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