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In This Issue:
CDC:–Test Baby Boomers
Alan Franciscus, Editor-in-Chief
Lucinda K. Porter, RN
HealthWise: - Hepatitis C Treatment Tips from Patients
Lucinda K. Porter, RN
HCV and Coinfection Updates from the International AIDS Conference
The Waiting Game
Alan Franciscus, Editor-in-Chief
HCV Advocate Eblast
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CDC - Test Baby Boomers
—Alan Franciscus, Editor-in-Chief
On August 17, 2012 the Centers for Disease Control and Prevention (CDC) released their final recommendations to test people born 1945 – 1965 (baby boomers) for hepatitis C. The report with recommendations came out in the Morbidity and Mortality Weekly Report (MMWR)—it also provides background information about the analysis that lead to the recommendations, the benefits of testing, recommendations for testing methods, management of those who test positive, and an overview of current and future therapies to treat hepatitis C (HCV).
A one-time HCV test for people who were born 1945 to 1965—this would account for about 75% of HCV infections in the U.S. and it would mean testing roughly 27% of US population.
In the U.S., it is estimated that there is a 3.25% prevalence of hepatitis C in people born 1945 to 1965.
The report studied the potential risk/benefits and came to the conclusion that the potential benefits of testing baby boomers outweigh the potential harm.
The one-time test will identify more than 800,000 HCV infections and could potentially save more than 120,000 lives.
The report recommended that those who test antibody positive should be referred to follow-up testing and care and advised to avoid alcohol, follow a healthy diet and exercise.
The recommendations will hopefully accomplish what risk factor assessment has not—that is, getting the majority of people infected with hepatitis C identified. Risk factor assessment should always be a part of the testing process especially for people who may have had a recent exposure. But the reality is that it has prevented medical providers from asking about risk factors and patients from having to self-identify risks.
The recommendations for testing are receiving a lot of attention especially in the national media. The medical advisor from one national news TV program put it this way: “It’s time for baby boomers to step up to the plate and get tested.” How great is that?
The only way that the recommendations will be successful, however, is to educate medical providers—especially primary care providers—about the importance of testing their patients. Hopefully, medical associations will work with their members to tackle “baby boomer” HCV testing that could save over a hundred thousand lives.
MMWR vol 61.no4
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—Lucinda K. Porter, RN
Article: Chronic Hepatitis C Virus Infection Increases Mortality from Hepatic and Extrahepatic Diseases: A Community-Based Long-Term Prospective Study – Lee MH, Yang HI, Lu SN, et al.
Source: Journal of Infectious Disease July 2012 (Advanced Access) DOI: 10.1093/infdis/jis385
This Taiwan-based study followed 23,820 adults (30–65 years old) from 1991–2008. Among these, 1095 were hepatitis C virus (HCV) antibody-positive (anti-HCV+), and nearly 70% of these had detectable HCV RNA; 19,636 were negative for hepatitis B, 18,541 negative for HCV. There were 2394 total deaths in the study period.
The Bottom Line: Participants who were anti-HCV+ had a higher mortality risk than those who were anti-HCV-negative; those with detectable HCV RNA had an even higher mortality risk. Increased mortality for anti-HCV+ participants was seen across the board—whether caused by liver, extrahepatic, diabetes, circulatory, or kidney disease as well as many types of cancer (colon, esophageal, liver, prostate, thyroid, leukemia).
Editorial Comment: For many years I uttered the phrase, “Most HCV patients will die with, rather than of HCV.” I try not to say this anymore as I am concerned that these words undermine the important message regarding the potential seriousness of HCV. This research emphasizes the grave nature of HCV. Fortunately, it comes at a time when there is effective treatment for HCV, along with exciting possibilities in the treatment pipeline.
Article: Vitamin B12 Supplementation Improves Rates of Sustained Viral Response in Patients Chronically Infected with Hepatitis C Virus – Rocco A, Compare D, Coccoli P, et al.
Source: Gut: An International Journal of Gastroenterology and HepatologyJuly 2012 doi:10.1136/gutjnl-2012-302344
In laboratory studies, vitamin B12 acts to inhibit HCV replication. In this Italian study, 94 chronic HCV patients with no prior treatment were randomly assigned to treatment (peginterferon and ribavirin) or treatment plus vitamin B12 injections (5000 mcg/monthly).
The Bottom Line: Sustained Viral Response (SVR) rates were about 34% greater for patients in the treatment group that included B12. Even those with genotype 1 or high viral loads had significant improvement.
Editorial Comment: This is a preliminary study and the results need to be confirmed. However, vitamin B12 deficiency is a fairly common occurrence in older adults, and if you have concerns about your B12 level, talk to your medical provider about this.
Article: Can Zinc Enhance Response to Interferon Therapy For Patients With HCV-Related Liver Disease? – Toru Ishikawa
Source: World Journal of Gastroenterology July 2012; Vol.18
This paper discusses the role of zinc, particularly in the manufacture of liver enzymes. The author reviews prior research, showing the correlation between insufficient zinc and liver disease. Zinc supplementation may delay the progression of liver fibrosis and may improve symptoms of hepatic encephalopathy.
Of particular interest is the relationship between zinc and HCV. Those with HCV appear to have lower blood levels of zinc, and since increased zinc may inhibit fibrosis, then perhaps zinc supplementation will slow down disease progression. Unfortunately, this research has not been conducted.
However, there have been small studies using zinc during interferon-based HCV treatment, and the outcomes point to a possible benefit of zinc supplementation. One Japanese study showed that in addition to improved SVRs, zinc reduced certain side effects, particularly dry mouth, dysgeusia (metallic taste) and mouth sores.
The Bottom Line: More research is warranted for the use of zinc supplementation for those with liver disease.
Editorial Comment: In general, more research is needed regarding the use of supplements for many diseases, not just liver disease. However, supplementation is a complicated area, particularly when it comes to the liver. Use caution and reliable medical advice before embarking on a regimen using supplements.
Article: Effect of Silymarin (Milk Thistle) on Liver Disease in Patients with Chronic Hepatitis C Unsuccessfully Treated with Interferon Therapy –Fried M, Navarro V, Afdhal N, et al.
Source: JAMA July 18, 2012; Vol. 308, No. 3
This multicenter, double-blind, placebo-controlled study enrolled 154 HCV patients with abnormal liver enzymes (ALT), all of whom had been previously treated unsuccessfully with interferon-based therapy. Subjects received either 420 mg silymarin, 700 mg silymarin, or placebo taken 3 times daily for 24 weeks. The researchers were looking for normal or reduced liver enzymes; changes in HCV viral load or quality of life were also measured.
The Bottom Line: When compared to placebo, silymarin did not provide any benefit.
Editorial Comment: Gastrointestinal complaints were the most commonly reported adverse event in this study, mentioned by 12% of those taking silymarin vs. 5% of those taking placebo. The researchers stated this is not clinically significant. Silymarin is generally safe, but since the liver metabolizes it, silymarin can interact with other medications, making them more or less potent.
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HEALTHWISE: Hepatitis C Treatment Tips from Patients
—Lucinda K. Porter, RN
In May 2011, two protease inhibitors bolstered the fight against chronic hepatitis C virus (HCV) infection. The FDA approved boceprevir (Victrelis) and telaprevir (Incivek) for treatment of patients with genotype 1. Either drug (but not both) is used, along with peginterferon and ribavirin. With response rates hovering around 80%, these are weapons of mass destruction.
I have a lot of experience with HCV treatment, both personally and professionally, so much that I wrote a book (Free from Hepatitis C) to help patients through the process. However, I have not experienced triple therapy, and I am curious about the real story, the nitty-gritty experiences beyond clinical trials, so I asked the experts—patients.
The following is a collection of tips from triple-therapy patients. Talk to your medical provider before trying any of these. Although brand names are mentioned, generic versions may be cheaper. Some contributors have given permission to use their names. To all, named and unnamed—thank you.
Patient advocacy, in particular self-advocacy was mentioned. “Meet the members of your treatment team BEFORE you start treatment.” advises blogger Selena Inouye (www.ohmyachesandpains.info) Sometimes patients meet their primary nurse the day of the first interferon shot, but ask to be seen earlier to see if you feel comfortable with the nurse. This gives patients time to think about what they were told and formulate follow-up questions.
Selena recommends bringing someone with you to appointments to take notes and act as your advocate. Ideally, your doctor has given you information about what to expect, the risks and available resources to help you navigate treatment. Be sure to discuss what side effects need reporting, who and when to report these to and who will be the main person managing them. Find out how to reach medical personnel when the office is closed and what to do in an emergency.
Write everything down and keep all your notes in one place. Don’t rely on your memory. Document everything your medical provider says, record when you took your pills, note your appointment times, and keep copies of all of your labs.
Know your treatment protocol. Confirm that your medical provider uses a highly sensitive viral load test with a lower limit of HCV RNA detection of ≤ 10-15 IU/ml, and quantification of ≤ 25 IU/ml. If something seems amiss or your medical provider deviates from the protocol, ask questions. Use the pharmaceutical company help lines to educate you, support you, and verify all concerns. Your pharmacy is another resource to use.
Mary Northrup finished treatment in May. “This treatment taught me to be my own advocate. Understand that there will be times where you have no choice but to push through the pain and discomfort, but don’t be afraid to rely on your medical team and your support system to lend you a hand.”
“Don’t be afraid to bug your nurse with questions,” says Mary, and if you are like most, you will have many questions. This solid advice is hard for some to practice. We don’t want to be a nuisance. However, as a nurse, I appreciated questions from patients. Patients with questions are engaged in their treatment. In fact, the ones I worried about the most were the ones who never asked me anything.
Here are some more tips:
Order the patient starter kits from the drug companies before you begin your treatment. Read all the materials before your education session and bring a written list of questions with you.
Don’t try to do too much. Accept help and food when offered.
Ask for help. Delegate.
Rest more, pace yourself and conserve your energy.
Let go of as much as possible.
Remember that “No” is a complete sentence and don’t be afraid to use it.
If you and your medical provider think that you should go on disability, then by all means, do it.
Nutrition and 20 Grams of Fat Diet
Many people stressed the importance of maintaining nutrition, and for those taking telaprevir (Incivek), the 20 grams of fat diet headed the list. This is particularly important, as fat optimizes the effectiveness of telaprevir. Deanne English points out that although this is difficult for nighttime doses it is important.
John Adamski (Lake Tahoe HCV Support Administrator) mentioned that insufficient fat with telaprevir caused anal burning and discomfort, and that taking telaprevir 20 minutes after eating worked best for him. Many echoed Teri Gottlieb’s suggestion of collecting lists of foods with 20 grams of fat. Choose food with high quality fat, such as peanut butter, avocado, eggs, and whole milk.
Eat as healthy as you can, as this provides energy. Before you start, stock up on staples and frozen foods. Include items that may help with tummy upset, such as crackers, rice, applesauce, Melba toast, tea, and ginger-flavored items. Selena suggested variety. Nuts, seeds, and bars are handy to have. Always have on hand the fixings for shake mixes. Selena added a tablespoon of canola oil to Boost Carb Control.
Digestion and Anal Issues
What goes into the body is important, but the other end of the digestive tract dominated discussion about telaprevir. The big issues are diarrhea, anal burning and itching, and butt rashes. To avoid bottom problems and control diarrhea, John suggests taking a good probiotic with 8 ounces of Kefir. Many used Imodium; one patient took a smaller dose more frequently, with meals. Soluble fiber supplements were also mentioned, helping with both diarrhea and constipation.
To protect the bottom, everyone had personal favorites. One wrote, “Get both Analpram and A&D Ointment. Use Analpram only for anal itching. All other days, always apply a generous amount of A&D Ointment after defecation; it will save you from considerable pain the next time.” Other recommendations were Balneol lotion, zinc ointment, and diaper rash products such as Desitin.
Although itching and rashes were common side effects before, these are more so for triple-therapy. Alyson Shuck and others suggest cool showers and antihistamines such as Benadryl, Zyrtec, or prescription Atarax. Keep the skin moist and use fragrant-free products such as Gold Bond Ultimate (soothing, fragrance-free) lotion. Trader Joe’s moisturizing cream is also good. Selena used Cetaphil Restoraderm body wash and moisturizer. The consensus was to avoid hot showers and the sun.
A critical part of success is to take medications on time and as directed. Selena bought the biggest pillbox she could find and labeled it with pill times. Program electronic devices, such as your phone or watch to remind you.
“Start pounding down water two weeks before therapy,” says John Adamski. “The goal is one-half your body weight in ounces/day.” In other words, if you weigh 150 lbs, then aim for 75 ounces of water daily.
Find a way to track your water intake. Selena bought a container that held eight glasses of water from www.bluewavebottles.com. She added flavors such as lemon, lime, mint, cucumbers, a splash of fruit juice, and MiO mix (sucralose-based drink mix).
John mentioned that numerous studies showed that people with high vitamin D levels achieved a higher cure rate. Caffeine also seems to give people an edge. This month’s HCV Snapshots includes information about vitamin B12 and zinc supplementation. If you are interested in supplements, talk to your medical provider about these prior to using them.
Managing the emotional highs and lows of HCV treatment can be summarized in two words: antidepressants and support. Pretty much everyone I talked to used antidepressants during treatment.
“The first thing I learned was to STAY CALM,” wrote Mary Northrup. She did whatever she could to achieve that goal, including turning off the news. “Go easy on yourself. This therapy can be harsh on one mentally...give yourself permission to be a goof ball.”
Attend an HCV group. Education, information and identification of resources are a valuable focus of HCV groups. Mary received information and found groups acted as a sanity check. Humor is another benefit often gained by being with those who know what you are going through. Where else can you find a group of people who laughingly refer to themselves as the Friday Night Dart Club?
Keep friends and family informed. Mary did this via an online journal (or blog). Selena, started blogging and then found that Facebook and Twitter were better ways to communicate.
As for support, Selena says, “Recruit a cheering squad. I used Sign Up Genius to engage my social network.” On difficult days, use your support network to vent. Remember to practice restraint of pen and tongue. If you feel angry or defensive, talk to a friend and don’t post anything hostile for at least 24 hours after running it by a trusted confidant.
Surround yourself with things you enjoy. During difficult times, distract yourself with anything that holds your attention: audio books, movies, TV, scenery, etc. Every day do something that makes you happy and treat yourself to whatever you need to get through this time. One man praised the power of a relaxing bath using herbal bath salts (legal ones) while listening to calm music.
Celebrate treatment milestones as you go along—there will be many (first shot, first week, first day that you forgot you were on treatment). “Invite your friends to party with you, even if it is virtually on Facebook or Twitter,” advises Selena.
“Patients contemplating this therapy need to be determined and accept the fact that they will be fairly miserable for at least a few months of this therapy,” said John. “But look at the CURE RATES !!!” Yes, the cure rates make it all worth it.
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HCV and Coinfection Updates from
the International AIDS Conference
The XIX International AIDS Conference, held July 22-27 in Washington, DC, included several presentations on hepatitis C in people with HIV. Hepatitis C has become an increasingly prominent topic in the infectious disease field as direct-acting antiviral agents have ushered in a new treatment paradigm.
The full AIDS 2012 program, abstracts, slides, and videos of key presentations are available online at www.aids2012.org.
Since the advent of effective antiretroviral treatment for HIV, HCV-related liver disease has become a leading cause of illness and death for HIV-positive people.
In an overview of the changing epidemiology of opportunistic infections in the era of combination antiretroviral therapy (ART), Henry Masur from the National Institutes of Health (abstract MOAB0105) explained that while certain AIDS-related infections are no longer among the most common reasons for hospitalization of people with HIV, hepatitis C has now moved into the top ten.
Starting about a decade ago, researchers began reporting outbreaks of apparently sexually transmitted hepatitis C among HIV-positive gay and bisexual men, first in large cities in the U.K. and continental Europe and later in Australia and the U.S. Risk factors include certain sex practices, having other sexually transmitted infections, and recreational drug use, but specific predictors vary from study to study.
Anouk Urbanus from the Amsterdam Public Health Service (abstract TUAC0503) presented a 15-year overview of one of the first and most closely watched sexually transmitted hepatitis C epidemics.
A total of 777 HIV-positive and 1513 HIV-negative men who have sex with men attending a large sexual health clinic between 1995 and 2010 participated in surveys about behavioral risk factors and were tested for HIV and HCV; only 3.5% reported ever injecting drugs.
The researchers saw evidence that the decade-long outbreak in this population may have leveled off in the past few years. HCV prevalence (total cases) gradually rose from 2.8% in 1995 to 3.8% in 2003, followed by a steeper increase to a peak of 17.3% in 2008. Levels then stabilized and even decreased a bit, though the decline was not statistically significant. In contrast, HCV prevalence among HIV-negative gay men remained steady at about 0.5%, even though they engaged in similar sexual activity and drug use.
Urbanus and colleagues suggested that this trend might be explained by reduced risk behavior, earlier HCV testing, more hepatitis C treatment, and "saturation" within the population at highest risk. But new acute infections continue to occur, leading them to recommend routine HCV screening at sexual health clinics and better education of patients and providers.
Liver Disease Progression
HIV/HCV-coinfected people especially those with advanced immune deficiency experience faster fibrosis progression, on average, than people with HCV alone. Combination antiretroviral therapy appears to slow liver disease progression, but HIV-positive people may still be at a disadvantage relative to HIV-negative individuals.
Vincent Lo Re from the University of Pennsylvania and colleagues (abstract WEAB0102) conducted a retrospective study of patients in the Veterans Aging Cohort Study Virtual Cohort during 1997-2010, comparing 4,280 ART-treated coinfected people and 6,079 HCV-monoinfected people matched for age and race/ethnicity (almost all were men).
The researchers looked at clinical conditions related to liver decompensation—including ascites (fluid accumulation in the abdomen), bacterial peritonitis, and bleeding esophageal varices (swollen veins) as well as hepatocellular carcinoma and death due to any cause.
Despite being on ART, HIV/HCV-coinfected people remained at higher risk for liver complications than those with HCV alone after a median follow-up period of seven to ten years.
Coinfected patients were significantly more likely to experience liver decompensation than those with hepatitis C alone (6.3% vs. 5.0%, respectively; hazard ratio 1.83). The risk of decompensation fell somewhat for coinfected people with low HIV viral load, but it remained higher than that of HIV-negative people. The additional risk was greater for HIV-positive people with CD4 counts below 200 compared to those in the 200-349 or 350-499 range. Rates of hepatocellular carcinoma were statistically similar in the two groups, but occurrence of severe liver events and overall mortality were significantly higher in the coinfected group.
Lo Re concluded that providers must assess risk factors and develop ways to detect subgroups of patients at highest risk for rapid progression so they can be prioritized for hepatitis C treatment and trials of new therapies.
While the biological mechanisms underlying accelerated liver disease progression in people with HIV is not fully understood, both Masur and Lo Re suggested that increased inflammation in individuals with two persistent viral infections may play a role.
Does Order of Infection Matter?
Historically most coinfected people have contracted HCV before HIV because HCV is more easily transmitted, for example through shared drug injection equipment. But the recent outbreaks of sexually transmitted hepatitis C involve gay/bisexual men who were already HIV-positive when they acquired HCV.
In 2007 Daniel Fierer from Mt. Sinai School of Medicine in New York City first reported on a small number of HIV-positive men with sexually acquired acute hepatitis C whose liver biopsies revealed extensive fibrosis despite only a short period of infection.
At AIDS 2012 Fierer gave an invited lecture on rapid fibrosis progression as part of a session entitled "HCV: A New Era Dawns" (presentation WEAB0101). He noted that progression to severe fibrosis or cirrhosis still usually takes decades in HIV/HCV-coinfected people, and only a minority progress to liver failure or liver-related death.
But if HIV infection occurring after HCV infection modestly accelerates progression, the effect may be much greater when HIV infection occurs first. While studies show that most HIV-negative people with acute hepatitis C have Stage 0 (absent) or Stage 1 (minimal) fibrosis, nine of 11 men in Fierer's HIV-positive cohort already had Stage 2 (moderate) fibrosis just four months after diagnosis. Likewise, researchers in Belgium have reported that 22 of 37 HIV-positive gay men with acute HCV infection had biopsies showing Stage 2 or 3 (advanced) fibrosis seven months after diagnosis.
Fierer presented some not yet published data on four individuals with especially rapid progression. Three of the men showed Stage 3 fibrosis on their first biopsy after acute hepatitis C diagnosis. Decompensation occurred within 17 months to 6.5 years—much sooner than expected. Two patients died and one underwent liver transplantation.
"What really matters is in what order [HIV and HCV] infections happened, and it matters even more how immunocompromised a patient is," Fierer concluded, noting that the men with the lowest CD4 counts in this series were the first to experience decompensation.
These findings are controversial, however, because other researchers have not observed similar rapid fibrosis progression in people with HIV during early HCV infection. In particular, Martin Vogel and colleagues studying the European NEAT cohort saw very high estimated fibrosis progression rates using transient elastometry (FibroScan) during the first few months after HCV infection. But progression rates then fell to match those of people with chronic HIV/HCV coinfection, leading the researchers to attribute the early spike to liver inflammation, which the elastometry method can mistake for fibrosis.
A New Era of Treatment
Norah Terrault from the University of California at San Francisco presented an overview of hepatitis C therapies in the pipeline for HIV/HCV-coinfected people (presentation WEAB0104).
Direct-acting anti-HCV drugs have shortened treatment duration and improved cure rates for HCV-monoinfected people. "It's a dramatic, substantial improvement over what we had previously," according to Terrault. But these new therapies are not yet approved for coinfected patients.
Studies to date indicate that the HCV protease inhibitors boceprevir (Victrelis) or telaprevir (Incivek) in combination with pegylated interferon/ribavirin are effective for coinfected people, with cure rates approaching those of monoinfected patients. (See the May 2012 HCV Advocate for boceprevir and telaprevir coinfection data presented at this year's Conference on Retroviruses and Opportunistic Infections.)
Boceprevir and telaprevir both must be used with interferon, and triple therapy adds to side effects. Furthermore, dosing is "suboptimal" – having to be taken three times daily–costs are high, and many coinfected patients are considered ineligible for various reasons. Some direct-acting antivirals have the potential to interact with HIV antiretrovirals, however, which could compromise effectiveness or lead to worse toxicities. Data are still needed on treatment-experienced coinfected patients and whether response-guided therapy is effective for HIV-positive people.
"It's hard to believe that just over a year ago we were eagerly awaiting the first HCV protease inhibitors, and now that they're here we're already looking toward the next thing," Terrault said.
She explained that she is mainly treating three types of patients in her practice: 1) people with cirrhosis who need treatment now or soon; 2) people with minimal disease progression but who want to be free of infection; and 3) people who want to be treated now because they are worried about losing their jobs and health insurance.
Second generation agents now under study are more potent, more tolerable, and some are once-daily, she continued. Many patients are unwilling or unable to take interferon and want to wait for all-oral regimens. Terrault predicted that interferon-free regimens will come in the "next couple of years," but at first will only be available for easier-to-treat patients–which does not include the coinfected.
But on an optimistic note, she concluded, "Ideally, I think in the future there will be all-oral regimens that are safe, tolerable, and will be the kind of therapy that will be successful at curing the majority of our HCV-infected patients."
The following publications can be found at: www.hcvadvocate.org/hepatitis/
- A Guide to HIV/HCV and Hep C Coinfection
- Easy C - A Guide to HIV and Hep C Coinfection
- Frequently Asked Questions about HIV & Hepatitis C
- HIV/HCV Coinfection: Pegasys plus Copegus
- HIV/HCV Coinfection
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The Waiting Game
—Alan Franciscus, Editor-in-Chief
Back in July 2010, I wrote an editorial about whether it was safe to wait for the new HCV protease inhibitor combination therapy. At that time, I was of the opinion that the sooner that people were treated the better. Examining the same issue 2 years later I realize that this time it is not such a black and white issue. The medications (PEG/RBV and HCV protease inhibitor) we were waiting for in 2010 have been approved. However, studies of newer therapies to treat hepatitis C have escalated at a phenomenal rate and there is a very real possibility that the newer therapies could be available within 2 to 3 years. But is it safe to wait? In this article I will explore some of the issues that patients and medical providers should consider before making “the” decision.
The current standard of care is pegylated interferon/ribavirin (PEG/RBV) for genotypes 2 and 3 and the triple combo of PEG/RBV and an HCV protease inhibitor (telaprevir or boceprevir) for genotype 1. These therapies can cure up to about 80% of people who take them. But treatment is not easy—current therapies include a large pill burden and serious side effects. PEG is injected once a week, RBV is taken twice a day—the number of pills depends on the genotype and brand of ribavirin—and the HCV protease inhibitors are taken every 7 to 9 hours (boceprevir daily pill total is 12, and telaprevir requires 6 pills/day). I think that everyone is familiar with the side effects of PEG/RBV that can range from difficult to very difficult. When you add in the HCV protease inhibitors (PIs) some of the side effects of PEG/RBV are even more pronounced and boecpreivr and telaprevir have additional side effects of their own. But the big pay-off could be a cure!
The next generation of HCV therapy will be a triple combination of PEG/RBV with the addition a direct acting antivirals (DAAs) –TMC 435, BI 201335 or BMS-790052 for the treatment of genotype 1.
GS-7977 plus RBV entered into phase III studies this year for genotypes 2 and 3. The benefit of these therapies is that the addition of a new DAA to PEG/RBV means a lower pill burden (the DDA will be once-a-day) and a shorter treatment duration for some. The combination of GS7977/RBV promise an interferon-free therapy for genotypes 2 and 3 and, even further down the road, for genotype 1. In phase II studies the new DAA combination therapies also had higher cure rates and a lower side effect profile. The reality, however, is that we won’t have a better picture of the cure rates or side effect profile until the phase III studies are completed and the data is tabulated and released. It looks like at least one of the new DAA therapies will be approved by the end of 2013 or early 2014 if there are no glitches in the clinical trials and Food and Drug Administration (FDA) approval process.
Not So Near Future
What everyone is waiting for is the approval of a combination HCV interferon-free therapy for HCV genotype 1. That timing of an all oral therapy is a bit trickier because of the unknowns—potential toxicities or side effects, development of drug resistance, time to drug approval, durability of cure and cost of the new medications. However, it is more of a question of WHEN rather than IF. Currently, there are 10 DAA interferon-free studies in phase II clinical development.
Weighing Risk and Benefit
The question of whether to treat now or wait is a very serious issue that a patient and medical provider should carefully consider. It is clear that treatment now is appropriate for some patients and that some patients can wait, but for many people the decision is less clear.
Treatment Now …….
Those patients who are more likely to have higher risk for disease progression are clearly the people who should be considered for treatment now. This includes people who have factors that could increase HCV disease progression or lower chances of achieving a cure in the future:
Fibrosis—stage 2, 3 or compensated cirrhosis (stage 4): The more the liver is damaged the more likely that newer treatment may not work. Additionally, if the damage to the liver progresses to decompensated cirrhosis (stage 4), future treatment options may be limited especially if interferon is part of the treatment.
Age: treatment does not work as well in someone who is older so waiting might mean that the treatments won’t work as well as they may now.
Fatty liver disease: If a form of fatty liver disease that can lead to inflammation and scaring develops or becomes worse treatment will not work as well.
Age (40 yo or older) at time of infection: a person infected after age 40 should be treated sooner rather than later because of the increased risk of disease progression.
Viral load: generally HCV RNA increases over time so waiting could mean a higher viral load which is a negative predictor of treatment outcome.
There are many other issues to take into consideration when making the decision including:
Would treatment help with the symptoms of hepatitis C: fatigue, muscle or joint pain, brain fog, etc.?
Is there an extrahepatic disorder ((EH) cryoglobulemia, non-Hodgkins lymphoma, etc.)) that may respond to HCV treatment?
Is your work-life situation at a point where treatment would be doable?
But it’s also not that easy to take into consideration the above factors because some of them predict a lower treatment response now. That’s why you have a medical provider who can offer the professional guidance needed to make a decision.
On the other end of the spectrum are people who have a lower degree of liver damage (stage 0 – 1 and maybe early stage 2). Most would agree that those who have little or no damage, are relatively symptom free and who do not have an EH can wait until some of the newer therapies are approved. The only caveat with this view is that those who have less damage and who are at a younger age are more likely to respond to current therapy.
If you and your medical provider decide to postpone treatment, now would be a good time to start some careful planning for the day when the newer treatments are available. Start to investigate your medical insurance coverage, support and work-related issues. It would also be a good time to make some of those not so easy lifestyle changes (eating well, exercising, etc.) that would increase the chances of being cured of hepatitis C. I think that most people would agree that the best therapy outcomes are the result of good planning.
Are you totally confused? There are a lot of issues to weigh and questions to ask, but that’s why we have medical providers: Talk to your provider, ask the hard questions and come to a consensus together about whether it is safe for you to wait or if you should be treated now.
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