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VIGILANCE NEEDED DURING HCV TREATMENT

3/26/2015

Nicole Cutler L.Ac.

March 19, 2015

Improve your chance of success and prevent drug resistance by religiously sticking to your Hepatitis C dosing schedule.

Just a few decades ago, antibiotics were revered as wonder drugs because they were so effective at curing deadly diseases. While a majority of Americans have benefitted from some form of antibiotics, the evolution of drug resistance has reduced antibiotic effectiveness and created even more dangerous strains of bacteria.

Drug treatment for Hepatitis C is approaching the same miraculous status as antibiotics used to occupy. New drug combinations are eliminating the Hepatitis C virus in record numbers; however, resistance to these medications is yet to be fully realized.

The antibiotic era began in 1929 with Alexander Fleming’s observation that bacteria would not grow near colonies of the mold Penicillium. Following this discovery, penicillin drastically reduced deaths from bacterial diseases. Many lives were saved by this medical marvel. But, eventually, drug resistance began to emerge. The sexually transmitted disease gonorrhea exemplifies this change:

In the 1960s the antibiotics penicillin and ampicillin were able to control most cases of gonorrhea.
Today, more than 24 percent of gonorrheal bacteria in the U.S. are resistant to at least one antibiotic.
Today, 98 percent of gonorrheal bacteria in Southeast Asia are resistant to penicillin.

The pharmaceutical industry is well aware of the problem of drug resistance, the ability of microbes to mutate and grow in the presence of a chemical (drug) that would normally kill or limit its growth. A challenge present in most healthcare settings today, MRSA (methicillin-resistant Staphylococcus aureus) is a type of staph bacteria that is resistant to several antibiotics. Likely a result of decades of overprescribing antibiotics and the evolution of superbugs, an estimated two percent of the population now carry MRSA – a severe and very difficult to treat infection.

Considering how stubborn the Hepatitis C virus is, and how long it has taken to create effective treatments, clinicians are rightfully cautious about Hepatitis C drug resistance. Just like humans, microbes will evolve (mutate) to escape their demise. As such, there is a risk of drug resistance when attempting to annihilate any pathogen. In general, there are three concepts heeded to minimize Hepatitis C drug resistance:

Full Strength – Take the prescribed medications at full strength to prevent viral survivors. Any particles that survive a mild drug dose are likely to be somewhat resistant.
Combinations – All of the current Hepatitis C drug regimens rely on a combination of drugs to improve effectiveness and reduce the chance of drug resistance. Combining medications applies different types of pressure to the virus, doing a better job of causing their extinction, not their evolution.
Dosing Schedule – Each Hepatitis C drug treatment has its own dosing schedule; whether it is taking one pill once a day, three pills three times a day, or six pills daily with a weekly injection. Regardless of the schedule requested, it is vitally important to adhere to it. Missing a few doses could give the virus enough forgiveness to develop drug resistance.

Up to 90 percent effective, the newer Hepatitis C drugs stop the virus from making more copies of itself. These drugs have fewer side effects and need to be taken for a shorter duration than previous treatments. However, forgetting to take the medications poses the biggest threat for halting progress and allowing the virus to mutate. Most people would not knowingly take a lower dosage or just pick one medicine out of three prescribed for Hepatitis C treatment. Unfortunately, human error does occur. Especially if feeling overwhelmed or having issues remembering, accidentally skipping medications is a reality.

The new medications for Hepatitis C have not been used long enough to pinpoint how drug resistance will arise. Although it is relatively rare, studies have documented mutations of the Hepatitis C virus resulting from treatment. Just like with all microbe-killing drugs, the more people treat, the greater these incidences will become.

If dose skipping seems like a possibility, utilize pill counters or reminders to stick with your treatment regimen. The new drugs for eliminating the Hepatitis C virus are the result of millions of dollars in research, countless trials and medical perseverance. By reducing the emergence of drug resistance, we have an opportunity to wipe out Hepatitis C before it mutates into an even harder to kill pathogen.
http://www.hepatitiscentral.com/news/vigilance-needed-during-hcv-treatment/?eml=hepcen226

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Opioid Agonists May Lower HCV Incidence in Young Drug Abusers

3/23/2015

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PAIN MANAGEMENT NEWS
Clinical Pain Medicine Share on facebook Share on twitter Share on linkedin Share on blogger Share on wordpress ISSUE: MARCH 2015 | VOLUME: 13(3)printer friendly | email this articleOpioid Agonists May Lower HCV Incidence in Drug AbusersIn a group of young users of injection drugs, recent maintenance opioid agonist therapy with methadone or buprenorphine for opioid use disorders, such as heroin addiction, was associated with a lower incidence of hepatitis C virus (HCV) infection, according to a recent study (JAMA Intern Med 2014;174:1974-1981).

The use of injection drugs is a primary route of HCV transmission and young injection drug users (IDUs) are at the core of the HCV epidemic, so they may be an important target to reduce HCV transmission, according to researcher Judith I. Tsui, MD, MPH, of Boston University School of Medicine. In this cohort of IDUs, maintenance treatment with methadone or buprenorphine might be an important strategy to prevent the spread of HCV, the researchers wrote.

In an observational cohort study, Dr. Tsui and her colleagues examined the effects of opioid agonist therapy in a group of 552 young IDUs in San Francisco, from January 2000 to August 2013. Every three months, they interviewed some of the subjects and took blood samples (≥2 follow-up visits).

Most of the IDUs were men, white and homeless; the median age was 23 years; and all tested HCV-negative. The median duration of drug use was 3.6 years, and 33.3% of participants used drugs daily. Nearly 60% reported that heroin was the drug they used most often in the past month. Only 4.2% reported receiving maintenance opioid agonist treatment in the previous year.

During the study period, 171 new cases of HCV infection occurred, for an incidence of 25.1 per 100 person-years. Participants who reported receiving methadone or buprenorphine maintenance therapy in the past three months had a significantly lower incidence of HCV infection than those who reported receiving no therapy (P=0.02).

The rate ratio was significantly lower for participants who reported recent maintenance opioid agonist therapy (P=0.001), but not for those who reported recent non-opioid forms of treatment (P=0.02).

“Young injection drug users are a major driving force in the epidemic of HCV infection in the United States and Canada, and therefore are an important target for prevention. Our results suggest that treatment for opioid use disorders with maintenance opioid agonist therapy can reduce transmission of HCV in young adult IDUs, and should be offered as an important component of comprehensive strategies for prevention of primary HCV infection,” the researchers concluded.

—PMN Staff

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HEPATITIS C: ONLY A STEP AWAY FROM ELIMINATION?

3/21/2015

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Posted: 20 Mar 2015 06:48 AM PDT

The Lancet

Editorial

Volume 385, No. 9973, p1045, 21 March 2015

Globally, an estimated 185 million people are infected with hepatitis C virus (HCV). Acute HCV infections are usually asymptomatic. However, about 75% of patients develop chronic infection, which can lead to liver cirrhosis and hepatocellular carcinoma. 700 000 deaths worldwide could be attributed to HCV in 2013. While most people affected live in low-income and middle-income countries in Asia, Africa, and the Middle East, in the UK an estimated 200 000 individuals are infected with HCV, and annual deaths from HCV have quadrupled since 1996. These figures are appalling, surely. But the extraordinary recent developments in treatment for hepatitis C offer substantial grounds for optimism. A series of new drugs—more effective in viral clearance with fewer side-effects—are changing the landscape for hepatitis C.

Today's Lancet gives a sense of the remarkable past few years it has been for hepatitis C. As described in Paul Webster and colleagues' comprehensive Seminar, until recently interferon in combination with ribavirin was the main treatment for hepatitis C, but eligibility, safety, tolerability, and effectiveness were limited. The development of direct-acting antiviral drugs towards NS3/4A protease, NS5B polymerase, and NS5A replication complex has progressed tremendously and now allows for interferon-free therapies. Four clinical trials with new regimens are published in today's issue. The C-WORTHY trial assessed a single-tablet once-daily regimen of grazoprevir (protease inhibitor) and elbasivir (NS5A inhibitor) with or without ribavirin for patients with HCV genotype 1. Eric Lawitz and colleagues report a sustained virological response (SVR) at 12 weeks, irrespective of ribavirin and duration of treatment. Similarly, Mark Sulkowski and colleagues report very encouraging results (SVR at 12 weeks: 87–97%) in patients co-infected with HIV. With about 25% of individuals infected with HIV being co-infected with HCV, inclusion of this group of patients in trials is also of utmost importance. In the PHOTON-2 trial, Jean-Michel Molina and colleagues specifically assessed the recently approved regimen sofosbuvir (NS5B inhibitor) plus ribavirin in patients infected with HCV genotypes 1–4 co-infected with HIV. They confirm the pan-genotypic potential of sofosbuvir (SVR 12 weeks: 84–89%), offering HIV co-infected patients a useful interferon-free option. The fourth trial published in today's issue goes a step further and assesses whether the addition of a third direct-acting antiviral drug to an interferon-free, ribavirin-free combination (sofosbuvir and ledipasvir) would allow shorter treatment duration—an important factor for a patient population in which treatment compliance and adherence can be an issue.

These trials are important because they offer new effective treatment options for HCV infection. “An opportunity now exists to almost eliminate this infection from the UK”, wrote Roger Williams and colleagues in The Lancet Commission on Addressing liver disease in the UK. Highly effective new antiviral drugs not only can cure those treated but also can reduce transmission of HCV and therefore its prevalence. The Commission estimated that with these new antiviral drugs we could contemplate the “eradication of infections from chronic hepatitis C virus in the UK by 2030”. Indeed, modelling studies for England showed that increasing diagnostic and number of people treated by 27 times would result in a 95% reduction in the prevalence of HCV infection, an 80% reduction in hepatocellular carcinoma, and avert 5200 deaths by 2030.

While new drugs offer new opportunities, new challenges also arise. Scaling-up treatment—in any country—will face important cost issues. But the high costs of these new medicines, which should be robustly scrutinised and, where appropriate, challenged, must not inhibit a careful and comprehensive analysis of the broader benefits they might bring. For example, as Melanie Calvert and colleagues argue this week, patient-reported outcomes offer the opportunity to have the patient's voice more forcefully heard in health policy decision making. The self-reported benefits to patients from these new anti-HCV regimens might prove to be substantial. And the financial returns from reduced health-care costs and higher economic activity might easily outweigh the expense of the medicines themselves. This kind of broader cost-effectiveness work needs to be urgently completed.

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MISSED WEBINAR: NAVIGATING HEP C: WHAT PATIENTS NEED TO KNOW- IT'S ONLINE

3/19/2015

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@NVHR1: Miss our webinar Navigating Hep C: What Patients Need to Know? It's online: http://t.co/DMwGs29PzP @LucindaPorterRN @HepatitisCmsg @help4hep Sent from my iPhone

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NAVIGATING HEPATITIS: WHAT PATIENTS NEED TO KNOW WEBINAR MARCH 18TH

3/16/2015

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NVHR Webinar:
Navigating Hepatitis C: What Patients Need To Know
Wednesday, March 18, 2015
2 pm Eastern

Join us for our upcoming webinar Navigating Hepatitis C: What Patients Need to Know. This webinar will cover the most important elements that patients need to know regarding screening, access to care, receiving and paying for treatment, and living with hepatitis C. Our speakers include Bruce Burkett of HepC Alliance, Lucinda Porter of the Hepatitis C Support Project and Hep Magazine; Robin Lord Smith of the Hepatitis C Association and Help-4-Hep (a program of The Support Partnership); and Ronni Marks of Hepatitis C Mentor & Support Group.

You can register for the webinar here. Space is limited.

After registering, you will receive a confirmation email containing information about joining the webinar.

Please also visit our newly redesigned Hepatitis C Baby Boomer Resources Page!

For more information about this webinar or the resource page, contact T ina Broder, Senior Program Manager.

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HOPE IN HEPATITIS C PANDEMIC

3/12/2015

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Hepatitis C is a worldwide issue with an estimated three million infected people in the United States alone. Treatment for hepatitis C is difficult, with sometimes severe side effects, and medications are expensive, limiting treatment to those who can afford it. However, recent advances in clinical trials and changes by drug manufacturers could change the way hepatitis C is treated in the near future.

Some of the most difficult hepatitis C cases to treat are patients who are co-infected with hepatitis C and HIV. Potential side effects, possible drug interactions with antiviral medications used to treat HIV, and an inability to physically tolerate the treatment are just a few of the reasons co-infected patients are unable to receive treatment for the hepatitis C portion of the infection, which can lead to death. The ALLY-2 phase III trial may have changed that. A combination drug therapy consisting of Bristol-Myers Squibb’s Daklinza (daclatasvir) and Gilead Sciences’ Sovaldi (sofosbuvir) was found to have cured 97 percent of hepatitis C infections in the HIV/HCV co-infected study participants.

What’s more, the HIV treatment did not have to be altered for the hepatitis C combo to be effective. Patients were given a daily regimen of the combination therapy over a 12 week period.

Gilead Sciences has also developed a separate drug for hepatitis C, Harvoni (ledipasvir and sofosbuvir), a daily single tablet treatment that resulted in a 96 percent cure rate of hepatitis C in co-infected patients participating in the phase III ION-4 trial.

Co-infection isn’t the only area of the hepatitis C battle seeing progress. Harvoni, as well as Gilead Sciences’ drug Sovaldi, has been shown to be effective in hepatitis C patients; but all of these medications, though effective, are expensive. The cost of a single Harvoni pill is $1,125, making access to the drug an impossibility for many, but costs have been going down.

Addressing the global nature of the hepatitis C epidemic, the Express Tribune reported today that the Pakistan federal government announced a price reduction on Sovaldi, cutting it by almost 40 percent, and promising that adequate amounts of the drug would quickly be made available. The World Health Organization estimates there are 180 million cases of hepatitis C worldwide.

But price cuts on the drugs are not exclusive to government bodies, according to Bloomberg News, Gilead Sciences will discount Harvoni and Sovaldi by an average of 46 percent. The discounts should make treatment more affordable and should affect policy change in the United States, to widen the scope of hepatitis C cases to which the new medications should be prescribed.

““What we’re recommending to our plan sponsors is that we treat everyone,” said Steve Miller, Chief Medical Officer at Express Scripts Holding Co., in an interview with Bloomberg News

Additional hepatitis C studies are planned for Harvoni. Unity Health Care, in partnership with Family and Medical Counseling Services, the National Institutes of Health, and the University of Maryland, recently announced that it will soon begin their ASCEND study in Washington, DC.

ASCEND will screen 600 hepatitis C patients in Washington, D.C., where Unity Healthcare hopes to discover the effectiveness of Harvoni in a community health setting versus that of the clinical studies that have already been conducted.

Hepatitis C is a viral infection that attacks the liver. Symptoms in early onset are nearly undetectable, but when left untreated, can lead to cirrhosis of the liver, liver cancer, and liver failure.

Read more at http://www.inquisitr.com/1886276/hope-in-hepatitis-c-pandemic/#uFukf3VsXFhlqkVM.99

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NAVIGATING HEPATITIS C :WHAT PATIENTS NEED TO KNOW

3/3/2015

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Wednesday, March 18, 2015

11 am PST/2 pm EST

Please register here:

https://attendee.gotowebinar.com/register/1891787085823963394

This webinar will cover the most important elements that patients need to know regarding screening, access to care, receiving and paying for treatment, and living with hepatitis C.

Featured panelists:

Bruce Burkett of the Hep C Alliance
Lucinda Porter of the Hepatitis C Support Project and Hep Mag
Robin Lord Smith of Hepatitis C Association and Help-4-Hep
Ronni Marks of Hepatitis C Mentor & Support Group

For more information contact Tina Broder, Senior Program Manager, at tbroder@nvhr.org

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VIGILANCE NEEDED DURING HCV TREATMENT

Opioid Agonists May Lower HCV Incidence in Young Drug Abusers

HEPATITIS C: ONLY A STEP AWAY FROM ELIMINATION?

MISSED WEBINAR: NAVIGATING HEP C: WHAT PATIENTS NEED TO KNOW- IT'S ONLINE

NAVIGATING HEPATITIS: WHAT PATIENTS NEED TO KNOW WEBINAR MARCH 18TH

HOPE IN HEPATITIS C PANDEMIC

NAVIGATING HEPATITIS C :WHAT PATIENTS NEED TO KNOW

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