Commemorated on July 21, the day was created by the London-based sexual health organization NAZ and IAPAC in collaboration with the Global HIV Collaborative and other organizations to raise awareness around HIV and act against the stigma that surrounds it.
“Our 2023 theme of Human First is meant to emphasize the human dimension of people living with and affected by HIV, because we are all Human First,” the organizers wrote. “It means… we see the person before the virus, that a person living with HIV is first a human, they need to be recognized and acknowledged and they deserve every human right just like everyone. Any discrimination against people living with HIV should be seen as a human right violation.”
July 21 was chosen because it is the date that Prudence Nobantu Mabele became the first South African woman to go public with her HIV-positive status, in 1992. She addressed issues of gender-based violence in addition to her HIV work and helped found the Positive Women’s Network in 1996.
“The only thing preventing us from ending all new HIV transmissions by 2030 is stigma,” said NAZ CEO Parminder Sekhon.
To watch the Human First documentary on YouTube, GO TO bit.ly/human-first-doc.
GO TO zerohivstigmaday.org.
Mpox chapter added to OI guidelines
A comprehensive chapter on mpox has been added to the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. The guidelines are produced by an expert panel brought together by the U.S. Department of Health and Human Services (DHHS).
According to the new chapter, “Strategies to prevent mpox exposure are similar for people with and without HIV. Regardless of vaccination, people with HIV at risk for mpox should avoid skin-to-skin or other close intimate contact (including sex) with people who may have constitutional symptoms or a rash suspicious for mpox, avoid contact with contaminated surfaces or objects (including linens) used by a person with mpox, and perform frequent hand hygiene after touching rash material or surfaces that may have had contact with rash material.”
The new section includes recommendations for vaccination and for treatment.
GO TO clinicalinfo.hiv.gov.
Profile of people living with HIV
The Medical Monitoring Project (MMP), a national survey of clinical and behavioral aspects of people living with HIV, released its latest report in August. Organized by the Centers for Disease Control and Prevention (CDC), MMP asks people about such aspects of life as smoking, mental health concerns, food insecurity, sexual behaviors and pregnancy.
The latest survey, covering June 2021–May 2022, reports that:
- At year-end 2022, an estimated 1,072,051 persons in the United States and 6 dependent areas were living with diagnosed HIV
- In 2020, the number of new HIV diagnoses was 30,692
Among medical findings for the 3,995 individuals responding to the survey:
- 66% were virally suppressed (had less than 200 copies HIV per mL on a viral load test, also called undetectable)
- 95% had received outpatient HIV care during the past 12 months
- 81% did not miss any HIV care appointments
- 80% were prescribed antiretroviral therapy (ART, or HIV medication)
Nearly all (99%) had health insurance or coverage for care or medications: 47% through the Ryan White HIV/AIDS Program, 43% through Medicaid and 42% through private insurance.
Other findings include:
- 37% had one or more visit to the emergency room
- 17% had one or more hospitalization
- 33% of cisgender female adults had experienced pregnancy since their HIV diagnosis
Reasons for missing an ART dose:
- Forgot to take HIV medicine, 65%
- Change in daily routine or were out of town, 42%
- Fell asleep early or overslept, 40%
- Felt depressed or overwhelmed, 17%
- Had a problem getting a prescription or a refill for HIV medicines, 16%
GO TO bit.ly/MMP-survey.
USPSTF adds injectable PrEP to its recommendations
The United States Preventative Services Task Force (USPSTF) in August added injectable PrEP, Apretude, to its list of recommendations for the prevention of HIV. The “A” rating for pre-exposure prophylaxis (PrEP) drugs to prevent HIV is important for allowing these medications to be provided for free, including lab tests. Legal challenges and congressional opposition continue to threaten access to PrEP.
USPSTF noted that, “PrEP is underutilized, particularly for Black and Hispanic/Latino persons with indications [evidence of need] for PrEP.”
In an interview with Ayesha Rascoe of National Public Radio following the USPSTF update, Carlos del Rio, MD, noted that while various funding sources help in accessing PrEP, “The reality is that, at the end of the day, it’s not enough. There’s a group of academic researchers, of lawyers, of community advocates that have proposed a national PrEP program—really optimize PrEP access equitably because if we were to use PrEP appropriately, we would be able to really prevent many new HIV infections.”
Listen to the interview, “People with insurance will now have easier access to HIV-prevention medication,” at bit.ly/NPR-del-Rio-PrEP.
GO TO uspreventiveservicestaskforce.org. The guidance was published in the August 22 issue of JAMA.
From the USPSTF PrEP recommendations
The USPSTF recommends that the following individuals be considered for HIV PrEP:
1. Sexually active adults and adolescents weighing at least 77 lbs. (35 kg) who have engaged in anal or vaginal sex in the past 6 months and have any of the following:
- A sexual partner who has HIV (especially if the partner has an unknown or detectable viral load).
- A bacterial sexually transmitted infection (syphilis, gonorrhea or chlamydia for men who have sex with men and transgender women; gonorrhea and syphilis for heterosexual women and men) in the past 6 months.
- A history of inconsistent or no condom use with sex partner(s) whose HIV status is not known; assessing risk in conversation with the patient and considering factors such as number of partners, the specific sexual activities a person engages in, and whether their sex partner or partners are in a group with a higher prevalence of HIV (e.g., men who have sex with men or with men and women, transgender women, persons who inject drugs, and persons who engage in transactional sex).
2. Persons who inject drugs and have a drug injecting partner who has HIV or who shares injection equipment.
Transgender women are at especially high risk of HIV acquisition and should be considered for PrEP based on the criteria outlined above.
Persons who engage in transactional sex, such as sex for money, drugs, or housing, including commercial sex workers or persons trafficked for sex work, constitute a group at increased risk of HIV acquisition and should be considered for PrEP based on the criteria outlined above.
Statement from HIV+Hepatitis Policy Institute
Executive director Carl Schmid issued this statement following the PrEP announcement: “Including a long-acting drug as part of the USPSTF PrEP recommendation is an important step in improving HIV prevention efforts in the United States. While daily oral PrEP is highly effective, adherence can be an issue. That is why the FDA called long-acting PrEP superior to daily oral PrEP. With PrEP uptake deeply lagging in Black and Latino communities compared to Whites, long-acting PrEP can be a game-changer. Now we urge the federal government to immediately issue guidance to direct insurers to cover all forms of PrEP without cost-sharing. It took two years after the initial 2019 USPSTF PrEP recommendation for the Center for Consumer Information and Insurance Oversight (CCIIO) to issue coverage guidance to insurers. That delay helped lead to many PrEP users being charged cost-sharing by insurers, a situation that still continues today. People seeking PrEP must not face any additional barriers as they seek to access the form of PrEP that best meets their individual needs.”
Good results with children’s STR: IMPAACT 2019
Development of medications for children lags behind that for adults. In HIV, this means that single-tablet regimens (STRs) which began revolutionizing antiviral therapy two decades ago are still largely unavailable to many children around the world.
Noting that “child-friendly, fixed-dose combination (FDC) antiretroviral therapy (ART) options are limited,” the international IMPAACT 2019 pediatric study published early Phase 1/2 results using both a dispersible formulation and the regular STR formulation containing dolutegravir (DTG) that is sold under the brand name Triumeq.
“Both FDC formulations were overall safe and well tolerated in our study population through 24 weeks of treatment,” the study team reported.
IMPAACT 2019 enrolled 57 children weighing at least 13.7 pounds (6 kg). In addition to determining safety, the study achieved its goal of meeting pharmacokinetic targets (including drug levels) at all weight levels of the study. (Dosing for children is often determined by weight.)
The vast majority of the children (54, or 95%) had undetectable viral load (less than 200 copies of HIV per mL of blood) at the six-month mark.
The IMPAACT 2019 study team made the following points by way of a background statement:
- The combination of dolutegravir, abacavir and lamivudine [brand name Triumeq] is recommended globally [by the World Health Organization, or WHO] but is not widely available for children in a fixed-dose combination formulation.
- FDC tablets only recently became available within the U.S. in immediate-release form for children weighing at least 55 pounds [25 kg] and dispersible form for children weighing at least 22 pounds [10 kg].
- However, no child-friendly dolutegravir-containing FDC formulations are available outside the U.S. or for children weighing less than 22 pounds within the U.S., thus requiring the use of several tablets and formulations to provide a complete ART regimen for more children with HIV globally.
- High pill burden can present adherence and administration challenges in children, often resulting in poor treatment outcomes for this vulnerable population.
In a comment piece in the issue, “A step closer to optimal ART for all children,” Intira Jeannie Collins and Anna Turkova of University College London explain that, “Dolutegravir-based anti-retroviral therapy (ART) is the WHO-recommended first-line and second-line treatment for children and adults with HIV. Tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD) is a once-a-day, highly efficacious and safe fixed-dose combination, widely available as a low-cost generic formulation in low- and middle-income countries (LMICs) for adults and adolescents. However, there is currently no equivalent fixed-dose combination specifically designed for children.
“The publication is timely and commendable,” they continued further into the comment. “This treatment will be the only fixed-dose combination providing a complete and WHO-recommended regimen for children in LMICs weighing 6 kg [13.7 pounds] or more, given that TLD is not recommended until children reach 30 kg [66 pounds] because of tenofovir-related renal and bone toxicity concerns, and pediatric fixed-dose combinations of tenofovir alafenamide are not yet available in many LMICs.
“The study provides important supportive data on a long-awaited pediatric fixed-dose combination of abacavir, dolutegravir and lamivudine, which has been on the Pediatric ARV Drug Optimization priority list for LMICs and will simplify ART treatment for children across several weight bands,” note Collins and Turkova, adding that, “Affordable generic versions of this formulation are expected to be available this year.”
According to the commentary, half of the world’s children living with HIV are on antiviral treatment compared to three-quarters of adults, and a child dies of AIDS-related causes every five minutes. In other statistics, the study article says that children make up 5% of the global population living with HIV, but account for 15% of individuals who died from AIDS-related causes.
The IMPAACT clinical trials group conducts research to improve the health of parents living with HIV and their children. It is funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and others. The IMPAACT 2019 study results were published in the August 2023 issue of The Lancet HIV medical journal.
Children’s HIV treatment
Here in the United States, most of the HIV single-tablet regimens (STRs) are available to children, with limitations related to their size and age. Also available in pediatrics is the only complete HIV treatment via long-acting injection, Cabenuva, which can be given once every two months.
The latest advance came in March 2022, when a new formulation of the STR Triumeq was approved by the U.S. Food and Drug Administration (FDA). The new pediatric formulation, Triumeq PD, is dispersible in liquid. The number of pellets are taken based on the weight of the child.
This new formulation allowed an STR to be given to children as small as 22 pounds (10 kg). Previously, only two of the STRs could be used by children weighing as little as 55 pounds. Only one of those, Biktarvy, is commonly used.
At the same time, the original larger Triumeq tablet was approved for pediatric use at a lower weight, from 88 pounds (40 kg) down to 55 pounds (25 kg).
The backbone medication in Triumeq, dolutegravir (brand name Tivicay), has had a PD formulation since 2021, for children as young as four weeks old and weighing at least 6.6 pounds (3 kg). Again, this would require multiple medications instead of an easier-to-take STR, since HIV drug regimens are made up of at least two medications and usually three (such as Triumeq ). Two other STRs contain dolutegravir—Dovato and Juluca. Both of them contain only two medications. Neither has an FDA approval for pediatric use.
Globally, dolutegravir is considered a “preferred” drug for HIV treatment in WHO guidelines. According to those guidelines, “By September 2021, 78% of the people receiving ART were receiving TLD (50% in September 2020).” This STR is not sold in the United States, but made available at generic prices in other countries, often provided through PEPFAR (the United States President’s Emergency Plan for AIDS Relief).
HIV criminalization handbook
Released in August, All Pain, No Gain: HIV Criminalization in Pennsylvania is a new handbook from the AIDS Law Project of Pennsylvania in collaboration with several other organizations and legal writers. The book is useful to everyone everywhere because it details the history of HIV criminalization laws in the United States and what can be done about them. It covers the dated science behind the laws—how often negligible risks of transmission are treated as an actual risk. There’s no reason for HIV to be specifically singled out for criminal law involvement. It details the meanings behind certain legal terms (such as reckless endangerment, simple assault and even terroristic threats). It discusses “sentence enhancements” for people in jails and prisons or for sex workers. (Note: sex work is different from sex trafficking, a point that continues to evade some people.)
Under “The Alternatives,” the authors write, “No one benefits from prosecuting and incarcerating people with HIV for consensual sexual activity. Prosecution may result in the disclosure of private medical information, creating a potential risk of partner violence and a negative and irreversible impact on all parties. Incarceration increases stigma, impedes access to healthcare, and upon release causes instability in housing and employment, for the individual, their families and their community. Instead, alternatives to criminalization should be considered for any person who engages in consensual activity and feels harmed because they think they may have been exposed to or infected by HIV.”
In the conclusion, they note that, “HIV criminalization undercuts important public health initiatives by ignoring actual transmission risk, exacerbating stigma, and devaluing the importance of personal responsibility in HIV prevention. Criminalization makes it more difficult for those who have been diagnosed with HIV to disclose their HIV status to partners or to access and stay in care. In short, it’s all pain and no gain. Pennsylvania can and must do its part to reduce HIV transmission by ending HIV criminalization.”
All Pain, No Gain was produced in collaboration with the Center for HIV Law and Policy, the Sero Project and the Philadelphia Regional Chapter of Positive Women’s Network-USA, with the review or support of many other organizations and individuals. To download it, GO TO bit.ly/all-pain-no-gain-handbook.
ACTG updates its name
It was previously short for “AIDS Clinical Trials Group,” but now ACTG stands for Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. In a brief announcement, the longstanding research group stated that the updated name better reflects what it does today. With its global work, ACTG helps with the prevention and treatment of other conditions, such as tuberculosis. Its focus, however, remains heavily HIV-related.
‘All children can be born free of HIV, syphilis and hepatitis B’
That’s the message from the Clinton Health Access Initiative (CHAI), which discussed the extent of these conditions in pediatric and promoted a “triple elimination” strategy in an announcement issued in August. There are missed opportunities to protect children despite the availability of safe, effective and affordable interventions, the group said.
“Over 1.5 million babies are infected by human immunodeficiency virus (HIV), syphilis, and hepatitis B virus (HBV) each year globally. About 80 percent of these infections occur in low- and middle-income countries (LMICs),” the announcement reported.
“Pregnant women living with HIV, syphilis or HBV can pass these infections on to their infants during pregnancy, delivery or post-partum. This is known as vertical transmission. Without access to preventive measures, infants at risk of these infections can progress to chronic disease and early death.
“Safe, effective, and affordable tools exist to prevent transmission of these deadly infections from mothers to babies,” CHAI continued. “Expanding access to prevention measures, including stopping new infections among people of reproductive age, timely screening, treatment and HBV vaccination, all delivered through a common reproductive, maternal and child health (RMCH) platform can increase the survival of babies significantly. However, implementation of these measures in LMICs differs dramatically across the three diseases, reflects uneven investment levels, and political will.”
GO TO clintonhealthaccess.org.
For people with a detectable, but low-level viral load, an ‘almost zero’ chance of sexual transmission
Much has been said about undetectable equals untransmittable—known as U=U— the science-based principle that people living with HIV (PLWH) have a “zero chance” of transmitting the virus if they are adherent to their antiretroviral therapy (ART) regimen and, as a result, have a viral load that is undetectable, that is, fewer than 200 copies per milliliter of blood. But what about people who, while not undetectable, have low level viremia, whose virus is “suppressed but not undetectable”
A systemic review of HIV studies has found that PLWH who are adherent to their antiretroviral treatment regimen and whose detectable is viral load is 1,000/mL or less have an “almost zero risk of sexual transmission of HIV.” The report’s deliberate wording was intended to fit next to the context of U=U science.
“Although an undetectable viral load is the goal for all people living with HIV on ART, these data demonstrate that the risk of sexual transmission of HIV at low-level viremia is almost zero,” the review said.
From 244 HIV studies published between 2010 and 2022, the review analyzed findings from eight studies on sexual transmission of HIV, representing 25 countries and comprising a total of 7,762 couples—mostly heterosexual and who were serodifferent, where one partner was living with HIV and the other was HIV-negative. Only studies that provided viral load data were reviewed.
Three studies showed no HIV transmission in which the partner living with HIV had a viral load less than 200 copies/mL. The other studies totaled 323 cases of HIV transmission, none from people who were considered “stably suppressed [undetectable] on ART.” Among all studies, there were two cases of transmission in which the positive partner’s most recent viral load was greater than 1,000 copies/mL, however, this was complicated in both cases by the amount of time between the last viral load test and transmission date—50 and 53 days.
None of the studies assessed transmissibility of HIV through the sharing of injection drug use equipment when a person’s viral load was less than 1,000 copies/mL. The findings do not apply to vertical transmission, from pregnant parent to child, the report added, stating that transmission can occur during pregnancy, at childbirth or through breastfeeding/chestfeeding feeding.
Published in The Lancet in July, release of the review was timed to coincide with the 12th International AIDS Society Conference on HIV Science in Brisbane, Australia (coverage of IAS 2023 begins on page 28).
At the same time, the World Health Organization issued a policy brief describing the role of HIV viral suppression. It outlined three categories of HIV viral load measurements: unsuppressed (greater than 1,000 copies/mL), suppressed (detectable, but less than 1,000 copies/mL) and undetectable (less than 200 copies/mL, or too low to be measured by the test being used).
At the IAS conference, one of the study’s authors, Lara Vojnov, PhD, explained what the “suppressed” category could indicate. “There is some virus replicating and present, but too little to be quantified. It could be due to missing doses, recent treatment initiation or drug resistance.” But she stressed that “people living with HIV who have a suppressed viral load have almost zero or negligible risk of transmission to their sexual partners.”
In addition to Dr. Vojnov, the review was authored by Laura N Broyles, MD; Robert Luo MD, MPH; and Debi Boeras, PhD.
“By demonstrating that the risk of sexual transmission of
HIV is almost zero when the index partner has a viral load less than 1,000 copies per mL,
our findings underscore the importance of prevention campaigns, while also suggesting that the U=U message applies to people living with HIV experiencing low-level viremia,” the review said. “This message is crucial for low-income and middle-income countries where the disease and infrastructure burdens are high and national programs are often reliant on alternative sample types and technologies to fully expand access of viral load testing to all people living with HIV. Further, it might encourage more positive and clear messaging on the role of ART in preventing transmission to sexual partners.”
The report concluded, “The benefits of treatment as prevention are clearer than ever before, which should encourage [PLWH] to seek and adhere to treatment and support efforts to destigmatize and decriminalize HIV.”