I have a particular interest in the aging HCV infected population, this stems from my own infection acquired at the age of 19, I underwent treatment in1999 at the age of 44, and achieved my SVR status. Yes, I am from the often media touted HCV "baby boomer generation." (individuals born between 1946 and 1964)
Today is my birthday, hated it. After I celebrated with my family, I returned home to update this blog. I found myself looking back on HCV and thought I may share those early days with you. Oh yes, I am still SVR at 55.
HCV and testing was relatively new back then, with the "baby boomer generation." not being diagnosed until after decades of acquiring this disease, some us had bridging fibrosis, cirrhosis, or worse.
We all witnessed far too many people who treated once, twice or three times, without achieving SVR. More then a few of these brave individuals treated for 3 years straight. The men and women who were diagnosed with HCV were also being told they had surmountable liver damage. Hell, we didn't even understand most of what we were being told back then, it was a time of fear, and uncertainty. Our community was made up of a group of people who all had one thing in common, HCV. Thank goodness for sites like NATAP, HCV Advocate and HIV and Hepatitis. I owe you everything, we all do.
On the blog is data I compiled deemed: The Origin Of Hepatitis:HCV and HBV , where you can view the timeline of the FDA approval of drugs we had to treat HCV and other relevant information.
We often questioned the insane treatment protocol, still we cheered one another on, stick it out, be strong, you can do this, although they fought hard, many beautiful people fell victim to this disease.
We drank too much water, went on antidepressants, suffered with anemia, joint aches, headaches, fear, rage, rashes, fatigue, chronic cough, nausea, fever, or worse, we stuck with it; We were all naive and determined. Babes kicking dragon butt, as we fought our way to freedom. Our goal was the elusive SVR.
Desperation haunted us, if we didn't do something cirrhosis may come knocking at our door. You have to understanding in our community people were dying, cirrhosis was common, friends were undergoing liver transplants, the outcome wasn't desirable. As more and more individuals relapsed or didn't respond, helplessness grew. When treatment fails someone who has cirrhosis, they know what the future holds. We all knew what came next.
I deeply admired a few of these people in our community who supported us, in our safe little chat room or on those life saving message boards. One person in particular was a woman named Patty. She is currently living with cirrhosis, treatment failed her, more then twice. Patty was at the bedside of a friend who passed from HCV, she saw first hand what this disease can do. (ESLD) End stage liver disease is a slow death, seldom is it acute, its painful and debilitating.
Patty gave over nine years of her life online, cheering friends on, celebrating when they achieved SVR. The hours she spent giving support took precious time away from her family, those years I know now she wishes she had back. As Patty watched her friends suffer or die from HCV, she knew her own disease was progressing. Her offering of support was nothing short of heroic. Numerous people have lent their support to the HCV community over the years online, but if I could mention a few more ladies I hold in such high esteem, Janis, Sue, Lisa,Coreen, Joy and a lovely woman who goes by the name of Imkindly. You can visit her site here.
During that time treatment was often unsuccessful, (still is, hurry up telaprevir/boceprevir) this population of people had major liver damage folks, coupled with the lack of effective antiviral therapy. We were in a no win scenario, but the thing was we really didn't know it.
The field of Gastroenterology exploded, we all needed a specialist. Instead, we had our general practitioners who officially told us; " You have nothing to worry about, this is a benign disease." Thus was born the lovely quote used over and over; "Most people will die with hepatitis C and not from it."
That was the beginning of the end for me. Personally I despise that phrase, to this day when I read it the hairs on the back of my neck begin to raise up. I knew this was a serious disease back then, not for all of us, but for far too many of us.
Unfortunately, in those days we had little data on disease progression, medical research was still in its infancy. Oh yes, we had the 1999 study of the 704 Irish women who received batches of anti-D immune globuanti-D between 1970 and 1994, for many of us it was our bible. On the blog you can find the data here.
Today, statistics from the "baby boomer generation" is used by researchers to define the progression of this disease. Yep, the same people who were told this disease is pretty much harmless make up the data . Enter us.
Aging of Hepatitis C Virus (HCV)-Infected Persons in the United States: A Multiple Cohort Model of HCV Prevalence and Disease Progression
A paper published in the February 2010 issue of Gastroenterology, from researchers at Baylor University Medical Center and Baylor Regional Transplant Institute in Dallas, Texas found;
The prevalence of hepatitis C cirrhosis and its complications will continue to increase through the next decade and will mostly affect those older than 60 years of age. The study noted HCC (liver cancer) in people over the age of 65 with HCV infection had doubled during the last several years. This researchers suggested the chronic hepatitis C that we have become familiar with during the last 30 years, is much different than the hepatitis C we will come to know during the next decade or 2.
If only we knew then what we know now, the importance of treating this disease early is at the forefront, prior treatment was often unsuccessful in this population, as mentioned, with many patients not being diagnosed until after complications were present. With improved new agents showing better responses this will significantly reduce the impact of disease progression in the future. Quoted from the study;
"It is in the immediate best interest of patients, providers, insurers, and governments to promote guidelines and encourage better screening for infection and early antiviral treatment. Without such a proactive policy, it is likely that we will spend a considerable amount of resources during the next 2 or 3 decades dealing with liver failure in our elderly population."View The Full Data at NATAP
Recently the EASL issued clinical practice guidelines on the management of hepatitis C infection, with the importance on detecting and treating HCV before disease progression leads to complications, such as cirrhosis and possibly liver cancer.
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Hepatitis C in the Elderly: Epidemiology, Natural History, and Treatment
In a 2009 study from the University of Maryland School of Medicine pubilshed at Medscape, entitled Hepatitis C in the Elderly: Natural History, concluded;
View The Full Data HereElderly patients with chronic HCV infection have been an understudied population owing to several factors. These factors include exclusion of subjects older than 65 years of age in several clinical trials, reluctance to treat HCV infection in the elderly because of fear of dealing with more HCV therapy-related adverse effects, comorbidities and risk factors of aging such as decreased glomerular filtration rate that might cause more severe hemolytic anemia with ribavirin, and interactions of interferon and ribavirin with several potential geriatric drugs.[34-37] Despite these challenges, previous studies have shown that HCV treatment generally was well tolerated by the elderly and there was little or no significant difference in SVR as well as therapy discontinuation rates secondary to adverse effects compared with younger age groups. However, there is a need for prospective randomized controlled trials to be conducted in HCV patients older than 65 years of age to better evaluate the safety and efficacy of HCV treatment in this age group. In addition, more epidemiologic studies are needed to better assess the prevalence as well as the risk factors of chronic HCV infection in elderly subjects.
When the results started coming out of the telaprevir trials the "baby boomers" knew this was something big. Here is the latest from the EASL;
Also See; EASL Telaprevir Improved SVR Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful
EASL: Telaprevir Helps in Prior HCV Tx Failures
By Walter Alexander, Contributing Writer, MedPage Today
Published: April 01, 2011
http://www.medpagetoday.com/Gastroenterology/Hepatitis/25668
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
Action Points
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Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Explain that in this study, adding telaprevir to peginterferon alfa-2a plus ribavirin significantly increased sustained response rates for patients with genotype 1 hepatitis C virus infection who had previously failed the standard regimen.
Note that response rates were best for those who had relapsed following the two-drug standard therapy and better for those who had been partial responders compared with nonresponders.
BERLIN -- Adding telaprevir, an investigational oral protease inhibitor, to peginterferon alfa-2a and ribavirin substantially increased sustained response rates in patients with genotype 1 hepatitis C virus (HCV) infection who had previously failed the standard therapy, a researcher said here.
Results from the phase III REALIZE trial indicated that, among prior relapsers, sustained response rates with two telaprevir-containing regimens were 83% and 88%, compared with 24% for peginterferon alfa-2a and ribavirin plus placebo (both P<0.001), reported Stefan Zeuzem, MD, of Johann Wolfgang Goethe University Medical Center in Frankfurt am Main, Germany.
Lower sustained viral response rates were seen in patients who previously showed partial or no response to the two standard drugs, but they were still significantly better than in the placebo group (41% in both telaprevir arms versus 9% in the control group, P<0.001).
Zeuzem presented the findings here at the European Association for the Study of the Liver (EASL) annual meeting.
"T plus P plus R was superior to P plus R alone in treatment-experienced populations including prior relapsers, partial responders, and null responders," he told attendees.
The findings confirm those of earlier studies, including one reported last year in the New England Journal of Medicine.
The current standard of care for HCV is the combination of peginterferon alfa-2a and ribavirin, Zeuzem explained, but it fails to achieved sustained viral responses in 60% of patients with HCV genotype 1.
REALIZE assigned 662 patients to three treatment arms in a 2:2:1 ratio:
T12/PR48: Telaprevir, peginterferon, and ribavirin for 12 weeks followed by placebo plus peginterferon and ribavirin for four weeks and then the two standard drugs alone for 32 weeks
LIT12/PR48: Placebo plus peginterferon and ribavirin for four weeks, followed by telaprevir and the standard drugs for 12 weeks, and then the standard drugs alone for 32 weeks
Pbo/PR48: 48 weeks of peginterferon plus ribavirin, with placebo for the first 16 weeks
The REALIZE primary endpoint was the proportion of these patients achieving sustained viral responses, defined as undetectable plasma HCV RNA at 24 weeks after the last planned intake of study medication. Whether the four-week lead-in with standard therapy alone made a difference in responses was a secondary objective.
Telaprevir was given at 750 mg every eight hours. Standard doses of the other drugs were used (180 mcg/week for peginterferon, 1,000 to 1,200 mg/day for ribavirin).
Null responders, partial respondersders, partial responders, and relapsers to previous peginterferon plus ribavirin constituted about 28%, 19%, and 54%, respectively, of the cohort. Nearly half of patients were in advanced stages of disease; 89% had a baseline HCV viral load of >800,000 IU/mL. Median age was about 51 and more than two-thirds were men.
Sustained viral responses were seen in 83% of the T12/PR48 group and 88% of the LIT12/PR48 patients versus 24% of the Pbo/PR48 group.
These results, Zeuzem pointed out, indicated that the four-week lead-in with standard therapy did not improve response rates compared with including telaprevir from the outset.
Responses rates of 41% were seen in the previous null or partial responders in both the T12/PR48 and LIT12/PR48 groups, compared with just 9% of the previously unresponsive Pbo/PR48 patients.
Zeuzem said that sustained response rates were higher for prior partial responders than for prior null responders.
Relapse rates were 10% each for the two telaprevir-containing arms and 23% for the Pbo/PR48 arm.
Among the most common adverse events during any treatment phase, fatigue occurred in 55% of the T12/PR48 patients, 50% of the LIT12/PR48 group, and 40% of the Pbo/PR48 group. Frequencies of pruritus were similar.
Anorectal symptoms (anal pruritus, anorectal discomfort, hemorrhoids) were reported in 28%, 22%, and 8% of the T12/PR48, LIT12/PR48, and Pbo/PR48 groups, respectively.
For each of these adverse events, and for anemia, rash, nausea and diarrhea, the incidence was more than 10% greater in the T12/PR48 arm than in the Pbo/PR48 arm.
Discontinuations of any study drug during telaprevir treatment occurred in 29% of patients. Rash and anemia were the most common adverse effects associated with drug stoppage.
"These are really exciting results for this particularly difficult-to-treat group of patients," commented Mark Thursz, MD, a hepatologist at Imperial College in London and vice-secretary of the EASL.
"Over 60% achieved an SVR. Compared with patients who previously relapsed after P-plus-R treatment, those who are partial responders did less well, and the null group was disappointing, but that was not entirely surprising."
A marketing application for telaprevir has been filed with the FDA, which is giving it priority review. The agency's deadline for a decision is May 23.
Zeuzem disclosed relationships with Abbott, Achillion, Anadys, BMS, Gilead, iTherX, Merck, Novartis, Pfizer, Pharmasset, Roche, Santaris, Tibotec, and Vertex.
Thursz declared he had no relevant industry relationships.
Primary source: European Association for the Study of the Liver
Source reference:
Zeuzem S, et al "REALIZE trial final results: telaprevir-based regimen for genotype 1 hepatitis C virus infection in patients with prior null response, partial response or relapse to peginterferon/ribavirin" EASL 2011; Abstract 192.
As for boceprevir, from HIV and Hepatitis
Boceprevir Helps Hepatitis C Patients with Cirrhosis
SUMMARY: Chronic hepatitis C patients with advanced liver fibrosis or cirrhosis were more likely to achieve a cure when they added boceprevir to standard therapy, according to a report this week at EASL 2011.
Of interest;
Prevalence and Challenges of Liver Diseases in Patients with Chronic Hepatitis C Virus Infection :
Discusses disease progression, fibrosis, cirrhosis and liver cancer in the HCV population.
In closing I wish you all a safe journey, trust your instincts, find a specialist, and seek out your option's.
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