Thursday, July 27, 2023

Smoking and its Impact on People Living with HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Smoking-related diseases and death remain some of the most preventable health issues today. While the prevalence of smoking habits has been continuously declining, in 2021, 11.5% (28.3 million) of the general U.S. population aged 18 or older still currently smoked cigarettes.[1] The designation of “currently smoking” is defined as having smoked 100 or more cigarettes in a lifetime combined with present daily use or every few days. Data shows that the prevalence of cigarette smoking among people living with HIV (PLWH) is significantly higher than the general population, estimated to be between 34-47%.[2] This is an alarming trend because smoking reduces the life expectancy of PLWH who smoke compared to those that do not.[2] Additionally, 94% of lung cancers among PLWH who smoke could possibly be prevented by smoking cessation.[2]

Person holding cigarette
Photo Source: AIDSmap

There are several medical issues, other than lung cancer, among PLWH that are linked to smoking: bacterial pneumonia, heart disease, chronic obstructive pulmonary disease (COPD), and other non-AIDS-defining cancers.[3] Research shows that these same issues are also comorbidities that take the lives of PLWH about ten years sooner than the HIV-negative population.[5] Data also shows that smoking PLWH who have achieved viral suppression through consistent antiretroviral treatment are more likely to die from lung cancer than traditional AIDS-related causes.[4] Most importantly, HIV is an independent risk factor for smoking-related cancers.[3] This means that being HIV positive increases the risk of developing smoking-related cancer much higher than the odds expected from smoking alone. 

A recent study conducted at Florida International University aims to explore why HIV infection exacerbates the adverse health outcomes of conditions like COPD in PLWH who smoke.[5] A smoking robot takes the smoke from standardized research cigarettes and exposes HIV cells to the smoke. The specific cells are cells from the respiratory tract lining in HIV-associated COPD. The research aims to discover what encourages lung inflammation in PLWH, hoping to create treatments that reverse the damage to restore function or at least prevent further deterioration.[5]

Given the importance of encouraging smoking cessation among PLWH, it is crucial also to understand the characteristics of the populations of PLWH who smoke. To examine the comorbidities and characteristics of PLWH who smoke, a group of researchers investigated data from an ongoing study of PLWH in Washington, DC, called the D.C. Cohort Longitudinal HIV study. The DC Cohort study participants are PLWH who get their care from a group of fifteen medical care sites in Washington, DC. Clinical data is collected to help improve the treatment and outcomes of PLWH in the area. Researchers found that half of the 8,600 subjects are smokers.

Examination of the data revealed intersections of socioeconomics, gender, race, and comorbidities.[7] Almost half of the smoking subjects had a mental health disorder. Four percent suffered from cardiovascular disease, eight percent had cancer, and two percent had pulmonary disease. Those with mental health challenges were more likely to be female, white, and older; likely to be uninsured or have public health insurance; and have housing instability. Those with cardiovascular disease, cancer, or pulmonary disease were more likely to be older, female, non-Hispanic Black race/ethnicity, or with housing instability. Regarding other characteristics, about 75% of the smoking subjects were unemployed, 15% had private insurance, and 57% were younger than age 50.

Tobacco & HIV/AIDS
Photo Source: Breathe DC

These data points show how the population of PLWH who smoke is not a monolith in any way. Therefore, efforts to encourage smoking cessation must specifically meet those affected on the level of where they are in their lives. Success requires targeting particular subgroups of marginalized and high-risk individuals. Continued medical research into the specificity of how smoking affects PLWH differently is paramount as well. Research has even shown that PLWH metabolize nicotine faster than HIV-negative smokers, thus making it harder for them to stop smoking. 

One popular way suggested by some as a means to reduce the harm of smoking tobacco while still helping those with nicotine addictions is vaping, also known as e-cigarettes.[6] However, research suggests chemicals in e-cigarettes harm the heart and lungs. E-cigarettes that contain nicotine have been associated with elevated blood pressure and heart rate. The vaping products that do not contain nicotine have also been shown to be harmful due to their flavoring ingredients and other unknown proprietary chemicals. Moreover, e-cigarettes have been correlated with developing ailments like COPD in the same manner as combustible cigarette smoking.

Smoking cessation is another challenge, like substance abuse disorder, that needs to be normalized as part of the whole-person healthcare treatment of PLWH.

Don't Burn Through Your Meds
Photo Source: DC Tobacco Free Coalition

[1] CDC. (2023, May 4). Burden of cigarette use in the U.S. Retrieved from https://www.cdc.gov/tobacco/campaign/tips/resources/data/cigarette-smoking-in-united-states.html

[2] NIH. (2023, June 22). Tobacco and HIV. Retrieved from https://cancercontrol.cancer.gov/brp/tcrb/tobacco-hiv#:~:text=Over%201.2%20million%20people%20in,34%2D47%25%20smoke%20cigarettes

[3] U.S. Department of Health and Human Services. (2022, December 7). Smoking and HIV. Retrieved from https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/smoking/

[4] Reddy KP, Kong CY, Hyle EP, et al. Lung Cancer Mortality Associated With Smoking and Smoking Cessation Among People Living With HIV in the United States. JAMA Intern Med. 2017;177(11):1613–1621. doi:10.1001/jamainternmed.2017.4349

[5] Varela, I. (2023, July 17).Robot helps researcher study effects of smoking on people with HIV. Retrieved fromhttps://news.fiu.edu/2023/robot-helps-researcher-study-effects-of-smoking-on-people-with-hiv

[6] Sforza, L. (2023, July 18). Vaping harms heart and lungs: American Heart Association. Retrieved from   https://thehill.com/policy/healthcare/4103481-vaping-harms-heart-and-lungs-american-heart-association/

[7] Wolters Kluwer Health. (2023, July 14). Gender, race and socioeconomic status are associated with comorbidity in people with HIV who smoke. Retrieved from https://medicalxpress.com/news/2023-07-gender-socioeconomic-status-comorbidity-people.html

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.   

Thursday, July 20, 2023

The State of Long-Acting Injectable Medicaid Coverage

By: Marcus J. Hopkins, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)

A review of state Medicaid programs has revealed that coverage of recently approved Long-Acting Injectable (LAI) drugs used for the treatment of HIV is mixed, with several key states making access to these drugs difficult for patients. Currently, such products include Cabenuva (cabotegravir; rilpivirine| ViiV Healthcare), Sunlenca (lenacapavir | Gilead Sciences), and Trogarzo (ibalizumab | Theratechnologies).

Cabenuva received full approval from the U.S. Food and Drug Administration (FDA) in 2021 and is used to treat patients who have already proven to be adherent to daily pill regimens and have achieved undetectable viral suppression, meaning that they have fewer than 50 copies of the HIV virus per milliliter of blood. Cabenuva is a series of two injections (200mg cabotegravir; 200mg rilpivirine) administered to patients by a healthcare provider once every month or every other month.

Sunlenca is a salvage therapy—a treatment option utilized in patients who have multi-drug-resistant strains of HIV or who have experienced drug toxicity—that is administered twice a year and used in combination with other antiretroviral drugs.

Trogarzo is also a salvage therapy — a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. The drug is approved, in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.

The FDA approval of LAIs presents Persons Living with HIV/AIDS (PLWHA) with one of the most exciting opportunities to ever occur in the HIV treatment landscape: the chance to remain undetectable without having to remember to stop every day to take your HIV medications. Cabenuva is specifically designed for patients who have a proven track record of medication adherence, and the prospect of having to treat your HIV only once every month or every other month is both appealing and revolutionary—a sea change in a treatment landscape that has all too often been beset by horrific, painful, disfiguring, and/or sickening side effects and short medication half-lives that placed patients at risk of developing multi-drug-resistant strains of HIV after missing even a single dose.

LAIs still face several barriers they must overcome before they become the first-line standard of care, including (but not limited to) provider and patient awareness and acceptance of the regimens, payor Prior Authorization limits, and the requirement that the drugs be administered by clinicians rather than by patients, themselves. The latter barrier makes prescribing LAIs in rural and remote areas a difficult proposition, as patients in those regions often face their own barriers to accessing care and treatment, including geographic, transportation, and financial barriers.

The new review of state Medicaid programs in the United States found that 38 states provide coverage for Cabenuva, of which 20 states list it as a Preferred Drug, 7 as a Non-Preferred Drug, and 13 have Prior Authorization requirements restricting access to the drug. 13 states Medicaid Programs—AR, CO, DE, GA, IN, IA, KS, KY, MT, NE, SC, TN, WI—offer either no coverage or list the drug as non-formulary (Figure 1).

Figure 1 – State Medicaid Preferred Drug List Coverage of Cabenuva, July 2023

State Medicaid Preferred Drug List Coverage of Cabenuva, July 2023

State Medicaid program coverage of Sunlenca is less robust, which is to be expected given that the drug only received FDA approval in January 2023. 30 states currently offer coverage for Sunlenca, of which 23 states list the drug as a Preferred Drug, 7 as a Non-Preferred Drug. 21 states offer either no coverage or list the drug as Non-Formulary (Figure 2).

Figure 2 – State Medicaid Preferred Drug List Coverage of Sunlenca, July 2023

State Medicaid Preferred Drug List Coverage of Sunlenca, July 2023

State Medicaid program coverage of Trogarzo is even less robust. 30 states currently offer coverage for Trogarzo, of which 22 states list the drug as a Preferred Drug and 8 as a Non-Preferred Drug. 21 states offer either no coverage or list the drug as Non-Formulary (Figure 3).

Figure 3 – State Medicaid Preferred Drug List Coverage of Trogarzo, July 2023

State Medicaid Preferred Drug List Coverage of Trogarzo, July 2023

Several states have restrictions against prescribing Cabenuva as a treatment regimen, including Delaware, which requires failure with two Preferred Agents before Prior Authorization requests will be approved, and Wisconsin, in which both Cabenuva and Sunlenca are considered “Non-Formulary” (Table 1).

This review of Medicaid PDL coverage was initiated after receiving a report from Positive Health Clinic in Morgantown, WV, that West Virginia’s state Medicaid program was denying virtually all prescriptions for Cabenuva. A Patient Care Navigator reported that West Virginia’s Medicaid program has essentially classified the drug as a salvage therapy through its Prior Authorization requirements.

To date, Positive Health Clinic has had all new prescriptions denied by the state’s Medical Director, even after multiple appeals and conversations with state Medicaid officials. Those appeals included copies of the FDA approval and treatment indication, highlighting that the state has misclassified the drug.

The one exception has been an approval as a result of medication continuation. A patient who moved to West Virginia from Pennsylvania and was already prescribed the regimen. In order to get their prescription approved, Positive Health Clinic had to submit multiple forms of proof that the patient was fit to continue therapy, including:

  1. An active prescription for the drug
  2. Evidence that the patient was 100% compliant with receiving each dose
  3. Proof that the patient would continue to remain compliant.

We reviewed West Virginia’s state Medicaid PDL and Cabenuva Prior Authorization form in order to confirm this report and found the following guidance:

Cabenuva requires review by the Medical Director and is available only on appeal. Medical reasoning beyond convenience or enhanced compliance over preferred agents must be provided.

This approval guidance exists in direct opposition to the FDA’s approval and treatment indication guidance:

CABENUVA, a 2-drug co-packaged product of cabotegravir, a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

While Prior Authorization requirements for new (and often expensive) therapeutic drugs are not uncommon, the West Virginia Medicaid program’s blanket preemptive denial of a highly effective and proven HIV therapy appears to be an attempt to staunch what they believe will be an influx of prescriptions for an expensive drug. This approach is likely a response to increased efforts on the part of HIV and Harm Reduction advocates to utilize Cabenuva as the go-to therapy in West Virginia’s hard-to-reach, hard-to-treat patient populations.

Since 2018, West Virginia has endured two concurrent, unrelated (according to molecular surveillance), and unabated HIV outbreaks in Cabell and Kanawha Counties. These outbreaks, for which the state has received very limited funds from federal agencies to combat, have occurred primarily in populations of Persons Who Inject Drugs (PWIDs)—populations that are notoriously difficult to reach, treat, and retain in care.

Prior to 2018, West Virginia saw an annual average of just 67 new HIV diagnoses. Beginning in 2018, the state began seeing significant increases in new diagnoses, more than half of which were directly related to Injection Drug Use. This outbreak of new diagnoses among PWIDs was further exacerbated by the state’s increasing hostility toward comprehensive harm reduction measures, specifically Syringe Services Programs (SSPs). Even in 2020, when COVID-19-related shutdowns led to a 2/3 reduction in the number of HIV tests administered in the state of West Virginia, the state identified 135 new HIV infections, of which 108 (80%) were directly related to IDU.

Since 2020, the state has struggled significantly with increasing provider buy-in for proactive HIV testing, leaving the bulk of HIV testing to be done in hospital emergency rooms during overdose events (using an opt-out delivery method that requires informed denial of testing) and by a mere handful of non-profit agencies and the state’s overworked, but extremely dedicated, Director of HIV Care and Prevention. This Director is one of the very few in the United States who regularly goes into communities to conduct testing events. His efforts are, however, hampered by inadequate levels of state and federal funding and increased scrutiny from a state legislature that continues to grow more hostile to HIV testing and prevention efforts.

According to the most recent report, West Virginia identified 140 new cases of HIV in 2022, of which 98 (70%) were directly attributed to IDU. 2023 is likely to be an equally devastating year, with 25 of the 48 cases identified to date (52.1%) being directly related to IDU.

The thinking behind utilizing LAIs as the first-line treatment option in PWIDs is that it has the potential to increase treatment adherence in a population that often faces numerous barriers to care and treatment, including a potential lack of stable housing, a lack of safe places to store daily HIV regimens, a potential inability to remain consistent with treatment regimens.

Prior Authorization requirements for drugs that treat infectious diseases already create arguably unnecessary barriers to treatment for patients. West Virginia’s blanket refusal to cover an FDA-approved and highly effective HIV treatment regimen for patients who are already adherent and virally suppressed serves as an unacceptable and unconscionable barrier to care in a state that is in desperate need of more convenient treatment options.

While Cabenuva, Sunlenca, and Trogarzo are still relatively new drugs, state Medicaid programs should be jumping at the opportunity to decrease treatment abandonment rates and increase easy treatment options for qualifying patients. We hope that more programs will abandon unnecessary restrictions upon this vital tool in the HIV treatment toolkit.

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.  

Thursday, July 13, 2023

Modern Antiretroviral Therapy is Less Toxic, but Not Free from Side Effects

By: Ranier Simons, ADAP Blog Guest Contributor

Antiretroviral therapy (ART) has indisputably improved the medical outcomes of people living with HIV/AIDS (PLWHA). ART increases life expectancy, prevents people with an HIV-positive diagnosis from reaching an AIDS diagnosis, brings many patients back from AIDS into healthier CD4 counts, and even renders many undetectable. Today’s current lines of defense are also increasingly less toxic than earlier drugs. 

Medication Side Effects
Photo Source: 4Life4Me+

AZT, the first antiretroviral (ARV) used alone against HIV, was so toxic that it caused a faster health decline than HIV would have in people left untreated. The side effects, including damage to bone marrow, made people feel worse than they did without it. Although ART has evolved significantly, it is not perfect. Current ARVs have fewer serious or unbearable adverse issues; however, many PLWHA still deal with side effects.

Some side effects are short term lasting only a few days or weeks. Conversely, some can be much more long-term. It is important to remember that the side effects of one medication can vary from person to person in type, severity, and number. Additionally, some drugs take months to years to develop side effects. PLWHA are living longer and thus are on ART for more extended periods. Researchers are concerned about the potential cumulative toxicity that can develop from long-term use.[1] 

Diarrhea, depression, other mood changes, and hypertension are three common side effects of ART.[2] Diarrhea is one of the most prevailing side effects and causes some people to stop taking their medications. Commonly, it is a side effect of protease inhibitors like ritonavir which may damage the intestinal lining.[3] Immodium (loperamide) is a common over-the-counter remedy used to help PLWHA deal with diarrhea. There are frequently prescribed solutions such as Mytesi (Crofelemer) as well. Derived from the red sap of the Croton lechleri plant, it is just the second botanical prescription drug approved by the U.S. Food & Drug Administration (FDA).[2] Unfortunately, while effective, some State AIDS Drug Assistance Program (ADAP) drug formularies do not offer it.

Depression in PLWHA can have many causes. For some, it can be the psychological result of dealing with having the disease. It can also be caused by the penetration of HIV across the blood-brain barrier and infection of the central nervous system.[4] However, it can also be a side effect of some ARVs. In fact, many list depression or strange dreams as a side effect.[4] Efavirenz, which is in drugs like Atripla, is known for causing nightmares, vivid dreams, or depression.[5] While being a comorbidity among PLWH, hypertension is also shown to be a side effect of some ARVs. Studies show that the chronic inflammation associated with HIV and ART is a significant factor in the high prevalence of PLWHA with high blood pressure.[2]

Man holding his head, appearing in despair
Photo Source: Ivan Toms Centre

A side effect of ART not well-known by many is Diabetes. Some older nucleoside reverse transcriptase inhibitors and older protease inhibitors that are no longer used as much, such as zidovudine and lopinavir, respectively, cause pancreatic damage.[2,6] Newer treatments, such as integrase inhibitors like dolutegravir and bictegravir, have been correlated with weight gain.[6] Unhealthy weight gain increases the risk of developing Diabetes as well. Integrase inhibitors have been shown to lead to faster viral suppression than some other ARVs.[6] Thus, eating well and exercising when using them is essential to mitigate any possible weight gain.

Fortunately, with the breadth of current options available, PLWHA are not stuck dealing with lifestyle challenges or unpleasant and possibly severe side effects to maintain viral suppression. Suffering from adverse effects results in poor medication adherence or complete abandonment. PLWHA are encouraged to communicate with their care team when a medication switch may be necessary. Sometimes PLWHA feel as if too many medications are becoming toxic in their body. In this case, their physician may be able to switch them from a three-drug regimen to a one or two-drug regimen.[7] 

Some ARVs have to be taken with food or even specific types of food. When that becomes a problem, there are options for those who have specific dietary restrictions by choice or necessity. HIV-positive pregnant women must beware of birth defects some ARVs can cause. For them, dolutegravir-based regimens are recommended.[7] PLWHA at risk of kidney problems are directed not to use regimens like Stribild and Truvada, which contain tenofovir disopoxil fumarate (TDF), which can cause them harm.[7] Regimens containing tenofovir alafenamide (TAF), such as Biktarvy or Descovy, better serve that population.[7] Even novel options exist for those who do not wish to take pills. The FDA approved Cabenuva, a two-shot injectable regimen containing rilpivirine and cabotegravir, in 2021. The two injections are administered in a doctor’s office every two months.[7]

All drugs cause side effects, even essential established medications like aspirin. Although newer ARVs don’t have the number or severity of side effects as ones from the past, it is misleading to describe newer regimens as “free from side effects.” Knowledge of possible side effects of regimens enables PLWHA and their doctors to make informed decisions about their care. Moreover, awareness empowers patients to distinguish between side effects and adverse outcomes caused by other issues. Being educated is empowering as well as informs realistic expectations.

[1] Chawla, A., Wang, C., Patton, C., Murray, M., Punekar, Y., de Ruiter, A., & Steinhart, C. (2018). A Review of Long-Term Toxicity of Antiretroviral Treatment Regimens and Implications for an Aging Population. Infectious diseases and therapy, 7(2), 183–195. https://doi.org/10.1007/s40121-018-0201-6

[2] Yahoo News. (2023, July 3). 2023 Treatment Guide: Dealing With HIV Med Side Effects? Retrieved from https://news.yahoo.com/2023-treatment-guide-dealing-hiv-134944629.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

[3] MacArthur, R. D., & DuPont, H. L. (2012). Etiology and pharmacologic management of noninfectious diarrhea in HIV-infected individuals in the highly active antiretroviral therapy era. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 55(6), 860–867. https://doi.org/10.1093/cid/cis544

[4] Rapid Response Service. (2009, March). HIV medication and depression. Retrieved from https://www.ohtn.on.ca/rapid-response-hiv-medication-and-depression/

[5] Cairns, G.(2012, October). Efavirenz and the brain: are we nearer to solving a mysterious side-effect?.Retrieved from https://www.aidsmap.com/news/oct-2012/efavirenz-and-brain-are-we-nearer-solving-mysterious-side-effect

[6] Haynes, R. (2021, January).Type 2 diabetes and HIV. Retrieved from https://www.aidsmap.com/about-hiv/type-2-diabetes-and-hiv#:~:text=Some%20anti%2DHIV%20medications%20may,taken%20them%20in%20the%20past

[7] Yahoo News. (2023, June 29). 2023 Treatment Guide: Is it Time to Change Your HIV Regimen? Retrieved from https://www.yahoo.com/entertainment/2023-treatment-guide-time-change-203031820.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

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.  

Thursday, July 6, 2023

Viral Suppression Linked to Access to Timely, Appropriate Care and Treatment

By: Ranier Simons, ADAP Blog Guest Contributor

One of the most critical factors influencing positive health outcomes of people living with HIV/AIDS (PLWHA) is viral suppression. Viral suppression means that the HIV viral load in the blood is so low that it cannot be detected or measured by laboratory tests. Viral suppression is officially defined as having less than 200 copies of HIV per milliliter of blood.[1] Antiretroviral drug therapy (ART) is the current scientifically established most effective way to achieve undetectable viral load status. Studies have routinely shown that viral suppression is a directly associated with PLWHA having access to timely, appropriate care and treatment.

Stethoscope with a timer
Photo Source: Ideal Healthcare

ART is as vital for prevention as it is for treatment. Maintaining an undetectable viral load means the virus cannot be transmitted to an HIV-negative person through sexual contact.[2] Maintaining undetectable status requires consistent adherence to ART regimens. Unfortunately, many PLWHA face barriers which make medication adherence a challenge. Two significant barriers are affordability and access to ART regimens. 

AIDS Drug Assistance Programs (ADAPs) were created in 1987, and then incorporated under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act in 1990 to provide HIV-related prescription drugs to low-income PLWHA who have limited or no prescription drug coverage.[3] The state-administered programs pay for insurance and medical care for 20% of PLWHA in the United States.[4] The Ryan White law states that the purpose of ADAPs is to "provide therapeutics to treat HIV disease or prevent the serious deterioration of health arising from HIV disease in eligible individuals, including measures for the prevention and treatment of opportunistic infections."[5] ADAPs achieve this goal for low-income PLWHA by providing antiretroviral medications and paying for health insurance that covers HIV-related treatments.

To participate in ADAPs, recipients are required to regularly recertify their eligibility for the programs. People are eligible when they meet the criteria of having a documented diagnosis of HIV, fall within the program parameters that define low-income, and meet a particular ADAP’s residency criteria within its service area.[6] Data has shown that many PLWHA struggle to complete the recertification requirements and thus become dis-enrolled. For an in-depth description of the burdensome recertification process, please see a previous ADAP Advocacy blog discussion on the topic here. In an effort to examine the effects of dis-enrollment on viral suppression, a group of researchers performed a study of ADAP clients in Washington state who failed to re-certify and were dis-enrolled.

Washington State Department of Health
Photo Source: Washington State

A retrospective cohort study published in May 2023 was performed on 5238 clients in Washington State's ADAP from 2017 to 2019.[4] The researchers used various quantitative and statistical analyses to determine the risk difference of viral suppression before and after dis-enrollment. Several factors, or what are statistically known as unmeasured confounders, overlap in regard to causing dis-enrollment and medication discontinuation. Those confounders include housing instability, poor mental health, binge drinking, and illicit drug use.[4] Stringent statistical efforts were used to isolate the influence of dis-enrollment from those confounders.

A total of 1336 study subjects were dis-enrolled at least once or more than once within the time parameters examined. Results showed that overall, 12 out of every 100 PLWHA lost viral suppression due to dis-enrollment. Disenrollment had an exceedingly harmful effect on those with dual Medicaid/Medicare insurance (22/100) compared to those with private insurance (8/100).[4] Having dual Medicaid/Medicare coverage means that a person has a disability.

During the 2017-2019 window of the cohort study, ADAP clients were required to recertify every six months. Researchers found that those who failed to recertify lost viral suppression almost immediately afterward.[4] Around 83% were virally suppressed before dis-enrollment versus 69% after. This indicates that changes need to be made in the re-certification process to make it less complicated for enrollees to complete and reduce the administrative burden on providers.

In October 2021, Health Resources & Services Administration (HRSA) removed the six-month re-certification requirement. Given that the six-month requirement has deleterious effects on enrollment, it is recommended that ADAPs end the practice of using the six-month default and adopt the newer flexibility in the re-certification policy. The study also noted that Washington state ADAP offers a more extensive breadth of services than most other states. Thus, some Washington state clients who are ADAP enrollees use it for other services and obtain their medications by other means. Therefore, dis-enrollment could have a much more significant impact on viral suppression in other states where every person enrolled in ADAP is dependent on it for their ART.

[1] Centers for Disease Control. (2022, July 21). HIV Treatment as Prevention. Retrieved from https://www.cdc.gov/hiv/risk/art/index.html

[2] World Health Organization. (2018, July 20).Viral suppression for HIV treatment success and prevention of sexual transmission of HIV. Retrieved from  https://www.who.int/news/item/20-07-2018-viral-suppression-for-hiv-treatment-success-and-prevention-of-sexual-transmission-of-hiv

[3] Kaiser Family Foundation. (2017, August 16). AIDS Drug Assistance Programs (ADAPs). Retrieved from https://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.

[4] Erly SJ, Khosropour CM, Hajat A, Sharma M, Reuer JR, Dombrowski JC (2023) AIDS Drug Assistance Program disenrollment is associated with loss of viral suppression beyond differences in homelessness, mental health, and substance use disorders: An evaluation in Washington state 2017–2019. PLoS ONE 18(5): e0285326. https://doi.org/10.1371/journal.pone.0285326

[5] Penner, M. (2008, October 1). AIDS Drug Assistance Programs: A Lifeline for People With HIV. Retrieved fromhttps://www.thebodypro.com/article/aids-drug-assistance-programs-lifeline-people-hiv#1

[5] Resources Health and Administration Service. (2021, August). Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program. Report No.: PCN 21–02. Retrieved from https://hab.hrsa.gov/sites

[6] Feller, S. (2023, May 13). Monoclonal antibody speeds time to HIV viral suppression, study finds. Retrieved from https://www.healio.com/news/infectious-disease/20230512/monoclonal-antibody-speeds-time-to-hiv-viral-suppression-study-finds?utm_medium=social&utm_source=twitter&utm_campaign=sociallinks

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.