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Five years after the FDA approved Cabenuva, a long-acting combination of cabotegravir-rilpivirine for HIV treatment, availability of this and other longer-acting antiretroviral therapies remains limited in low- and middle-income countries, according to Monica Gandhi, M.D., M.P.H.

Gandhi, a professor of medicine at the University of California, San Francisco, and medical director of the HIV clinic at Ward 86, noted that this pattern of limited availability has occurred before, citing the example of oral antiretroviral therapy.

History of Antiretroviral Treatment

The history of antiretroviral treatment (ART) spans over 30 years, with milestones including the advent of nucleoside reverse transcriptase inhibitors and the first integrase inhibitor, raltegravir, in 2008.

Early in the epidemic, recognition of the latency of HIV infection made it clear that long-term treatment would be necessary, Gandhi said.

Long-Acting ART

Gandhi referenced data from a UNAIDS report showing wide variation in HIV virologic suppression rates across regions, with rates as low as 48% in Eastern Europe and 49% in the Middle East.

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Researchers are grappling with the adherence challenge, pointing to the LATITUDE and IMPALA trials, which showed promising results for long-acting ART.

The LATITUDE trial reported that participants receiving once-monthly injections of cabotegravir and rilpivirine were half as likely to develop high viral loads as those on daily oral ART.

Gandhi noted that while these trials were designed to assess long-acting ART in those who had been virologically suppressed, data on people who are viremic have come from observational studies.

Real-World Experience

Gandhi and her colleagues have reported results from their clinic, including a research letter published in JAMA in 2025, which showed that 98% of patients with initial viremia had undetectable viral loads after 48 weeks of treatment with cabotegravir and rilpivirine.

Gandhi noted that the use of long-acting ART in viremic patients is now endorsed by HHS and IAS-USA guidelines, based partly on data reported by her and her colleagues.

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Seraphina Wentworth

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