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Sun. Jul 14th, 2024

Hope for patients as once-every-two-month ARVs show promise

By Vaseline May31,2024

Two years ago, some 162 Kenyan women with HIV agreed to stop taking ARV pills every day.

Instead, they would receive an injection once every two months. The injectable drug had already been proven to suppress HIV. But it had never been tested as a treatment option in Africa.

Researchers have now released long-awaited results on how the shot performed, raising hopes of an early approval for use in Kenya.

The results show that the long-acting injection for HIV treatment is as effective as daily oral pills in suppressing HIV among adults in Africa.

The Kenyan women were among 512 participants in this study, known as CARES, which was conducted in eight locations in Kenya, Uganda and South Africa.

The Kenyan sites are at the Aga Khan Hospital, Kemri in Kericho and Ampath in Eldoret.

Half of women still take daily ARV pills, while the others receive an injection known as Cabenuva (containing the drugs cabotegravir and rilpivirine) once every two months.

The researchers followed the participants for the past two years.

“This study showed that switching to long-acting therapy maintained high levels of viral suppression, which was noninferior to continuing an oral regimen,” the researchers said in the results published Wednesday in The Lancet Infectious Diseases.

They found that 96 percent of participants in the injectable group maintained viral loads below 50 copies per ml, compared to 97 percent in the oral therapy group.

The women were recruited between September 2021 and August 31, 2022 and were tested for viral suppression every six months.

The study also assessed the safety profile of the injectable substance. Adverse events of grade 3 or more occurred more frequently in the injectable group (nine percent) compared to the oral therapy group (four percent). Grade 3 events are symptoms that are serious or medically significant, but not immediately life-threatening.

Two participants in the injectable group experienced virological failure and developed drug resistance, while none in the oral therapy group did. However, the overall virological failure rate was very low, researchers say.

Their article is titled “Switch to long-acting cabotegravir and rilpivirine in virologically suppressed adults with HIV in Africa (CARES): week 48 results from a randomized, multicenter, open-label, non-inferiority study.”

They said the results of this study are significant for several reasons. First, the non-inferior efficacy of the injectable regimen provides an alternative for individuals who have difficulty with daily pill therapy.

“This is particularly important in African settings, where the stigma and logistical challenges associated with daily medication can be significant,” they said in the paper, published in the journal Lancet Infectious Diseases.

The Kenyan researchers are Prof. Reena Shah from the Aga Khan University Hospital, Nairobi, Abraham Siika and Charity Wambui from Moi University, and Josphat Kosgei from the Kenya Medical Research Institute.

The World Health Organization licensed the two injectable ARVs in 2020 because studies in Europe, America and Asia showed they were as good as daily pills.

In December 2022, the Star spoke to researchers who oversaw the trial in Uganda, Kenya and South Africa.

“But these studies have been done among men in those regions and here (in Africa) it is mainly women who are affected. The HIV subtype is also different here. Our disease environment is also different and we have more pregnancies. So it was necessary to repeat those studies here to generate guidelines for WHO,” said Dr. Cissy Kityo, a Ugandan epidemiologist overseeing the trial in the three countries.

Cabenuva is approved in the US, Canada, the European Union (under the brand names Vocabria and Rekambys), Australia and Switzerland, among others.

In the US, the website drugs.com gives a list price of $4,000 per month, but costs vary depending on the treatment plan, the cost of hospital visits, and any negotiated discounts.

Prof. Speaking separately to Star on Thursday, Omu Anzala, director of the Kenya Aids Vaccine Initiative, said research into HIV treatment is now moving towards long-acting drugs.

Prof Anzala did not participate in the Cabenuva study.

“A medication that can support you for three months or more before taking another medication, or a medication that can support you for six months before taking another medication, will actually increase compliance. It will ensure that individuals do not drop and discontinue their treatment,” he said.

“And that in that way the issues of maintaining the viral load and maintaining suppression will actually be achieved. Because we know that when the virus is completely suppressed, that person is unlikely to transmit the infection to anyone else.”

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