World AIDS Day Marks Success, Progress, and Challenges That Remain

Today, December 1, marks World AIDS Day. It is a day to raise awareness of AIDS and reflect on those we have lost to the virus. This year's theme is “Let communities lead”. Communities living with, and affected by, HIV, networks of people from key populations and youth leaders have been, and continue to be, essential for progress in the HIV response.

According to the World Health Organization (WHO), HIV/AIDS has claimed 40.4 million lives, and there continues to be transmission in all countries, with some reporting increased incidence rates when they had previously been on the decline.¹

It is also a time to remember the first generation of people who were infected with HIV and subsequently died, as well as the clinicians and public health officials who did their best, despite not having antiretroviral therapies (ART).

In President Joe Biden’s official proclamation of World AIDS Day, he reminded the nation of the great losses suffered from it. “I urge the Governors of the United States and its Commonwealths and Territories, the appropriate officials of all units of government, and the American people to join the HIV community in activities to remember those who have lost their lives to AIDS and to provide support, dignity, and compassion to people with HIV.”²

Even today, there are millions of people who are not in the continuum of care. WHO reports that globally, 9.2 million people do not have access to HIV treatment, and that each day 1700 lives are lost from HIV-related causes, and 3500 people are infected, with many not knowing their status or having access to treatment.³

It is also a day to acknowledge progress, especially as medicine has been able to transform HIV/AIDS from a disease with a high mortality rate to one that can be a treatable, chronic condition. There is so much to be grateful for in terms of the advent of ART and PrEP, as well as newer developments for treatment include long-acting injectables and other evolving modalities such as HIV-prevention rings for women.

Listed below are some updates related to HIV/AIDS.

Legislative Front

One area of concern for people with HIV relates to insurance copays and medication coupons. Specifically, insurers have had the ability to refuse to count copay coupons or prescription drug rebates toward patients' deductibles or out-of-pocket maximums. Some people have relied on copay coupons to afford prescriptions, and for people who have HIV and need ART therapy this care scenario could come into play.

Learn more about how one woman is dealing with this for her chronic health condition.

This fall, a US District Court ruling issued a major win for patients who depend on prescription drugs.⁴ The court ruled that in most cases, insurers must count copay assistance towards a beneficiary's out-of-pocket maximums, making it unlawful for insurers to effectively double-charge patients by pocketing the assistance instead. ⁵

However, the Biden administration announced 2 actions that may prevent people from experiencing the benefits. The administration won't enforce the court's ruling, and they filed an appeal with the US Court of Appeals for the DC circuit. 

The HIV + Hepatitis Policy Institute, the Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition who are plaintiffs in the case released a statement responding to the ruling. "We can't comprehend why the Biden Administration, which has championed access and affordability of prescription drugs for the American people, would appeal this decision," said Carl Schmid, executive director of the HIV + Hepatitis Policy Institute.⁶

Novel Modality

This week, the Population Council and IPM South Africa announced the dapivirine vaginal ring (DVR), a product designed to help women reduce the risk of HIV infection, has now gained regulatory approval or authorization through import permits for use in 11 countries in East and Southern Africa. Africa continues to experience the highest prevalence rates for HIV, especially in the sub-Saharan portion of the continent. According to the Population Council and IPM South Africa, the ring is currently being offered to women through more than 30 implementation and pilot studies across six countries: Eswatini, Kenya, Lesotho, South Africa, Uganda and Zimbabwe.⁷

“Women bear the brunt of the HIV/AIDS epidemic,” Jim Sailer, the Council’s interim co-president and executive director of the Council’s Center for Biomedical Research, the non-governmental organization spearheading the international rollout of the DVR, said in a statement. “The virus is one of the biggest threats to the health and well-being of women. In sub-Saharan Africa, one adolescent girl or young woman becomes infected with HIV every three minutes. We cannot achieve the Sustainable Development Goal (SDG) of ending HIV by 2030 unless we curtail this epidemic in women. Women deserve multiple options to protect themselves against this lifelong disease.”⁷

Research

In recent years, there have been new developments to ART and PrEP therapies to include long-acting injectables and make adherence to management and prevention measures more seamless.

Another consideration for HIV prevention has been research and addressing vulnerable populations. Whereas in Africa, women are a high-risk population for HIV incidence, globally, another obvious population to consider is infants.

A new study found that certain antibodies that pass through the placenta are associated with the improved survival of infants who acquire HIV through nursing. The study was published in Open Forum Infectious Diseases, and that preexisting antibodies that target a specific region of Env—a protein on HIV’s surface—were correlated with delayed HIV acquisition in infants exposed to the virus as well as a lower amount of virus circulating in the blood of infants who acquired HIV. Both of these conditions are known to help extend survival in infants with HIV.⁸

Env is also a key target of neutralizing antibodies for vaccine developers. In regards to vaccines, Moderna has developed 2 HIV vaccine strategies using germline targeting and immune-focusing approaches. Earlier this year, Moderna announced 2 trials for the vaccines.

In January, Moderna announced it began its phase 1 IAVI G002 HIV vaccine trial. The company is partnering in testing of HIV vaccine antigens mRNA-1644 and mRNA-1644v2-Core, which is sponsored by IAVI and supported by the Bill & Melinda Gates Foundation.

The other HIV vaccine trial is an open-label, multicenter, randomized study (HVTN 302), and will evaluate the safety and immunogenicity of their experimental HIV trimer mRNA vaccine (mRNA-1574). The trial is expected to enroll approximately 100 HIV-negative adults, aged 18 to 55 years.

To learn more about the challenges and progress made with HIV vaccines, read a recent article that appeared in the Contagion publication.

What Remains

The test of our progress is not whether we add more to the abundance of those who have much it is whether we provide enough for those who have little. —Franklin D. Roosevelt

The aforementioned quote from FDR can be applied broadly to 2 groups of people with HIV. There are those who have medical insurance, are in the continuum of care, and have been able to reduce their HIV viral load; and there is a secondary group that may be experiencing health disparities, including limited to no insurance, and do not have their viral load under control.

For the former group, HIV/AIDs can be viewed as a chronic condition in which HIV needs to be treated but a livable one. For those in the latter group, they are stricken with an active virus wreaking havoc on their health.

With continued days of awareness like today, as well as broad initiatives such as the Ending HIV Epidemic, HIV incidence numbers can decrease and make further progress towards reduction overall.

References

1.HIV and AIDS. WHO. Updated July 13, 2023. Accessed December 1, 2023. https://www.who.int/news-room/fact-sheets/detail/hiv-aids

2.A Proclamation on World AIDS Day, 2023. White House Press release. November 30, 2023. Accessed December 1, 2023. https://www.whitehouse.gov/briefing-room/presidential-actions/2023/11/30/a-proclamation-on-world-aids-day-2023/#:~:text=NOW%2C%20THEREFORE%2C%20I%2C%20JOSEPH,2023%2C%20as%20World%20AIDS%20Day.

3. WHO celebrates the role of communities in driving progress towards ending AIDS. WHO press release. November 29,2023. Accessed December 1, 2023. https://www.who.int/news/item/29-11-2023-who-celebrates-the-role-of-communities-in-driving-progress-towards-ending-aids

4. Copay Assistance for Drugs Must Now Count in Most Instances. HIV + HEP Policy Institute press release. October 2, 2023. Accessed December 1, 2023. https://hivhep.org/press-releases/court-strikes-down-hhs-rule-that-allowed-insurers-to-not-count-copay-assistance/

5. Co-Pay Assistance 101. Oncolink. September 19, 2022. Accessed December 1, 2023. https://www.oncolink.org/support/insurance-legal-employment-financial-concerns/access-to-medications/co-pay-assistance-101

6. The HIV + Hepatitis Policy Institute, the Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition Informs Court It Will Defy Ruling & Not Enforce Victory for Patients press release. November 28, 2023. Accessed December 1, 2023. https://hivhep.org/press-releases/u-s-government-appeals-drug-copay-assistance-court-ruling/

7. Innovative HIV Prevention Product for Women that Promotes Choice – Dapivirine Vaginal Ring (DVR) – Gains Momentum Across Africa. Population Council press release. November 30, 2023. Accessed December 1, 2023. https://popcouncil.org/media/innovative-hiv-prevention-product-for-women-that-promotes-choice-dapivirine-vaginal-ring-dvr-gains-momentum-across-africa/

8. Yaffe, ZA et al. Passively Acquired Constant Region 5-Specific Antibodies Associated with Improved Survival in Infants Who Acquire Human Immunodeficiency Virus. Open Forum Infectious Diseases. DOI: 10.1093/ofid/ofad316 (2023).