Infectious Disease

Injectable PrEP could possibly be a “discreet” HIV prevention possibility for girls

January 27, 2021

4 min read

Source / information

Source:

Delany S. et al. Abstract 1479. Presented at: HIV Research for Prevention; 27.-28. January and 3-4. February 2021 (virtual meeting).

Disclosure:
Delany does not report any relevant financial information. At the time of publication, Healio was unable to confirm any relevant financial information for Landovitz.

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Injectable cabotegravir given every 8 weeks was associated with approximately nine times fewer HIV infections in cisgender women than daily oral PrEP, according to results from a phase 3 study.

Sinead Delany-Moretlwe, MBBCh, PhD, DTM & H., A researcher at the University of Witwatersrand in Johannesburg presented results from Study 084 of the HIV Prevention Trials Network (HPTN 084) during the virtual conference HIV Research for Prevention.

Sinead Delany-Moretlwe

The study compared ViiV’s long-acting injectable cabotegravir with oral emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) in cisgender women. The data from the study was released by ViiV Healthcare back in November, soon followed by the FDA, calling the drug a breakthrough therapy.

HPTN 084 was a companion study to HPTN 083 that showed the therapy was also effective in transgender women and cisgender men who have sex with men. Delany-Moretlwe said a license package for the therapy could be filed with the FDA in 2021, with a decision possible by the end of the year.

“We need a range of HIV prevention options for women that fit into their lives.

Currently, many women have problems with condom use – not under their direct control – or oral PrEP due to difficulty taking pills on a daily basis, and concerns about stigma or fear of violence from partners or judgment from family and community members . This can limit oral use of PrEP. “ Delany-Moretlwe said Healio.

“An injectable PrEP could be discreet and address some of these challenges,” she said. “We need to find out if injectable cabotegravir was safe and effective in preventing HIV in cisgender women.”

More than 3K participants

To assess its effectiveness, Delany-Moretlwe and colleagues randomly assigned HIV-uninfected and PrEP-able cisgender women in a 1: 1 ratio to either active long-acting cabotegravir (CAB-LA) plus FTC / TDF placebo or get active FTC / TDF plus CAB-LA placebo. According to the study, participants received daily oral product for 5 weeks, followed by intramuscular injections every 8 weeks after an initial 4-week interval loading along with daily oral pills.

A total of 3,224 participants were enrolled at locations in South Africa, Zimbabwe, Uganda, Malawi, Botswana, Eswatini and Kenya. Of those participants, 54% had two or more partners in the past month, 32% had a partner with HIV or unknown status, 19% had chlamydia, and 7% had gonorrhea at enrollment, the researchers reported.

According to the study, a total of 38 infections occurred in the CAB-LA arm over 3,808 person-years (HIV incidence 1%; 95% CI, 0.71-1.37) (HIV incidence 0.21; 95% CI, 0, 06-0.54)) and 34 in the TDF / FTC arm (HIV incidence 1.79%; 95% CI, 1.24-2.51) (HR = 0.11; 95% CI, 0.04 -0.32). In a random subset of 375 TDF / FTC participants, 62% of the plasma samples had detectable TDF / FTC and 46% had concentrations consistent with daily dosing, said Delany-Moretlwe and colleagues.

They found that adverse events were mild to moderate and similar between the experimental arms, although injection site reactions were more common in the CAB-LA arm (32% versus 9%) and nausea was more common in the TDF / FTC arm (9%) ) 5%).

Further studies evaluating CAB-LA in pediatric populations are ongoing, according to Delany-Moretlwe. Given the concerns that pregnant women taking the drug for HIV treatment had related to dolutegravir and neural tube defects, the researchers requested that all women in HPTN 084 use long-acting contraception out of caution, as dolutegravir did too an integrase is an inhibitor and similar to CAB, said Delany-Moretlwe. However, she said that after reassuring data emerged on dolutegravir use in pregnancy, the researchers planned open-label extension studies of CAB-LA for use during pregnancy.

“CAB-LA is safe and effective in preventing HIV infection in cisgender women,” said Delany. “Women given CAB-LA were 89% less likely to develop HIV infection than women given daily oral Truvada, likely because 8-weekly injections had overcome the barriers to liability associated with daily pill use.”

“You get more coverage”

When taken as prescribed, oral PrEP is hard to beat as an HIV prevention method. Raphael J. Landovitz, Professor of Medicine at the University of California, Los Angeles Center for Clinical AIDS Research and Education, told journalists in a webinar prior to the conference. However, the drug isn’t always taken as prescribed, said Landovitz, who – like Delany-Moretlwe – hypothesized that this explains why CAB-LA has outperformed daily oral PrEP in studies.

“It’s easier not to have to remember to take a pill so you can get more coverage,” Landovitz said. “People with different priorities have a hard time taking one pill enough to get high levels of drugs” in their system.

Monica Gandhi, MD, MPH, The professor of medicine at the University of California at San Francisco previously told Healio that scientists need to confirm that the “breakthroughs” from the CAB-as-PrEP injectable studies “did not occur with integrase inhibitor resistance, as it did the performance would decrease the ability to use first-line dolutegravir-based therapy for their treatment. “Landovitz said the COVID-19 pandemic has slowed analysis of samples and resistance data is expected in the first quarter of 2021.

Scientists told reporters during the conference that it was too early to say how much CAB-LA will cost, but that both HPTN studies are doing a cost-benefit analysis to determine the price.

The FDA recently approved a long-acting injectable regimen containing CAB for the treatment of HIV. Therapy consists of monthly injections of CAB and rilpivirine, with costs close to the top of daily oral therapies on the market, ViiV said.

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