Co-Infection: HIV & Hepatitis C Therapies Under State AIDS Drug Assistance Programs

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

According to amfAR, The Foundation for AIDS Research, there are an estimated 1.2 million people living with HIV/AIDS in the United States, with as many as 150,000 unaware of their status.[1] The U.S. Centers for Disease Control & Prevention (CDC) estimates one percent of the adult population, or nearly 2.4 million Americans, are living with Hepatitis C (HCV).[2] The intersection between these dual epidemics continues to place significant strain on the nation's public health system. In 2009, approximately one in five of the HIV-infected adults who were tested for past or present HCV infection tested positive.[3] It is unknown how the ongoing Covid-19 pandemic is influencing HIV/HCV co-infection.

Photo Credit: iStock (rights purchased)

What we do know is people living with HIV-infection face a higher risk of long-term liver failure as a result of co-infection with HCV. In fact, HCV-related liver failure has become the leading non-AIDS-related cause of death among people living with HIV-infection in the United States – and as such, treating HCV is of paramount importance.[4]

HIV/HCV co-infection remains a growing and evolving epidemic. Advances in HIV medication since the introduction of highly-active anti-retroviral therapy in 1996 has increased a detection of sexually transmitted HCV infection. Dating back to 2011, sexual transmission of HCV is becoming a growing concern amongst men-who-have-sex-with-men (MSM).[5] 

The HIV/HCV Co-Infection Watch — a program of the Community Access National Network (CANN) — delivers relevant information from a “patient-centric” perspective on access to care and treatment. The three primary groups best suited for this information include patients, healthcare providers, and community-based AIDS Service Organizations.

Of particular importance to the ADAP Advocacy Association are the patients who frequently rely on coverage provided by state- and federally-funded programs – such as the AIDS Drugs Assistance Program (ADAP). According to the National Alliance of State & Territorial AIDS Directors (NASTAD), "While ARVs represent 95% of all CY2018 ADAP drug expenditures, 0.4% and 1% were expended on hepatitis B and C treatment, respectively."[6]

Dating back to the passage of the Affordable Care Act, NASTAD has detailed the availability of testing, care and treatment for individuals who are mono-infected with HCV and co-infected with HCV and HIV, in light of newly available curative treatments for HCV.[7]  NASTAD has also made available an interactive map highlighting the important work of health department HIV and viral hepatitis programs.

Additionally, CANN's HIV/HCV Co-Infection Watch includes detailed information on States whose ADAP drug formularies cover HCV therapies. Summarized Jen Laws, Project Director for the HIV/HCV Co-Infection Watch, “For purposes of our monitoring, coverage is broken down into ten categories - Basic Coverage, Sovaldi, Harvoni, Zepatier, Epclusa, Vosevi, Mavyret, Pegasys, Harvoni (generic), and Epclusa (generic). This will be expanded as newer treatment options become available."

Photo Source: HIV/HCV Co-Infection Watch

While 47 of the country's 56 state and territorial ADAPs provide some form of HCV coverage, only 44 provide coverage for direct acting agents matching with the standards of care provided for by American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. The quarterly report monitors for changes in HCV medication coverage. Most recently published in April 2021, it notes several changes with regard to HCV treatment coverage among ADAPs, primarily as a result of budget impacts due to COVID-19. For example, Texas's program has ceased coverage of any HCV therapies except for Epclusa (brand only), and Georgia's ADAP has stopped paying for all HCV therapies, while maintaining them as drugs on the formulary.

Laws further reflected, "Program information can be challenging to navigate and the Watch is an invaluable as a tool to help patients navigate what's available to help them, when they need it." Laws added, "As far as HCV treatment coverage, given the significant rate of HCV coinfection with HIV, it's unfortunate to see some ADAPs treat access to and coverage of HCV medications as optional or fail to adopt medication coverage in alignment with standards of care because we know treating the medical needs of PLWH holistically leads to a higher rate of positive health outcomes."

The HIV/HCV Co-Infection Watch list-serve sign-up form is available online: https://www.tiicann.org/signup_listserv.php.

[1] amfAR, The Foundation for AIDS Research (June 2020). Statistics: United States. Retrieved online at https://www.amfar.org/about-hiv-and-aids/facts-and-stats/statistics--united-states/#:~:text=An%20estimated%201.1%20million%20people%20in%20the%20United,15%25%20of%20those%20don’t%20know%20they%20are%20infected.

[2] Centers for Disease Control & Prevention (2018, November 18). CDC Estimates Nearly 2.4 Million Americans Living with Hepatitis C. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/nchhstp/newsroom/2018/hepatitis-c-prevalence-estimates-press-release.html. 

[3] Centers for Disease Control & Prevention (2020, September 21). People Coinfected with HIV and Viral Hepatitis. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/hepatitis/populations/hiv.htm. 

[4] Community Access National Network (April 2021). HIV/HCV Co-Infection Watch – About. Retrieved online at https://www.hiv-hcv-watch.com/about.

[5] U.S. Centers for Disease Control & Prevention, MMWR Vol. 60 No.28, July 22, 2011.

[6] National Alliance of State & Territorial AIDS Directors (2020, August 10). NATIONAL RYAN WHITE HIV/AIDS PROGRAM (RWHAP) PART B AND ADAP MONITORING PROJECT: 2020 ANNUAL REPORT. Retrieved online at https://www.nastad.org/PartBADAPreport.

[7] National Alliance of State & Territorial AIDS Directors (2014, December 4). Access to Care and Treatment for HCV Mono-Infection and HIV/HCV Co-Infection. Retrieved online at https://www.nastad.org/sites/default/files/resources/docs/HCV-HIV-Care-Access-Webinar-December-2014.pdf.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Danger Zone: Intimate Partner Violence Among People Living with HIV

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The U.S. Centers for Disease Control & Prevention (CDC) recently reported what too many people living with HIV/AIDS (PLWHAs) in the United States had already known...they are at higher risk for intimate partner violence. According to the findings, which were published in the American Journal of Preventive Medicine, "26.3% reported having ever experienced intimate partner violence, and 4.4% reported having experienced intimate partner violence in the past 12 months."[1] Sadly, it means one in four PLWHAs are probably more worried about surviving physical abuse than battling their HIV diagnosis. 

Photo Credit: iStock (rights purchased)

Aside from the act of violence itself, what is equally troubling it how it impacts the emotional, mental and physical health of the survivors of domestic abuse and intimate partner violence. Among PLWHAs who experienced intimate partner violence during the previous year, CDC found they were:[2] 

• Less likely to maintain medication adherence. 
• Less likely to be engaged in routine HIV care.
• Less likely to have good HIV clinical outcomes.
• More likely to seek emergency care services.
• More likely to engage in risky behaviors, such as intravenous drug use.
• More likely to have unmet needs for supportive services. 

Gender and sexual orientation were both important factors for lifetime prevalence of intimate partner violence. Homelessness also was identified as a risk-factor, with 37.6% experiencing physical abuse from a partner with in the past twelve months.[3]

CDC's analysis used interview and medical record data from the 2015−2017 cycles of the Medical Monitoring Project,[4] which was prior to the ongoing Covid-19 pandemic. Unfortunately, all reports indicate that domestic abuse and intimate partner violence have increased over the last year during the Covid-19 isolation.[5] The ADAP Advocacy Association, in fact, worked closely last year with Simply Amazing You Are (SAYA) to highlight, COVID-19 is Exacerbating Existing Epidemics. 

SAYA, a Miami, Florida-based nonprofit organization, has been on the front lines battling this dual epidemic using empowerment focused intimate partner violence prevention and intervention. SAYA's programming includes direct assistance like escape planning and protective order assistance, as well as policy advocacy campaigns, referral for support services, and linkage to care and victim services navigation. SAYA currently relies on a word-of-mouth model in order to ensure the safety of their clients. Through the COVID pandemic, SAYA has also partnered with Panera Bread end night donations to provide to IPV survivors facing homelessness or the risk of homeless.

Connie Reese, SAYA's Founder & Executive Director, is survivor of intimate partner violence. "When is your enough...enough," Reese said upon urging survivors of intimate partner violence in South Florida to seek support. But according to Reese, Covid-19 has made it more difficult for people to seek help.

"For many women, even the fear of contracting the coronavirus is stopping them from seeking out medical care after experiencing physical abuse, in addition to being HIV-positive," said Reese. "SAYA, although in the process of applying for federal and local government funding, has provided unlimited services out-of-pocket to ten women who have experienced intimate partner violence in Miami-Dade County during Covid-19."

To that end, SAYA was instrumental in helping the ADAP Advocacy Association publish its infographic on the intersection between intimate partner violence and HIV. For anyone experiencing domestic abuse or intimate partner violence, please call the National Domestic Violence Hotline at 1-800-799-7233, or the Rape & Incest National Network (RAINN) National Sexual Assault Hotline at 1-800-656-4673.

[1] Ansley B. Lemons-Lyn, Amy R. Baugher, Sharoda Dasgupta, et al. (2021, March 31). Intimate Partner Violence Experienced by Adults With Diagnosed HIV in the U.S. American Journal of Preventive Medicine. Retrieved online at https://www.ajpmonline.org/article/S0749-3797(21)00079-9/fulltext.

[2] Ansley B. Lemons-Lyn, Amy R. Baugher, Sharoda Dasgupta, et al. (2021, March 31). Intimate Partner Violence Experienced by Adults With Diagnosed HIV in the U.S. American Journal of Preventive Medicine. Retrieved online at https://www.ajpmonline.org/article/S0749-3797(21)00079-9/fulltext.

[3] Lily Wakefield (2021, April 18). A quarter of HIV-positive Americans have experienced intimate partner violence. Retrieved online at https://www.pinknews.co.uk/2021/04/18/hiv-intimate-partner-violence-america-health-outcomes-cdc/. 

[4] Ansley B. Lemons-Lyn, Amy R. Baugher, Sharoda Dasgupta, et al. (2021, March 31). Intimate Partner Violence Experienced by Adults With Diagnosed HIV in the U.S. American Journal of Preventive Medicine. Retrieved online at https://www.ajpmonline.org/article/S0749-3797(21)00079-9/fulltext.

[5] Karen Nikos-Rose (2021, February 24). COVID-19 Isolation Linked to Increased Domestic Violence, Researchers Suggest. University of California, Davis. Retrieved online at https://www.ucdavis.edu/news/covid-19-isolation-linked-increased-domestic-violence-researchers-suggest.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

PLWHA Perspectives on Covid-19

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association has dedicated significant resources over the last year to understanding the intersection between the global Covid-19 pandemic and its impact on people living with HIV/AIDS (PLWHAs). In fact, recently one in ten people living with HIV/AIDS in the United States indicated that they had tested positive for Covid-19, according to our online survey. 

The national survey, IMPLICATIONS OF CORONAVIRUS FOR PEOPLE LIVING WITH HIV/AIDS, was a project conducted in collaboration with the Community Access National Network (CANN), Community Education Group (CEG), HealthHIV, and the Legacy Health Endowment. The survey generated 390 response, of which 45 were disqualified for the respondent not being HIV-positive, and additional 14 were disqualified for not being residents of the United States. Thus for the purposes of the survey, n=331.

In a nutshell, 11.52% of the respondents tested positive for Covid-19. Whereas an open-access survey is not the same as a scientifically conducted poll, but the survey results do provide a glimpse into how Covid-19 is impacting our community. The results are as follows...

Have you tested positive for the Covid-19 virus? n=330

• 11.52% Yes (38)
• 88.48% No (292)

* one respondent didn't complete this question/survey 

Have you fully-recovered from Covid-19 or are you still lingering with Covid-19 health issues (Editor's Note: if you answered "No" to question 3 or question 4, then please skip this question)?

• 13.00% Yes (36)
• 07.94% No, still lingering (22)
• 79.06% N/A (219)

 * 40 respondents didn't complete this question/survey 

Have you been hospitalized for Covid-19?

• 01.60% Yes (5)
• 98.40% No (308)

* four respondents didn't complete this question/survey

Respondents who completed the survey came from thirty-seven states (37), plus Puerto Rico and the District of Columbia. The breakdown includes survey responses from AL - 04, AK - 00, AZ - 05, AR - 00, CA - 69, CO - 04, CT - 06, DE - 00, FL - 16, GA - 04, HI - 02, ID - 01, IL - 18, IN - 00, IA - 00, KS - 02, KY - 01, LA - 01, ME - 01, MD - 11, MA - 04, MI - 03, MN - 01, MS - 00, MO - 01, MT - 00, NE - 01, NV - 01, NH - 00, NJ - 04, NM - 01, NY - 24, NC - 06, ND - 00, OH - 10, OK - 01, OR - 04, PA - 07, RI - 01, SC - 04, SD - 00, TN - 03, TX - 23, UT - 00, VT - 00, VA - 14, WA - 14, WV - 01, WI - 01, WY - 00, P.R. - 03, D.C. - 19.

A snapshot of the survey results is available online at https://www.surveymonkey.com/stories/SM-9JVQK5TC/.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Co-Pay Accumulators are an Extremely Dangerous, Anti-Patient Policy

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Today's lexicon outside healthcare policy discussions probably doesn't include the words, co-pay accumulators. But that is slowly changing as more and more people encounter what is widely recognized as an extremely anti-patient health insurance policy. Co-pay accumulators amount to nothing more than the greedy health insurance industry (and other payers) making prescription drug coverage less affordable for patients, especially for those living with chronic health conditions such as HIV/AIDS.

The Hepatitis B Foundation defines a copay accumulator (or accumulator adjustment program) as "a strategy used by insurance companies and Pharmacy Benefits Managers (PBMs) that stop manufacturer copay assistance coupons from counting towards two things: 1) the deductible and 2) the maximum out-of-pocket spending."[1]

Last year in the ADAP Blog, guest contributor Marcus J. Hopkins provided an excellent description on these potentially harmful policies: "Essentially, what a co-pay accumulator attempts to do is increase the amount of money consumers pay in order to decrease the amount of money insurers have to pay, once their annual deductible and/or Out-of-Pocket Maximum (OPM) is met. When consumers are allowed to count co-pay assistance cards against their deductible/OPM, they reach those limits sooner, meaning that insurers are then on the hook for every pharmaceutical fill after that date."[2]

Photo Source: Bankrate

Co-pay accumulators are particularly problematic for the HIV community because they rely on specialty drugs, such as anti-retroviral medications. In 2018, Dr. Adam J. Fein with the Drug Channels Institute warned, "Patients today are being asked to pay a significant share of prescription costs for more-expensive specialty drugs, because of high coinsurance amounts."[3]

Unfortunately, increasingly health insurance companies and PBMs have elected to institute co-pay accumulators. Make no mistake about it, but these co-pay accumulators will lead to patients being unable to afford their medication...and that will lead to less medication adherence...and that will lead to higher costs for the entire healthcare system. Our response is simple: It is time to advocate for the patient!

The AIDS Institute recently published an in-depth report, "Double Dipping: Insurance Companies Profit at Patients' Expense - An Updated Report on Copay Accumulators." According to the report's findings, in 45 states and the District of Columbia, there is at least one plan with a copay accumulator adjustment policy.[4]

For people living with chronic health conditions, such as HIV or viral hepatitis, co-pay accumulators generally pose significant problems for patients. As the report highlights: "With the many crises plaguing our health care system today, this very confusing issue can easily be dismissed. However, for the patients it affects, it simply cannot be ignored. And for those who haven’t experienced a copay accumulator yet, it may only be a matter of time."[5]

The problem for patients is much broader, though. According to the Patient Access Network Foundation (PAN), more than 10 percent of seniors shared that they took on credit card debt to afford prescriptions, while nearly 20 percent of seniors said they reduced spending on everyday purchases, including groceries and transportation.[6]

Photo Source: PAN Foundation

The Biden-Harris Administration recently had the opportunity to pump the brakes on co-pay accumulators, similar to the way they stopped the harmful demonstration project designed to weaken the six protected drug classes under Medicare's Part D. They failed to so, and the patient advocacy community was quick to express its concern.

“We are deeply disappointed that CMS passed on addressing the issue of copay assistance for prescription drugs and requiring insurers and pharmacy benefit managers to count assistance towards patient out-of-pocket cost-sharing and deductibles,” commented Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “Even before COVID-19, patients were struggling to afford their medications and relied on copay assistance from drug manufacturers. Now, the need is even greater. We know that the Biden-Harris administration wants to improve patient affordability of healthcare, particularly for vulnerable communities; however, they missed a perfect opportunity to demonstrate this commitment.”[7]

In a recent letter, U.S. Representatives A. Donald McEachin (VA-04) and Rodney Davis (IL-13) asked President Biden to halt the Trump Administration's copay accumulator policy ― which was included in the 2021 Notice of Benefit and Payment Parameters (NBPP).[8] It is now left in the hands of the Congress to reverse course on the extremely dangerous, anti-patient policy known as co-pay accumulators. Patient health depends on it!

[1] Hepatitis B Foundation (2020, March 4). Copay Accumulators – What They Are and What They Mean For Your Prescriptions. Retrieved online at https://www.hepb.org/blog/copay-accumulators-mean-prescriptions/#:~:text=A%20copay%20accumulator%20–%20or%20accumulator%20adjustment%20program,the%20deductible%20and%202%29%20the%20maximum%20out-of-pocket%20spending.

[2] Marcus J. Hopkins (2020, July 16). CMS Co-Pay Accumulator Rule Aims to Increase Consumer Costs. The ADAP Blog. ADAP Advocacy Association. Retrieved online at https://adapadvocacyassociation.blogspot.com/2020/07/cms-co-pay-accumulator-rule-aims-to.html.

[3] Adam J. Fein, Ph.D. (2018, January 3). Copay Accumulators: Costly Consequences of a New Cost-Shifting Pharmacy Benefit. Drug Channels. Retrieved online at https://www.drugchannels.net/2018/01/copay-accumulators-costly-consequences.html.

[4] The AIDS Institute (March 2021). Double Dipping: Insurance Companies Profit at Patients' Expense - An Updated Report on Copay Accumulators. Retrieved online at https://aidsinstitute.net/documents/2021_TAI_Double-Dipping_Final-031621.pdf.

[5] The AIDS Institute (March 2021). Double Dipping: Insurance Companies Profit at Patients' Expense - An Updated Report on Copay Accumulators. Retrieved online at https://aidsinstitute.net/documents/2021_TAI_Double-Dipping_Final-031621.pdf.

[6] Amy Niles (2021, April 19). Morning Consult survey: high out-of-pocket costs causing concern for seniors. PAN Foundation. Retrieved online at https://www.panfoundation.org/high-out-of-pocket-costs-causing-concern-for-seniors/. 

[7] Carl Schmid (2021, April 30). Biden Administration Passes on Protecting Patient Affordability of Medications. HIV+Hepatitis Policy Institute. Retrieved online at https://hivhep.org/press-releases/biden-administration-passes-on-protecting-patient-affordability-of-medications/.  

[8] The Honorable A. Donald McEachin (2021, March 22). McEachin Leads Bipartisan Letter Asking President Biden to Reverse Previous Administration’s Copay Accumulator Policy. The Office of U.S. Representative A. Donald McEachin (VA-04). Retrieved online at https://mceachin.house.gov/media/press-releases/mceachin-leads-bipartisan-letter-asking-president-biden-reverse-previous.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.