New HIV-prevention drug could help Atlanta end epidemic

New injectable drug blocks HIV in patients who do not have the virus, but equal access to it will be critical to its success

It’s not quite an HIV vaccine, but experts are calling it the closest science has come so far: a shot given twice a year blocked the spread of HIV in everyone who participated in a landmark study. Experts in Atlanta hope the medicine, called lenacapavir, could be added to the city’s own HIV-prevention arsenal.

“The results are historic,” said Leisha McKinley-Beach, a national HIV consultant and CEO of the Black Public Health Academy, which prepares Black health department employees for leadership positions. “It’s great for once we see results among Black women, a group disproportionately impacted by HIV.”

Lenacapavir is currently marketed under the brand name Sunlenca by drugmaker Gilead Sciences, and used to treat people living with HIV. The study in Africa revealed that this same drug is successful at preventing HIV transmission in those who are HIV negative. The human immunodeficiency virus (HIV) is the virus that causes AIDS.

The study enrolled 5,300 women and adolescent girls age 16 to 25 across 25 sites in South Africa and three sites in Uganda. It compared the safety and efficacy of twice-yearly lenacapavir injection to prevent HIV infections, versus two other medicines made by Gilead: Descovy and Truvada, which are pills taken once daily.

Both Descovy and Truvada are approved by the FDA for use to prevent HIV infections — they are known as a “PrEP” or pre-exposure prophylaxis treatment.

The lenacapavir study’s outcome was zero cases of HIV infection among 2,134 women. A handful of women who took Descovy and Truvada tested positive by the study’s end. That’s because for the pill form of those drugs to be 100% effective, users need to take them every day and that appears not to have happened: In the Descovy and Truvada groups, the study noted, adherence was low.

Descovy and Truvada are two of just three drugs approved by the FDA for use as a PrEP treatment. Like lenacapavir, the third, Apretude, is also an injectable drug that is highly effective, but it has not been widely used because most insurance won’t pay for it. It costs about $22,000 per year, per patient.

The hopeful news is that injectables have the potential to help Atlanta tackle the HIV crisis. But the drugs’ high prices means access isn’t always equitable, said Justin C. Smith, who directs the Campaign to End AIDS at Positive Impact Health Centers in the Atlanta area.

Doctors Without Borders and other groups are calling for global action to break Gilead’s monopoly on lenacapavir to allow mass production of the drug and reduce its cost. Gilead charges $42,250 per patient per year for lenacapavir in the United States, according to Doctors Without Borders. Gilead previously said it was committed to lowering the cost of its drugs in low-income countries.

“As with all forms of PrEP, the challenge is ensuring that the communities that can stand to benefit from it the most are able to have access to this powerful HIV prevention tool,” Smith said.

Worldwide there are about 1.3 million new HIV infections every year, with women and girls accounting for 44 percent of them.

Metro Atlanta has the third-highest HIV rate in the U.S., according to the CDC. The numbers have been high for years, and the burden hasn’t been spread equally: 74% of new HIV cases in 2021 were among Black Atlantans.

Though the success of lenacapavir in cisgender women and girls — whose gender identity matched the sex they were assigned at birth — was remarkable, it will need to be replicated. Success must also be shown in cisgender men and other groups, such as transgender women and men, before the drug can gain FDA approval for use as PrEP, said Christian Grov of the Department of Community Health and Social Sciences at the CUNY Graduate School of Public Health and Health Policy.

“The timeline to when it may be FDA-approved as PrEP is unclear to me,” Grov said. “We would also need the results from other populations it is being studied in so that broad approval is possible.”

The advantage of injectable HIV prevention drugs is that people can access them discreetly, and in situations where taking a daily pill isn’t practical, said Elizabeth Armstrong-Mensah, Clinical Associate Professor of Health Policy & Behavioral Sciences at the Georgia State University School of Public Health.

But the injection isn’t a panacea, she cautioned.

“Ending the HIV crisis in Georgia goes beyond putting HIV negative people on twice-yearly lenacapavir,” she said. “While this medication will help to prevent the incidence of new HIV cases among people who are HIV negative, it will not cure people who are living with HIV.”

To reach that goal, she is calling for stepped up HIV testing, access to HIV medication for all people living with HIV, emphasis on condom usage, and elimination of HIV-related stigma.

One barrier to care has been insurers’ unwillingness to pay for injectables like Apretude, which has been available as an injectable PrEP medication since 2021, but has seen low uptake, said researcher Alexa D’Angelo with the CUNY Institute for Implementation Science in Population Health. It’s possible lenacapavir could meet with the same difficulties.

“I struggled to identify plans that were covering injectable PrEP,” she said of her earlier work looking at insurance denials. “Limited coverage may limit the reach of injectable PrEP and its ability to protect those who might really benefit from it.”

Fulton and DeKalb county residents who wish to access PrEP in injectable or pill form to prevent HIV are encouraged to seek care through Grady Hospital’s PrEP program. The program is open to everyone, and those who do not have insurance can receive care for free, said Twala Drayton, Patient Navigator at Grady’s PrEP Program.

“Each patient who we speak to will be presented with different PrEP options — Truvada, Descovy, and the injectable, Apretude,” Drayton said. “We do an education intake with each patient based on their documented interest.”

For more information and to book a free appointment, call 404-616-7737, email getPrEP@gmh.edu, or visit www.gradyhealth.org/get-prep-hiv-prevention-pill/.

How to get free HIV-prevention medication (PrEP) in Atlanta:

Fulton and DeKalb County Residents:

Visit: www.gradyhealth.org/get-prep-hiv-prevention-pill/ to book appointment

Call: 404-616-7737

Email: getPrEP@gmh.edu

Or walk in: Grady Hospital, 80 Jesse Hill Jr Drive SE Atlanta, GA 30303

Cobb County Residents:

Visit: https://cobbanddouglaspublichealth.com/services/hiv/hiv-prevention/

Click “Make an Appointment”

Scroll down to Sexual Health Services, click “PrEP Initiation”

Or call: 770-514-2300

Gwinnett County Residents:

Visit: https://www.gnrhealth.com/services/community-health/prep/

Call: Contact PrEP coordinator at 770-339-4283 Ext. 420 or our HIV program manager at 678-442-6897 Ext. 135.