a half months after a car crash in 2002, I was on heroin and thus the highest risk group as a potential needle user, and I was not tested. Enough is enough! Luckily, researchers at the American University in Cairo may have swayed the tide. 

It was announced on Wednesday that a team of its researchers have designed a faster and cheaper test for all types of hepatitis C. In Egypt, over 10 million Egyptians are infected with the virus and  close to a majority do not know they are infected. The new cutting edge development "reduces the two-step testing process carried out over a number of days to a one-step process that takes less than an hour... at a fraction of the cost of traditional diagnostic protocols," the university said.

The New Blood Test Is Inexpensive And Fast - One Day, Not Two

The liquid chemistry test now diagnoses hepatitis C using gold nanoparticles. "Our test is sensitive and inexpensive, and it does not need sophisticated equipment. Detecting HCV during the first six months raises the recovery rate to 90 percent. Little is done on the national level to combat the alarming prevalence of hepatitis C in Egypt" said Hassan Azzazy, professor of chemistry and head of the research team.

The AUC said Egypt has about 10 million people who suffer from the hepatitis C virus (HCV), with the blood-borne pathogen infecting almost 500,000 every year in Egypt. It is a staggeringly high rate of infection. Worldwide, around 170 million people are estimated to be living with the chronic disease caused by the virus. Unlike hepatitis A or B, most people infected with HCV cannot battle the virus with their own immune system. Once it starts affecting the liver and as it evolves, HCV morphs into stronger variants.

The World Health Organisation estimates that across the entire world, three to four million people are newly infected with HCV each year. The WHO says Egypt has one of the highest rates of hepatitis C prevalence in the world, putting the rate of infection in the country at 22 percent. Contamination can occur through blood transfusions, blood products and organ transplants, and the virus can also be passed on to a child if the mother is infected.

It clearly is not all about needles and sex and stigmatization. Rather, it is about poor testing and the inefficiency of third world hospitals. Let's not forget that if the blood supply is not tested effectively, the highest percentage of blood donors will always be drug addicts needing money for a fix. America started testing in 1992, Europe slowly caught up, but the Third World is far behind with no clear answers on the horizon. That is why a cheap blood test to reveal the infection is an absolute necessity, and I personally congratulate and thank the American University research team.

An Apology For Not Sharing The Miracle Of Being Cured Of Hepatitis C And A Long Silence

On March 1, 2012, I went in to Dr. Peter Ruane's office on Olympic Avenue in Los Angeles to mark the sixth month of treatment. It actually was a little over six months since I took my first dosage of the drugs on September 18, 2012. I was told I would find out the results of the clinical trials and whether or not I had been clear of the Hepatitis C virus since the 4th week of the trials. I knew that I had been clear for the past two months, but if I had been clear since the 4th week, the trials were over, and I was officially cured. I must admit I was not surprised by the answer.

John Lavitt Taking His First Dose With A Smile On 9-18-11

As I sat in the waiting room, Chris Rice, the nurse who manages the trials, entered my name into the computer database in the back offices. I literally hear a whoop of delight as Chris came running back into the waiting room with my results in hand. With tears in his eyes, jumping up and down, Chris told me that I was cured, the first one in the Los Angeles trials, and I no longer had to take the medicine anymore. Finally, after six months of pain and suffering, it was over. And I was jubilant and exhausted and speechless and calling everybody and utterly overwhelmed.

Before I go any further, I want to apologize for everyone who has been reading this blog for not letting you know sooner and for once again sinking into the morass of a long silence. There is no reason that makes any sense. I should have told you right away, even if most of you found out on Facebook or other means and ways from text messages to phone calls in which the information was shared. It was almost as if the miracle was too much to handle when it came to these words, and there was so much to say that I strangely or typically chose to say nothing. I am sorry.

The first thing I did when I heard was to call and text everyone close to me, letting them know what had happened. The love and celebratory responses I experienced took my breath away. When I went into the examination room to take off my clothes, get several vials of my blood taken once again, and have the remains of the rash and everything else examined, I was surprised by what happened next. 

Chris came in with my files and he was overflowing with happiness and joy. Although they ran both Hepatitis C and HIV clinical trials in the office, Chris told me that they had never seen someone go through such extreme side effects and not stop treatment and resign from a trial. He described as the most courageous (sometimes I think the most stupid, even being healed) patient they had ever seen, and he was so happy that the result of the trials had been successful. I was 90 to 95% certain of being cured of Hepatitis C, although my blod would have to be taken once a month for the next six months to guarantee the results. Still, I would take those odds in Vegas on any day. Chris actually told me that seeing me cured gave a sense of meaning to his work and this most recent of clinical trials for a drug that is never coming to market. Why? It has already been eclipsed.

A lot has happened in the past ten days, and I will be writing many blogs describing the strange and wonderful and surprisingly difficult experience of being cured. It is beautiful and lovely, but it is not all good and the minefields that have revealed themselves have been surprising. It is important for me to note two things now that will be described in detail later...

1. I stopped taking the drugs - the Ribavirin and the Interferon - five days before I found out my results. The sudden increase in disgusting side effects was crazy. Every time another one popped up, I would shake my head and say out loud, "Really? After all I have been through?" I knew I was cured on a holistic level that was intense and profound. I have never been so in touch with my body and I knew without question it was the right decision.
2. The first thing I did after leaving the doctor's office, after buying a bag of fresh jacima, coconut, and pineapple with a touch of chile and lots of lemon from a Mexican fruit cart, was to call everyone who had helped me through the worst times of the clinical trials when the rash would not stop itching and the staph infection was screaming and it was hell on earth. What I did was express gratitude and thank them for being there for me. When you see someone you care about suffering on such an intense level, it is hard not to turn away.

My First Hepatitis Free Los Angeles Fruit Cart Experience

Hepatits C Has Killed More People In The United States Over The Past Decade Than HIV and AIDS Or Any Other Form Of Viral Infection

Let’s be perfectly clear – the Hepatitis C virus, known as HCV, has killed more people in the United States over the past ten years than the AIDS-causing HIV virus. But HIV information and education resources are everywhere, and Hepatitis is the ignored and forgotten killer.  HCV is the leading chronic virus infection leading to death in the United States. The victims most often are baby boomers and most of them do not know they have the virus until it is too late. As many as 2 million of the 5.5 million infected American citizens do not even know they have the virus. While the fight against HIV has been championed, HCV has been allowed to invade our country and do extreme damage that we have chosen to ignore with a smile and a shrug of our shoulders.

Enough is enough!  Researchers from the US Centers for Disease Control and Prevention (CDC) found in a study published in the February 21, 2012 issue of the Annals of Internal Medicine that hepatitis C had overtaken HIV as a cause of death in the United States by 2007. Deaths in the United States due to HIV infection have been steadily decreasing, and dropped below 13,000 in 2007, while deaths from hepatitis C infection have been steadily increasing, first surpassing 15,000 per year in 2007. The good news is that the various drug combination strategies that have done so much to transform HIV infection from a death sentence to a manageable disease are poised to further boost cure rates for those infected with hepatitis C.

PERSONS AT RISK According To The CDC

Chronic Hepatitis C has been diagnosed in about three million people in the United States. If you received a blood infusion before 1992 in any country, including America, you are at risk. If you received a blood transfusion in any European country prior to the past ten years, you could be at risk. If you received a blood transfusion in a third world country last year, you could be at risk. A major problem is that HCV often causes no symptoms before it is almost too late and the only viable treatment is a liver transplant. Many who have been infected for years or even decades may remain unaware until deadly symptoms finally appear with a vengeance. The ultimate cause of death attributable to chronic infection is cirrhosis or liver cancer, and there is no vaccine.

Compared to HIV or hepatitis B, the risk of hepatitis C being transmitted by sex is low. However, like HIV, that risk is increased in homosexual encounters. The idea of screening the general population seems obvious. At least, offer screenings at local businesses and clinics like they do with HIV. The problem is that the HCV test is much more expensive and much more difficult to do than the HIV test, What has been controversial is whether or not all baby boomers should be screened, but why the insurance companies are ignoring the threat to their clients and rejecting screening opportunities. Yet, another study suggests that a one-time blood test ordered by primary care providers to screen for antibodies to hepatitis C in those born between 1945 and 1965 would be cost effective – costing $2,874 for each chronically infected patient identified – and would lead to the identification of more than a million previously undiagnosed cases.

SCREENING RECOMMENDATIONS OF THE CDC

It is important not to mistake Hepatitis A or Hepatitis B for Hepatitis C. Despite having the same name, they are very different diseases. Hepatitis A is the traditional version of hepatitis that we have head about since we were kids. Hepatitis B chronically infects about half as many as hepatitis C in the United States, but it hits those of Asian descent particularly hard. Hepatitis B is responsible for about 1,800 deaths yearly in the United States. Despite the similar names, the two viruses are not closely related. Hepatitis B is spread much more easily through sexual intercourse, and passes from mother to newborn child much more easily. In most adults who become infected the immune system successfully controls infection. In addition, there are vaccines for hepatitis B.

It is time for a medical revolution in regards to Hepatitis C and a powerful campaign across all traditional lines of media to raise awareness. When two million Americans, despite past lifestyle choices, are in critical danger and do not even know it, enough is enough. We must take action or watch the death rates rise even higher until it becomes a black spot on the soul of our country.

How Do I Make Sure I Do Not Lose Touch With Lessons Born Screaming From Hepatitis C Treatment Side Effects And All That Suffering?

I had such a powerful and unexpected experience today. I was transferring my iPhoto pics from my MacBook Pro to my new iPad, and I saw for the first time in almost two months, the extreme pictures of the rash and what happened to me. It was horrifying. I simply could not believe how truly bad it was even though it happened to me. As I heal, it is a part of me but it seems so far away as well. If I lose touch with the horror, do I lose touch with my gratitude? And it was horrific... for example, here is a pic taken on November 22, 2011 of my right leg and left foot. The treatment already had lasted two months. And it got much worse over the next ten days as the wounds became a staph infection...

I should look at these pictures every day. It might not be very appetizing, but it will be such a strong reminder of why I should be grateful and humble and happy to be alive. It is so easy to lose touch with your gratitude. I am a master at tossing it out a window as the wanting takes over and I dance with the devil, comparing myself to other people, wading in envy and jealousy, feeling either less than or more than, but never being myself. I know it is normal, but it is so careless as well. I have gone through a nightmare and I have survived; if it is to mean anything, I must truly change and transform the lessons wrought screaming from my body into everyday practices. A hard way to learn those lessons, but more valuable than I can ever express.

Here is a picture of me on September 15, 2011 in the doctor's office as I take my first dosage of Ribavirin right after I had given myself the first injection of Interferon in my stomach. I so believed that it would be a tough process, but not all that bad, and I would get through it with little damage and healed of the virus. I seriously had no idea what was coming down the pike like a runaway school bus with all the kids screaming and terrified. Okay, maybe not that awful, but it truly sucked!

Yes, it all began on that day, and I am grateful to be healed of this virus. At least, there's about an eighty to ninety percent chance that I am healed, and I will take those odds in Vegas any day. 

But, honestly, I am not the same guy anymore, and I am trying to process the changes, both negative and positive. The scars are healing, although they will always be visible on my legs. But the physical scars do not represent the change. The change is a spiritual shift into realizing the beauty and wonder of this gift of a life and truly valuing it on a daily basis. No more excuses and no more bullshit as I embrace the sometimes difficult and always challenging path of my authentic self. 

Will everything be okay in the end? I think so because I choose to live in faith and not in fear. Rather than being overwhelmed by and terrified of the question mark, I embrace the strange wonders of this mystery that lies before me. I do not know what it is right now and I am always a bit neurotic and worried, but I promise to do my best to truly walk the walk and no longer just talk the talk.

As 2012 Begins, NASDAQ Reports That New HCV Drugs Are At The Forefront Of Another Year Of Sky High Pharmaceutical Profits

A Booming Biotech High With HCV Market Overflowing:

There is a Question of Love, a Question of Our Humanity —

Can People Come Before Profits?

A Common Goal With The Occupy Movement - People Before Profits

Another Year, Another High… The biotechnology sector, though a risky investment arena, offers a tremendous potential for huge gains. Binary events like clinical trial results and FDA decisions are typical in biotechnology companies, and can cause significant swings in share price. The following are some of our bio stock picks of 2011 that have been setting new highs.

Pharmaceuticals Inc. (IDIX) is a biopharmaceutical company building a pipeline of drug candidates for hepatitis C, a market with high levels of unmet need. IDIX was trading around $5.06 when we alerted readers to the stock on September 6, 2011, and it set a new 52 week high of $15.25 in intraday trading on Jan.19, 2012, representing a gain of 201 percent. The stock closed Friday's trading at $11.68.

The acquisition of Inhibitex Inc. (INHX), a hepatitis C drug developer, by Bristol-Myers Squibb Company Co (BMY) on Jan.9, for $26 a share, or about $2.5 billion, which was a 163% premium, sparked an interest in other hepatitis C drugmakers.

Achillion Pharmaceuticals Inc. (ACHN) is a biopharmaceutical company focused on the development of antivirals for the treatment of chronic hepatitis C. ACHN was trading around $4.37 when we alerted readers to the stock on October 7, 2011, and it set a new 52 week high of $12.95 in intraday trading on Jan.13, 2012, which implies a gain of 196 percent. The acquisition of Inhibitex Inc. (INHX), a hepatitis C drug developer, by Bristol-Myers Squibb Company Co (BMY) on Jan.9, for $26 a share, or about $2.5 billion, which was a 163% premium, sparked an interest in other hepatitis C drugmakers.

Based upon recent results of clinical trials, Achillion is planning further exploration of ACH-1625 in combination with other oral antiviral agents for the treatment of all HCV genotypes and continues to evaluate ACH-2684 in a phase 1 clinical trial. Achillion plans to submit an investigational new drug application and initiate a phase 1 clinical trial with ACH-3102 during the second quarter of 2012. During the second half of 2012, Achillion plans to initiate an interferon-free, all-oral combination clinical study evaluating a protease inhibitor and a NS5A inhibitor, with or without ribavirin, for the treatment of HCV.

Can Profits Before People Shift To People Before Profits In Health Industry

Without question, the development of an interferon free, all oral protease inhibitor will revolutionize worldwide the HCV market. The question is can the people come before the profits. If the treatments costs too much and is too expensive for people to access without bucket loads of assets or the perfect insurance plan, then this is not what the world needs. The focus has to be that everyone should be taken care of and given access to a treatment that potentially can and will save lives.

The Shift Must Be Made - 

People Before Profits, Not Profits Before People 

When It Comes Down To The Health Industry

The So-Called Biotechnology Sector
?Beyond Our Understanding?
No More Excuses or Rationalizations

Accessible Medical Treatment For All!