"All Natural" Alternatives for Erectile Dysfunction: A Risky Proposition

Since everything is processed by the liver, I thought it was important to post this warning...Alan

Men, beware! Products falsely marketed as “dietary supplements” or “foods” that promise to enhance your sexual performance or increase sexual stimulation might contain hidden drug ingredients or other undisclosed ingredients — and can endanger your health.

Thus far, FDA lab tests have found that nearly 300 of these products contain undisclosed drug ingredients. These can include the same active ingredients found in prescription drugs that are FDA-approved for the treatment of erectile dysfunction (ED), such as Viagra, Cialis and Levitra. Not only do these products contain undisclosed drug ingredients, but they also sometimes may include combinations of undisclosed ingredients or excessively high doses, both potentially dangerous situations.

Even a cautious consumer can’t tell that these products are, in fact, tainted with undisclosed drug ingredients, because their labels do not list the potentially hazardous ingredients, says M. Daniel Dos Santos, Pharm.D., Ph.D., of FDA’s Division of Dietary Supplement Programs. Consumers may be misled to believe these products are safe because their labeling often suggests they are “all-natural” or “herbal” alternatives to FDA-approved prescription drugs for the treatment of ED.

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Regulus to Present Updated Data Supporting RG-101 as Novel microRNA Therapeutic for the Treatment of HCV at The Liver Meeting® 2015 (AASLD)

-Phase I Clinical Data will be Featured in Viral Hepatitis Plenary Session-

LA JOLLA, Calif., Oct. 2, 2015 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that two abstracts related to RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 ("miR-122") for the treatment of chronic Hepatitis C Virus (HCV) infection, were accepted for presentation at The Liver Meeting®, the 66th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), to be held November 13-17, 2015 in San Francisco, CA.

Viral Hepatitis Plenary Session, November 17, 2015, 8:45am - 9:00am: A Single Dose of RG-101, a GalNAc-Conjugated Oligonucleotide Targeting miR-122, Results in Undetectable HCV RNA Levels in Chronic Hepatitis C Patients at Week 28 of Follow-up

Investigators will present extended follow-up data from the Phase I clinical study of RG-101 demonstrating that a single subcutaneous administration of either 2 mg/kg or 4 mg/kg of RG-101 as monotherapy resulted in HCV RNA levels below the limit of quantification in 6/22 patients with various HCV genotypes at week 28 of follow-up.

Poster Presentation, November 17, 2015, 8:00am - 12:00pm: Treatment with the Anti-miRNA122 Oligonucleotide RG-101 Results in a Decrease in IP-10 but Does Not Affect the Levels of Other Cytokines in Patients with Chronic Hepatitis C

Investigators will present data examining immunological changes observed in the plasma of patients who received a subcutaneous administration of RG-101 in the completed Phase I study.
Results demonstrated that HCV patients had significantly higher IP-10 levels at baseline compared to healthy controls. In HCV patients who received a subcutaneous administration of RG-101, a significant decline was observed in IP-10 serum concentrations compared to baseline, and RG-101 did not trigger a systemic immune activation

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AbbVie Demonstrates Commitment to Hepatitis C Patients with New Data on VIEKIRA PAK™ and Ongoing Clinical Development Program at The Liver Meeting® 2015

Note:  There are some interesting studies of AbbVie drugs being presented that will feature new combination of drugs that will offer shorter treatment durations and more treatment options for people with genotypes 1, 2 and 3.  

- New data to be presented on VIEKIRA PAK in genotype 1 hepatitis C patients with chronic kidney disease and on AbbVie's investigational HCV pipeline medicines, ABT-493 and ABT-530

NORTH CHICAGO, Ill., Oct. 1, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research-based biopharmaceutical company, today announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17, further demonstrating AbbVie's strong leadership and ongoing commitment to patients with chronic hepatitis C virus (HCV) infection.

Presentations will highlight new data from Phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis. Additionally, new clinical studies will be presented on AbbVie's HCV pipeline medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks.

"We are pleased to present new data from studies of the VIEKIRA PAK regimen in HCV patients, including those with chronic kidney disease and GT1b compensated cirrhosis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These data, as well as our findings from our investigational compounds, further demonstrate AbbVie's firm commitment to supporting the care of patients with chronic HCV infection."

Select AbbVie clinical presentations include:

RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir +/- Ribavirin in Non-Cirrhotic HCV Genotype 1-infected Patients With Severe Renal Impairment or End-Stage Renal Disease; Pockros, P, et al.; Poster #1039; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)RUBY-I is an ongoing open-label study evaluating 3D+/-RBV in patients with stage four or five chronic kidney disease and GT1 infection.

TURQUOISE-III: 12-Week Ribavirin-Free Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir for Patients with HCV Genotype 1b and Cirrhosis; Poordad, F, et al.; Poster #1051; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Hepatitis C virus infected patients have historically been more difficult to treat when they have cirrhosis. This poster reports on the safety and efficacy of the 3D regimen without RBV in patients with HCV GT1b infection and compensated cirrhosis. VIEKIRA PAK is not recommended for patients with decompensated liver disease.

Efficacy, Change in MELD Score, and Safety by Baseline MELD Score in Patients With Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/r and Dasabuvir Plus Ribavirin in Phase 3 TURQUOISE-II Trial; Jacobson, I, et al.; Poster #1106; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Model for end-stage liver disease (MELD) scores assess liver disease severity. In this analysis, the efficacy and safety of 3D+RBV and changes in MELD score by baseline MELD score is evaluated.

Preliminary Safety and Efficacy Results in TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-infected Patients Receiving Ombitasvir/Paritaprevir/r and Dasabuvir +/-Ribavirin; Reau, N, et al.; Poster #1065; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)TOPAZ-I (ex-U.S.) and TOPAZ-II (U.S.) are evaluating the impact of SVR12 on the progression of liver disease through five years post-treatment in a broad population of HCV GT1-infected patients receiving 3D+/-RBV. This interim analysis reports on-treatment safety and efficacy of 3D+/-RBV among patients in the TOPAZ-II study.

Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV GT1-Infected Patients With or Without Cirrhosis; Zeuzem, S, et al.; Poster #1086; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)In this analysis, the efficacy through post-treatment week 48 of the 3D regimen in HCV GT1-infected patients with or without cirrhosis is examined.

SVR4 Results in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null Responders with the Combination of the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 (SURVEYOR-1); Poordad, F, et al.; Oral presentation #41; Sunday, November 15, 2015, 4:00 p.m. – 4:15 p.m. PT; Parallel Session 5, Hep C Clinical TrialsIn this Phase 2 study, treatment with ABT-493 and ABT-530 for 12 weeks is evaluated in HCV GT1-infected subjects without cirrhosis. Efficacy and safety results are reported.

SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection (SURVEYOR-2); Wyles, D, et al.; Oral presentation #250; Tuesday, November 17, 2015; 12:00 p.m. – 12:15 p.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without RBV in non-cirrhotic GT2-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.

SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection (SURVEYOR-2); Kwo, P, et al.; Oral presentation #248; Tuesday, November 17, 2015, 11:30 a.m.– 11:45 a.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in non-cirrhotic GT3-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.

Select Health Economics and Outcomes Research (HEOR) abstracts include:

Lifetime Risks of Liver Morbidity and Mortality in Patients with Chronic Genotype 1 Hepatitis C Virus and HIV Coinfection Treated with 3D±R (Ombitasvir/ Paritaprevir/ Ritonavir, Dasabuvir ± Ribavirin) vs other Standards of Care in the U.S.; Saab, S, et al.; Poster #1087; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m.

Hepatitis C: Therapeutics (Approved Agents).  This study evaluates the lifetime risks of liver morbidity and mortality in patients with GT1 HCV and HIV coinfection treated with 3D±R for 12 or 24 weeks compared to other standards of care in the U.S.PT

The Healthcare Cost Burden of HCV-infected Baby Boomers in the U.S.; Brookmeyer R, et al.; Poster #1068; Sunday, November 15, 2015,  8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)This study quantifies healthcare costs for 50-64 year-old "baby boomers" with HCV by diagnosis and insurance status.

The full AASLD 2015 scientific program can be found at www.aasld.org.

HCV Advocate Eblast: October 1, 2015

Check out what we have in store for you in the October 2015 Newsletter -

HCV Drugs by Alan Franciscus, Editor-in-Chief

Read about Achillion’s latest clinical trial results from their PROXY study, information about insurance denials, how far we have come in treating the most difficult to treat patients, but how far we still have to go to cure everyone with hepatitis C, drug-drug interactions and re-treatment issues.

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HealthWise by Lucinda K. Porter, RN

In this month’s column, Lucinda answers some important post-treatment questions from people living with hepatitis C.

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What The Heck Are RAVs? by Alan Franciscus, Editor-in-Chief

If you have been treated before with a direct-acting antiviral medication, but not cured, this brief overview is an important topic to understand.

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SnapShots by Alan Franciscus, Editor-in-Chief

Three studies that look at treating people with advanced liver disease and re-treatment  of people who had been previously treated with direct-acting antiviral medications but did not achieve a cure.

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What's New? by Alan Franciscus, Editor-in-Chief

We have merged our HBV Website to our HCV Website – find out more…. Don’t forget to check out our newly re-designed Facebook and Twitter accounts!  Just go to Facebook and Twitter and type in 'HCV Advocate'.  Follow us and learn all the latest information about hepatitis C and about what we are doing.

To read the newsletter click here

The Five: Coffee —Alan Franciscus, Editor-in-Chief

In celebration of National Coffee Day.....but remember adding a bunch of sugar and cream most likely eliminates the benefits! Alan

For some people that morning cup of Joe is the perfect way to start the day.   Surprisingly, there are many published studies that show that caffeinated coffee can improve the health of the liver and provide other health benefits.  There are some caveats to these health claims that I will discuss at the end of this article.  First let’s talk about the good news—the possible health benefits:

1. Liver Fibrosis / HCV Disease Progression:  
In a review of 177 patients—121 patients with HCV who drank about 2 ¼ cups of coffee a day were found to have reduced levels of liver fibrosis.  The results were only found in those who drank caffeinated coffee.

In another review, 766 participants in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial found more good news.  Those who had hepatitis C-related bridging fibrosis or cirrhosis on a liver biopsy and who failed to achieve a cure after being treated with pegylated interferon and ribavirin therapy also yielded some surprising results.  Those with advanced liver disease who regularly consumed coffee were found to have lower rates of HCV disease progression.

2. Liver Cancer: 
A small study found that people who drank one to three cups of coffee a day had a 29% lower risk of developing liver cancer compared to those who drank 6 cups or less a week.

Another study which reviewed 16 different studies involving over 3,200 patients found that drinking more than 3 cups of coffee a day might cut the risk of liver cancer by up to 50%.

3. Other Conditions:  
There are many studies that show a link between the reduction or prevention of certain types of cancers and drinking caffeinated coffee (skin, breast, colon, prostate, uterine, oral).  There are also studies that show that caffeinated coffee can lower the risk of diabetes and death.

4. The Downside: 
Now, I am going to burst the bubble!  Coffee, specifically caffeine, is a drug (a stimulant).  Moreover, with any drug you can have withdrawal: It can take more than eight weeks to withdraw entirely from caffeine—although, caffeine withdrawal is usually just an annoying headache and some light fatigue.
Drinking or consuming caffeine can raise blood pressure, lead to heart arrhythmia (irregular heartbeats), can cause cramps, diarrhea and other gastrointestinal health issues.  If you drink it too close to bedtime, it can cause insomnia.  Too much caffeine can cause depression, anxiety and other types of nervous behaviors.    Although rare there have been serious health consequences from people drinking energy drinks and shots.

Examples of the typical amount of caffeine:*

• Coffee – 100 mg per cup
• Tea – 14 mg to 60 mg per cup
• Chocolate – 45 mg in 1.5 oz bar
• Most colas (unless they are labeled “caffeine-free”) – 45 mg in 12 oz. drink
• Candies, energy drinks, snacks, gum – 40-100 mg per serving

*http://www.nlm.nih.gov/medlineplus/ ency/article/002445.htm

There are many other side effects of caffeine, but I will stop here.  However, for most people caffeine in moderation is safe and well-tolerated!

5. Final Thoughts:  
What does all of this mean?   It is hard to draw concrete conclusions from these studies because you cannot measure what people drink, how it is made and what chemicals are in the coffee.  However, there must be something in caffeinated coffee that is contributing to all of these positive outcomes.  There are over 1,000 natural chemicals in coffee, and some of these chemicals may be contributing to the caffeine and providing these benefits.  Scientists are studying the various chemicals, and we may soon have more concrete information that may lead the way to more potent medications to treat many conditions.  In the meantime, it could not hurt to have a cup of Joe—that is if your health allows it.

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.