Why needle exchange programs work

 By Kara Blake

As a vocal advocate for harm reduction and needle exchange services, I have often been asked, “why needle exchange?” To public health professionals, needle exchange programs (NEPs) are an obvious and urgently needed intervention. Research study after research study continues to show conclusively that NEPs reduce the transmission of HIV and viral hepatitis, are tremendously cost-effective, and provide a range of other services that benefit the participants and greater community. Even though the evidence is clear, public and political pushback against NEPs persists across the country. Cape Cod is no exception.

Without proper information, it might make sense that a citizen or politician may be resistant to the idea of a needle exchange. How could this intervention possibly support drug users? Won’t this only perpetuate their addiction and its consequences? Won’t this facility increase crime and drug use in my community? The answer, plainly, across the board, is no.

Someone who accesses a needle exchange is making what can be the first contact with a professional about their addiction. Recognizing that not all people using drugs are ready, willing or able to stop using at that moment, staff compassionately discuss and educate participants on the potential harms associated with their drug use, and how to reduce those harms. Rather than shame drug users and require abstinence, staff meet and talk with people where they are in their addiction without judgment. This approach is called “harm reduction.” Through such relationships, participants are also able to access services such as screening for HIV, hepatitis C and sexually transmitted infections, access to Narcan and overdose prevention, enrollment in health insurance, and referrals to substance use treatment and medical care.

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Emotional Issues When Leaving Work on Disability —By Jacques Chambers, CLU, September 2015

QUOTE: There is frequently a feeling of loss of control over not only the direction of your life, but also a sense of losing control over your very own body. Likewise, the medical condition is now dictating your future.

For persons dealing with HCV, the recent introduction of the new medications that appear to provide the complete annihilation of the virus truly is miraculous. Access to the medications is another story, however. Insurance companies want to protect their profits; Medicaid programs are scrambling to find a way to budget the enormous cost of providing these medications to those who need them.

Also, as marvelous as the medications are at killing the virus, they are unable to repair the damage to the body that the virus has already caused, up to and including cirrhosis. While dealing with the physical and medical issues is vital, there are emotional issues as well that need to be at least acknowledged and dealt with should you find yourself in the position that you are no longer able to work and stay healthy.

The emotional impact of such an event may seem like one of those issues that is too basic to spend much time thinking about. Of course, there’s an emotional impact on leaving work for disability. Who wouldn’t be depressed? However, there is usually more to it than that, and not being prepared for it can put you into a tailspin that can affect your mental well being as well as your physical health.

In my years of working with clients, I have found that making the transition from work to disability is a major life event, right up there with getting married or moving, and it can have broad repercussions on actions as well as feelings and emotions. It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.

What, emotionally, will happen to me?
Don’t worry, you won’t “totally lose it.” As with medical symptoms the emotional impact will vary from person to person. The emotional repercussions of leaving work on disability often take the form of depression, lack of concentration, inability to focus on a goal and achieve it, as well as general feelings of malaise,  helplessness, and fear of the future. It can also interfere with your ability to think objectively and react rationally. There may be other symptoms both emotional and physical. The important thing to remember is that, uncomfortable as these symptoms are, they are a natural part of this change you are making, and they will pass. Everyone in a similar situation goes through a similar process.

Why does this happen?
Part of it is obvious. You are moving from active work to inactive disability; that’s a major life event and would upset anyone. There are other factors as well, primarily the sense of loss of control and having to battle old messages drilled into you by society since childhood. In many cases, a person self-identifies with the work they do.

There is frequently a feeling of loss of control over not only the direction of your life, but also a sense of losing control over your very own body. Likewise, the medical condition is now dictating your future. You may feel like you no longer have the power to decide what direction to take or what to do next. Such a feeling of helplessness can be devastating emotionally and can create all sorts of symptoms.

Finally, there are all those good work ethic messages you learned growing up and which you are probably still replaying from the early stages of your condition till now. Many people feel that stopping work is “giving up” or “surrendering” to the medical condition; that the disease is now in control of his or her body and all he or she can do is watch helplessly. Who wouldn’t have emotional issues if, in the back of their mind, they keep thinking things like:

• You’re giving up by stopping work. You’re a quitter.
• You’re surrendering to the disease.
• You’re no longer a contributing member of society.
• You’re taking a giant step closer to “The End.”
• You’re going to “milk the system.”
• You’re weak, needy, plus many other not-so-nice adjectives.

Of course, none of these are true or even rational, but our emotions aren’t based on reason.

Those messages even may get communicated from friends and family. People who haven’t been disabled do not understand the price you must pay for stopping work. I have heard some refer to their disabled friend as “retired” or “taking it easy.” There may even be “jokes” about “envy you.”

Also, do not forget that disability benefits are not always easy to obtain, whether from a private insurance company or Social Security. A denial, which should always be appealed, can cause those messages to replay even louder.

Family dynamics as well as your social relationships will be changing. Your family and friends have known you as one person. Now, even though it is not true, they may perceive you as someone different. This can cause a strain in these relationships that you need to be ready to recognize and work through.

What can I do about it?
Fortunately, there’s a lot you can do about it, and all of the suggestions below would come under the overall title of “Take back control of your life.”

• Control how and when you leave work – Know what you are doing. Make your plans; do your research; create your own timetable for stopping work.
• Take one step at a time to avoid being overwhelmed – You can do this by breaking down your tasks into smaller steps. First, work with your doctor on the process of leaving work, and then apply for the employer’s sick leave and short-term disability. Then decide whether to continue the employer’s health insurance to COBRA or switch to a health plan under the Affordable Care Act (Obamacare). Next you should apply for your employer’s Long Term Disability coverage, if available, then for Social Security Disability (SSD). A list or timeline will help you focus your attention on the next small step without being overwhelmed by the entire process.
• Build, activate and use your support network – Your family, friends, and caregivers can give you emotional support as well as practical assistance, but you may need to ask for it.
• Consider short-term therapy – Perhaps your support network is strong enough that they will give you all the help you need to get through this time. Many clients have also found that a few months with a therapist trained in the emotional issues of the disabled can be of great help as well.
• Speak up, politely but firmly – Do not hesitate to tell those who don’t understand what you are going through that this is not a vacation and you wish you could return to work and understand any snide or “comic” remarks are coming from ignorance.
• Be a little selfish – Finally, it is time, for at least a while, to take care of yourself first. You have been accommodating to others and have been putting their needs and wants ahead of yours. It is time to take a break from that. Let them know as much as you love them that you need to focus on yourself right now, and deeply appreciate their support through this period.

But what will I do once I go on disability?
Many people worry that after they leave work, they will have nothing to do. Some people have an image of themselves lying in bed, face to the wall, doing nothing but waiting. That’s not the way it is. More than one of my clients has worried that they will have too much time on their hands only to return after leaving work to tell me they are so busy, they have no idea how they were able to work full-time.
Initially at least, there’s a lot to do, applications and claims to file, health insurance to adjust, government benefits to apply for. I have heard complaints that, initially, they are busier with those than when they were working; an exaggeration perhaps, but it may seem so.
If you are the type of personality that was always busy before, trust me, you will be as busy as you want and are able to be once you leave work on disability. Depending on how you feel and your interests, there are classes to be taken, family to be enjoyed, other people or agencies that you could volunteer to assist.
Be aware that you can expect some emotional upheaval when leaving work. Recognize it as a natural part of the process and don’t let it scare you into believing that it is more than just a passing reaction to what’s going on with your life at the moment. It will pass; you will move on. Life will continue; you will be healthier and happier for it.

QUOTE: It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.

Hepatitis C Doctor Investigation Report Released -- Health Department Releases Report in Dr. Thomashefsky Investigation

This is unbelievable in this day and age......Alan

Santa Barbara, CA.  The Santa Barbara County Public Health Department has released a report into the investigation of Allen Thomashefsky, the Santa Barbara doctor accused of malpractice that lead to several patients contracting Hepatitis C

The report found that during an unannounced visit to Thomashefsky's medical practice by health officials, the physician did not wash his hands prior to a procedure. "When questioned, the physician stated that the sink was in the kitchen, he didn't want to walk back and forth, and believed his hands were clean," the report says.

According to the report, the physician did not wear gloves during the procedure either and when asked to wear gloves, he replied, "He has been practicing the same way for over 30 years and has never had a patient report any problems...The physician declined to wear gloves and used bare hands during the procedure."

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THE FIVE: Cirrhosis —Alan Franciscus, Editor-in-Chief

This month’s column is about cirrhosis—the causes, how it develops, the symptoms and
consequences and issues about HCV treatment related to cirrhosis.
 
1.  What are the Causes of Cirrhosis?  

Cirrhosis is caused by many substances (alcohol), viruses (hepatitis B, C and D), and even by metabolic disorders (diabetes). Currently, the most common reason for liver transplantation in the United States is from complications from the hepatitis C virus.  Cirrhosis caused by hepatitis C is responsible for  more than 19,000 deaths every year.  Prior to the emergence of hepatitis C, the most common cause of cirrhosis was alcohol consumption. Fatty liver is also a common cause of cirrhosis, and it is expected to surpass the hepatitis C virus as the most common cause of cirrhosis and liver transplantation in the next two decades.

2.   How Does Cirrhosis Develop?

In the case of hepatitis C, the development of cirrhosis is a complex process of liver cells becoming damaged or destroyed by the hepatitis C virus.  Furthermore, the body’s immune system seeks out and identifies the hepatitis C virus (and the destroyed liver cell) as a foreign pathogen—attacks it and kills it.  As a result, scar tissue develops.  Usually, the liver can repair itself, but as the hepatitis C virus causes more and more damage, it overwhelms the body and the damage builds and builds.  As more scar tissue develops the damaged cells start to connect, and fibrosis develops. Over time, the scar tissue can be so extensive that it can interfere with the functioning of the liver.  This is called cirrhosis. Cirrhosis is classified into two types: compensated and decompensated. Compensated means that the liver is extensively scarred but can still perform most of its functions; decompensated means that the liver is extensively scarred and unable to perform many of the functions that keep the body healthy.  

3.  What are the Tests to Identify Cirrhosis?

There are many types of tests to find out if someone has cirrhosis.  In the past, the most common test was a liver biopsy.  The procedure requires a medical person to  insert a needle through the skin to extract a piece of liver tissue and examine it under a microscope.  The liver biopsy is still being used, but it is also being replaced by other procedures such as a Fibroscan (an imaging test), Fibrometer (combination of blood tests), and other blood tests to gauge the degree of liver damage.

There are many models used to grade and stage the degree of liver damage.  The most common is the Metavir. The Metavir has an inflammation and fibrosis scoring stage—in this article I am just listing the fibrosis stages:

• Stage F0 = no fibrosis
• Stage F1 = mild fibrosis
• Stage 2 = moderate fibrosis
• Stage 3 = bridging fibrosis
• Stage 4 = cirrhosis 

Note:  This is important to know because many insurance companies are using this system to approve or deny insurance for HCV treatment claims.

4.  What are the Symptoms and Consequences of Cirrhosis? 

In the early stages of extensive scarring—called compensated cirrhosis—the symptoms may be similar to hepatitis C—fatigue, loss of appetite, muscle and joint pain, flu-like symptoms, nausea, indigestion, headaches and many other symptoms.  As cirrhosis develops and reaches the later stages—called decompensated cirrhosis—the symptoms become more pronounced and can become life-threatening.  In addition to the symptoms described above I have listed some of the more common serious conditions below:

• Portal Hypertension: blood cannot flow through the liver because of the extensive scarring. 
• Encephalopathy: the liver is not able to remove toxins such as ammonia, and the result is that these toxins invade the brain.  Symptoms include personality changes, and changes in sleep patterns (sleep reversal—awake all night, sleep all day).
• Ascites:  accumulation of fluids in the abdominal cavity.  
• Edema: accumulation of fluid in the extremities—usually in the feet and legs.  
• Coagulopathy: the liver is not able to produce clotting factors that stop the blood from bleeding.
• Male and Female Hormone Regulation:  the liver may not be able to regulate female and male hormones.
• Severe Itching: the impairment of bile flow that can cause severe and at times debilitating itching.
• Wasting Syndrome: the liver is not able to process nutrients so people can have severe muscle wasting and weight loss.  

Most of these conditions can be managed effectively with lifestyle changes, medications and medical procedures—at least in the short term. The most important step is to be medically monitored and managed on a regular basis.  At this point, a person should be evaluated for a liver transplant.  The problem is that there are only an estimated 6,000 available livers for the estimated 15,000 livers needed every year for transplantation in the U.S.

5.  HCV Treatment  

Hepatitis C treatment can now cure most people, the treatment duration is shorter, and treatment side effects are lower than ever.  However, once people develop cirrhosis, it becomes more difficult especially for those who are infected with genotype 3 and who have cirrhosis—the second most prevalent genotype in the United States.  Unfortunately, we also know that many insurance companies are denying coverage of hepatitis C medications to only those who are in the early stages of HCV infections (F0, F1, F2).  Many insurance companies are only covering F3 and F4 unless there are other severe complications.  Here’s the problem—if you wait until stage F3 or F4 and are cured you will have to be medically followed for the rest of your life since there is a possibility that you could still have liver disease progression. However, if you are treated early (F0, F1, F2), and cured you are free of future complications.  Does this scenario make any sense to you?  It does not make any sense to me either!

The True Cost of an Expensive Medication

It was supposed to be a miracle, but now it’s what keeps Laura Bush, a nurse-practitioner near Albuquerque, awake at night.

There’s a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for all 12 weeks of treatment.

Bush’s clinic, First Choice Community Healthcare, is a federally qualified health center in the rural town of Los Lunas, New Mexico, which means she sees a disproportionate number of patients who are uninsured, underinsured, and on Medicaid, the government insurance program for the poor. In other words, they can’t afford Sovaldi.

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PCORI approves $83m for hepatitis C and other studies

The Patient-Centered Outcomes Research Institute (PCORI) has approved $83m to fund 26 patient-centered, comparative clinical effectiveness research (CER) studies on a range of conditions and patient populations.

About $29.5m will support studies on caring for people affected with hepatitis C virus (HCV). Awards totaling around $7.4m will fund research on rare conditions in response to PCORI's offer of a special pool of funding for supportingt rare disease research.

The HCV studies will include national advocacy organizations, professional associations, and stakeholder groups in their research design and implementation.

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HCV Current Initiative: Addressing the National Epidemics of Prescription Opioid misuse and Hepatitis C through Unique Partnerships

By Dominique Saunders, Viral Hepatitis Prevention Coordinator, Kansas Department of Health and Environment and Sarah Knopf-Amelung, Project Manager, Mid-America ATTC, University of Missouri-Kansas City School of Nursing and Health Studies - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.

Recently, there has been a spotlight on America’s prescription opioid misuse and overdose epidemics.  However, too often, people remain unaware of the related hepatitis C virus (HCV) epidemic. The Centers for Disease Control and Prevention (CDC) reported an estimated 150% increase in new HCV infections from 2010 to 2013 and, further, that most of the new infections were associated with injection drug use. An analysis of state and national data indicate that a large proportion of new HCV infections are occurring in young people (<30 years of age) in rural and suburban areas who use oral prescription opioid analgesics before transitioning to injecting. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.

At the same time, recent years have seen advances that have revolutionized the field of hepatitis C. Groundbreaking treatments with cure rates as high as 90-100% are now available.  Preventive screenings without cost-sharing under the Affordable Care Act make HCV screening more accessible for many people.  And the national Viral Hepatitis Action Plan increases coordination across federal programs and includes among its priorities the urgent need to reduce viral hepatitis associated with drug use behaviors. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.

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Hepatitis and the Sustainable Development Goals: time for an end run - Here, Jeffrey Lazarus talks about the need for a global goal of eliminating viral hepatitis.

This is unfortuante especially with a 'cureable' disease.....AF

Well it’s official. The governments of the world have committed to ending HIV, tuberculosis and malaria, but merely ‘combatting’ viral hepatitis.

When the United Nations General Assembly voted to adopt the Sustainable Development Goals (SDGs) on 25 September, I don’t doubt that advocates of many stripes were left feeling that this highly influential agreement did not sufficiently recognize the urgency of their claims.

It is not my intention to argue that viral hepatitis advocates have been short-changed any more than those who care deeply about other issues. I do, however, think it is important for everyone committed to ending viral hepatitis to think about what this aspect of the SDGs means to us.

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September 2015 Mid-Month Edition - SNAPSHOTS —Alan Franciscus, Editor-in-Chief

This month’s Snapshots is about recently published studies on all-oral therapies to treat hepatitis C in people coinfected with HIV.  We have really come a long way in such a short period of time with medications to treat a population in high need of effective therapies.    
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Article: Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1—S Naggie et al.

Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1501315

Results and Conclusions
The study included 335 patients coinfected with HIV-1 and hepatitis C genotype 1 or 4.  The median age was 52 yo (48-58 yo).  The majority of patients were White 61% (203 pts) and Black 34% (115 pts), male 82% (276), genotype 1a 75%, genotype 4 two percent, cirrhosis 20%, median CD 4+ cell count 628 (469-823), treatment naïve 45%, previously treated 55%. The treatment period was 12 weeks.  Note: I am not including the genotype 4 patients since there were only 8 patients.  

The Bottom Line
The cure rates were 96% for genotype 1a, and 96% for genotype 1b. The cure rates were similar regardless of prior response or degree of liver damage.  The most common side effects were headache, fatigue and diarrhea.  No patients discontinued treatment due to side effects.

Editorial Comment
These results are excellent across subtypes (1a/1b), races, and prior treatment responses.  Gilead has filed for marketing approval with the Food and Drug Administration.  The American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) recommend Harvoni as a treatment for HCV for people coinfected with HIV and hepatitis C.

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Article: Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial—J K Rockstroh, et al

Source:  The Lancet HIV Volume 2, No. 8, e319–e327, August 2015

Results and Conclusions
The study was conducted in people with HIV/HCV coinfection to evaluate grazoprevir/elbasvir (one pill, once-a-day) to treat HCV genotype 1, 4, and 6. The treatment period was 12 weeks. There were 218 patients in the phase 3 trial.  The trial was conducted in Europe, the United States and Australia.

The Bottom Line
The overall cure rate was 96% (210 of 218 patients).  All patients who had cirrhosis were cured.  The most common side effects were fatigue, headache and nausea. No patients discontinued treatment due to side effects.

Editorial Comment
The high cure rates and fewer side effects plus no treatment discontinuation due to treatment-related side effects equals very good news for patients.

The once-a-day combination of grazoprevir/elbasvir when approved is going to be a welcome addition to the other therapies to treat hepatitis C in people who are HIV and HCV coinfected.  

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Article: Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1—D L Wyles et al.  
Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1503153

Results and Conclusions
There were 3 different treatment groups. All the groups received daclatasvir plus sofosbuvir. Note: Since there was a small number of genotype 2, 3, and 4 patients—I omitted these results.  For this article I am just listing the genotype 1 results.    

The Bottom Line
The patient characteristics, treatment durations and cure rates are included below:

1. Naïve (untreated patients): 101 patients; median age 52 yo; male sex 91%; race: White 65%, Black 30%; genotype 1a: 70%, genotype 1b: 12%; cirrhosis 9%; median CD4+ count 520 (122-1147). Treatment duration = 12 weeks. Cure rate = 96%
2. Naïve (untreated patients): 50 patients; median age 51 yo; male 84%; race White 56%, Black 38%; Genotype 1a 70%, Genotype 1b 12%; cirrhosis 10%; treatment duration = 8 weeks.  Cure rate = 76%
3. Treatment Experienced:  52 patients; median age 57 yo; male 83%; race White 60%, Black 38%; genotype 1a 63%, genotype 1b 21%; cirrhosis 29%; treatment duration =12 weeks.  Cure rate = 98%

The most common side effects were fatigue, nausea, and headache.  No patient discontinued due to side effects.

Editorial Comment
The 12-week treatment groups had good cure rates as opposed to the 8-week treatment response group.  The treatment-experienced group #3 with a 38% Black population and a relatively high cirrhotic population achieved nearly perfect cure rates. The drawback of this combination is going to be the high price tag of the combination of these two drugs.

Note:  Another issue with treating hepatitis C in people with HIV is the potential drug-drug interactions with HIV medications.  For more information visit the AASLD/IDSA  HCV Guidelines http://www.hcvguidelines.org/full-report-view.

MediaplanetUSA’s “Hepatitis & Liver” campaign

We recently participated in MediaplanetUSA’s “Hepatitis & Liver” campaign where industry professionals and associations came together to draw attention to the importance of liver health, while highlighting hepatitis awareness, testing education, and treatment to erase the stigma and judgments attached to the disease. The campaign was distributed within the centerfold of USA Today on September 23, 2015 and is published on a Mediaplanet original site. 

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Hepatitis C drug costs challenges DOC budget

Covering the cost of a new treatment for hepatitis C treatment for a growing number of patients is a challenge for the Department of Corrections.

Oregon faces budget-busting costs for expensive new treatments for hepatitis C, and the issue is not limited to the state’s Medicaid program.

The prison system also faces higher costs from a new drug that cures many people of the potentially deadly disease, but costs the Department of Corrections roughly $70,000 per inmate for the 12-week treatment. The Legislature already approved an additional $3.2 million in a supplemental budget bill earlier this year to cover the drug Harvoni for inmates, after the number of inmates treated rose sharply in December. The increase was also part of the reason the Legislature boosted the Department of Corrections’ latest two-year budget for medical supplies by nearly 32 percent.

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Efficacy and safety of Paritaprevir/r/Ombitasvir/Dasabuvir ±Ribavirin in GT1 HCV infected patients treated in real life settings (AMBER study - interim analysis

Editor's Note:  Read our Fact Sheet HCV in Japan:   click here: 

AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval in Japan for the Treatment of Genotype 1 Chronic Hepatitis C

• New interferon and ribavirin-free treatment option for patients with most common type of hepatitis in Japan, genotype 1 chronic hepatitis C, including those with compensated cirrhosis[1]
• VIEKIRAX consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily[1]
• Approximately 1.5 to 2 million people are living with hepatitis C in Japan, one of the highest rates of hepatitis C infection in the industrialized world[2],[3]

NORTH CHICAGO, Ill., Sept. 28, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved VIEKIRAX® (ombitasvir/paritaprevir/ritonavir), as a new interferon and ribavirin-free treatment option for adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis.1 VIEKIRAX consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily.

"Today's approval represents an important step forward for the treatment of Japanese patients, a population with specific needs based on patient and viral characteristics," said Jean-Michel Pawlotsky, MD, PhD, professor of medicine at the University of Paris-Est, France. "VIEKIRAX is a valuable new addition to a number of treatments that are changing the face of hepatitis C, making it possible to achieve high virologic cure rates, even in patients whose disease has progressed to compensated liver cirrhosis."

Japan has one of the highest rates of hepatitis C infection in the industrialized world, with approximately 1.5 to 2 million people living with HCV.2, 3 Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the genotype 1b (GT1b) sub-type.4

"We are pleased to provide VIEKIRAX as a new treatment that offers a high probability of virologic cure for GT1b HCV patients and are working to support access to our treatment in Japan," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We are also prioritizing disease education and awareness by collaborating with stakeholders to identify and address the diverse challenges across Japan, such as supporting screening and diagnosis initiatives, and providing accurate information to the medical community about treatment options."

The approval is supported by the Phase 3 GIFT-I study.1 An overall 95 percent (n=140/148) of treatment-naïve and 94 percent (n=102/109) of treatment-experienced GT1b HCV infected patients achieved SVR12 with VIEKIRAX.1

The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load. A secondary endpoint in GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR12.5

Across all treatment arms three patients (n=3/363) experienced on-treatment virologic failure, eight patients (n=8/354) experienced post-treatment relapse and three patients discontinued treatment due to adverse events. The most commonly reported adverse events (>5 percent in any arm) were nasopharyngitis, headache, peripheral edema, nausea, pyrexia and decreased platelet count.5 In April 2015, AbbVie was granted priority review by the MHLW for VIEKIRAX, on the basis of clinical usefulness of the treatment and recognizing the severity and unmet need of the disease in Japan.

About the GIFT-I Study5

GIFT-I comprises 363 patients in two sub-studies.

In sub-study 1, 321 genotype 1b (GT1b) patients without cirrhosis, both treatment-naïve and interferon (IFN) [with or without ribavirin (RBV)] treatment-experienced, were randomized to receive either ombitasvir/paritaprevir/ritonavir (Arm A) [OBV/PTV/r] or placebo (Arm B) [2:1 randomization ratio, stratified by treatment history, past response, viral load and IFN eligibility]. Patients initially randomized to placebo (Arm B) then received OBV/PTV/r for an additional 12 weeks of open-label treatment. Sustained virologic response was assessed 12 weeks post-treatment (SVR12) as a primary efficacy endpoint in a sub-group of previously untreated, non-cirrhotic GT1b patients who were eligible for therapy with IFN and had a high viral load, defined as an HCV RNA level ≥ 100,000 IU/mL and received at least one dose of the double-blind, active study drug.

In sub-study 2, 42 GT1b treatment-naïve and IFN (with or without RBV) treatment-experienced patients with compensated cirrhosis received open-label treatment for 12 weeks (Arm C) with SVR12 and assessed as a secondary efficacy endpoint.

One patient from each arm (n=3/363) experienced on-treatment virologic failure [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106); Arm C, 2.4% (n=1/42)]. Across all arms, eight patients (n=8/354) experienced post-treatment relapse [Arm A, 2.4% (n=5/209); Arm B, 1.0% (n=1/105); Arm C, 5.0% (n=2/40)].

AbbVie studied its two direct-acting antiviral treatment regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b.

About VIEKIRAX in Japan

Indication in Japan

VIEKIRAX is indicated for the improvement of viremia in chronic hepatitis C or compensated hepatic cirrhosis C in patients of serogroup 1 (genotype 1).

Summary of Safety Information

Contraindications

VIEKIRAX is contraindicated in patients with a history of known hypersensitivity to an ingredient in VIEKIRAX, patients with severe hepatic impairment (Child-Pugh C) or patients being treated with the following drugs: azelnidipine, triazolam, iv midazolam, blonanserin, pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, sildenafil citrate [Revatio], tadalafil [Adcirca], rivaroxaban, vardenafil hydrochloride hydrate, riociguat, simvastatin, atorvastatin calcium hydrate, carbamazepine, phenytoin, phenobarbital, rifampin, efavirenz, foods containing St. John's Wort (Hypericum perforatum), ethinyl estradiol-containing medicinal products.

Precautions for Use

Positive result for HCV RNA should be confirmed before administering VIEKIRAX and decompensated cirrhosis should be excluded.

When VIEKIRAX is used for patients co-infected with HIV/HCV, administer VIEKIRAX only to patients whose virological suppression has been achieved by anti-HIV therapy as ritonavir may cause resistance against a HIV protease inhibitor.

During the administration of VIEKIRAX, perform liver function tests regularly because hepatic function disorder may occur.

Co-administration of VIEKIRAX with drugs that are substrates of CYP3A4, P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs, potentially requiring dose adjustment or clinical monitoring.

The safety of VIEKIRAX in pregnant women has not been established. VIEKIRAX should be used in pregnant women and women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment.

Do not administer VIEKIRAX to nursing mothers. If VIEKIRAX is administered to a nursing mother by necessity, breast feeding must be discontinued during treatment.

Safety and effectiveness have not been established in children.

Adverse Reactions

Major adverse reactions included peripheral edema in 15 subjects (4.1%), headache in 12 subjects (3.3%) and nausea in 10 subjects (2.8%)

About AbbVie's HCV Clinical Development Program in Japan

AbbVie's HCV clinical development program in Japan focuses on our two direct-acting antiviral treatment and is designed with the goal of achieving high SVR rates in chronic HCV infected patients, including additional genotypes and patients with compensated cirrhosis.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 VIEKIRAX [package insert]. Tokyo, Japan: AbbVie Ltd; 2015.

2 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html

3 Gower, E.  Global epidemiology and genotype distribution of the hepatitis C virus infection. Journal of Hepatology 2014; 61: S45-S57, Table 2. 

4 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. Available from: http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html

5 Kumada H, et al. Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology. 2015 Jul 3. doi: 10.1002/hep.27972.

SOURCE AbbVie

For further information: Media: Judy Low, +65 9880 2604, judy.low@abbvie.com; or Jane Woo, +1 (847) 937-4754, jane.woo@abbvie.com; or Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

Australia: Hepatitis C drug buyers club aims to set up new source of support

 "The FixHepC Buyers Club has successfully helped patients with a doctor's prescription to arrange personal importation and testing of a course of the drugs for a fraction of the US cost - between $US930 ($A1292) and $US1980 ($A2795). The cure rates from these generic medications have reportedly been excellent with results posted on the fixhepc.com website."

A group of campaigning patients and doctors has launched a Dallas Buyers' Club-style operation to help Australia's estimated 233,000 hepatitis C sufferers get new life-saving drugs without paying astronomical bills.

The move comes after the Kirby Institute for infection and immunity in society published a report showing the number of Australians with hep-C related severe liver disease has more than doubled in 10 years.

The FixHepC Buyers Club has been set up to import new wonder drugs such as Harvoni  and Sovaldi from China, instead of waiting for Gilead Sciences, the American pharmaceutical giant which owns the patents, to negotiate a price with the Pharmaceutical Benefits Scheme.

Read more: http://www.smh.com.au/national/health/hepatitis-c-drug-buyers-club-aims-to-set-up-new-source-of-support-20150924-gjts1t.html#ixzz3mnntLHL7

One senator's push to fund hepatitis C treatment for veterans

Many veterans who fought to protect and defend our country are still fighting to get the support they need from the federal government. Fortunately, help may be on the way for veterans living with hepatitis C, one of the greatest threats facing former servicemen and women.

Recently, the Senate Appropriations Committee followed the lead of Sen. Mark Kirk (R-Ill.) and approved a budget for the Department of Veterans Affairs (VA) that included an additional $200 million to fund critical hepatitis C treatments for a total of more than $1.5 billion for hepatitis C over the next two years. The measure is now on its way to the full Senate for a final vote. This means that Kirk's pathway to securing these needed treatments for the veterans community may come in contact with federal budget cap debates and be blocked as the next federal fiscal year approaches. It will make a big difference if veterans of all generations contact their members of Congress to insist that veterans' healthcare priorities must be left untouched during spending debates. Veterans have sacrificed enough — especially those living with hepatitis C — than to have to stand by while Congress fights about the numbers.

While hepatitis C has reached epidemic levels nationwide, the veterans community has a hepatitis C infection rate that is nearly double the national average. For veterans, this deadly, blood-borne disease is a leading cause of liver failure, catastrophic liver damage and liver cancer. It impacts veterans disproportionately due to a variety of factors, including battlefield blood exposure, emergency transfusions and mandatory vaccinations in the era before hepatitis C testing became common.

Read more...

Gilead Drug Combo Could Be Indicated for All Forms of Hepatitis C

Study shows drug may eliminate need for HCV genotype testing altogether

A new Gilead Sciences drug combination that targets six genotypes of the hepatitis C virus (HCV) has achieved promising results in four international phase III clinical studies.

 Gilead has announced results from ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. The studies evaluated a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) with velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of genotype 1 to 6 chronic HCV infection.

In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1 to 6 HCV infection received 12 weeks of SOF/VEL. Among these patients, 21%% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was a sustained virological response at week 12 post-treatment (SVR12)

Read more.....

U.S. Food and Drug Administration Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer

PETACH TIKVA, Israel, Sept. 17, 2015 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug's development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.

"We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.

About CF102 

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company's CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Read complete press release here

Researchers find HCV treatment uptake declined over time among HIV/HCV coinfection

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In the Swiss HIV Cohort Study, researchers found that hepatitis C virus infection treatment uptake over the last 13 years has been low and many patients co-infected with HIV and hepatitis C remained untreated since 2013.

“The Swiss HIV Cohort Study offers an ideal platform to study the natural course of HCV infection and long-term influence of HCV treatments in a nationwide representative population of HIV-infected patients,” the researchers wrote in the Journal of Hepatology. “We aimed to assess the changes in epidemiology, clinical course and therapy of HCV infection between 2001 and 2013 and to characterize the population who remains eligible for the new HCV treatment options by the end of 2013.”

Of 12,401 patients, 17% were positive for HCV RNA (n = 2,107) and 23.8% were seropositive for HCV. Thirty-percent of the HCV RNA-positive patients (n = 636) began therapy with an incidence of 5.8 per 100 person-years (95% CI, 5.3-6.2). Of the patients treated with pegylated interferon and ribavirin, 50% achieved sustained virologic response, which represented 15% of all participants with replicating HCV infection, according to the research. Also, of the 636 treated patients, 11% were treated twice and 2% were treated at least 3 times.

Read more....

Hepatitis C Workshop Set

ALAMOSA — Hepatitis C is an infectious (contagious) liver disease that spreads through blood-to-blood contact with an infected person.

Andres Guerrero with the Colorado Department of Public Health and Environment and Chris Grano with Hep C Connection in Denver will present the workshop ”Hep C- What you need to Know” on Thursday, October 8, in Alamosa.

The workshop will be held at SLV Heath Education Center at 1919 Main St. in Alamosa. Two times for the same program are available — 3:30–5 p.m. and 7– 8:30 p.m.

Hep C testing will be available at no charge for people who use injection drugs, were born between 1945 and 1965, had sex partners who are Hep C positive, had tattoos in prison or jail and/or had blood products or tissue before 1992. Testing is available for those who qualify with the above criteria through the Colorado Department of Public Health and Environment from 1– 2:30 p.m. October 8th at the SLV Heath Education Center at 1919 Main St. in Alamosa. No appointment is needed for testing and spaces are limited.

Call the SLV AHEC at 589-4977 for further information or to register by October 6.

Read more....

Managing Hepatitis C: Advances in treatment & evaluation

Improvements to the efficacy and side effects of hepatitis C medications have simplified the disease management calculus, tipping the scales towards treatment.

The availability of effective oral medication has also raised the bar for clinicians: is there a way to make similar progress in the evaluation side? What would it take to stage the disease quickly, safely, and without discomfort for the patient?

The stiffness of the patient's liver tissue, categorized at a certain stiffness as "fibrosis," provides hepatologists important diagnostic information about the extent and stage of hepatitis C. Liver biopsy has long been the gold standard for obtaining this information. However, biopsies are time-consuming invasive procedures that routinely cause patients pain and, in some rare instances, lead to greater complications such as internal bleeding. These procedures take up clinical staff time, necessitate bed space, and incur instrument and room sterilization costs. Lastly, they are subject to not insignificant sampling limitations, as each biopsy takes only a small sample from a large organ.

Read more...

What We Talk About When We Talk About Hepatitis C

Since 2007, more people have died every year from hepatitis C than from HIV. Fortunately, the latest hepatitis C medications can cure nearly everyone in a relatively quick, easy fashion. So, if it is so easy to cure hepatitis C, why haven't we?

Ostensibly, it is because of the cost. At $1125 a pill for Gilead Sciences' drug Harvoni, a 12-week course of hepatitis C treatment would amount to $94,500. Trying to manage these costs, many state Medicaid programs and insurance companies have severely restricted access to treatment. You save money if you deny treatment to people, and dead people cost nothing.

This means that although we can cure hepatitis C, we aren't. Under many insurance plans, patients have to prove that they have cirrhosis. In short, treatment is approved when liver damage has progressed to its worst stage. It is like refusing to pay for diabetes drugs until the patient is blind or minus a few toes.

Read more....

Achillion Reports 100% SVR12 From Second Cohort of Patients in the Previously-Completed Six Week Phase 2 Trial Evaluating Odalasvir (ACH-3102) and Sofosbuvir for Genotype 1 HCV ("Proxy Study")

- 100% SVR12 reported for all patients treated for six- (n=18) or eight-weeks (n=12) —
- Odalasvir (ACH-3102) is the subject of an exclusive, worldwide development and commercialization license granted to Janssen -

NEW HAVEN, Conn., Sept. 17, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced additional interim results from a Phase 2 study evaluating odalasvir (also known as ACH-3102), a NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for either six or eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection. Of the patients treated for six weeks in this cross-over cohort, 100 percent (n=6/6) remained HCV RNA undetectable twelve weeks after completing therapy (SVR12). Previously, Achillion reported results from this study including 100 percent SVR24 for the initial cohorts including 12 patients treated for eight weeks and 100 percent SVR24 for 12 patients treated for six weeks.

In May 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir, ACH-3422, and sovaprevir.

ACH-3102 - 017: Phase 2 pilot study evaluating six- and eight-weeks of treatment in combination with sofosbuvir for genotype 1 treatment-naïve HCV

Achillion conducted a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of odalasvir and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study was determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were initially enrolled, including six observational patients (group 1). Twelve patients completed eight weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV. At baseline, the median HCV RNA was 7.15 log10 (range 5.5 — 7.8 log10). Of the 12 patients, 100 percent achieved SVR24. Odalasvir and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment.

Following achievement of the pre-specified response rate of 100 percent, the six observational patients plus six additional patients (group 2) were enrolled and received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Median HCV RNA at baseline was 6.95 log10 (range 6.2 — 8.0 log10) and six patients had GT 1a HCV. Of the 12 patients, 100 percent achieved SVR24.

Six additional rollover patients (group 3), enrolled into the final cohort, also received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Baseline characteristics included five of six patients with genotype 1a HCV, four of six patients with non-CC IL28B (two patients with IL28B TT), and a median baseline HCV RNA of 6.32 log10 IU/ml (range 6.0 — 7.3 log10 IU/ml). In all, a total of 18 patients (group 2 and 3) received six weeks of treatment and all subjects, 100 percent, achieved SVR12.

About the Achillion Worldwide HCV Collaboration with Janssen

On May 19, 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir. A key objective of the collaboration is to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. Achillion announced on August 3, 2015 that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) had initiated a Phase 1 clinical trial to evaluate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 in healthy volunteers. Janssen previously stated its goal of initiating Phase 3 development with a triple regimen for HCV by early 2017.

About HCV

The hepatitis C virus (HCV) is one of the most common causes of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-quarters of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection.

About Achillion Pharmaceuticals

Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients' lives. Achillion believes that its scientific excellence, integrated capabilities and experienced team position it to successfully achieve its goal of advancing new products along the entire continuum from the bench to the patient. Achillion's pipeline is currently focused on small molecule therapeutics for infectious disease and complement-related diseases. www.achillion.com

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," "focus," "will," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: comply with its obligations under and otherwise maintain its collaboration agreement with Janssen on the agreed upon terms; demonstrate, either alone or through its collaborators, the requisite safety, efficacy and combinability of its drug candidates, and advance the preclinical and clinical development of its drug candidates under the timelines it projects in current and future clinical trials; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete effectively and successfully; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014, its quarterly report on Form 10-Q for the quarter ended June 30, 2015, and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.


Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com

Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com

Investors:
Tricia Truehart
The Trout Group, LLC
Tel. (646) 378-2953
ttruehart@troutgroup.com

3-Drug Therapy Deemed Effective Hepatitis C Treatment

An investigational combination of 3 interferon-free drugs has proven effective at treating hepatitis C virus (HCV) in a recent trial. The study, published in the Journal of the American Medical Association, examined a 12-week dose of daclatasvir, asunaprevir, and beclabuvir in patients with HCV-related liver cirrhosis. None of the 3 medications has yet been approved for use in the United States, although daclatasvir is currently under review by the FDA.

The researchers found that the combination cleared HCV in 93% of trial participants who had not been previously treated, as well as in 87% of those with past failed therapies. However, the addition of a fourth drug, ribavirin, increased the cure rate of patients with past failed therapies to 93%, comparable to that of patients who were receiving treatment for the first time.

“The development of interferon-free treatments has been a tremendous step forward in the standard of care,” said lead author Andrew Muir, MD, MHS, in a press release. “These drugs are highly effective and well tolerated by patients at all stages of liver disease.”

Read more.....

Image of the Week: Gamification Approach Educates Delegates at World Hepatitis Summit

Earlier this month, MCI worked with the World Health Organization (WHO), the Scottish Government and the World Hepatitis Alliance to deliver the first ever World Hepatitis Summit in Glasgow, Scotland.

A key objective for the three-day programme was to help attendees – a mix of government officials, healthcare professionals and patient representatives – realise how to form a national plan should an outbreak of hepatitis happen.

MCI’s creative team knew that engaging the audience through an immersive experience would be more effective than simply presenting facts and figures, so created an experiential session that inspired attendees to think on their feet and gain practical skills in terms of assessing the level of threat to their countries and preparing a National Plan for Hepatitis.

Read more....

Benitec Initiates a Fourth Site in Hepatitis C Clinical Trial

SYDNEY, Sept. 16, 2015 /PRNewswire/ -- Benitec Biopharma Limited (NASDAQ: BNTC; NASDAQ: BNTCW; ASX: BLT) a clinical-stage biotechnology company developing innovative therapeutics based on its gene-silencing technology, DNA-directed RNA interference (ddRNAi), is pleased to announce it has initiated a new site for its ongoing Phase 1/2a TT-034 trial at the Methodist Health System Clinical Research Institute in Dallas, Texas.  The site has commenced pre-screening hepatitis C patients and is led by principal investigator Dr. Parvez Mantry, a gastroenterologist and hepatologist.

This brings the total number of trial sites to four, with Benitec already having established sites at the Duke Clinical Research Institute, the University of California San Diego and the Texas Liver Institute.

Benitec CEO and Managing Director Dr. Peter French said, "We are pleased to welcome a fourth site to join our first-in-man trial of TT-034, an innovative therapeutic based on Benitec's gene silencing technology, ddRNAi. The addition of this site reflects the growing interest from the medical community in Benitec's potentially transformational approach to treating and curing hepatitis C. Recruitment and dosing for the trial is proceeding well."

More detail on the TT-034 trial:  TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a "triple therapy" even though it is a monotherapy, and minimises the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells it enters the nucleus and produces three separate short hairpin RNAs continuously for the lifetime of the cell. Thus it has the potential to not only treat the existing HCV infection but to guard against reinfection for months to years without the need to re-treat. It has been extensively tested in pre-clinical in vivo studies and no adverse effects were seen at any therapeutic dose.  However, as it is regulated as a gene therapy, the trial design is to primarily ensure that treatment with TT-034 is safe, hence the gradual dose escalation.

Read complete press release here: http://www.prnewswire.com/news-releases/benitec-initiates-a-fourth-site-in-hepatitis-c-clinical-trial-300143931.html

Medical Office Responsible For Transmitting Hepatitis C To Patients Can Reopen

SANTA BARBARA, Calif. -The Santa Barbara medical office of Dr. Allen Thomashefsky may reopen after it was shut down for unsafe injection practices.

The Public Health Department for Santa Barbara County released the following statement:
"Santa Barbara County Health Officer, Charity Dean, MD, MPH, has rescinded the Health Officer Order closing the medical office of Dr. Allen Thomashefsky. This action follows a number of measures that have been implemented to assure infection control practices are maintained at the medical office.

Genetic testing of Dr. Thomashefsky's former patients revealed at least four people who had procedures at his office the same day tested positive for Hepatitis C. A fifth may have contracted the deadly disease prior to treatment.

Read more...

Hepatitis C in Children

—Alan Franciscus, Editor-in-Chief

It is estimated that Hepatitis C (HCV) occurs in about 0.15% of 6-11 year-olds and 0.4% of 12-19 year-olds.  It is estimated that there are 23,000 to 46,000 children in the US with HCV.1  The actual number of children with HCV is unknown because children are not routinely tested for it.

Prior to 1992, the most common transmission route for HCV in children was through blood transfusion, blood products, and organ transplantation.  Now that blood products and organs are screened for hepatitis C the most frequent transmission of hepatitis C in infants is mother-to-child transmission.  The second most common transmission route in children and teenagers is in those who share equipment to inject drugs (needles, cookers, cotton, water, etc.)

Transmission of HCV from an HCV-infected mother-to-infant occurs about 6% of the time.  It can occur up to 10% of the time if a mother is coinfected with HIV and hepatitis C.  Also, a high viral load increases the risk of mother-to-infant transmission.   Unfortunately, there are no effective strategies or drugs to prevent the transmission of HCV from mother to child.  

When a baby is born to an HCV-infected mother, the child will acquire the mother’s HCV antibodies. For this reason, the child will not be tested for HCV antibodies for 18 months.  This is the period that it takes for the baby’s body to clear out the mother’s antibodies.
An HCV RNA or viral load test can be given as early as one month.  It might be too early since the HCV RNA, or viral load fluctuates during the acute infection phase.  Also, babies have a high rate of natural clearance.  Most medical providers prefer to wait out the 18-month period to test for HCV antibodies and the confirmatory HCV RNA (viral load test).

Table 1.  Children for whom screening is recommended.

• Children and adolescents with unexplained elevated aminotransferasesChildren at risk for vertically acquired HCV
• Children from regions with high prevalence of HCV (adoptees, refugees, immigrants)
• Children and adolescents with HIV
• Children or adolescents who are victims of sexual assault
• Adolescents with multiple sexual partners
• Adolescents who are or were intravenous drug users, even if only once in the past
• Children or adolescents who have ever been on dialysis
• Sexual partner of HCV-infected person
• Children or adolescent who have received needle stick (needles, piercing or tattooing)*

Source:  Mack CL1, Gonzalez-Peralta RP, Gupta N, et al. NASPGHAN practice guidelines:
Diagnosis and management of hepatitis C infection in infants, children, and adolescents Pediatric Gastroenterol, Nutr 2012;54:838-855

Baker R. Viral Hepatitis. In: Pohl JF, editor. Pediatric Gastroenterology. Baton Rougue, FL: CRC Press: 2014.  pp 313-327

*I read this recommendation with interest because we know that receiving a tattoo or piercing in a commercial parlor is safe.  .

Chronic Infection
Approximately 75% of infants who are acutely infected with hepatitis C will continue to chronic infection.  In children, the rate of disease progression is slow.  There is, however, a small percentage (estimated at less than 2%) of children in whom there is a rapid rate of disease progression that could lead to fibrosis and cirrhosis.

Watch, Wait and Protect
A baby born to an HCV-infected mother should receive the hepatitis A and hepatitis B vaccines to protect the child from becoming infected with another liver disease.  As well the baby and child should receive other immunizations to protect the health of the child.

Hepatitis C is not spread by casual contact and infected children should not be restricted from attending daycare or school.  Children should be taught that they should not share toothbrushes, nail clippers, razors or any other items that have the potential to transmit hepatitis C.

Any drug, herb or supplement that the child is given should be screened to make sure that it is liver safe.  When the child is older, a discussion should take place about sex, drugs, and alcohol.

Most importantly, a child should be medically monitored on a regular basis.

When to Tell a Child
Telling a child that they have hepatitis C can be one of the most difficult decisions a parent can ever make.  The timing is the most important decision.  The best advice is never to lie to a child.  We have an excellent fact sheet that can provide plenty of advice to parents.  http://hcvadvocate.org/hepatitis/factsheets_pdf/TellChild_HCV.pdf

Treatment
As stated above most children have a slowly progressive disease.  For the small percentage that have severe fibrosis or cirrhosis, immediate treatment may be needed.   The decision to treat or not is never easy and in children it is even more difficult.  Some questions that are important to consider include:

• Can treatment be postponed until the interferon-free therapies are available?
• Is there an interferon-free clinical trial that your child can enroll in?
• Are you and your child ready to take on interferon treatment and the side effects?
• The new medications are very expensive—there is always the possibility that your insurance company may not cover the new medications.

Current treatment of pegylated interferon plus ribavirin is approved for children who are three years and older with compensated cirrhosis.

Again, most children have slowly progressive disease, and it takes decades before serious liver disease develops.  By this time, children will age to adults and be eligible for interferon- and ribavirin-free therapies that approach 100% effectiveness.

The Future
Hepatitis C infections are on the rise.  The so-called Second Epidemic of hepatitis C is affecting females equally as males.  As a result, there will be many women of child-bearing age that will become pregnant and have children who may also have hepatitis C.

For the first time, there is an opportunity to prevent mother-to-child transmission. Direct-acting antiviral medications without ribavirin that are pregnancy category B.

Pregnancy Category B: In humans, there are no well-controlled studies. However, in animal studies, pregnant animals received the medicine, and the babies did not show any problems related to the medicine.

However, there have not been any clinical studies using the interferon- and ribavirin-free medications in pregnant women.  As a result, studies are needed to evaluate the safety and effectiveness of these new drugs for the mother and the infant.

1American Liver Foundation
Source:  Hepatitis C in Children in Times of Changes, Robert D. Baker and Susan S. Baker Walters Kluwer Health, Inc.

Women Living with HIV Face Higher Rates of Cancer Diagnosis: Study

Vancouver, BC [September 15, 2015] Due to the introduction of modern highly active antiretroviral therapy (HAART), people living with HIV are now much less likely to develop AIDS-related cancers, which were characteristic of the epidemic in the 1980s. However, a new study published in HIV Medicine shows women living with HIV still have a higher likelihood of being diagnosed with certain cancers, when compared with the general population.

While rates of AIDS-defining malignancies may be decreasing over time, there has been an observed increase in non-AIDS defining malignancies among women living with HIV compared to the general population. This trend primarily involves cancers with underlying infectious causes such as human papillomavirus (HPV) and hepatitis.

“This research suggests chronic inflammation, immune-suppression, aging and viral infections may be contributing to the cancer risk,” said Dr. Robert Hogg, Senior Research Scientist at the BC Centre for Excellence in HIV/AIDS (BC-CfE) and Professor at Simon Fraser University. Dr. Hogg is the thesis supervisor for Kate Salters, the study’s main author. “The study highlights the importance of ongoing access to HIV care and cancer screening practices that are specific to the risks facing women living with HIV. With sustained treatment, women with HIV are now able to live longer, healthier lives – making it increasingly important to address emerging health needs.”

Read more....

Big Questions about Hepatitis C 

Answers to some common questions about hepatitis C and its treatment. 

—Lucinda K. Porter, RN

Do you lay awake pondering questions about hepatitis C? If so, you probably need some answers so you can sleep better. This month, I answer some common questions I hear from patients. 

I just finished hepatitis C treatment. My final hepatitis C viral (HCV) load test result was “not detected.” I was hoping that my viral load would be “negative” rather than “not detected.” My doctor was happy with the result. What does this mean?

Undetected (or nondetected) means that hepatitis C is gone, and presumably all gone. The confusion over this test is because viral load tests don’t measure down to zero. Viral load tests vary. For instance, the Abbott RealTime HCV assay (assay is a fancy word for a test that determines and counts the ingredients of something) measures down to 12 IU/mL in a 0.5 mL sample of blood. This means that if you have 12 IU/ml of hepatitis C (HCV RNA) in your blood, the test can measure it. If you have less than 12, the test can’t measure it. In some cases, the test may not even see the virus.

Each test has its own detection range, some 

lower than others. The main thing is this: 

“Not detected” = negative for hepatitis C

“Detected” or an actual number of how much 

HCV RNA you have = positive for hepatitis C

If you are concerned that you may have some residual HCV swimming around in your body, that will someday become a full-blown infection, rest assured, as this is quite unlikely. Hep C replicates a trillion times a day, so “not detected” might as well be zero. It is extremely unlikely that a small amount of HCV will remain alive in your body without having replicated to much higher amounts. In fact, viral load tends to replicate at much higher numbers when treatment fails.

My HCV load was nondetectable and my doctor says I am cured. How do I know for sure that the virus won’t come back?

Doctors have been treating hepatitis C for more than two decades. In the beginning, only a small percentage of patients responded to treatment. We weren’t sure these patients were permanently cured, so the term sustained viral response (SVR) was used. Over time, we learned that a sustained viral response (SVR) equals a cure, and that once gone, hepatitis C does not return unless there is exposure to a new infection. The rare exception to this is when a patient has cryoglobulinemia or a rare immune condition.  I’ve worked in this field for 18 years, have crossed paths with thousands of patients, and have never known anyone who had an SVR but the virus came back, except for those who were reinfected or had an error in their testing procedure.

So, are you saying that if I am cured, I can get hep C again?

Yes. The chance of a hepatitis C reinfection with hepatitis C is low, but it is not impossible. Risk of reinfection is higher if you are HIV positive or use injection drugs. 

In a poster presented this year at CROI in Seattle, Andrew Hill and colleagues analyzed data from 11,071 patients in 66 studies. (Five-Year Risk of Late Relapse or Reinfection with Hepatitis C after Sustained Virologic Response: Meta-analysis of 49 Studies in 8534 Patients) They found:

•HCV mono-infected persons with low risk of exposure to the virus had a 1.14% reinfection rate 

•HCV mono-infected persons who injected drugs or prisoners had a 13.22% reinfection rate 

•HIV/HCV co-infected persons had a 21.72% reinfection rate

•All of the patients reviewed were treated with the dual regimen of pegylated interferon and ribavirin. 

The best way to avoid reinfection is to reduce risky behaviors that may expose you to hepatitis C. Never share needles or syringes. Do not share injection or inhaled drugs or equipment associated with it. Avoid blood-to-blood contact with others. Use condoms if you are sexually active with a new partner or with a partner who has used injection drugs.

If hepatitis C can live on a surface for up to 63 days, then shouldn’t I change my toothbrush (razor, cuticle scissors) during treatment, particularly when I am nondetectable. I don’t want to reinfect myself.

I haven’t seen a single study on this. There is probably no chance of reinfecting yourself with your own virus, particularly while you are taking antiviral medication. Also, the chances of hepatitis C being viable on a toothbrush, razor, or other personal instrument are extremely slim. Add to this the low reinfection rate, and I’d say the chances of self-reinfection are slim to none. 

However, I had hepatitis C once, and I know full well that sometimes we just don’t care what science says. It won’t hurt you to be overly cautious, and if you want to change these items, then go ahead. Rather than throw away perfectly good personal care items, you can store them for a few months and then use them later. You can also clean them with one part bleach to ten parts water.   

I just finished HCV treatment, but my viral load was detectable at week 8 and 12.  Does this mean my chances of being cured are low?

No. In the old days, back when treatment was long and used interferon, there were clear milestones that helped us know what our chances were of permanently clearing hepatitis C. Now with new direct-acting antivirals (DAAs), things have changed. Research by the NIH Clinical Center showed that low levels of HCV RNA at the end of treatment are not predictive of treatment response among patients with hepatitis C virus treated with interferon-free regimens. (Clinical Infectious Diseases, March 2, 2015).  Harvoni was used in this study, but the trend is likely to apply to all treatments using HCV DAAs. 

For years I thought I had genotype 1a, but a recent genotype test revealed I have 1b. How did this happen? 

It may be that you have more than one genotype at the same time. When this occurs, often the genotype test shows whichever genotype is more predominate, and sometimes the genotype can switch. 

Having more than one HCV genotype is not rare, with studies placing it in the 5 to 10% range. There are various ways a person could have more than one hepatitis C genotype: 

•Dual infection –This occurs when a person is infected with more than one hep C genotype at the same time. Hemophiliacs who received clotting factors, which are derived from thousands of sources, were at risk for dual infections. 

•Co-infection – This happens when someone is exposed from two different sources of hep C within a short time span, and acquires hep C from a second source before the first infection is established.

•Superinfection – Someone whose hepatitis C infection is established, and then they are infected with another genotype. 

There is also something called HCV recombination. In this situation, a person may be co-infected with more than one HCV genotype, and the viruses exchange genetic material. 

If I have more than one genotype, how do I know which treatment is best for me? 

If only one genotype shows up on the test, your doctor will treat you based on that genotype. If more than one genotype is apparent, then likely your doctor will recommend a regimen based on the harder to treat genotype. 

  

Will the Giants win the series this year? 

I admit, no one has ever asked me this, but they should. Lying awake worrying about hep C makes no sense, especially when there are more important issues to lose sleep over, such as whether the Giants will win the series again. 

QUOTE:

Sustained Viral Response (SVR) equals a cure, and that once gone, hepatitis C does not return unless there is exposure to a new infection. 

Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of 

Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com