Source – https://theconversation.com/

Women make up more than half of the people living with HIV around the world. Young women between the ages of 10 and 24 are twice as likely to get HIV as young men in the same age group. In East and Southern Africa young women will acquire HIV on average five to seven years earlier than their male peers.

Researchers have been working hard to find effective HIV prevention measures.

Most notable is the pre-exposure prophylaxis (PrEP) pill known as Truvada. This is a combination of two antiretroviral drugs – tenofovir and emtricitabine. This can be effective in preventing HIV acquisition. But taking a pill every day is not practical for many people.

Scientists from the HIV Prevention Trials Network recently found that a PrEP regimen of long-acting cabotegravir (CAB LA) injections once every eight weeks was better than the daily tablet used for HIV prevention. Ina Skosana spoke to Sinead Delany-Moretlwe, a research professor at the University of the Witwatersrand in South Africa and director of research at the Wits Reproductive Health & HIV Institute to find out more.

Can you tell us about the study?

This study, known as HPTN 084 is the first one to compare the efficacy of two HIV prevention or pre-exposure prophylaxis regimens.

The first regimen consisted of an injection of the long-acting antiretroviral drug, cabotegravir given every eight weeks. The second regimen was the daily oral dose of Truvada. Truvada has been shown to be highly effective for HIV prevention when taken as prescribed in a variety of populations and contexts.

We enrolled over 3,200 sexually active, HIV-uninfected cisgender women at 20 sites in seven countries. Research took place in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe between November 2017 and November 2020.

Our study randomised participants to one of two arms. One arm received active cabotegravir and a Truvada placebo. The other arm received active Truvada and placebos for cabotegravir. Cabotegravir was administered daily by mouth for 5 weeks and via intramuscular injection at 8-weekly intervals after an initial 4-week interval load.

What did you find?

Preliminary findings show that overall 1% of participants were infected with HIV during the study period. This suggests that both cabotegravir and Truvada are highly effective for HIV prevention in this population.

The 34 incident infections detected in participants assigned to Truvada is equivalent to an incident of 1.79%. And the four infections detected in the participants assigned to cabotegravir is equivalent to an incidence of 0.21%. This confirms a new prevention option for women that offers a significant advantage over existing oral PrEP which requires consistent daily use and is associated with significant adherence challenges.

We observed roughly 9 times the number of incident HIV infections in the Truvada arm compared to the cabotegravir arm. This finding suggests that cabotegravir is much more effective than Truvada in preventing HIV infection in women. And the threshold for early stopping of the trial was met. Based on these findings the independent data and safety monitoring board recommended that the blinded portion of the study be stopped early and the results released to the scientific and broader community.

An earlier sibling study in cisgender men and transgender women called HPTN 083  showed similar results. A prep regimen containing long-acting cabotegravir injectable once every 8 weeks was superior to the daily oral Truvada in that population.

What are the next steps?

The study results are important and timely as more methods to prevent HIV among women at higher risk of HIV are urgently needed. These include methods that do not depend on daily or near-daily pill-taking, condom use or abstention from sex. The development of alternative methods to prevent HIV, and more adherence-friendly schedules than are currently available, will increase the HIV prevention choices and acceptability for women and reduce new HIV infections.

We have communicated with the research ethics committees and national drug regulators overseeing this study, and site investigators and study participants are being notified about the results as soon as possible. Participants will be able to learn about the medication that they were receiving. A protocol amendment will be submitted for regulatory review to allow participants to continue taking their assigned medication or to switch to cabotegravir if they choose.

Participants on Truvada will be offered cabotegravir as soon as the medication can be made available. All participants will be asked to continue on the study. And if they chose not to remain on the study, they will be referred for the best locally available HIV prevention services. We look forward to presenting these results in a peer-review setting at upcoming conferences as we finalise the primary analysis.

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If you’ve been told you only have to worry about getting the top number of your blood pressure down, you may want to get a second opinion.

That’s what researchers in a new study are saying.

“The take home message here is that when you’re getting your blood pressure checked, we need to pay attention to both numbers, the systolic and the diastolic,” Dr. Alexander Flint, a stroke specialist at Kaiser Permanente in Northern California and lead author of the study, told Healthline.

The top number, or systolic, reflects how hard your heart is working to pump blood into your arteries. The bottom number, or diastolic, indicates the pressure as your heart relaxes between beats.

Researchers concluded that both numbers were independent predictors of heart attacks and strokes.

“Both the top and the bottom number are strongly linked to outcomes of ischemic stroke, the type of stroke where a blood clot blocks an artery in the brain, as well as hemorrhagic stroke, bleeding in the substance of the brain, and heart attacks,” Flint said.

“This study goes against previous data which shows systolic blood pressure is generally more important,” Ramin Oskoui, a Washington, D.C., cardiologist, told Healthline.

Oskoui is also chief executive officer of Foxhall Cardiology and is affiliated with Sibley Memorial Hospital, Suburban Hospital, and Washington Hospital Center.

In fact, Flint says the findings turn upside down decades of commonly held beliefs about blood pressure readings.

“There had been quite a lot of discussion in the medical literature about this idea that systolic blood pressure was so much more important than diastolic blood pressure, based on previous studies. That perhaps we don’t have to pay attention to diastolic blood pressure. And if that were true, it might present an opportunity to simplify therapy. Let’s only talk about the one number,” Flint explained.

“Here the data are telling us that if we were to ignore the diastolic blood pressure, that would be to the detriment of our patient’s care,” he added.

What researchers learned

This study is being called the largest of its kind.

Between 2007 and 2016, the research team analyzed 36 million outpatient blood pressure readings from more than 1 million adult members of Kaiser Permanente in Northern California.

They concluded that while systolic blood pressure had a greater impact, both systolic and diastolic pressures influenced your risk factors.

That was true whether measured against the older threshold of 140/90 or the newer guidelineof 130/80.

How does it change treatment?

Flint said the findings won’t change much when it comes to treating your blood pressure with medications.

“It turns out that the medications do both, so we don’t have to make things more complicated in terms of picking and choosing medications,” Flint said.

“Everybody reacts to the medications in different ways. Really, it’s just a matter of working with your physician to find the right medication, the right dose to achieve both of those numbers. All the classes of anti-hypertensive medications work for both numbers,” he said.

“While these findings may not make much difference in the medications I give my patients, it is an opportunity to reinforce with the lay public that the lower your blood pressure, the lower your risk of heart attack, heart failure, stroke, and kidney disease,” Oskoui said.

“We can remind our patients to cut out alcohol, exercise in moderation, and lose weight. Even a 10 to 15 pound weight loss can mean the difference between medication or not,” Oskoui added.

That advice echoes what the American Heart Association recommends:

• Eat a well-balanced diet low in salt.
• Limit your alcohol.
• Get regular physical activity.
• Manage your stress.
• Maintain a healthy weight.
• Quit smoking.
• Take your medications as prescribed.
• Work with your doctor.

Next steps in the research?

“We can look at mortality, we can look at different predictors related to blood pressure, specifically the ‘pulse pressure,’ which is a mathematical subtraction of the systolic and diastolic numbers,” Flint said. “In certain circumstances, it may be an independent predictor that is important, so we’re exploring that.”

Flint says this study was carried out using a big data approach with information from the Kaiser healthcare system.

“We have many, many clinics and all those clinics are putting data into electronic medical records, so we are really able to do analytics like this at a close to population-level,” Flint said.

In the not-too-distant future, he said, researchers may be gathering blood pressure data from noninvasive wearable sensors.

“This is sort of a stepping stone toward that even bigger data approach to learning more about the relationship between blood pressure and other factors and the risk of cardiovascular events. We could hopefully identify people at much finer level who are at risk and tailor medical therapy for them,” Flint added.FEEDBACK:

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