Monthly Archives: June 2016

An Interactive Site in a 21st Century World

By: Marcus J. Hopkins, Blogger

I had my semi-annual appointment with my Infectious Disease doctor, last week, and during my visit, we took a few moments to talk about the state and amazing progress of the HCV treatment regimens. When I asked him about how Zepatier was working out for him, and he was pretty straightforward:

It works great, if you can find anyone whose current drug regimens don’t interact with it.”

Zepatier pill box

Photo Source: multivu.com

Being the HCV drug nerd that I’ve become, I decided to look into his complaint, and what I came away with isn’t promising. Most of the newer HIV combination therapies contain at least one component that essentially prevents a patient from safely taking Zepatier as a cure for HCV. This troubles me, as Merck, the maker of Zepatier, had really impressed me by introducing an effective HCV drug at a comparatively affordable price point – $54,000 Wholesale Acquisition Cost (WAC), to Harvoni’s (Gilead) $94,000k. While that lower price point is great, for people co-infected with HIV, those savings are unlikely to be realized.

I decided to compare the seven currently available DAA HCV drugs with my current regimen – Gilead’s very popular and effective Stribild – and what I walked away with was, “I’d better not get HCV.” Of the four individual components in Stribild – elvitegravir, cobicistat, emtricitabine, and tenofovir – at least one of those components had a negative drug interaction with six of the seven HCV drugs. The only drug that showed no counterindication was Gilead’s Sovaldi. Even then, there’s a risk of counterindication, because Sovaldi needs to be paired with either Olysio or Ribavirin to be truly effective against HCV, both of which have a potentially negative interaction with one of the component drugs.

What this would mean, for me, was the need to use ribavirin in order to avoid a serious interaction, but even then, there’s a high potential for a mild interaction. Essentially, I would have to switch drug regimens for HIV prior to treating HCV, which can be a bad thing for someone whose regimen has been working well to keep their HIV virally suppressed. While achieving a “cure” for HCV can take less than a year, with twelve weeks being the current standard duration, that year can be difficult if the new HIV regimen has adverse side effects.

For those interested in figuring out which HCV treatment would be right for you in conjunction with your current HIV regimen, I highly suggest the following resource: HEP Drug Interactions. This site is an easy to use project of the University of Liverpool, in Liverpool, England. You use the left column to select the various HCV treatments, and the right column to find whichever drugs you take that may have a counterindication. This is an invaluable tool, and can be a lifesaver.
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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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220 is the Magic Number

By: Marcus J. Hopkins, Blogger

Earlier this month, The Wall Street Journal reported that the CDC has listen 220 counties in the United States as being at high risk of an HIV and/or Hepatitis C outbreak, largely related to opioid Injection Drug Use/Users (IDUs). Out of over 3,100 counties in the U.S., these 220 counties – including Scott Co., Indiana, home of one of the highest profile mass HIV/HCV outbreaks in recent U.S. history – share specific factors that seem to be related to a high rate of new HIV/HCV infections, such as high unemployment rates, overdose deaths, and sales of prescription opioid painkillers.

For those of us who have been covering opioid prescription and heroin abuse issues, none of this is news. These factors have long been contributing factors to opioid and heroin abuse, but because of the remote nature of many of these counties, little attention was ever paid and little due diligence was ever done in the way of addressing their needs. These areas, while rich in natural beauty and great for those who prefer life away from the so-called “Big Cities,” are also home to some of the highest levels of endemic poverty in the U.S. Economic development in these areas has been hampered by a number of issues – lack of qualified workers, resistance or reluctance to modernization (many of these counties still lack adequate high-speed Internet access), the remote nature of the areas in relation to centers of commerce, and a regional distaste for “outsiders” – all of which leaves residents with few, if any, good options for work. Residents are lucky to find full-time employment at all, and many are forced to subsist off of part-time and contract work, the opportunities for which are few and far between.

With endemic unemployment and poverty rates high, the sad fact is that sheer boredom comes into play as a factor for drug abuse. Many of my high school friends who ended up addicted to prescription opioid drugs started not because they suffered from high levels or long-lasting chronic pain, but because they were bored, and there was nothing else to do, except for snort some pills; once those pills were made “abuse proof,” they learned how to cook them down, filter out the plastic coating with a piece of mesh, and inject them directly into their bloodstreams. Once needles come into play, what was once a way to survive the boredom turns into a full-blown addiction, anecdotally harder to kick than any other.

Map of the United States showing counties at risk for HIV and HCV outbreaks

Photo Source: Wall Street Journal

Of the 220 suspect counties shown on the WSJ’s map, the vast majority cover Kentucky, Tennessee, and West Virginia, three states as well known for their contribution to the entertainment industry’s portrayal of poverty as they are for hillbilly jokes. The jovial Appalachians from the Beverly Hillbillies still serve as a point of reference for outsiders, but that well-meaning-yet-easily-conned stereotype bears little resemblance to real life Appalachians, where striking oil would be the best thing to ever happen, but residents are far likelier to tap a vein for injection, rather than natural resources.

Compounding the problem is the reality that the remote nature of these counties makes increasing access to adequate healthcare and treatment services both difficult and costly. While telemedicine is quickly becoming a valuable resource, those resources are already stretched to capacity, with few applicants lining up for jobs and limited financial means to pay for additional staff. All three of the aforementioned states are currently facing massively budget shortfalls for a variety reasons, one of which includes the flight of higher-income citizens to states with better job prospects, leaving them to rely upon an increasingly impoverished tax base, which bodes poorly for advocates of additional funding.

Confronting this high-risk label is going to be a unique challenge for the counties in question, and there are no easy answers or quick fixes. This is going to be a multi-year, if not multi-decade, fight to expand educational, employment, and economic opportunities to these areas that will help address generations of poverty and joblessness. Those efforts must be accompanied by concurrent healthcare efforts, without which I fear that we will continue to see high levels of opioid abuse and equally high levels of accompanying HIV and HCV infections.
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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

 

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It’s Always a Matter of Resources

By: Marcus J. Hopkins, Blogger

This past week, I was privileged to attend the National Strategy for the Elimination of Hepatitis B and C at the National Academies in Washington, DC. This was he third such strategizing meeting in which a panel of well-regarded specialists gather information from various state, Federal, private, and advocacy organizations in an effort to devise a workable and feasible national strategy recommendation for confronting the nation’s deadliest health condition. For two days, testimonies are heard from a wide variety of sources who speak to the roles their organization plays or has played in the fight against Viral Hepatitis.

As a policy vs. reality wonk, I find these meetings to be of the most use for advocates, even if they are not necessarily aware of its existence. It is at these types of events that we hear how the fights are going on the ground, rather than simply looking at a set of national statistics that may not tell the whole story.

I gleaned from this meeting several pages of notes, but was really intrigued by three moments in the conversations, about each of which I could write dozens of pages: (1) Hepatitis advocates, while fewer in number than their HIV-related advocacy peers, face a dearth of materials, research, and statistical data to use in their advocacy efforts; (2) the Centers for Disease Control & Prevention (CDC) has only 30 states that report data for both HBV and HCV, and openly admits that there are neither resources, nor reliable reporting datasets to create the resources that advocates need; (3) Gilead’s justification for the high price tags on their HCV drugs is surprisingly well-reasoned and convincing, but using their argument may do little to assuage the concerns of cash-strapped states when considering their pharmacy budgets.

Photo of the CDC Headquarters

Source: George Mason University

Perhaps the most telling, yet largely overlooked, statements in the meeting was made by Ryan Clary of the National Viral Hepatitis Roundtable: to paraphrase what he said, it is increasingly difficult to make a convincing, evidence-based argument to legislator and budget committees about the dire need to provide additional funds for Hepatitis C without the adequate tools available to do so. While advocates and organizations can make impassioned pleas, relying solely upon “…what we know in our guts to be true,” without reliable, comprehensive, and timely data related to HCV incidence, prevalence, and mortality rates, we are truly unable to make arguments that can be backed up by peer-reviewed or official statistics.

We at HEAL Blog have been sounding this trumpet for the past year, after nine months of largely fruitless efforts to get reliable monthly reporting from individual states. The CDC has STILL not made any real effort to define the reporting standards or requirements (to the contrary of Dr. John Ward’s response that “…definition [wasn’t] really the problem) for the states in the same manner they did with HIV over twenty years ago; the problem, according to Dr. Ward is that there are simply no resources to expend or allocate to require regular national reporting.

It segues nicely into the second moment – only 30 states currently report data for both HBV and HCV, and even with those states, there is little consistency between them. With only 3/5 of U.S. states reporting inconsistently, the CDC must rely heavily on mathematical modeling, rather than on verifiable data. How can advocates be expected to effectively convince legislatures and budget committees without sufficient data to do so; if Hepatitis is such a pressing threat, according to the CDC’s own admittedly insufficient data, why does the virus receive literally a fraction of the funding enjoyed by HIV? While the CDC does not control the budgeting process, it seems that it would be incumbent upon the CDC to force the issue by requiring states to at the very least collect and report data, even if they don’t have the funds to track patients through the treatment cascade.

Finally, Gilead, the maker of Sovaldi and Harvoni, made a very compelling argument in an effort to justify the high cost of their HCV drugs: Curing HCV with Harvoni can be accomplished in a single quarter, as opposed to MS (2.41 years), Cancer (3.28), and Rheumatoid Arthritis (4.55); as such, the price per for achieving a Sustained Virologic Response (SVR, or “cure”) is comparable to those chronic conditions, with the only difference being that the price is up front, rather than apportioned over time. Additionally, the price per SVR has dropped considerably when taking into account the high failure and non-adherence rates for the older, less easily tolerated HCV therapies – essentially, with the new Direct Acting Agents (DAAs) for HCV, fewer patients fail to complete the regimen, the regimen has a 95-98% SVR rate, meaning fewer patients have to repeat the regimen it fails, and the regimens are one-a-day pills, making it easier for patients to remain compliant with the regimen.

While these arguments are very well-reasoned, it’s unlikely that states already facing budgetary shortfalls will be able to afford the cost of treating all HCV patients on their respective Medicaid rosters, regardless of the cost-effectiveness at hand. Plainly put, American politicians are rarely “long-term thinkers,” when it comes to budget issues. No matter how many times you argue that spending a lot of money in the present will save money in the future, the current atmosphere of “WE MUST CUT SPENDING, AT ANY COST!!!” simply doesn’t allow for high, one-time expenses. With a starting point of “Slash and Burn” economics, it is unlikely that Gilead’s argument will hold much weight with anxious legislators who campaign on lower spending.

The National Strategy meeting was a fantastic learning experience, and hearing from industry, government, and medical professionals about the state of HCV treatment and funding in the U.S. was both heartening and somewhat temporarily bleak, in terms of short-term affordability. In all honesty, there will likely be little movement until after the elections on November 8th, the outcome of which may fundamentally shift the prospects of funding, entirely. Ultimately, we still remain in a holding pattern, but the National Strategy committee members are doing phenomenal work in reaching a well-reasoned and realistic eradication strategy.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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States Struggle to Afford Costly HCV Treatments as Problems Burgeon

By: Marcus J. Hopkins, Blogger

Virtually every state in the U.S. is facing mounting – and seemingly insurmountable – costs related to treating Hepatitis C (HCV), and there appears to be little respite in sight, if the growing number of opioid abusers has anything to say about it. More and more often, states are reporting that new waves of HCV are being driven not by the Baby Boomers who once typified the common HCV patient, but by droves of younger, poorer, and whiter heroin and opioid prescription drug abusers.

For those of us who have been following the issue have seen this coming down the pike for well over a decade. As highly effective and powerful prescription opioids became easy to obtain in the late 90s and early 00s, the number of people abusing these drugs took an unsurprising upward tick, as well. While state and Federal governments attempted to quell the problem by tightening the reigns on prescribing and purchasing opioid drugs, they did little to confront the problem of addiction to those drugs. It became easier for addicted patients to leave behind the pricy prescription pills, and obtain the much more readily available and cheaper heroin that was waiting in the wings.

 

Medicine in a rolled up $50 bill

Photo Source: dreamtime.com

With this wave of new HCV infections, state and federal healthcare programs such as Medicaid and the Ryan White program saw an influx of clients, all of whom health officials are quick to tell you “deserve” to receive adequate treatment for their disease. The fiscal reality of paying for those drugs, however, has been such that Direct Acting Agents (DAAs) for treating HCV have been largely relegated to the treatment of last resort; for those who are the sickest, and whose livers are already significantly scarred. That may be about to change…whether states can afford it, or not.

U.S. District Judge John C. Coughenour recently granted a preliminary injunction on May 27th that requires Washington state’s Health Care Authority to cease a 2015 policy that restricted access to DAA drugs based on a measure of liver scarring in a response to a class-action lawsuit filed on behalf of two clients of Apple Health, Washington’s version of Medicaid. The judge ruled that the state’s requirement was not consistent with existing state and Federal Medicaid requirements that drugs be dispense based on medical need, rather than on degree of sickness.

MaryAnne Lindebald, Washington’s state Medicaid director, is previously stated in a letter to the U.S. Senate that treating all of Washington’s Medicaid patients living with HCV would cost thrice the amount of the budget for the entire Medicaid program, not just the funds allocated to treating the disease. It is unclear when Apple Health clients can begin receiving DAA HCV drugs through Apple Health, but the judge’s ruling ordered all parties to report back in sixty days.

Despite all the good will Merck and Co, Inc. has built up from releasing its much cheaper Zepatier at a $54k Wholesale Acquisition Cost (WAC), the fact is that states are STILL struggling to afford the cost of treatment. Pennsylvania, for example – a state that still restricts access to these drugs based on liver scarring – has seen it’s yearly cost per patient expense more than double since 2013, from $33,734 to $76,425. In the span of two years, the state Department of Human Services’ Medicaid program has seen its bill for HCV drug treatments jump from $33.7 million to $138.1 million (Twedt, 2016). The problem is unlikely to get any more affordable, especially if Pennsylvania removes the liver scarring requirement from barring treatment.

Ultimately, it’s unclear whether or not “market forces” will convince drug manufacturers to lower the prices of their drugs. With so few DAA treatment options currently available (seven, at the time of writing), there’s no real way to measure market effects on HCV pricing, and manufacturers are unabashedly defending the high cost of their products, despite public and professional outcry against them. At some point, however, something will have to give, and unfortunately, the people who will suffer the most will be those who can least afford to do so.
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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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