Congress’s PDUFA Delay Puts Patients at Risk

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

As Congress returned from their August recess, Americans could be forgiven for thinking that major healthcare legislation is off the table for the rest of the year following the passage of the Inflation Reduction Act – the budget reconciliation bill that included numerous healthcare-related provisions. However, Congress must pass legislation that has enormous ramifications for prescription drug availability and the development of new medications by September 30th: if lawmakers don’t act by this deadline, current and future patients dependent upon effective treatments could pay a very steep price. Despite a last-minute deal amongst squabbling lawmakers, it cannot be stressed enough how important is this legislation.

Photo Source: Physicians Committee for Responsible Medicine

Those of us who are alive today because of pharmaceutical innovation and a well-funded U.S. Food and Drug Administration (FDA) understand the stakes involved here. I’m a 20-year HIV long-term survivor, and I’m only alive today because of the safe, effective medications that were brought to market in a timely manner. Today, my HIV is undetectable. Recently, I also initiated long-acting agent therapy so that, instead of taking pills every single day, I receive two injections every other month. Other patients may not be so lucky if, this fall, the FDA must start laying off professionals and operating short-handed because of a lack of funds. 

Every five years, Congress reauthorizes the Prescription Drug User Fee Act (PDUFA), which provides critical financial resources to the FDA so it can hire the experts who review and approve new treatments and therapies. Each iteration of PDUFA also contains provisions to modernize the drug development and approval process, to keep the FDA on top of rapidly changing science and technologies. Congress has reauthorized PDUFA on a timely and strong bipartisan basis every five years since 1992. It is crucial that today’s Congress uphold this precedent and recognize the important role PDUFA plays in upholding the FDA’s drug review program as the worldwide. 

It is not enough for Congress to reauthorize PDUFA in a timely manner, though. It is also imperative that they pass a bill free of provisions that have nothing to do with supporting the FDA or the drug review and approval process. Some Members of Congress even want to go so far as attach proposals that would undermine drug safety, such as enabling the wholesale importation of prescription drugs from Canada.

Photo Source: NBC San Diego

This is a bad and unworkable idea on its own merits and certainly shouldn’t be included in a bill intended to properly fund the FDA and support the drug review process. We already know that the Canadian government has said it won’t participate in a drug importation plan, given that country’s ongoing trouble with drug shortages. And, at a time in which many of our communities and our law enforcement agencies are already overwhelmed with an influx of counterfeit medications containing deadly doses of fentanyl, it would seem particularly unwise to welcome medicines of unknown foreign origin that have not been part of our closely-protected prescription drug supply chain. 

We are quickly approaching the deadline to reauthorize PDUFA and any debates around including irrelevant or controversial policies like importation will only slow an already delayed process down further. We do not have time to waste. Missing the reauthorization deadline for legislation that has broad bipartisan support is egregiously irresponsible. We are nearing the point at which staffers at the FDA will begin receiving notices that they are going to be furloughed due to the expiration of the current user fee law. Some of these talented people may choose to pursue positions in the private sector rather than have their salaries put at risk by political gamesmanship. 

If we lose regulatory expertise at the FDA, this is not an easily replaceable commodity. Patients like me will lose access to new treatments as the FDA finds its ability to study and approve new drugs and assure the public of their safety and effectiveness severely undermined. This is unacceptable. 

The clock is ticking. With Congress back in Washington, it needs to pass PDUFA without extraneous and irrelevant attachments. It’s not hyperbole to say that lives depend on it. Stop playing politics and put patient care first!

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. 

Special Interests Favor S.4395, but Patients Oppose It...Here's Why

By: Brandon M. Macsata, CEO, ADAP Advocacy Association & Jen Laws, CEO, Community Access National Network

The very first words of the Ryan White HIV/AIDS Treatment Extension Act of 2009 read, “An Act to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS.” These words reflect the true legislative intent of the Act, which is to provide life-saving care and treatment for people with HIV/AIDS (PLWHA). For over thirty years, these words have represented a contract between our government and PLWHA, reflecting a commitment to patients. The Ryan White HIV/AIDS Program (RWHAP), as the payor of last resort, has literally served as the only lifeline for hundreds of thousands of patients in some of the most marginalized communities. That is why the ADAP Advocacy Association and the Community Access National Network (CANN) have led a national advocacy campaign to thwart any effort to undermine the legislative intent.

A proposed bill, S.4395 (otherwise known as the "Ryan White PrEP Availability Act"), would, for the first time in the 32-year history of this life-saving contract, open the Act to divert programmatic funding from PLWHA to people who are not living with HIV. The legislation is not only ill-conceived, it is potentially very dangerous. The special interests behind this legislation, as well as their inside-the-beltway lobbying tactics, do not reflect the general sense of the much broader HIV patient advocacy community. 

In fact, nearly 100 national, state, and local organizations joined the ADAP Advocacy Association and Community Access National Network in submitting a sign-on letter to Congress expressing the HIV patient advocacy community's collective concerns over the legislation. The sign-on letter was sent to Chair and Ranking Member of the Senate Committee on Health, Education, Labor & Pensions (HELP), Chair and Ranking Member of the House Committee on Energy & Commerce (E&C), and the Co-Chairs of the Congressional HIV/AIDS Caucus. Several of these offices applauded our efforts upon acknowledging receipt of the letter.

David Pable, who has been deeply embedded in South Carolina's patient advocacy community, expressed strong sentiments against the legislation. Pable said, "For almost 20 years, Ryan White has been a lifeline for me, and it was truly the safety net that saved my life. Ryan White-funded medical care, case management, and mental healthcare services have transform my life and the lives of countless others to survive and thrive." Pable's views are shared by nearly all PLWHA who learn about the potential danger lurking behind S.4395.

Over the years, Pable had the opportunity to be involved in many planning meetings for prevention services, including the need for an adequate PrEP program with dedicated funding. According to Pable, never in any of those meetings was it discussed as a good idea to funnel funding from the Ryan White Program to pay for PrEP. "Treatment, care and prevention make up three sides of the triangle," he said. "Together they each hold up the other, but take one piece away to support the other and eventually it will all fall apart." 

S.4395 would authorize the Health Resources & Services Administration (HRSA) to divert already limited resources away from providing care and treatment for PLWHA. The legislation reads, in part, "Any eligible area, State, or public or private nonprofit entity that receives a grant under part A, B, C, or D may use program income received from such a grant to provide to individuals who are at risk of acquiring HIV... drugs and biological products for pre-exposure prophylaxis (PrEP)... medical, laboratory, and counseling services related to such drugs and biological products...and referrals and linkages to appropriate services for the prevention of HIV."

The legislation is extremely ill-advised for numerous reasons. Amending the Ryan White Program (Pub.L. 101-381) would:

• Open-up the law, (which is currently unauthorized) and thus subject it to potentially harmful changes in a hyper-partisan political environment. 
• Change the purpose of the law, in that the purpose of the Ryan White Program is serving people living with HIV/AIDS.
• Create yet another access barrier for the approximately 400,000 PLWHA who are not in care.
• Further isolate PLWHA who are already disproportionally impacted by homelessness, hunger, substance use disorder, and undiagnosed and/or untreated mental health conditions. 
• Impede Ending the HIV Epidemic's efforts to both increase enrollment and expand services for low-income PLWHA, especially since discretionary funding is already limited.

Unfortunately, special interests continue to push false narratives in their efforts to shove the harmful legislation through the Congress. Probably one of the most egregious claims, “The bill’s intent and text doesn’t take money from people living with HIV.” This is false! 

Indeed, legislative language reads, “To allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV.” While subsection “B” of the legislation entitles the program as “voluntary” and to not allow federal grant dollars for the use of funding PrEP or PrEP services, it would allow federal grant dollars to be used for referrals – explicitly providing funding for people not living with HIV.

Photo Source: oncnursingnews.com

More concerning, special interests supporting the legislation conflate programmatic revenue as not grant dollars, as a somehow meaningful distinction. There is no difference in this distinction because each funded RWHAP recipient and subrecipient is required under current law to use their programmatic revenue to support providing services included in the grant – for people living with HIV. The design of these programs are significantly dependent on revenues generated from the 340B Drug Discount Program (340B) in order to meet the goals outlined in each of the grants. 

And that gets to the heart of the issue here. 340B's intent was “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program, amid much criticism, allows federal grants funding public health programs count on 340B revenues in order to show they can operate a sustainable program.

Let's be clear: S.4395 would divert RWHAP programmatic revenues – including 340B dollars – away from providing services and supports to PLWHA who are living at or below 400% of the federal poverty level (the income threshold for qualifying as eligible for receiving RWHAP funded services). It is important to remember that more than 50% of the patients receiving care from the State AIDS Drug Assistance Program are living at or below 100% of the federal poverty level. More than 250,000 patients, or approximately one quarter of all the estimated people living with HIV in the United States are earning less than $13,000 per year. 

Kathie Hiers, President & CEO of AIDS Alabama argued, "The HIV community needs to get its act together around funding for PrEP.  We have been told by the Director of the Office of National AIDS Policy that our messaging is not cohesive. At AIDS Alabama, we understand that stable PrEP programs are absolutely necessary if we ever hope to end HIV as an epidemic. However, raiding the Ryan White Program to fund prevention is not the answer, particularly as the needs of an aging HIV-positive population continue to grow."

As it stands, gaps in care still remain for too many marginalized communities. It isn't uncommon for patients to fall out of care because they have to prioritize work, or child care, or buying food, or finding affordable housing, or finding transportation. Funding to meet the needs for these patients is already stretched way too thin and the current inflationary pressures have only made things harder for far too many PLWHA. There are tens of thousands of people living with HIV who have no roof over their heads when they try to find a safe spot to sleep tonight.

Photo Source: debralmorrison.com

Robbing Peter to pay Paul is not the solution to funding HIV prevention efforts in the United States. A better option to meet the needs of people who would benefit from PrEP, and that is additional HIV prevention funding. This approach would allow patient choice in medicines and support for ancillary services, provider education and outreach. Additionally, HIV prevention funding could be directed to communities that are most in need of prevention medicines and services, thereby providing more equitable access. This approach would also use and could strengthen the existing HIV prevention infrastructure.

One local health department official (who asked to remain anonymous) in Florida said the people behind the legislation did not understand the nuances between funding for HIV prevention and HIV treatment. We couldn't agree more!

The HIV+Hepatitis Policy Institute's Carl Schmid summarized, "It's not an issue of not wanting clinics that receive Ryan White Program funding to be engaged in PrEP, we think they are the perfect places for PrEP to be delivered. It is an issue of taking funding generated from caring and treating for people living with HIV away from the intended purpose of the Ryan White Program – to provide for people living with HIV. With so many people with HIV living longer, who are not in care or have fallen out of care, you would think that these Ryan White grantees would devote that money to people who are living with HIV, as it was intended."

With more than a decade of science to back the position that effectively treating PLWHA, ensuring viral suppression both empowers positive health outcomes for PLWHA and prevents new transmissions. One of the most startling and, frankly, concerning shifts in the public policy conversation regarding Ending the [domestic] HIV Epidemic is a move away from focusing on the needs of PLWHA in favor of PrEP. The policy issues at hand, including the necessary funding, should not be proposed as an “either/or” situation, but an “and” situation. The same things that make a person vulnerable to contracting HIV are the same things that are killing people already living with HIV. 

While the U.S. Centers for Disease Control and Prevention (CDC) 2020 Surveillance data found 70% of white PLWHA were virally suppressed, only 60% of their Black/African American peers were virally suppressed. Additionally, while the U.S. Department of Housing and Urban Development (HUD) reported a general homelessness rate across the country as about 0.2% of the population, the CDC’s 2019 data found that PLWHA among communities of color were experiencing homelessness at a rate of 11%. It cannot be understated how the power RWHAP dollars hold to address these disparities specifically affecting patients. Failing to do so not only betrays the contract at the center of the legislative intent, it perpetuates injustices levied against our peers, our family, and our community. Raiding precious dollars from this program is nothing short of consenting to the unjust neglect of our communities.

Said Murray Penner, U.S. Executive Director for Prevention Access Campaign: "The Ryan White Program is crucial for people living with HIV, providing treatment and supportive services to keep people healthy and undetectable so they will not sexually transmit HIV. With over 400,000 people living with HIV in the U.S. who are not virally suppressed, there is significant unmet need for additional services. S.4395 would move money out of the Ryan White Program, potentially leaving people without the crucial treatment and services that keep them healthy and prevent new transmissions. Ensuring that the Ryan White Program is fully funded is critical for us to improve the quality of life for people living with HIV and thus improve our country's viral suppression rate and help us end the HIV epidemic."

A cornerstone of the HIV patient advocacy community's success over the last 40 years has been its desire to come together for a common purpose, which has centered around the notion of do no harm! S.4395 and the special interests and inside-the-beltway lobbyists pushing it have failed to meet that test. Raiding Ryan White programmatic funding for PrEP would negatively impact patients. Trying to authorize or amend an already underfunded program, when there is still so much unmet need in its originally intended population, undermines the goals of the program. If we try to be everything to everyone, we will end up failing on all fronts. The powers that be in Congress have assured us that this legislation "ain't going anywhere" this year!

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 & Monkeypox: More Answers Yield Even More Questions

By: Ranier Simons, ADAP Blog Guest Contributor

As the current Monkeypox outbreak continues to develop, so does ongoing research and discourse. A previous blog post, HIV & Monkeypox: What Patients Need to Know,[1] discussed early research regarding possible connections between HIV and Monkeypox. One main takeaway was that clinicians need to expand the list of symptoms they look for in Monkeypox infections. The current outbreak is not behaving as it has historically in the areas of Africa where it is endemic. Symptoms and related conditions can be mistaken for other sexually transmitted infections (STI's) or other illnesses. Additionally, it was noted that clinicians should adopt a heightened caution and suspicion of Monkeypox disease in at-risk groups. Recent research strongly reinforces the need for clinicians to increase their efforts to look for monkeypox disease in at-risk populations and the need for targeted education and messaging.

Photo Source: Medical Express

A report published September 9, 2022, in the U.S. Center for Disease Control & Prevention's (CDC) Morbidity and Mortality Weekly Report (MMWR) shows that people who are HIV-positive or have STI’s are disproportionately represented among those infected with Monkeypox.[2] Data from health departments in eight different U.S. jurisdictions was analyzed to examine Monkeypox clinical differences regarding HIV and STI status. Out of the 1,969 people infected with Monkeypox, who were 18 years of age or older, 38% (755) were HIV-positive, 41% (816) had another STI diagnosed in the previous year, and 18% (363) had both.[2] Additionally, those people living with HIV and also infected with Monkeypox had a higher prevalence of having an STI diagnosis in the preceding year than those diagnosed with Monkeypox who were HIV-negative.

A similar study published September 4, 2022, in HIV Medicine with a much smaller cohort was conducted in Germany.[3] In this study, 546 monkeypox infections from 42 sites were analyzed. All of the subjects were men who have sex with men (MSM). There were 256 (46.9%) patients living with HIV, mostly with viral suppression, 232 (42.5%) were taking pre-exposure prophylaxis  (PrEP), and 58 (10.6%) had no HIV infection or PrEP use. 

The likelihood of hospitalization of HIV-positive patients diagnosed with Monkeypox is still unclear. The CDC study indicates that co-infection with HIV may increase the risk of hospitalization but, the German study does not.[4] The CDC study confirmed hospitalization records from around 1,300 out of the 1,969 subjects. Eight percent of those hospitalized were HIV-positive and 3% were not. Conversely, the German study did not show a significant difference in hospitalization rates. Among those 546 men the overall hospitalization rates were 4% regardless of HIV status.

Both studies have limitations thus, cannot be used to provide definitive generalizations regarding clinical differences in Monkeypox infections between MSM with or without HIV. However, what is abundantly clear is the increased prevalence of the Monkeypox infections amidst MSM living with HIV, with STI’s or both. Evidence shows the heightened prevalence of HIV in populations that regularly receive HIV and STI health services. Thus, it is imperative that clinicians increasingly offer Monkeypox testing to those being treated for HIV and other STI’s in addition to increasing HIV and STI testing for those being treated for monkeypox.

Photo Source: ABC News / AP Photo / Neil Redmond, File

The ongoing research continues to support the observation that Monkeypox is being spread among MSM through social/sexual networks. Therefore, Monkeypox vaccination as prevention coupled with testing and treatment for HIV, Monkeypox and other STI’s remain to be where efforts need to be focused. The CDC reports that recent findings could lead to expanded Monkeypox vaccination recommendations. The findings may lead to vaccines being recommended for “people with recent STD infections, people with HIV, people taking pre-exposure prophylaxis (PrEP) medications to prevent HIV infection and, possibly, prostitutes”.[5] 

Continuing studies will eventually confirm whether HIV infection definitively causes worse outcomes with those infected with monkeypox and/or if simultaneous HIV/STI infection clinically makes someone  more susceptible to contracting Monkeypox. However, it is simultaneously important to work towards stopping the spread of the disease.

[1] Simobns, Ranier. (2022, September 1). HIV & Monkeypox: What Patients Need to Know. The ADAP Blog. Retrieved from https://adapadvocacyassociation.blogspot.com/2022/09/hiv-monkeypox-what-patients-need-to-know.html
[2] Hoffman, C. et al. (2022). Clinical characteristics of monkeypox virus infections among men with and without HIV: A large outbreak cohort in Germany. HIV Medicine. Retrieved from https://onlinelibrary.wiley.com/doi/10.1111/hiv.13378
[3] Tarin-Vincente, E., Alemany, A., et al. (2022). Clinical presentation and virological assessment of confirmed human monkeypox virus cases in Spain: a prospective observational cohort study. The Lancet. 400(10353), 661-669. DOI:https://doi.org/10.1016/S0140-6736(22)01436-2
[4] Hein, I. (2022, September 2022). People with HIV more likely to be hospitalized with Monkeypox? Retrieved from https://www.medpagetoday.com/infectiousdisease/hivaids/100628
[5] Stobbe, M. (2022, September 8). US may expand monkeypox vaccine eligibility to men with HIV. Retrieved from https://abcnews.go.com/Health/wireStory/us-expand-monkeypox-vaccine-eligibility-men-hiv-89545619

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.

Prior Authorization: Friend or Foe?

By: Ranier Simons, ADAP Blog Guest Contributor

It is no secret that the United States has the highest healthcare expenditures in the world but does not have the healthcare outcomes to reflect the spending. Rampant healthcare expenditures financially burden individuals, health care systems, governments, and private industry. Discourse surrounding healthcare spending reform juggles questions of the pricing of pharmaceuticals and durable medical equipment, the fees paid for medical services and facilities, administrative fees, and even decisions of medical intervention based on perceived necessity. The Institute for Healthcare Improvement created a framework called the Tripe Aim: improve the health of the population, enhance the experience and outcomes of the patient, and reduce per person cost of care.[1] Unfortunately, many standard healthcare cost-benefit analyses do not benefit patients. They benefit profit. One such practice is Prior Authorization, also known as PA.

Photo Source: ViAANTE

PA is part of what insurance companies and other medical payers refer to as utilization management. Simply put, when a medical professional orders a procedure, modality, or medication, it is not automatically paid for by a patient’s insurance. Depending on the structure of the health plan, approval is required before an action is taken to guarantee it is covered by the insurance. If prior authorization is not obtained the patient and/or healthcare practice could face being required to pay full price out of pocket or healthcare providers not receiving reimbursement. Additionally, if a prior authorization is denied, that means the health plan will not pay and the patient is still faced with the question of paying full fees or forgoing prescribed treatment. 

In theory, Prior Authorization is supposed to lower health care expenditures by preventing waste. Waste in this case is defined as high utilization of expensive procedures, appliances, or medications in lieu of lower cost alternatives. Unfortunately, the current way PA operates can harm the patient, in favor of profit. 

A medical provider and patient together work on a treatment plan and decide on medications. The provider makes prescriptions based on what they feel is best for the health outcomes of the patient. When health plans deny Prior Authorizations, they often suggest alternative solutions based on cost that may not be as effective or effective at all. These plans use panels of professionals that include physicians and nurses to review and authorize/deny providers requests. Faced with a denial, a provider has to fight get the desired treatment approved.[2] Documentation has to be submitted providing rationale for desired treatment and why alternative treatment will not be as effective. Sometimes providers have to petition to show treatment is even necessary when PA denial is denial of any medical treatment at all.

Photo Source: MedPage Today

Prior authorization sometimes results in delays in care that can result in adverse health outcomes, hospitalizations, permanent bodily damage, or even death.[2] To address this issues New York state has something called prescriber prevails, which is prior authorization process that applies to Medicaid plans. Under prescriber prevails, for a select group of drugs, the process is an expedited three business days from request process where providers have the final say in approval instead of a third-party panel provided by a health plan.[3] The drug classes covered by prescriber prevails includes anti-depressants, anti-psychotics, anti-rejections, seizure and epilepsy, endocrine, hematologic, and immunologic.[4] This means that doctors have the final say for things like anti-viral medications for HIV. Unfortunately, it does not cover antiviral drugs for hepatitis C.[4]

Lowering health care expenditures should lower the financial burden of healthcare primarily for patients and medical providers. When lowering the costs of health plans results in poor patient outcomes, expenditures actually increase with resulting patient hospitalizations, treatment abandonment, and resulting later stage acute treatment utilization. Groups pushing for healthcare reform advocate for prescriber prevails policy to be expanded to other drug classes covered by Medicaid nationally, as well as forms of prescriber prevails for non-Medicaid health plans. Efforts to reform healthcare need to be patient-focused not profit-focused.

[1] Institute for Healthcare Improvement. (2022). Triple aim for populations. Retrieved from https://www.ihi.org/Topics/TripleAim/Pages/default.aspx
[2] Laws, J. (2022, Apr 4). Provider survey: Prior authorizations harm patients. Retrieved from https://www.hiv-hcv-watch.com/blog/4-4-2022
[3] Health Plan Association. (2019, Mar 4). Memorandum in opposition. Retrieved from https://nyhpa.org/2019/03/s-1794-a-a-2799-a-medicaid-prescriber-prevails/
[4] Hep Free NYC. (2016, Mar 16). Policy Brief: Prescriber prevails & Hep C in NYS. Retrieved from https://hepfree.nyc/policy-fact-sheet-prescriber-prevails-hep-c/

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 & Monkeypox: What Patients Need to Know

By: Ranier Simons, ADAP Blog Guest Contributor

Presently, there is not much research data concerning monkeypox and HIV. Due to the novelty of the recent monkeypox outbreak, there has not been enough time or volume of subjects to complete many studies. Monkeypox is a type of virus known as orthopoxviral. Smallpox is also an orthopox virus which is why the smallpox vaccine is used to protect against monkeypox. However, smallpox was eradicated in 1980 before the HIV/AIDS epidemic.[1] Additionally, monkeypox has existed for years in areas where it has been endemic, yet research has been neglected and underfunded.[2] Many questions need to be investigated. Medical science has already proven that T-cell deficiencies due to HIV render HIV-positive people more susceptible to viral and fungal infections.[1] Two main questions are: does HIV infection increase the risk of contracting monkeypox, and is HIV an aggravating factor in monkeypox infection/progression/severity? 

Photo Source: International Business Times

There is some medical evidence that having underlying immune deficiencies increases the risk of infection if exposed and the possibility of severe illness if infected.[5] People living with HIV are immunocompromised. However, the increased risk and negative outcomes of infection is more likely for those with untreated HIV. Untreated HIV means a much weaker immune system than those in treatment. Those in consistent medical treatment usually have well controlled HIV with many reaching viral suppression. Being undetectable results in a characteristically immunocompetent immune system more like those who are not living with HIV.[5]

The U.S. Centers for Disease Control & Prevention (CDC) last month updated its Clinical Considerations for Treatment and Prophylaxis of Monkeypox Virus Infection in People with HIV. The CDC contends that people with advanced HIV or who are not virologically suppressed with antiretroviral therapy can be at increased risk of severe disease with monkeypox, but they also note  that these considerations are based upon limited evidence available.

Two recently published studies give some developing insight into the relationship between HIV and monkeypox. One such study is a multinational study published in the New England Journal of Medicine. The study was performed by a collaborative international group of clinicians that spanned 43 sites in 16 countries.[2] Together they compiled a case series of 528 infections. In this sample set, 98% were gay or bisexual men, 2% were heterosexual men, 75% were white, 41% were HIV positive (the majority was well controlled), and the median age was 38.[2] The clinical presentation of those living with HIV and those not HIV positive were very similar, with no significant differences. 

This study confirmed sexual activity, among gay and bisexual men, as a significant transmission route. Tracking of infection indicated reports of infection clusters associated with sex parties or saunas. International travel and attendance of large gatherings linked to sex-on-site activities by some subjects support the developing theory of enhanced infection rates through sexual networks.[2] Notably, the study did not conclude that monkeypox was transmitted through semen. The genital, anal, and oral mucosal lesions were found to result from close skin-to-skin contact during sexual activity. However, testing 32 semen samples indicated results are inconclusive as to if the amounts and kinds of viral DNA found in the seminal fluid are replication competent.[2] More research is needed.

Photo Source: Physicians' Research Network

The second study was conducted in Spain. It was an observational prospective cohort study of 181 subjects from 3 sexual health clinics in Madrid and Barcelona.[3] A prospective cohort study means that the subjects are followed and observed over time to monitor the development of their outcomes. Of the 181 subjects, 166 identified as gay men or bisexual men, 15 as heterosexual men or women (6 were female), and 72 (40%) were HIV positive.[3] All of the subjects had skin lesions. Seventy-eight percent had anogenital lesions, and 43% had them in the oral and perioral regions. Additionally, other complications were observed. Proctitis was seen in 45 subjects; 19 had tonsilitis, 15 had penile swelling, and 8 had a widely spread-out rash. Notably, systemic symptoms (fever, headache, flu-like sickness, sore throat) before the appearance of rash occurred more often in those who had participated in anal-receptive intercourse than those who did not.[3]

The important takeaway from both studies is that clinicians need to expand the symptoms of what they look for in monkeypox infection. The current outbreak is not behaving like the outbreaks in the endemic area of Africa, which typically had hundreds of rashes with some as pustules. These studies showed cases where people have only had one lesion on the surface skin. Clinicians should be extra cautious and suspicious of monkeypox disease in at-risk populations. The virus can be present in atypical ways that may appear as other STIs, such as chlamydia or syphilis. Moreover, both studies showed the incubation period was, on average, about 7 to 8 days; thus, focusing energies on pre-exposure intervention is essential. 

Photo Source: The Nation

It is currently unknown how long people can spread disease after lesions have crusted over and healed. Condom use is suggested for eight weeks after healing. HIV subjects are overrepresented in the populations of the studies due to the way subjects were obtained. Subjects were picked from places like sexual health clinics where many HIV-positive patients receive treatment. Additionally, HIV-positive people with well-controlled disease are more likely to seek testing. The overrepresentation in the studies does not indicate that an HIV diagnosis necessarily equates to an increased likelihood of infection. However, more research is needed to investigate that. A recent study has also shown that a person can be simultaneously infected with HIV, Covid, and monkeypox.[4] Exploring the interaction with HIV is imperative.

Getting ahead of the current monkey pox infection wave with prevention is the most effective way to stop the current trajectory. Prevention includes behavior modification as well as testing and vaccination. Targeted  messaging to vulnerable groups will encourage behavior modification as well as testing. Widespread adoption of expanded protocols of symptom investigation by clinicians  will also increase the identification of monkeypox infection in those presenting with atypical symptoms. Halting the spread is paramount, before it has the chance to reach pandemic levels.

[1] Henderson, J. (2022, August 19). More data needed on monkeypox, HIV co-infection. Retrieved from https://www.medpagetoday.com/special-reports/exclusives/100279
[2] Thornhill, J., Barkati, S., Walmsley, S., et al. (2022). Monkeypox virus infection in humans across 16 countries — April–June 2022. New England Journal of Medicine. 387, 679-691. DOI: 10.1056/NEJMoa2207323
[3] Tarin-Vincente, E., Alemany, A., et al. (2022). Clinical presentation and virological assessment of confirmed human monkeypox virus cases in Spain: a prospective observational cohort study. The Lancet. 400(10353), 661-669. DOI:https://doi.org/10.1016/S0140-6736(22)01436-2
[4] Kneisel, K. (2022, July 26). How monkeypox can present like common STIs. Retrieved from https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/99912
[5] World Health Organization. (2022, August 4). Monkeypox. Retrieved from https://www.who.int/news-room/questions-and-answers/item/monkeypox#:~:text=Anyone%20who%20has%20close%20contact,illness%20or%20dying%20from%20monkeypox

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.