Tag Archives: HIV/HCV Co-Infection

2nd Annual HIV/HCV Monitoring Report Released

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

On September 21st, 2017, the Community Access National Network (CANN) hosted the 2nd Annual National Monitoring Report on HIV/HCV Co-Infection at the Pharmaceutical Research and Manufacturers of America (PhRMA) headquarters in Washington, D.C. Presentations were delivered by yours truly, and Amanda Bowes, Manager on the Health Care Access team for the National Alliance of State and Territorial AIDS Directors (NASTAD), both of whom focused on issues of coverage for Hepatitis C (HCV) Direct Acting Antivirals (DAAs) for the 59 AIDS Drug Assistance Programs (ADAPs) and Medicaid programs, as well as information about the U.S. Department of Veteran Affairs (V.A.) and Harm Reduction measures.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

Key findings of my presentation indicate that, as of August 2017, 33 state ADAP programs offer coverage for DAAs on their ADAP formularies, an increase of six states from August 2016. Additionally, all 50 states and the District of Columbia have offered expanded coverage for DAA drugs since August 2016. In March 2016, the V.A. began offering treatment with DAAs to every eligible veteran. In terms of Harm Reduction, several states have authorized Syringe Services Programs (SSPs) in an effort to prevent the spread of HIV, Hepatitis B (HBV), and HCV since Congress ended the ban on Federal funding for Syringe Exchange Programs in January 2016.

One other key finding was that, in seven of the states with the ten highest rates of HCV infection, ADAP programs offer either no coverage for HCV drugs or offer coverage only for older, less easily tolerated treatments requiring the use of Pegylated-Interferon (PEG-INF). These states include (in order of highest HCV infection rates): WV, KY, IN, NM, AL, NC, and OH.

Key findings of Mrs. Bowes’ detailed presentation indicate that NASTAD has actively been attempting to increase HCV DAA coverage by ADAP programs in cooperation with the Health Resources and Services Administration (HRSA) while still maintaining fiscal solvency. This consultation, in June 2016, included ADAP and Viral Hepatitis (VH) program staff, Federal partners including the Centers for Medicare and Medicaid Services (CMS), U.S. Department of Health and Human Services (HHS), HRSA, and the U.S. Department of Veteran Affairs (V.A.), providers specializing in treatment for HIV/HCV co-infection, community partners, and NASTAD staff. The meeting was comprised of a panel of Federal representatives, a presentation on the best practices for ADAP HCV treatment utilization, and a discussion of the various barriers preventing ADAP programs from expanding coverage, clinical management of HIV/HCV co-infection, and policies and procedures for HCV treatment among People Living With HIV (PLWH).

Additionally, NASTAD gathering detailed information related to how ADAP programs covered the cost of HCV DAAs, finding that programs that offered Insurance Continuation (purchasing private insurance coverage for ADAP clients) and paid for the co-pays, rather than paying the full prescription cost, were able to save considerably over paying directly for the medications.

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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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Scott County and Indiana’s Steep Learning Curve on HIV and 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

In early 2015, Scott County, Indiana was thrust into the global spotlight for an HIV outbreak among injection drug users abusing opioid prescription drugs and heroin (Hopkins, 2015). In a county that averaged a total of 5 new HIV infections each year, even doubling that number would’ve been a statistical anomaly. By the end of 2016, the county had 216 new HIV infections in the span of just two years, and of those, 95% were co-infected with Hepatitis C (HCV). So rare was the disease that county health department officials had never handled HIV cases, instead sending them all to the regional Sexually Transmitted Diseases Department in Clark County (May, 2016).

The outbreak in Scott County was, and still is, both instructive and reflective of several concurrent health crises faced by most of rural America. In one county, virtually every major health risk met in the middle: a prescription opioid addiction problem, the resultant heroin usage problem, and an access to comprehensive healthcare problem all walked into a bar, and out came one of the worst concentrated HIV epidemics in the U.S. in the past decade. Throw in a paucity of drug addiction, recovery, and Syringe Services Programs (SSPs), and you had the perfect case study for how outbreaks occur.

To be fair to Indiana’s legislature and then-Governor Mike Pence, the state responded intelligently to the crisis by legalizing for the first time SSPs…under certain previsions. Counties had to apply for approval, had to show that they had funding, and had to be located in a high-risk zone. Since Mike Pence’s departure from the state to swampier D.C. pastures, his replacement has actively attempted to ease those restrictions. Earlier this year, the Indiana General Assembly passed a bill allowing local governments to establish syringe or needle exchange programs without having to receive state approval (Rudavsky, 2017). His efforts have not, however, managed to convince everyone.

Map showing states with syringe exchange programs.

Source: HIV/HCV Co-Infection Watch

Madison County, for example, recently voted to remove all funding from their SSP, run by the county’s health department, and prohibited appropriations of funds for paying for both supplies and labor (Fentem, 2017). The ordinance, approved by five of the seven-person council, immediately shuttered the only operating SSP in the county, and was largely driven by stigma-based fears: discarded syringes were going to litter front lawns and public parks; drug addicts were going to wander over from neighboring counties, bringing their drug problems with them; “What about the innocent children?!” These well-worn excuses and arguments against the establishment and funding of SSPs have plagued the proven Harm Reduction measure since its inception. The fears are also unsupported by anything other than anecdotal evidence and hearsay, few assertions of which are backed up by any credible research or quantifiable proof.

Worse, still, is that the council members did nothing on their part to allay these fears. Council member Fred Reese is quoted as saying the following:

Some say if you don’t do the needle exchange, you’re going to have a spread of HIV, you’re going to have a spread of hepatitis C, but my concern is the innocents. I don’t want these needles out (Fentem).

This kind of statement on the part of an elected officials shows cowardice, rather than leadership. Part of the job of county councils is to do what’s in the best interests for everyone, rather than kowtowing to fear-based arguments that bear little resemblance to reality.

Clark County – where Scott County once sent its HIV cases for management – recently renewed their SSP for one year, after which it will be up for renewal in August 2018. About half of the program’s 150 participants have HCV, many of whom were diagnosed through the program (Beilman, 2017). Their hopes for the program include seeing a more balanced rate of return on needle collection. Of the nearly 16,000 needles distributed, the exchange collected almost 8,000 (Beilman).

In Boone County, where no SSP currently exists, Prosecutor Todd Meyer sent the following communique to county leaders:

A needle exchange program does not help in fighting the demand side, in fact, it will do the exact opposite by providing the users/addicts with the tools they need to continue to abuse illicit drugs…(Davis, 2017).

That this opinion was issued by a prosecutor should shock no one. Meyer’s position, however, is reflective of those espoused by [mostly Conservative] voters, legislators, and law enforcement officials, but again, bear little resemblance to reality. Instead, they rely upon fear and stigmatization, along with two terrifyingly short-sighted sentiments: “Not in my back yard!” and “It can’t happen here!” While Meyer contends that Boone County doesn’t have an HIV problem, now, let’s see if it has one in two years.

Back in Scott County, the SSP, run by the Scott County Health Department (SCHD), has another issue: it doesn’t keep track of HCV cases (de la Bastide & Filchak, 2017). For some reason, SCHD officials are only worried about their HIV problem. If that seems counterintuitive, that’s because it is. It was, in fact, a spike in new HCV cases that led to the discovery of the HIV epidemic. Additionally, with a 95% co-infection rate in the 216 HIV cases identified in the initial outbreak, as well as the more aggressive spread of HCV in the U.S. compared to HIV, it makes no sense, whatsoever, for the SCHD to fail to keep track of HCV.

The concurrent HIV and HCV outbreaks in Scott County, Indiana were just the beginning. Already, rural states and counties are beginning to see an uptick in new infections of both diseases as a result of Injection Drug Use (IDU). More concerning is the fact that most of those counties are deeply Conservative, which creates significant challenges for those hoping for proactive healthcare policies, rather than reactive cleanup measures. As for Scott County, there are several families with multiple generations infected with HIV, and very likely with HCV, as a result of prescription opioid and heroin abuse. Unfortunately for them, their county’s health department doesn’t see fit to track their issues.

Download the latest edition of the HIV/HCV Co-Infection Watch.

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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Lessons Learned About HCV and Aging

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

On Thursday, December 8th, the Community Access National Network (CANN) hosted a community roundtable on Hepatitis C (HCV) and Aging at the Pharmaceutical Research and Manufacturers of America® (PhRMA) headquarters in Washington, D.C. The event featured four presenters – Ambrose Delpino (PharmD, practicing HIV pharmacist [AAHIVP], Senior Manager, Virology, Walgreens), Fabian Ancar (a patient who successfully achieved a Sustained Virologic Response [SVR] while co-infected with HIV and HCV), Marissa Tonelli (Senior Manager of Capacity Building, HealthHIV, and Senior Manager of HealthHCV), and Chris Taylor (Senior Director, Hepatitis, National Alliance of State and Territorial AIDS Directors).

Of the four presenters, Dr. Delpino presented the most statistically pertinent presentation (as the others spoke primarily about their experiences, research, and how their organizations engage in advocacy on the local, state, and Federal levels), and the statistics that we’ll be reporting, here, are from his slides. Some of the issues raised during this panel will be further explored in further posts, so this entry will serve as a summation of his main points.

On the basics of infection, Dr. Delpino’s presentation reported that 2.7–3.9 million Americans are estimated to be infected with HCV, with an estimated 17,000 new infections annually. Both he and HEAL Blog note that this estimation is likely very low, as HCV screening, disease monitoring, tracking, and reporting are notoriously problematic, as capturing certain populations (e.g. – Rural, People Who Inject Drugs (PWIDs), et cetera) is difficult at best. It is also estimated that one in thirty Baby Boomers (people born between 1945-1965) are infected with HCV – five times greater incidence than other adults. The estimated cost to the healthcare system, including HCV-symptom-related hospitalizations and treatments is estimated to be over $80 billion over the next ten years.

The primary reason why Baby Boomers (the “birth cohort”) are so much more likely to be infected is related to the facts that HCV is a relatively new discovery in terms of diseases, blood supplies were not adequately screened for HCV prior to 1992, and universal precautions related to sanitation were not, prior to the discovery of HIV, necessarily the standard of care (SOC). This means that anyone who received a blood transfusion or any other blood product prior to 1992 is at risk of having contracted HCV; this also means that anyone who received transplanted organs or had improperly sterilized equipment used on them prior to universal precautions being in place is also at risk.

Outside of the birth cohort, it is estimated that 60% of all HCV infections are believed to be related to injection drug use (IDU). For every 100 people infected with HCV, 75-85% will develop a chronic infection, 60-70% will develop liver disease, 5-20% will develop liver cirrhosis, and 1-5% will die as a result of their infection. What makes this frustrating for HCV advocates is that the cost per SVR in a single 12-week round of the most popular treatment (Harvoni – $94,500) is far less expensive in the short term than the long-term costs associated with chronic HCV infection.

In future posts, we will be examining the pipeline process that it often takes for patients infected with HCV to receive medications to treat their disease, one of the most compelling slides in Dr. Delpino’s presentation. We will also be sharing some of the personal testimony of the patient, Fabian Ancar, whose story was presented at the panel.

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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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Do Black Boxes Mean Red Ink for Drug Companies?

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 U.S. Food & Drug Administration (FDA) has recently concluded that new Direct Acting Agents (DAAs) to treat Hepatitis C (HCV) require a boxed warning for the drugs advising clinicians and physicians to screen patients for evidence of a past or current Hepatitis B (HBV) infection before undergoing treatment for HCV. This warning, indicated by black box on the labels of all nine current DAAs, has many investors worried that, along with consistent questions about the Wholesale Acquisition Costs (WACs) of newer HCV drugs, stock prices may face volatility in the coming years.

The new DAAs for HCV have been on the market for roughly three years, beginning with the release of Sovaldi (Gilead) and the companion drug, Olysio (Janssen), in 2013. Since that time, there has been a tremendous outcry from virtually every stakeholder involved in the issue of pricing, save for the pharmaceutical companies, themselves. Additional concerns have been raised that the modules used by companies to determine initial WAC prices is neither transparent, nor representative of the will of consumers. Arguments that pricing structures take into account “what the market will bear” have served as little comfort to advocacy groups, state agencies, and Congressional panels, all of whom are becoming less tolerant of high drug prices.

Drug prices for specialty products – those that are designed to treat very specific conditions – continue to rise at meteoric rates, and regardless of what drug companies believe the markets can bear, state and Federal budgets are largely unequipped to handle the short-term costs to treat HCV without quadrupling their annual budgets, so vast is the pool of infected patients. Beyond just the traditional patient pool, the growing HCV infection crisis in prison populations, which is largely ignored in state reporting and which faces vast issues in screening, prison budgets may soon face extreme funding issues if Federal lawsuits go against them, and require them to provide treatment to all inmates infected with the disease.

These new concerns raised by the FDA represent just the latest hurdle for pharmaceutical companies whose HCV fortunes may turn in the coming years. HBV, an as-yet incurable form of the illness, is much more easily transmittable through sexual intercourse, which may pose an additional risk for HIV/HCV co-infected patients whose HBV infection flares up as a result of using DAAs for HCV. Whether or not the reactivation of HBV in HCV treated patients is widespread is unknown, as the FDA has only identified 24 cases at the time of their ruling.
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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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