Increased HIV Infection Numbers Spark Concern

By: Ranier Simons, ADAP Blog Guest Contributor

One of the most influential and basic tenets in the fight against HIV/AIDS is prevention. Testing is an integral tool for prevention. It is imperative to identify people living with HIV who are unaware of their status, which is globally estimated to be around six million people.[1] Testing stops individual disease progression by getting people into treatment and curbs the spread of HIV by informing individuals of their status in hopes of influencing behavior modification regardless of status. With the exception of the Washington, D.C. area, whereby decreased testing was actually associated with increased HIV diagnoses,[2] testing was adversely affected by the COVID-19 pandemic. National data shows that in healthcare and non-healthcare settings, there was a 43% and 50% drop in the number of the Centers for Disease Control & Prevention (CDC)-funded HIV tests administered.[3] 

Photo Source: aidsmap

According to the city’s Annual HIV, Hepatitis, Sexually Transmitted Infections (STIs), and Tuberculosis (T.B.) Surveillance Report released on February 7, 2023, there were 230 new HIV diagnoses in 2021, up from 219 in 2019.[2] About 1.8 percent of D.C. residents, 11,904, are living with HIV. The current new diagnosis numbers are much lower than the peak of 1,374 new cases in 2007, yet the upward trend is concerning.[2] The COVID-19 pandemic resulted in the closing of many healthcare facilities and changes in the capacity of remaining centers to deliver care. As a result, people did not seek out their regular preventive health visits and lost access to places that previously provided convenient testing. Kaiser Family Foundation reports that D.C. has the most HIV cases per capita and nearly three times the national rate compared to U.S. states.[2] This historical trend marks D.C. as one of the places the CDC watches closely. Thus, observing the increasing trend could shed light on trends that may be reported nationally as time goes on.

Washington, D.C. officials aim to reduce new infections to 130 per year by 2030, with a plan to have 95% of all people aware of their status, with 95% of diagnosed people on treatment, with 95% of those reaching undetectable viral suppression status.[2] HIV disproportionately affects Black residents, who comprise about 44 percent of the population of D.C. but almost 75 percent of HIV cases.[2] In response to this data, public health officials are looking into ways to reduce the stigma associated with prevention, testing, and treatment. Additionally, efforts to reduce socioeconomic barriers to HIV prevention are being explored.

Having stable housing is one crucial factor that contributes to improved health prevention. Stable housing enables people to have a home base to maintain their lives. Having a consistent place to stay makes it easier to maintain regular habits of antiretroviral treatment or PrEP. Stable housing also increases a sense of safety and community, giving people a support network. To examine the result of stable housing on the unhoused, in 2022, D.C. started a pilot program. The federally funded program paid for housing for one year for seven at-risk residents requiring them to set aside 30 percent of their income, undergo employment training, stay on PrEP, and participate in intensive case management.[2] The goal is to have all seven at a point where they can live independently. All seven have stayed in the apartment building and have maintained their PreP treatment.

Photo Source: aidsmap

To further reduce barriers to testing caused by the pandemic, D.C. started a free at-home HIV and STD testing program in June 2020. D.C. residents can request an at-home testing kit, mail it in and see their results on a secure online portal. This is in addition to free walk-in testing available at any Labcorp patient service center, even if someone does not have insurance or their insurance does not cover lab testing.[4]

As people slowly begin to resume pre-pandemic levels of preventative care behaviors, medical professionals are predicting continued increases in HIV infection numbers. It is imperative that all jurisdictions nationally examine their populations with the same rigor as D.C. has done to curb increasing rates of HIV infection. D.C. is just a microcosm of the nation at large.

[1] Ong, J. J., Coulthard, K., Quinn, C., Tang, M. J., Huynh, T., Jamil, M. S., Baggaley, R., & Johnson, C. (2021). Risk-Based Screening Tools to Optimise HIV Testing Services: A Systematic Review. Current HIV/AIDS Reports, 19(2), 154-165. https://doi.org/10.1007/s11904-022-00601-5

[2] Portnoy, J. (2023, February 7). HIV diagnoses up slightly in D.C. after testing dipped during pandemic. Retrieved from https://www.washingtonpost.com/dc-md-va/2023/02/07/hiv-dc-pandemic-testing-disparities/

[3] CDC. (2022) HIV Testing Dropped Sharply Among Key Groups During First Year of COVID-19 Pandemic. Retrieved from https://www.cdc.gov/media/releases/2022/p0623-HIV-testing.html

[4] D.C. Health. (2022). Get Checked DC. Retrieved from https://www.getcheckeddc.org/

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.  

FDA to Ease Restrictions on Blood Donations From Gay Men

By: Ranier Simons, ADAP Blog Guest Contributor

About 6.8 million people in the United States donate blood annually, and about 13.6 million units of whole blood and red blood cells are collected.[1] Not only are whole blood and red blood cells used to treat people, but blood components such as plasma and platelets are also used for treatment. Because blood and platelets cannot be manufactured, ensuring the safety and efficacy of the blood supply is paramount. Security includes protocols to keep the blood supply free from disease, primarily focusing on reducing the risk of HIV transmission through blood and blood products. Historically, these protocols included permanently barring or discouraging men who have sex with men (MSM) from donating blood. As a result of scientific data domestically and globally, in January, the U.S. Food & Drug Administration (FDA) released guidance planning to ease those previous rules that had been in place for decades.[2] 

Photo Source: The Boston Globe

The emergence of HIV/AIDS in the early 1980s irrefutably changed the blood system landscape. Initially, the disease was identified in MSM, associated with people who used intravenous drugs and people who exchanged sex for money. Before screening tests were created to test donor blood, the FDA was tasked with figuring out how to reduce the risk of HIV transmission through blood and blood products. In 1983, the FDA created official guidance and recommendations for educating donors about risk factors for AIDS. Blood collection agencies started using risk questions and rejecting blood from specific donors based on those factors. These measures helped reduce disease transmission, yet thousands of people still contracted HIV from blood transfusions before testing was available.[3]

HIV was identified as the cause of AIDS in 1984, which spurred research into the creation of donor blood screening tests. The first FDA-approved screening tests for antibodies against HIV occurred in 1985.[3] In September 1985, it was first recommended by the FDA that no male donors who had ever had sex with another man from 1977 onward would be allowed to donate blood.[3] In 2010, an Interagency Blood, Organ & Tissue Safety Working Group (BOTS Working Group) consisting of representatives from the Center for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), National Institutes of Health (NIH), HHS Office for Civil Rights (OCR), Office of the Assistant Secretary for Health (OASH), and FDA, was put together to investigate scientific evidence-based ways to change the policy.[3] Many different studies were conducted. The results from those studies, in combination with data from countries that had already shortened the indefinite deferral period for blood donation by MSM, resulted in the FDA recommending a 12-month deferral instead of a permanent ban in December 2015.[3]

The evolution continued. In 2014, FDA launched the Transfusion Transmissible Infections Monitoring System (TTIMS). It was to monitor the rates of relevant transfusion-transmitted infections (RTTIs) detected among blood donors before and after policy changes.[3] Two years after the 12-month referral was initiated, data showed there was no increased risk to the U.S. blood supply for HIV. Over time, other countries, including the United Kingdom and Canada, moved to a 3-month deferral recommendation with no reports of adverse outcomes from the change. Using the results from continued surveillance, the evidence from other countries, and the ongoing usage of testing that can detect HIV, HBV, and HCV within three months of initial infection, the FDA updated the recommendation to a 3-month deferral period for MSM in April 2020.[3] In addition to MSM, the proposal to move the indefinite ban to 3-month referral for people who exchanged sex for money and those who used non-prescription intravenous drugs was also instituted.[3]

Photo Source: Medical Express / Health Day

January 2023 has brought a new proposed policy change that is not wholly focused on MSM. As a result of ongoing U.S. research, in addition to epidemiological data from other countries that have already changed, the FDA is proposing to move to a gender-inclusive risk-based, individual behavioral assessment for blood donor referral. The new guidance suggests asking all donors the same questions regardless of gender. 

Donors, regardless of gender, would be asked if they have had a new partner or multiple partners in the past three months. If yes, they will be asked if any sex was anal. If the answer is yes, that person would be deferred from donation for three months. If the sex were vaginal only, they would be allowed. Donors are also to be asked about PrEP usage. If donors use oral PrEP, they will be deferred from donation for three months from their last dose. If they use a long-acting injectable form of PrEP, they will be postponed for two years following the most recent injection. Data shows that the usage of PrEP may delay the detection of HIV by currently licensed screening tests for blood donations, potentially resulting in false negative results in infected individuals.[3] Individuals living with HIV who have reached undetectable status with antiretroviral treatment are permanently denied blood donation. While undetectable status means untransmissible through sexual contact, antiretroviral drugs do not entirely eliminate HIV from the body; thus, transfused blood could still potentially transmit HIV infection.[3] The above questions highlight the newly proposed questions and deferral recommendations. To view a more exhaustive explanatory list, please view the FDA guidance document here.

Changing the guidance to ease restrictions on MSM and other risk-identified groups will potentially help with the nation's blood supply shortage. Most importantly, the move to gender-inclusive individual risk assessment will change the future research paradigm to be scientific and evidence-based to consider the fluidity and intersections of all genders and sexual preferences.

[1] American Red Cross. 2023. U.S. Blood Supply Facts. Retrieved from https://www.redcrossblood.org/donate-blood/how-to-donate/how-blood-donations-help/blood-needs-blood-supply.html

[2] Firth, S. (2023, January 27). FDA to ease restrictions on blood donations from gay men. Retrieved from https://www.medpagetoday.com/washington-watch/fdageneral/102863

[3] FDA. (2023, January). Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human

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.  

Colorado's Negligence: Drug Importation Continues to Miss the Mark

By: Jen Laws, President & CEO, Community Access National Network (CANN) & Board Co-Chair, ADAP Advocacy Association

Since 2019, Colorado has been trying desperately to put together a plan to import medications from Canada, known as a Section 804 Importation Plan (SIP) when applying for approval from the U.S. Food and Drug Administration (FDA). In December 2022, Colorado submitted its plan to the FDA (Colorado, 2022), thus joining Florida in a misguided state importation effort. Right now for patients living in both states, only the FDA is positioned to protect them from an ill-advised public policy.

Photo Source: Yahoo! News Canada

For what it’s worth, Florida’s plan has not yet been approved as that state continues to go back and forth with the FDA over clarifying language. The process has dragged on so long that Florida sued the FDA to speed things up (Kansteiner, 2022). Regardless of anything else that may or may not happen in either Florida or Colorado (protip: lots of things are not going to happen), Governor Polis’ promise that Coloradans are going to begin enjoying the fruits of this labor “soon” is just not going to be a thing. But beyond process, there’s some serious problems with this idea of importing medications from Canada and the idea that it will save Americans any dollars at the pharmacy counter. Those problems have been around since the idea of importation was introduced a government “solution” nearly 20 years ago and the answers to these problems has not changed or improved.

Back when the United States started toying with importation as an idea, the Canadian government balked and even introduced legislation to block the possibility. While that legislative effort failed, it’s being revived now as Colorado and Florida push to have access to the drug supply of a country with one tenth the size of the population of the United States. Outside of Canadian legislation, distribution agreements in Canada generally curtail what can and cannot be exported to other countries, a regulatory and enforcement move that neither the United States nor Colorado can do anything about. Canada’s biggest concern remains rooted in the potential for medication shortages to meet the needs of their own population, especially given the global issue of supply shortages on critically necessary medications.

It's not just the government of Canada or even manufacturers that remain concerned about the whole host of issues importation brings. Both the Canadian Pharmacists Association and the American Pharmacists Association have repeatedly cautioned against these proposals (CPhA, APhA, 2022). Despite what Colorado says these efforts will do, helping pharmacies isn’t in the reality of this effort. Targeting contracting tricks pharmacy benefit managers use to push out competition, particularly ridiculously low reimbursement rates and narrowing of network pharmacies, would go much further toward protecting independent pharmacies and ensuring patient access to them.

Photo Source: CPhA, APhA

Moving to another issue, the idea of “savings” offered under Colorado’s SIP are not rooted in reality. The first and foremost issue with any politician pitching “savings” on medication costs comes down to exactly “who” is going to enjoy these savings. Proposals to date do not establish “loss ratio” parity in medical and prescription insurance benefits – the Affordable Care Act (ACA) capped profits for medical coverage at fifteen or twenty percent but no such similar rule applies to pharmacy benefits or more commonly known as prescription drug coverage. These plans for “savings” do not necessarily translate to lower cost medications at the pharmacy counter for patients but for lower costs for governments and government programs – which should already be enjoying if those pharmacy benefit managers (PBMs) were actually fulfilling their promise of extending cost savings to their clients. They’re not and, respectfully, that’s precisely the issue most Americans care about – “What am I going to pay?” And it’s the answer politicians very carefully avoid giving.

An additional problem with Colorado’s assessment of savings is the SIP explicitly cites retail medication costs, not the costs the state government actually pays (which is often steeply discounted or enjoys rebates that bring those list prices down considerably). The calculation Colorado cites, very blatantly, is a lie.

Next, of the one hundred twelve medications Colorado specifies as targets for importation, HIV treatments are one of the highest cost medications on the list. We’ll get to why that’s particularly problematic for people living with HIV…now.

Safety security in the supply chain from importation does not align with the United States’ effort to ensure quality medications are getting to patients. The United States employs something called “track and trace” which requires electronic monitoring and labeling specific to the United States from the manufacturer throughout the entire chain of handling medications until they land in a patient’s hands. Importation from Canada (or anywhere else for that matter) would necessarily disrupt this system of tracking by requiring relabeling and Colorado, in its SIP, is challenging the FDA’s requirement to disclose when a medication is imported and from where (pg. 44-45 of the SIP). Colorado notes that while it disagrees with the relabeling requirements (which include notation when a medication is being imported without a manufacturer’s agreement), the state says it will not import medication without those same manufacturers agreeing. Generally speaking, manufacturers aren’t going to agree to participate in this program. They’ve already said so.

Photo Source: PhRMA

Safety and fear of counterfeit is such a significant concern that Colorado has promised to have a third party periodically sample medications to ensure they’re authentic. And fake HIV medications have already been an issue in the United States. Part of that comes down to this exclusive reliance on private entities (namely manufacturer) to identify counterfeit medications. ADAP Advocacy Association’s CEO, Brandon Macsata, has already detailed his own, personal, potentially life-threatening experience with counterfeit antiretrovirals. And loose guardrails which muddy up securing medication safety aren’t going to make these issues any better – indeed, they’ll expose more People living with HIV to this risk.

Florida, as the other state pushing hard for importation, already knows this is a bad idea. It’s why their SIP explicitly makes the importation program medications an experiment – to be tested on the poor and imprisoned, touting to effort at addressing the state’s medications needs for Medicaid and prisons. Florida’s plan is, quite frankly, a moral and ethical disgrace. Colorado’s is rife with gimmicks.

It's high time states and the federal government appreciate that the United States, despite our issues, enjoys one of the safest medication supply chains in the world. Few if any of us stop to consider if the medications we pick up from our pharmacy are legitimate. Let’s stop with importation proposals that, in reality, won’t help patients afford medications and only threaten our supply safety, our diplomatic relationships, and patients lives. Bringing down end-user costs of medications absolutely requires government action, but that action isn’t going to be importation.

[1] Colorado (2022, December 5). Section 804 Importation Program - Colorado's Drug Importation Program. Retrieved from https://hcpf.colorado.gov/sites/hcpf/files/Colorado%27s%20Drug%20Importation%20Program%202022%20Formal%20SIP.pdf

[2] Kansteiner, Fraiser (2022, August 31). In new lawsuit, Florida says FDA stalling on drug importation program. Fierce Pharma. Retrieved from https://www.fiercepharma.com/pharma/florida-tees-legal-showdown-fda-over-stalled-information-act-request-canada-drug-import-plan

[3] Panetta, Alexander (2022, December 8). Heads up, Canada: Colorado wants your drugs. CBC. Retrieved from https://www.cbc.ca/news/world/colorado-drug-imports-canada-1.6679290

[4] CPhA & APha(2022). American and Canadian pharmacist associations warn that drug importation policies could put patients at risk. Retrieved from https://aphanet.pharmacist.com/sites/default/files/audience/Joint%20Statement%20APhA%20and%20CPhA%20Importation%20.pdf

[5] Fein, Adam (2022, December 7). Drug Channels. Retrieved from https://twitter.com/DrugChannels/status/1600660225786318848?t=y1oWO_tiLVIuQIHrkOQmmw&s=19

[6] PhRMA (2023). Drug Importation. Retrieved from https://phrma.org/policy-issues/drug-importation 

[7] Partnership for Safe Medicines. (2022, September). Fake HIV Medication Reached U.S. Pharmacies—And Patients. Retrieved from https://www.safemedicines.org/2022/01/counterfeit-hiv-medications-in-the-u-s.html

[8] ADAP Blog (2020, November 19). How Drug Imports Can Endanger Patients. Retrieved from https://adapadvocacyassociation.blogspot.com/2020/11/how-drug-imports-can-endanger-patients.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.  

Intersection between Substance Use Disorder & HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Drug use and drug abuse intersect many aspects of the health journey of substance users and those with substance use disorders. This includes HIV. The complex intersection of HIV and drug use affects HIV acquisition, treatment, and spread. To create solutions with the goal of better health outcomes for those dealing with HIV and substance abuse issues, it is necessary to research and understand how drug use affects the HIV trajectory. It is equally important to understand the barriers in place that hinder effective outreach and care.

Photo Source: Recovery Research Institute

Past and present research indicates a higher level of drug use and drug abuse in the population of those living with HIV than to those who are not infected.[1] The drugs include alcohol, crack cocaine, methamphetamines, prescription opioids, and heroin.[2] There is a distinction between drug use and drug abuse. Drug use is more episodic, whereas drug abuse or substance use disorder is consistent and chronic. Regardless of the level of use or addiction, drug use results in suboptimal HIV outcomes.

Substance abuse affects the entire continuum of the HIV care cycle, starting with acquiring infection. Drug use and abuse have been shown to increase the odds of engaging in risky behaviors that lead to infection.[2,3,4] Research shows that being under the influence lowers inhibitions, can result in a higher prevalence of multiple sex partners, and poor judgment resulting in unprotected sex.[2,4] Moreover, injectable drug usage can be a direct path to infection when needle sharing is involved.

A good deal of research has been focused on HIV in MSM (men who have sex with men), given that the rate of HIV infection is higher in this group than in the general population. It is observed that the usage of amyl nitrites, methamphetamine, and club drugs is higher in this group as well.[4] Thus, it is imperative to target this group to curb the transmission of HIV within. Intervention would also benefit the general population since there are MSM who have sex with women. 

Recreational or episodic drug use can lead to substance disorders or drug abuse. HIV-positive people dealing with substance disorders have additional challenges. One substance abuse group research has focused on is injection drug abusers. Injectable drug users tend to inject opiates, like heroin, alone or in combination with other drugs, even stimulants such as cocaine.[4] Not only are injectable drug users at a higher risk of contracting and spreading HIV, but they are also more likely to contract other infections.

Photo Source: CDC

Regardless of the drug, drug use and abuse exacerbate poor HIV outcomes because it causes additional damage to the body. The drugs are taxing on organs such as the liver, heart, and kidneys. Illicit drug use has also been shown to suppress the immune system.[6] Having a decreased immune response is detrimental to drug users living with HIV. This can lead to a faster progression to adverse HIV outcomes, especially for HIV-positive addicts not on antiretroviral therapy.

Treatment adherence is another intersection of HIV and drug abuse. Research shows that substance abusers on ART have lower treatment adherence. A study from 2007 showed that drug use resulted in a fourfold greater risk of medication adherence failure.[5] Drug use affects cognitive functioning and psychosocial conditioning. Drug addiction makes it difficult to focus on the importance of consistent and timely taking of medication, especially when multiple pills and times are involved. Poor medication adherence can result in subpar treatment response or complete drug resistance.

To improve the outcomes of HIV-positive people with substance abuse issues, it is paramount to remove the stigma of drug use. It should be treated just as any other chronic medical condition. Encouraging a cultural change to remove stigma would result in treating substance abusers with dignity, which could result in self-motivated behavior modification. Stigma against drug abusers sometimes results in medical professionals not dealing with the addiction with compassion and prohibiting infected individuals from seeking consistent care. Stigma also creates policy that hinders people from getting the help they need.

Photo Source: Wellthy

Anecdotal and evidence-based research shows that it is best to reach drug-addicted HIV-positive individuals where they are in their journey. They should be treated without the expectation of stopping drug use. Ongoing drug use is not a contraindication for antiretroviral therapy.[3] Educating drug users to understand they can still be on ART while still being on drugs could increase adherence. Reducing stigma could also affect policy change. For example, many politicians are against needle exchange programs. However, needle exchange programs are places that drug-addicted people living with HIV are more likely to visit regularly. They are places where additional services can be provided, including treatment. Handing out clean needles, cookers, and pipes would lower the risk of transmission while also creating a space to meet other needs.

Navigating the intersection of HIV and drug use starts by acknowledging they do not exist in separate vacuums. Drug treatment programs should include HIV testing, and HIV treatment should involve screening for substance abuse.

[1] Shiau, S., Arpadi, S. M., Yin, M. T., & Martins, S. S. (2017). Patterns of drug use and HIV infection among adults in a nationally representative sample. Addictive behaviors, 68, 39–44. https://doi.org/10.1016/j.addbeh.2017.01.015

[2] CDC. (2021, April). HIV and substance abuse. Retrieved from https://www.cdc.gov/hiv/basics/hiv-transmission/substance-use.html

[3] HIV.GOV. (2021, June 3) Considerations for antiretroviral use in special patient populations. Retrieved from https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/substance-use-disorders-and-hiv

[4] Strathdee, S., Patterson, T. (2006) Behavioral interventions for HIV-Positive and HCV-Positive drug users. AIDS and Behavior, 10(2), 115-130

[5] Hinkin, C. et al. (2007) Drug use and medication adherence among HIV-1 infected individuals. AIDS and Behavior, 11(2), 185-194

[6] Nnorom-Dike, O., Ekwebelem, O., Ofielu, E., Attah, M., Ekwe, D. (2020, December 9). Long term immunologic consequences of illicit drug abuse. Retrieved from https://www.heraldopenaccess.us/openaccess/long-term-immunologic-consequences-of-illicit-drug-abuse

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.  

Intersection between Intimate Partner Violence & HIV

By: Ranier Simons, ADAP Blog Guest Contributor

As with any chronic disease, quality of life and effective disease management requires consideration of the whole person, not just the disease. Regarding HIV, many different social determinants of health affect treatment, outcomes, and disease acquisition. The social, cultural, and physical environment of people living with HIV can be a crucial positive or negative factor. A recent study investigates the intersection of domestic violence and HIV. The Lancet published a retrospective study in December 2022 exploring the relationship between intimate partner violence (IPV) and women’s acquisition of HIV and experiences in the HIV treatment and care cascade (Stillman, 2023).

Photo Source: Fighter Law

Globally, more than one in four women experience IPV in their lifetime (McGill University, 2023). IPV is a subset of domestic violence and is not limited to physical abuse. Its forms include sexual, psychological, and even economic abuse. IPV is defined as violence that happens between people in an ongoing or former intimate or romantic relationship (Cerulli, 2022). Men experience it as well. Nearly one in ten men has experienced it in their lifetime. The Lancet study focuses on women in Sub-Saharan Africa, the regions of Africa south of the Sahara. This includes West Africa, East Africa, Central Africa, and Southern Africa (Wikipedia, 2022).

The study is a retrospective pooled analysis of cross-sectional surveys encompassing 280,259 women across 30 countries administered between January 1, 2000, and December 31, 2020. Ages ranged from 15-64 years old, and all the women were currently or formerly married or cohabitating. Sub-Saharan Africa was chosen because, in global comparison, the region has a very high prevalence of IPV and HIV (Cerulli, 2022). For the purposes of the study, IPV was limited to physical and sexual abuse. The study estimated the effects of past-year physical, sexual IPV, or a combination of both. Four outcomes were the focus of the study: recent HIV infection, HIV testing in the past year, antiretroviral regimen adherence, and viral load suppression (Kuchukhidze, 2022).

Photo Source: Loma Linda University 

Overall, 21.2% of the women self-reported having experienced physical or sexual IPV in the past year, and 29.1% had experienced it at some point in their lifetime. Self-reporting of HIV testing was very similar between the groups of women who did and did not experience past-year physical or sexual IPV, and more than a quarter of both groups had been tested in the past year. 

Regarding the women in the study who are living with HIV, there were differences in antiretroviral adherence. The ones who reported past-year physical or sexual IPV had lower uptake of ART (64.2%) than those who did not report any past-year IPV (71.3%) (Kuchukhidze, 2022).Those who had experienced physical or sexual IPV had missed 2-3 times as many pills in the past month as those who had not experienced past-year IPV. Additionally, women on antiretroviral therapy who had experienced past-year physical or sexual IPV were 5% less likely to be virally suppressed than those who had not. Regarding infection, women who had experienced physical or sexual IPV in the past year were 3.22 times as likely to acquire a recent HIV infection as those who had not experienced it in the past year (Kuchukhidze, 2022).

The mechanisms by which IPV can affect HIV acquisition are layered. One major pathway is infection through sexual violence, and another is the culture of the men who are abusers. Many may have multiple concurrent sexual partners coupled with a lack of condom use which would increase HIV transmission if they live with HIV. Knowledge of HIV status is an essential initial factor in reducing the adverse effects of IPV on HIV. Another barrier caused by IPV is antiretroviral adherence. Some women may fear being tested, dreading the possible reactions from their abusers if the test is positive. Treatment adherence is negatively impacted due to women not disclosing their status out of fear of abuse from their partners, making it hard to get them into consistent care.

Photo Source: Harvard Health Publishing

The study highlights the need for more research into the effects of IPV on HIV and systemic change to help the women involved. The researchers suggest that healthcare providers need to be trained on how to have patients safely disclose their instances of living with IPV. Additionally, there need to be innovative ways to safely deliver consistent antiretroviral and HIV care to those living with HIV in IPV situations. Creating patient-focused safe service delivery platforms, such as safe medication pick-up points, are policies to be considered (Kuchukhidze, 2022).

The Lancet study is further confirmation that there are many levels of barriers to overcome in the fight against HIV. Networks that span locally to globally are necessary to manipulate the mesh of life factors that complicate the transmission and treatment of HIV.

[1] Stillman, A. (2023, January 9). The link between HIV and domestic violence. Retrieved from https://news.yahoo.com/between-hiv-domestic-violence-213422389.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

[2] McGill University. (2023, January 6). Women experiencing intimate partner violence three times more likely to contract HIV

[3] University of Rochester, Cerulli, C. (2022, March 23). What is intimate partner violence? It’s not just physical abuse. Retrieved from https://www.rochester.edu/newscenter/what-is-intimate-partner-violence-domestic-violence-516342/

[4] Sub-Saharan Africa. (2023, January 9). In Wikipedia. https://en.wikipedia.org/wiki/Sub-Saharan_Africa

[5] Kuchukhidze, S. et al. (2022, December 01). The effects of intimate partner violence on women's risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa. Lancet.Retrieved from https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00305-8/fulltext DOI:https://doi.org/10.1016/S2352-3018(22)00305-8

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.  

FDA Approves Promising New Injectable

By: Ranier Simons, ADAP Blog Guest Contributor

A new year is upon us, full of potential for progress in the fight against HIV/AIDS. The battle includes creating policy, improving the social determinants of healthcare inequality, and advancing medical science. A recent announcement by the U.S. Food & Drug Administration (FDA) presents itself as promising medical science news. On December 22, 2022, a new injectable antiretroviral called Sunlenca (lenacapavir) was approved by the FDA (FDA, 2022). The drug's manufacturer, Gilead Sciences, states Sunlenca will help people living with HIV/AIDS (PLWHA) who have limited options for successful antiretroviral treatment due to drug resistance, intolerance, safety considerations, or other issues (FDA, 2022). 

Photo Source: The Associated Press

Sunlenca is not a stand-alone treatment option like some current one-pill drug cocktails or other recent combination injectables. It is meant to be used in combination with other drugs. Sunlenca is part of a new class of medicines called capsid inhibitors. The capsid is a protein shell that protects the virus’ genetic material and enzymes needed for replication (HIV.gov). For a virus to infect a cell, it has to pass its genetic information that codes its replication into another cell. The capsid protects that information from being destroyed by enzymes as it passes from the virus into the target cell, as well as helps it to attach and penetrate the target cell’s membrane (FSU, 2015). Capsid inhibitors block the capsid's creation, thus inhibiting the vehicle necessary for infection.

One novel aspect of Sunlenca is that the injection occurs every six months. There is a “loading phase” of the treatment, consisting of tablet regimen by mouth and injections (Hassanein, 2022). Afterward, its maintenance phase requires injections just every six months. According to the U.S Centers for Disease Control & Prevention (CDC), about 44% of those in HIV treatment have not achieved viral suppression (CDC, 2022). This treatment would be especially beneficial for older patients who are treatment resistant due to being diagnosed much earlier in the HIV/AIDS epidemic when treatment regimens were complicated and challenging to adhere to (Hassanein, 2022).

Photo Source: The Associated Press

Additionally, those with barriers to care such as transportation issues, homelessness, or home stigma, would greatly benefit from a twice-yearly injection option (Hassanein, 2022). Another critical aspect of the treatment is that it is a subcutaneous injection in contrast to other injectable therapies that are intramuscular. The difference in administration could mean a better quality of life for those using injectables and possibly make it available for home use instead of requiring a clinic visit.

The expense of Sunlenca is a potential treatment barrier for many who may need it. It costs $42,250 to start the therapy and $39,000 annually for the maintenance shots. As discussed in the December 1, 2022, ADAP Blog, injectable treatments such as Cabenuva have already highlighted the dire need for policy and insurance formulary change that needs to occur to make injectable therapies equally accessible to all (Simons, 2022). It is likely these costs will decline as additional injectables are introduced to the market, as was witnessed with therapies for Hepatitis C (HCV).  

The novelty of capsid inhibitors like Sunlenca, in addition to its cost, adds to the challenge of getting it to those that genuinely need it. Sunlenca being approved by the FDA represents an important step in the fight to end the HIV/AIDS epidemic in the United States. Patient advocates will likely contribute to the national dialogue on Sunlenca, in hopes of seeing its promise grow unencumbered.

[1] FDA Press Release (2022, December 22). FDA Approves New HIV Drug for Adults with Limited Treatment Options. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options

[2] HIV.Gov. HIV/AIDS Glossary: Capsid Inhibitors. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options

[3] Florida State University. (2015). Virus Structure. Retrieved from https://micro.magnet.fsu.edu/cells/virus.html

[4] Hassanein, N. (2022, December 30). A new HIV treatment shot is given only twice a year. It could be a 'game changer.' Retrieved from https://www.freep.com/story/news/health/2022/12/30/hiv-injection-treatment-lenacapavir-approved-fda/10959568002/

[5] CDC. (2022). HIV Prevention in the United States: Mobilizing to End the Epidemic. Retrieved from https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-prevention-bluebook.pdf

[6] Simons, R. (2022, December 1). Advocacy Needed to Reduce Barriers to Accessing Long-Acting Agent Therapies. Retrieved from https://adapadvocacyassociation.blogspot.com/2022/12/advocacy-needed-to-reduce-barriers-to.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.  

HIV/AIDS Patient Advocacy: 2023 Insights

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

The New Year is here! Our patient advocacy work is likely to be influenced by numerous mitigating factors that fall completely outside of our control, most of which will make meaningful public health policy changes unlikely. A narrowly divided, partisan federal government, an indictment of a former president (pick a crime), an increase in anti-science rhetoric fueled by right-wing media and Internet-fueled conspiracies, and the ongoing economic uncertainty will all muddy the legislative agenda. But that is no reason to remain idle.

Photo Source: FreePik.com

The Covid-19 pandemic isn't over, especially here in the United States. According to the Kaiser Family Foundation, as of December 22, 2022, over 400 people in this country are still perishing daily to this virus. Aside from the human toll of the cumulative effect of the infections, hospitalizations, and deaths, Covid-19 has upended public health in so many ways. Its impact on our own HIV community cannot be overstated, as we outlined last year. Covid-19 also further exposed the significant gaps that remain in our HIV care delivery system. It has also defined the shape of the broader public health advocacy over the last three years.

Lest we forget there are still nefarious forces at play trying to undermine our drug supply chain with counterfeit medicines, evidenced by numerous high-profile cases involving fake HIV medicines. With our partners, we will continue to advise patients on how to spot fake HIV medicines. It is imperative that patient advocates resist ongoing attempts to reshape the national dialogue on drug pricing with faux policies, such as drug importation. The reality is drug importation won't lower the cost of prescription drugs for patients, but it could very well weaken the world's safest drug supply system. Look no further than the drug importation plans in Florida and Colorado. 

Our focus will also remain on improving access to care and treatment, expanding it as much as possible while fending off threats to the Ryan White HIV/AIDS Program (RWHAP). We fully anticipate another attempt by mega service providers and special interests to push for raiding RWHAP funding for PrEP-related rebates under the 340B Drug Pricing Program. Robbing Peter to pay Paul is never the solution, because the result is restricting access. We stand firm with people living with HIV/AIDS.

Long-acting agents for HIV therapy (LAAs) represents probably the single greatest opportunity to expand access, reduce community viral load, and further the U=U Gospel ("undetectable equals untransmittable"). The recent news by the U.S. Food & Drug Administration (FDA) to approve a new HIV drug for adults with limited treatment options is big news! It builds on the momentum already established with new LAAs, such as Cabenuva and Trogarzo. 

As the chaos continues to unfold in our nation's capitol, it is imperative for patient advocates to be armed with the resources and tools to influence public policy on HIV/AIDS. Our organization is eager to engage our community to meet any challenge head-on.

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.