Monthly Archives: April 2017

Treating HCV in Pediatric Patients

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

In April of this year, the Food and Drug Administration (FDA) approved the use of Sovaldi and Harvoni (Gilead) for use in treating Hepatitis C (HCV) in pediatric patients aged 12-17. This is an important step in treating HCV in no small part because children and teenagers are considered a vulnerable population. They are, for the most part, not properly equipped to make well-informed decisions about their health, leaving treatment decisions in the hands of the adults who care for them.

Stamp marked, "Approved" next to the initial, "FDA"

Photo Source: 3Dprint.com

Treating pediatric patients is a much riskier prospect, because people outside of the medical community consider children to just be “small adults;” virtually every treatment regimen for every disease must be modified to achieve commensurate outcomes. There are a variety of reasons why this is so, from bodyweight variances between children and adults, to the various ways that physical and chemical changes that occur during the growth and development process from childhood to adulthood can impact how medications behave in pediatric patients. Essentially, “results may vary.”

The new FDA ruling that expands treatment to pediatric patients allows patients weighing at least 77 lbs. to take an unmodified regimen. While access to treatment in adults has proven fraught with hurdles to overcome before being approved by payers, children covered by Medicaid may, in fact, face fewer hurdles than adults. This is due to the following provision: under Federal law, state Medicaid programs must cover “…early and pediatric screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses (Andrews, 2017). While that’s great for patients covered by Medicaid, those covered by private insurers may have a tougher road to hoe, as most within the industry expect the latter payers to largely maintain similar restrictions in pediatric clients as adults.

One of the reason pediatric patients are so vulnerable is that the majority of HCV-infected patients acquire the disease in the womb; only about 20% acquire it through drug use (Andrews). That said, the likelihood is very low – only a 6% chance that babies will acquire HCV if the mother has it.

Hopefully, pediatric patients will face an easier time gaining access to Sovaldi and Harvoni than adults, but only time will tell.

References:

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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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HCV Prescribing Lags While Prices Soar

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

An article in Newsweek in March 2017 talked about a “…crowded and confusing” landscape for treating Hepatitis C (HCV) that prevents many Primary Care Physicians (PCPs) from prescribing the new Direct Acting Agents (DAAs) to treat the disease (Wapner 2017). The argument posed is that, physicians are “…still too unfamiliar with the regimens to speak with confidence about them,” according to Ira Jacobson, a hepatologist who leads the department of medicine at Mount Sinai Beth Israel Hospital in New York. He posits that this discomfort leads them to send patients to liver specialists, or to delay treatment until more severe symptoms arise, the latter of which is a regular pre-requisite on virtually every Prior Authorization (PA) request form.

This argument caught my eye, as someone who writes about and researches coverage for these DAA drugs, as has done so since 2013. One of the most frequent conversations I heard when Sovaldi (Gilead) and Olysio (Janssen) were first released on the market was that there was confusion over which doctors could prescribe them. Unlike HIV, treatments for HCV largely lagged in the ‘completely intolerable’ realm, with patients dropping out of treatment like flies and a success rate of only around 50%. Things, however, have radically changed; the question, then, becomes, “Have doctors?”

Prescription Pad

Realistically, we have a considerable problem, in the United States, with aspiring doctors choosing to specialize, rather than going into general practice, in no small part because it guarantees them higher incomes. Higher incomes for them, however, means higher costs to consumers, in the same way that higher-priced drugs to treat chronic conditions get shunted into the highest pricing tiers. This gets passed along to consumers in the form of higher co-pays for visits ($25 for PCPs; $75 for Specialists), and higher co-pays for medications ($3 for blood pressure medication; $250 for HIV).

This problem extends, also, to prisons and jails – the high cost of treatment serves as a significant barrier to providing inmates with treatment, which presents a larger issue, because inmates have an exponentially higher incidence and prevalence of HCV than the general population (Gloucester Times, 2017). Testing prisoners is expensive, as well, as inmate populations swell, while prison healthcare budgets remain relatively stagnant. Once those prisoners are released back into the general population, if they’re unaware of being infected with HCV or whose infections have gone untreated, they can go on to infect those who are not part of the prison system, are also unlikely to be tested and treated.

Beyond just the cost of co-pays are the long-term costs of PCPs being reticent to screen or prescribe for HCV: failing to address HCV will lead to liver decompensation, liver cancer, kidney diseases and failure, higher HCV viral loads that make spreading the disease easier, jaundice, digestive illnesses, and thyroid issues, none of which are particularly cheap to treat. The host of accompanying side effects of leaving the disease untreated far outweigh the admittedly outlandish prices set by HCV drug manufacturers.

The reality is that any medical doctor who has prescribing privileges can prescribe these new treatment regimens. The vast majority of these doctors also have access to smartphones, all of which have any number of apps designed to compare new drug regimens with existing prescriptions to ferret out counter-indications; there is, in fact, an entire website specifically aimed at finding counter-indications (http://www.hep-druginteractions.org/) that also offers mobile apps. The argument that doctors are unsure of the counter-indications is really rendered moot by the existence of these easy-to-use tools.

With that, the biggest hurdle to overcome, for virtually every party involved, is the cost of treatment, and with the current administration’s funding priorities being…questionable, at best…it’s unapparent if even the existing treatment coverage landscape will exist. We’re hoping for more stable conditions, and less erratic proposals. Until then, we’ll just keep plugging to try and find a solution.

References:

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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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New River Valley Region Reports Sharp Rise in Hepatitis C

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The New River is 360 miles long that spans three states – North Carolina, Virginia, and West Virginia – flowing from south to north (one of only a handful of rivers in the world to do so) and serves as one of the most scenic rivers in the eastern United States. It’s known for hosting some of the best white water rafting and kayaking in the U.S., and for having the third-longest single-arch bridge in the world. Nestled along some of the most rural parts of the three states in spans, the New River Valley (NRV) region is also home to a growing Hepatitis C (HCV) epidemic.

HEAL Blog has covered the exploding rates of HCV in West Virginia many times since our inception in 2013, as well as having covered those rates in the rest of the Appalachian Mountain Region (AMR). What frustrates many advocates and healthcare workers who live and work in the NRV is that the sharp increase in new HCV infections is largely a product of pharmaceutical companies’ – and healthcare providers’ – making.

Map showing the New River Valley area

Photo Source: Snipview

During the early-1990s, Perdue Pharma using rural towns and counties in the NRV as testing grounds for OxyContin, one of the most widely prescribed opioid drugs of the late-90s and early-00s. HEAL Blog has previously reported on this issue (Cassandra in the Coal Mines), and I stand by the assessment that this region and its population have been systematically targeted by the manufacturers and wholesalers of prescription opioid drugs; wholesalers have, in fact, spent several tens-of-millions of dollars settling cases in West Virginia related to oversupplying the drugs and creating “pill mills” in the state.

There is a direct link between the opioid and heroin epidemics in this region and the vast increase in new HCV infections. In December 2016, Dr. Marissa Levine warned during a meeting of the Virginia Board of Health that the state should expect a “tidal wave” of HCV and HIV primarily related to Injection Drug Use (IDU). The state saw a 21.212% increase in new HCV infections in 2015, from 6,600 in 2014 to 8,000 in 2015 (Demeria, 2016). Dr. Levine also argued that the lack of a dedicated funding stream greatly hinders the ability of the Health Department to accurately capture and track the data accurately, an argument shared by virtually every state in the U.S.

Beyond just opioid drug injection, New River Health District Health Director, Noelle Bissell, M.D., has seen a spike in acute HCV infections (as opposed to chronic conditions) linked to tattoo parlors, the use of homemade tattoo guns at parties, and in people who report more than 10 sexual partners, as well as a trend in cases associated with IDU involving methamphetamine, and in pregnant women and women of childbearing age (SWVA Today, 2017). It should be noted, however, that the Centers for Disease Control and Prevention (CDC) specifically states that the transmission of HCV via sexual activity is “not common” (CDC, 2015). The virus is inefficiently transmitted in this manner, and while it is possible in the manner Dr. Bissell describes, much of the data provided during screening is self-reported by patients – self-reporting may lead patients to purposely omit or skew their answers in an effort to avoid embarrassment or mask other behavioral risk factors.

The rural areas along the NRV are very likely to be hit with a greater explosion of HCV and HIV, and HEAL Blog will be monitoring the situation in the coming months.

References:

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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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Generational Stigmata and HCV

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

When it comes to Hepatitis C (HCV), people in America have long assumed that it was (and is) a Baby Boomer problem. Recent statistics, however, indicate that a rapidly increasing number of new HCV diagnoses are linked to Injection Drug Use (IDU), and that IDUs will likely lead to an exponential explosion of new infections compared to previous years. With that reporting, however, a stigma has arisen amongst the Baby Boomer population (the Birth Cohort), leading some in the cohort to avoid screening for the disease. Research published in March 2016 (Joy, 2016), however, indicates that HCV infections within the Birth Cohort is much more likely to have arisen from unsafe medical practices on behalf of doctors and hospitals, rather than any lifestyle choices made on the part of patients.

The research, published in The Lancet Infectious Diseases journal, was conducted by scouring over 45,000 documents and records, examining 45,316 sequences of HCV Genotype 1a – the most common strain – and then used a technique called “phylogentic analysis” to focus on five HCV genes and trace the dynamics of the HCV epidemic. The results suggest that the initial peak of the HCV epidemic – the time when initial infection and introduction of the disease in the Birth Cohort – occurred between 1948 and 1963, far earlier than many had suggested.

These infections are most likely related to the techniques and equipment that medical professionals used in the post-World War II (WWII) era, prior to the establishment of safer technologies, equipment, blood screening, and techniques that came about in the wake of the initial HIV crisis of the 1980s and 1990s. Strict blood screening techniques were not, in fact, common place until the U.S. government mandated the practice in 1992. As such, anyone who received a blood transfusion or underwent invasive medical procedures prior to that year may have been exposed to HCV, and should be screened for the virus.

Stigmata are nothing new, however, for the Birth Cohort. This is a group who helped to push the sexual revolution and drug use of the 1960s and 70s, and began having children in the 1980s. During this time, reports of sexually transmitted diseases and viruses, as well as transmission via IDU, began gaining more media exposure, both of which gained a level of ignominy in the 1980s in relation to HIV. We must remember that many media reports indicated that HIV only impacted those in the “4 ‘H’ Club” – Heroin users, Hookers, Haitians, and Homosexuals. When this type of branding in the media and in government conversations occurs, stigmata arise that leads to people avoiding testing and treatment.

Since that time, however, infectious diseases have undergone something of facelift, with multi-million-dollar ad campaigns and outreach programs on the part of pharmaceutical companies and governments trying to spread the word about getting tested. These efforts are part of a concerted effort to reduce the stigma associated with chronic illnesses and infectious diseases that are both costly to treat and incredibly harmful to those living with them if they go untreated.

For the Birth Cohort, however, to feel as if they should be lumped in with what many view as an unsavory crowd simply goes counter to the reality of the epidemic. Screening for HCV isn’t just something that applies to those who practice risky behavioral patterns; rather, it should be something that is routine within the Birth Cohort, so that they can cure HCV and live their waning years without the concern of HCV-related illnesses and co-morbidities.

References:

  • Joy, J., McCloskey, R., Nguyen, T., Liang, R., Khudyakov, Y., & Olmstead, A., et al. (2016, March 30). The spread of hepatitis C virus genotype 1a in North America: a retrospective phylogenetic study. The Lancet Infectious Diseases16(6), 698-702. doi:10.1016/s1473-3099(16)00124-9. Retrieved from: http://dx.doi.org/10.1016/S1473-3099(16)00124-9

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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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