The International AIDS Society Conference on HIV Science, held recently in Brisbane, Australia, included new findings on a medication to prevent heart disease and the risk of severe mpox among people living with HIV.
REPRIEVE trial results
HIV-positive people who are at low to moderate risk for cardiovascular disease can reduce their risk even further by taking a daily statin medication, according to results from the large REPRIEVE study. Statins have been shown to lower the risk of cardiovascular problems and death in the general population, but their benefits for people living with HIV were uncertain until now.
"People with HIV are twice as likely to develop cardiovascular disease, and therefore [the findings] could have very significant real-world impact," IAS president and conference co-chair Dr. Sharon Lewin of the University of Melbourne said at an advance media briefing.
The international phase 3 trial, sponsored by the National Institutes of Health, enrolled nearly 7,800 HIV-positive people ages 40 to 75. They were on antiretroviral therapy and most had an undetectable viral load. They had no prior history of cardiovascular disease, and their demographics, comorbidities and laboratory values reflected low to moderate risk. But standard cardiovascular risk scores developed for the general population tend to underestimate the risk for people with HIV.
"We targeted a group that would not ordinarily have been prescribed a statin, or any therapy, who would have been simply told to go home," lead researcher Dr. Steven Grinspoon of Massachusetts General Hospital said at the briefing.
Study participants were randomly assigned to receive oral pitavastatin (brand name Livalo) or a placebo. In addition to bringing down LDL cholesterol, statins also have anti-inflammatory properties. Pitavastatin was chosen because it does not interact with antiretrovirals.
The trial was halted ahead of schedule in April after an interim analysis found that pitavastatin showed a significant benefit. The drug reduced the risk of heart attacks, strokes, severe chest pains, heart surgery and cardiovascular death by 35%.
The researchers calculated that, overall, 106 HIV-positive people would need to take pitavastatin for five years to prevent one major cardiovascular event. But for those with a higher cardiovascular risk score, that number fell to 35. The size of the effect was "very consistent" for men and women, across racial/ethnic groups and regardless of CD4 T-cell count or baseline LDL level, Grinspoon reported.
Pitavastatin was generally safe and well tolerated with no unanticipated safety concerns. People who received the drug were more likely than placebo recipients to develop diabetes, but the rates were low (about 5% versus 4%). Muscle-related side effects were also uncommon (about 2% versus 1%) and mostly mild.
"We would highly recommend that guidelines be changed" to recommend statin therapy for HIV-positive people with low to moderate cardiovascular risk, Grinspoon said. "Pitavastatin is effective, prevents major adverse cardiovascular events and will save lives."
Grinspoon noted that statins are cheap once they go off patent — as is expected for pitavastatin in early 2024 — which will help ensure equitable access. He stressed that statin use should be part of a broader cardiovascular disease prevention plan that emphasizes a heart healthy lifestyle.
Mpox and HIV
Mpox has declined dramatically since the outbreak peaked late last summer, and it remains at a low ebb in the United States, including San Francisco. To date, the Centers for Disease Control and Prevention has identified 30,647 cases and 46 deaths in the U.S. and 88,600 cases worldwide. Most cases outside of Africa have been among gay and bisexual men, usually linked to sexual contact.
According to the San Francisco Department of Public Health's database, there hasn't been a reported mpox case in the city since June 30.
Around 40% of people diagnosed with mpox in the U.S. were living with HIV, but HIV-positive people accounted for more than 80% of those hospitalized, and most people who have died of mpox in the U.S. were Black gay men with AIDS, according to the CDC.
Earlier this year, Dr. Chloe Orkin of Queen Mary University of London reported that mpox can be much more severe for people with HIV who have a very low CD4 count, leading her to call for mpox to be classified as an AIDS-defining opportunistic infection.
At the IAS meeting, Dr. Ana Hoxha of the World Health Organization presented findings from a larger analysis based on global surveillance data reported to WHO. Among the more than 82,000 mpox cases reported between January 2022 and January 2023, about 40% had available information on their HIV status, and of these, just over half were living with HIV.
Overall, people living with HIV were more likely to be hospitalized than HIV-negative people with mpox (4.3% versus 3.0%) and they had a higher risk of death (0.3% versus 0.03%). But while immunocompromised people with HIV were about twice as likely to be hospitalized, the risk for HIV-positive people with an adequate CD4 count was similar to that of HIV-negative people without immune suppression.
These findings indicate that HIV treatment that leads to viral suppression and CD4 cell recovery can help prevent severe mpox. Therefore, people who present for mpox testing or treatment should be tested for HIV if they do not already know their status and should be linked to care if they are not already on antiretroviral therapy.
"For individuals with unknown HIV status, mpox testing can be an opportunity for HIV testing, prevention, and care," Hoxha said at the IAS news briefing.
As the Bay Area Reporter previously reported, IAS conference participants heard about global progress toward ending HIV, another person cured of HIV after a stem cell transplant — the sixth such case ever — and a new World Health Organization brief reaffirming that people on antiretroviral treatment with an undetectable viral load have zero risk of transmitting HIV to their sex partners.
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