Daily HIV Prevention Pill (PrEP): Why It’s Urged for Healthy People at Risk

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With the success of antiretroviral therapy (ART), people living with HIV (PLWH) now enjoy longer life expectancies than ever before. However, this increased lifespan has brought a new challenge: a significantly higher risk of early cardiovascular disease (CVD).

Research shows that HIV-positive individuals are 1.5 to 2 times more likely to develop heart disease at a younger age compared to HIV-negative individuals. This article explores the underlying causes, scientific findings, and most importantly, how to reduce that risk through prevention and lifestyle changes.

Why Does HIV Increase Heart Disease Risk?

Cardiovascular disease in HIV patients is multifactorial, meaning it’s influenced by a mix of biological, lifestyle, and treatment-related factors.

1. Chronic Inflammation & Immune Activation

Even with effective ART and undetectable viral load, HIV causes persistent low-grade inflammation in the body. This leads to:

• Damage to blood vessel linings (endothelium)
• Increased plaque formation
• Accelerated atherosclerosis (hardening of arteries)

2. Immune System Dysfunction

HIV affects CD4+ T-cells, weakening the immune system. This dysfunction can:

• Promote autoimmune reactions
• Make the body less effective at repairing vascular damage

3. Side Effects of Antiretroviral Therapy (ART)

Some older or specific ART drugs (especially protease inhibitors and abacavir) are associated with:

• Increased cholesterol and triglyceride levels
• Insulin resistance
• Elevated risk of metabolic syndrome

4. Higher Prevalence of Traditional Risk Factors in PLWH

People living with HIV often have a higher rate of:

• Smoking
• Diabetes
• Obesity
• Sedentary lifestyle
• Co-infections like Hepatitis B/C, which can indirectly impact cardiovascular health

5. HIV-Associated Lipodystrophy

This condition, caused by some ART medications, leads to abnormal fat distribution and metabolic changes, further increasing the risk of heart disease.

What Does the Research Say?

Several key studies have demonstrated the link between HIV and heart disease:

• The REPRIEVE Trial (NIH, ongoing) is investigating whether statins can prevent heart disease in HIV patients.
• A study published in JAMA Cardiology (2020) found that HIV-positive individuals had a 50–100% higher risk of heart attack than the general population.
• A 2023 report in The Lancet HIV showed increased arterial stiffness and vascular inflammation in young adults with HIV — even those on effective ART.

In short, heart disease now rivals opportunistic infections as a leading cause of morbidity in aging HIV patients.

Early Warning Signs & Screening

HIV patients often experience “silent” heart disease, where symptoms may not be obvious until major events like a heart attack or stroke occur. Regular screening is essential.

Doctors typically monitor:

• Blood pressure
• LDL/HDL cholesterol
• Blood sugar and insulin levels
• C-reactive protein (CRP) — marker of inflammation
• Carotid intima-media thickness (CIMT) — ultrasound measure of artery wall thickening

Prevention Strategies: How to Lower the Risk

Fortunately, many of the risks can be controlled with the right interventions.

1. Stick to Effective ART

• Modern ART regimens are safer and more heart-friendly than earlier generations.
• Staying virally suppressed reduces inflammation and immune activation.
• If you’re on older ART (e.g., abacavir, lopinavir), talk to your doctor about switching.

2. Adopt Heart-Healthy Habits

3. Control Blood Pressure & Cholesterol

• Use statins if needed — they not only lower cholesterol but also have anti-inflammatory benefits in HIV.
• REPRIEVE trial is evaluating long-term statin use in HIV for prevention even in low-risk patients.

4. Manage Diabetes and Insulin Resistance

• Monitor A1C and fasting glucose regularly.
• Adopt a low-glycemic index diet and stay active.

5. Address Mental Health & Stress

• Chronic stress and depression (common in HIV) can raise cortisol and BP.
• Practice mindfulness, therapy, and sleep hygiene.

Summary Table: HIV and Heart Disease

Final Thoughts

People living with HIV now live longer — but with longevity comes greater vulnerability to chronic illnesses like heart disease. The good news is that with early screening, modern ART, and healthy lifestyle choices, heart disease in HIV-positive individuals is largely preventable.

HIV-positive people are living longer than ever because of therapies that prevent the growth of the virus. But these patients deal with more heart troubles and barriers to treatment than other individuals, according to the American Heart Association (AHA).

A scientific statement published in June 2019 in the journal Circulation highlighted that three-quarters of people over the age of 45 who are living with HIV are experiencing significantly more heart attacks, heart failure, and strokes earlier in life compared with those who don’t have HIV.

“Chronic inflammation and immune activation [or response] appear to be the primary drivers of high heart disease risk in HIV,” says Matthew Feinstein, MD, chair of the writing group for the statement and assistant professor of medicine and preventive medicine at the Feinberg School of Medicine at Northwestern University in Chicago.

He stresses that HIV treatment is essential, not only for controlling the virus, but also for reducing chronic inflammation and problems with immune regulation.

“Several studies have now shown that worse HIV control is associated with higher risks for heart disease,” Dr. Feinstein told Everyday Health. “So the first and most important step in preventing heart disease in HIV is getting the HIV under control with the right medications prescribed by HIV specialists and primary care doctors.”

Addressing Common Heart Disease Factors

The statement authors also observed that people living with HIV more often had factors commonly associated with heart troubles, such as heavy alcohol use, substance abuse, mood and anxiety disorders, low levels of physical activity, and poor cardiorespiratory fitness.

About 4 out of 10 are smokers, according to a nationally representative sample of HIV patients.

Quitting tobacco use, eating a balanced diet (such as the DASH diet or Mediterranean diet), and staying physically active can help lower risk, notes Feinstein.

Sarah Samaan, MD, a cardiologist with Baylor Scott & White Legacy Heart Center in Plano, Texas, who was not an author on the statement, has seen many HIV patients benefit from statin drugs to lower cholesterol and medication to lower blood pressure.

“Since some HIV medications can raise the risk of side effects from other drugs, it’s important to discuss the options for treatment with a knowledgeable physician,” say Dr. Samaan. “A good pharmacist can also help to ensure that the drugs that are prescribed are safe and appropriate.”

Living Longer But With More Health Problems

In an accompanying patient perspective published by the American Heart Association, Jules Levin, the founder and executive director of the National AIDS Treatment Advocacy Project (NATAP), expressed his concerns about the high numbers of serious medical problems in older people with HIV compared with the general population.

According to NATAP, those with HIV over 60 years old have an average of three to seven health conditions in addition to being HIV-positive. Comorbidities include heart attacks, strokes, heart failure, kidney disease, frailty, and bone diseases. Also, many take 12 to 15 drugs daily.

“Most people don’t know that HIV is causing accelerated aging,” says Levin, who has been living with HIV for 35 years. “Within a few years of initial infection, the immune system senescence [deterioration with age] sets in right away. Once people with HIV get into their sixties, they really have a double hit — from aging and from the effects of HIV.”

This is why Levin urges HIV-positive individuals to be screened for cardiovascular troubles as well as bone density, kidney disease, and cognitive impairment.

The scientific statement recommends trying the American Heart Association–American College of Cardiology Atherosclerotic Disease Risk Calculator as one way for getting some idea of your heart disease risk.

Overcoming Barriers to Treatment

Both Feinstein and Levin spotlight the need for improving access to healthcare for people living with HIV. The statement authors pointed out that this population is often stigmatized, and federal and local authorities could make more effort to increase care options for these individuals. Many living with HIV are homebound and cognitively impaired to a degree where they have difficulties paying bills and making decisions.

“What’s most needed are support services and better care in the clinics,” says Levin. “We need to actively demand that federal and local officials address this problem.”

He urges people to contact NATAP to explore ways to take action.

A Call for Further Research

Feinstein and his coauthors based this scientific statement on large observational studies investigating HIV and heart disease.

“But we don’t yet have much in the way of large-scale randomized trial data for heart disease prevention and treatment in HIV,” he says. “Although we have a reasonable understanding of why plaque buildup in the arteries occurs in HIV, we do not have as clear of an understanding of why the heart muscle often becomes dysfunctional or why blood clotting may occur more commonly in HIV.”

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“Reading the letters made me realize who they were,” Madeleine Fugate, 14, tells PEOPLE

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Sunday, February 7, 2021, is the annual observance of National Black HIV/AIDS Awareness Day (NBHAAD). The Strategic Leadership Council is the community group that sets the direction for NBHAAD. This year’s observance comes at a time of renewed concern and action for health equity and inclusion across the nation.

We’ve put together a list of resources from HIV.gov and our federal partners to help you get involved with NBHAAD and spread the word.

Where to Go

Our NBHAAD Awareness Day page has resources such as the NBHAAD logo, fact sheets, and other materials from the community and across the U.S. Government. We feature the Centers for Disease Control and Prevention’s (CDC) NBHAAD digital toolkit and their Let’s Stop HIV Together campaign resources that you can use and share. We’ll also add registration details for some upcoming webinars hosted by the HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) and CDC that anyone can join.

We encourage you to stay tuned for the Strategic Leadership Council’s communications about this year’s observance. And be sure not to miss the Ending the HIV Epidemic: A Plan for America (EHE) initiative quarterly stakeholder webinar on January 27, which will provide updates on major federal activities related to EHE implementation and highlight ways to improve HIV diagnosis, care and prevention outcomes for Black women. Register here  to join.

What to Know

Given the disproportionate impact of HIV on Black communities, we encourage you to learn what’s happening with EHE implementation. This data-driven, locally-implemented effort continues its important work to reduce new HIV infections even as our nation’s response to the COVID-19 pandemic proceeds.

PrEP is an important HIV prevention tool and the Ready Set PrEP program may be right for you or eligible individuals with whom you work. Please share information about the HIV Services Locator, where individuals can find PrEP providers in their local area.

HIV self-testing is a key strategy to improve testing uptake and increase diagnoses, particularly in these times when face-to-face testing services have been disrupted. Find information about self-testing on HIV.gov. Please use and share the Locator to find testing services nearby. (Be sure to call ahead to inquire about the availability of self-testing.)

HIV treatment helps people with HIV stay healthy and live longer. There is also a major prevention benefit: people with HIV who take HIV medicine daily as prescribed and get and keep an undetectable viral load have effectively no risk of sexually transmitting HIV to an HIV-negative partner. Please share information about the importance of getting and staying on HIV treatment.

For more information, we provide basic HIV facts about HIV prevention, diagnosis, and treatment. Know the facts and spread the word (along with your encouragement and support) with friends and family members who have not been tested for HIV, might be at risk, or are living with HIV.

How to Share

The hashtag for NBHAAD 2021 is #NBHAAD. Let your voice be heard by using the hashtag on your social media.

The following channels are part of the conversation, give them a follow, like or share:

• Facebook: HIVgov , CDC HIV , and Start Talking Stop HIV 
• Twitter: @HIVGov , @CDC_HIV/AIDS , @DrMerminCDC 
• Instagram: @HIVgov , @stophivtogether , @starttalkinghiv 

Find Out More

We’ll be posting content on our blog and on our social media channels throughout NBHAAD. Want to make sure you don’t miss out on the latest HIV resources, policies, and programs? Sign up to receive email updates.

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According to data provided to Ahmedabad Municipal Corporation, the year 2020 saw nearly 80 per cent drop in people tested. groups.

Several routine health activities have taken a backseat due to the ongoing Covid-19 pandemic and one among the worst hit was HIV-AIDS surveillance activities that saw a nearly 50 per cent reduction, as per the Ahmedabad Municipal Corporation (AMC).

Apart from the diversion of manpower, a major factor behind the drop was due to the fact that sex workers were largely out of work, migrants were away and truckers were dormant during the lockdown, making it difficult for NGOs and AMC to conduct targeted interventions for these groups.

Deputy health officer at AMC and project director at AMC AIDS Society, Mehul Acharya, says that unlike tuberculosis treatment where a directly observed treatment (DOTS) system is followed permitting better monitoring, anti-retroviral therapy (ART) for HIV, AIDS patients require them to visit a health centre.

Five key target demographies are female sex workers, male sex workers, truckers, drug abusers and migrants.

Surveillance is primarily conducted under four categories with maximum categories under the general population. Three other categories include pregnant women during antenatal checks (ANC), children below two years of age and children more than two years but less than 18 years of age.

Data provided by the AMC shows that compared to 2019-20 when 1.12 lakh of the general population were tested, this year saw nearly an 80 per cent drop in people tested. As a result, positivity too has gone up this year. However, the rate of linking HIV positive patients with ART has remained constant both years at 97 per cent.

Notably, of the nearly Rs 4.5 crore budget provided by the National AIDS Control Organisation (NACO) to Gujarat, a significant chunk of Rs 1.68 crore is allocated for targeted interventions for migrants.

Acharya said, “A major reason for our work getting affected this year was owing to the fact that truckers stopped plying during the lockdown and we saw migrants moving away en masse. Sex workers too wouldn’t go out due to the lockdown.”

Acharya says that a peculiar thing about this viral infection is the stigma around it that makes patients reluctant to be forthcoming. “Say a husband tests positive, the next task becomes convincing and counselling his wife to get tested,” he said.

He added that the surveillance activity is expected to pick up as AMC is working with 15 NGOs.

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The PEC is responsible for overseeing a continuous and comprehensive evaluation of the HPTN. The PEC designs and directs implementation and reporting of the internal evaluation of the HPTN. This includes assessing performance of the CTUs as well as key organizations and entities that are also part of the HPTN (e.g., Leaderships and Operations Center (LOC), SDMC, Laboratory Center (LC) and protocol teams).

The goal of the evaluation is to provide data to assist leadership in making any decisions or changes necessary to improve HPTN functioning. In regard to the CTUs, the primary purpose of the evaluation is to provide data to determine if the sites are contributing effectively to the protocols assigned and to elicit corrective action, if necessary, so that all sites are functioning at peak performance level.

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BIRMINGHAM, Ala. (AP/WIAT) — Alabama’s largest health care unit for treating HIV patients has relocated to a larger location.

The 1917 Clinic at the University of Alabama at Birmingham has moved from its old home in downtown to a new site in Birmingham’s Lakeview district. The clinic has more than doubled in size to 27 examination rooms. It also has added a second room for medical procedures and new space for counseling services.

“This move will allow for increased capacity to meet the existing and burgeoning need for HIV comprehensive multidisciplinary care and support service to people with HIV and the community,” said clinic director James Raper, Ph.D., CRNP. “It also allows us to more effectively do outreach to identify persons with HIV who are not engaged in care, and simultaneously do outreach and provide PrEP services to people at risk for HIV.”

With more than 3,600 active patients, clinic director James Raper says the expansion will help provide comprehensive care for people with HIV, which can cause AIDS.

While the 1917 Clinic occupies the majority of the Dewberry Building, Birmingham AIDS Outreach has space in the building as well, which is indicative of 1917’s mission to work with community partners and agencies to support all patient needs.

“This move will provide renewed synergy between 1917 Clinic and BAO as community partners in the fight to end the HIV epidemic while addressing the immediate needs of the HIV community,” Raper said. “I am excited about the decades of HIV patient care ahead of us in this new space.”

The 1917 Clinic has treated more than 12,000 patients with HIV in its three-decade tenure.

The Associated Press contributed to this report.

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Global solidarity and resilient HIV services

The global HIV epidemic is not over and may be accelerating during the  COVID-19 pandemic, with a devastating impact on communities and countries. In 2019, there were still 38 million people living with HIV infection. One in five people living with HIV were not aware of their infection and one in 3 people receiving HIV treatment experienced disruption to the supply of HIV treatments, testing and prevention services, especially children and adolescents. In 2019, 690 000 people died from HIV-related causes and 1.7 million people were newly infected, with nearly 2 in three (62%) of these new infections occurring among key populations and their partners.

Despite significant efforts, progress in scaling up HIV services was already stalling before the COVID-19 pandemic. Slowing progress means the world will be missing the “90-90-90” targets for 2020, which were to ensure that: 90% of people living with HIV are aware of their status; 90% of people diagnosed with HIV are receiving treatment; and 90% of all people receiving treatment have achieved viral suppression. Missing these intermediate targets will make it even more difficult o achieve the end of AIDS by 2030.

The breakdown in essential HIV services due to COVID-19 threatens lives. COVID makes it difficult and dangerous for frontline health workers to deliver continuous, high quality HIV services to everyone who needs them. Sickness and restricted movement make it difficult for people living with HIV to access services. Economic disruption caused by COVID can make HIV services unaffordable or unobtainable. And the pandemic may interfere with supply chains and service delivery. For example, as of July 2020, one third of people on HIV treatment had experienced drug stockouts or interruptions in supplies. Supply disruptions such as these are devastating; a WHO and UNAIDS modeling study showed that six-month disruption in access to HIV medicines could lead to a doubling in AIDS-related deaths in sub-Saharan Africa in 2020 alone.

Now is the time for us to once again make a leap in our response to work together to end COVID-19 and get back on track to end HIV by 2030. On World AIDS Day 2020, WHO is calling on global leaders and citizens to rally for “global solidarity” to overcome the challenges posed by COVID-19 on the HIV response.  WHO has chosen to focus on “Global solidarity, resilient HIV services” as the WHO theme for World AIDS Day this year.

The key actions are:

1. Renew our fight to end HIV

   The global AIDS response has slowed down: it’s time now to invest, to innovate HIV services with broader health care and the pandemic response to get back on track to end HIV by 2030. Missing the global targets for HIV for 2020 should not be a setback but a renewed call to do better.

2. Use innovative HIV services to ensure continued HIV care.

   There are many new approaches countries are adopting to ensure HIV care during the pandemic. WHO has recommended multi-month prescriptions of HIV medicines to protect the health of people on HIV treatment and to reduce the burden on overburdened health services.

3. Engage and protect our nurses, midwives and community health workers

   We urge policymakers to ensure that frontline health workers, nurses, midwives and community health workers are engaged and protected when delivering services for HIV and COVID-19. 

4. Prioritize the vulnerable – youth and key populations
   We need to ensure that children, adolescents and members of key and vulnerable populations affected by HIV do not fall through the cracks of health care disruptions during COVID-19.  Key populations include people who use drugs, men who have sex with men, sex workers, transgender people and people in prisons that are disproportionately affected by HIV. 
   

Please join us for a webinar to celebrate World AIDS Day on 1 December 2020 from 13:00 to 14:30 Geneva time (Central European Time). The event will cover global efforts to ensure global solidarity and resilient HIV services, including during the COVID-19 pandemic.

The speakers will include:

Dr Tedros Adhanom Ghebreyesus, Director General, World Health Organization (WHO)

Honourable Lizzy Nkosi, Minister of Health, The Kingdom of Eswatini

Mr Peter Sands, Executive Director, The Global Fund to Fight AIDS, Tuberculosis and Malaria

Ms Winnie Byanyima, Executive Director, Joint United Nations Programme on HIV (UNAIDS)

Dr J.V.R. Prasada Rao, Former Secretary of Health, India and Former SG’s Envoy for AIDS in in Asia and the Pacific

Dr Ren Minghui, Assistant Director-General, Universal Health Coverage/Communicable and Noncommunicable Diseases, WHO

Dr Meg Doherty, Director, Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, WHO

Ms Cindy Amaiza, National Coordinator, Y+ Kenya

Ms Sasha Volgina, Programme Manager, Global Network of People Living with HIV (GNP+)

Dr Adeeba Kamarulzaman, President, International AIDS Society (IAS)

Ms Erica Burton, Senior Advisor, International Council of Nurses (ICN)

Dr Alex Schneider, Founder, Life4me+

Mr Asghar Satti, National Coordinator, Association of People Living with HIV (APLHIV), Pakistan

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Among patients with HIV who are in care, the rate of hospitalization for any cause declined substantially during a recent 10-year period, according to study findings published in The Journal of Infectious Diseases.

Hospitalization rates declined despite the potential effects of aging, comorbidities and cumulative exposure to HIV and antiretrovirals, researchers said.

In their study, Thibaut Davy-Mendez, PhD, a post-doctoral fellow in the department of psychiatry and behavioral sciences at the University of California, San Francisco, Stephen A. Berry, MD, PhD, associate professor of medicine at Johns Hopkins University School of Medicine, and colleagues examined trends in all-cause and cause-specific hospitalization rates between 2005 and 2015 to assess the possible impact of ART improvements, aging and comorbidities on hospitalizations among people living with HIV (PLWH) who are receiving care.

The study included PLWH receiving care in six clinical cohorts in the United States and Canada.

Among the 28,057 patients ultimately included in the study, the median CD4 increased from 389 to 580 cells/µL, and the proportion of patients who were virologically suppressed rose from 55% to 85%.

According to the researchers, the unadjusted all-cause hospitalization rate decreased from 22.3 per 100 person years in 2005 (95% CI, 20.6-24.1) to 13 per 100 person years in 2015 (95% CI, 12.2-14). Additionally, unadjusted rates decreased for almost all diagnostic categories, whereas adjusted rates decreased for all-cause, cardiovascular and AIDS-defining conditions. They increased for non-AIDS-defining infection and were stable for most other categories.

According to Davy-Mendez and Berry, previous data showed similar results. Data from the 2000s revealed a decrease in hospitalization rates among PLWH but slight increases in cardiovascular and kidney disease hospitalizations. Additionally, more recent studies in North Carolina and Italy found a continued decrease in hospitalization rates among people with HIV through 2016.

“Our study is the most recent work reporting hospitalization trends across a large number of people living with HIV in the United States and Canada,” they said. “Based on previous studies, we expected that non-AIDS-defining infections would make up a substantial percentage of hospitalization reasons. However, we did not expect to see a small increase in the adjusted hospitalization rate [of] non-AIDS-defining infections.”

They said this finding will require further investigation to understand the drivers of these infections and possible ways to prevent them.

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Bikila Balis

Department of Midwifery, School of Nursing and Midwifery, College of Health and Medical Sciences, Haramaya University, Harar, Western Oromia, Ethiopia

Correspondence: Bikila Balis
School of Nursing, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia
Tel +251 921788619
Email bik.balis2008@gmail.com

Background: Human immunodeficiency virus infection has been one of the top health-related challenges for the past four decades. Ethiopia is extremely infected by HIV pandemic every year, whereby 22,300 people were newly infected and 690,000 were living with HIV at the end of 2018. Sexual behavior of HIV positive individuals visiting treatment clinics is a neglected issue. Nonetheless, it has been a significant way of HIV transmission to serodiscordant partners.
Methods: A facility-based cross-sectional study design was used on a sample of 432 women attending treatment clinics in west Oromia from February 26 to March 26, 2019. Systematic sampling was used to select the study participants. A pretested and structured interviewer-administered questionnaires were used to collect the data. The data were coded, entered, cleaned and exported to SPSS version 20.0 for analysis. Descriptive statistics were used to present frequency distributions. Variables with P-value < 0.25 during bivariate analysis were entered into multiple logistic regression models to control for all possible confounders. Odds ratio along with 95% CI were estimated to measure the strength of the association. Level of statistical significance was declared at a p-value less than 0.05.
Results: Out of total respondents, 240 (56.9%), 95% CI: (52.1– 61.6%) were involved in risky sexual practices in the prior 12 months. Urban residence [AOR: 3.24, (95% CI: (1.52, 6.89)], those with no formal education [AOR: 2.77, (95% CI: (1.18, 6.54)], being on ART for > 2years [AOR: 2.74, (95% CI: (1.13, 6.65)] and CD4 count ≥ 200 cells/mm³ [AOR: 3.20, (95% CI: (1.50, 6.82)] were factors significantly associated with risky sexual practice.
Conclusion: A considerable number of respondents were involved in risky sexual practices 240 (56.9%) due to being rural residence, not attending formal education, being on ART for > 2 years and CD4 count ≥ 200 cells/mm³.

Keywords: women, HIV/AIDS, risky sexual practices, Oromia, Ethiopia

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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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New research shows that electronic cigarettes (e-cigarettes) can help smokers quit smoking cigarettes, according to an editorial in JAMA by Nancy Rigotti, MD, director of the Tobacco Research and Treatment Center at Massachusetts General Hospital.

Nearly a half million Americans die each year from tobacco-related diseases such as lung cancer, heart attacks, strokes and emphysema, which makes smoking the leading preventable cause of death in the United States. Most smokers want to stop, and more than half try to quit each year, but only five to seven percent are able to abstain long term. Using treatments approved by the Food and Drug Administration (FDA) increases the likelihood of success, but many smokers who use these therapies still struggle to remain tobacco free, says Rigotti, who is also a professor of Medicine at Harvard Medical School.

Rigotti sees a promising role for e-cigarettes as a new option to help smokers quit. E-cigarettes are handheld devices filled with a liquid that usually contains nicotine and flavorings. The device heats the liquid to produce an aerosol that’s inhaled, or “vaped.” The devices appeal to smokers trying to quit because they mimic the experience of smoking while providing nicotine to avoid withdrawal symptoms.

Since e-cigarettes don’t burn tobacco, users don’t inhale toxin-filled smoke, as with conventional cigarettes. While not harmless, using e-cigarettes is likely far less dangerous than continuing to smoke conventional cigarettes. Skeptics note that e-cigarettes are not approved medicine for smoking cessation. Rigotti counters that there’s an urgent need for evidence showing that e-cigarettes are safe and effective at helping smokers quit.

In October, Rigotti and several colleagues published a review of 50 studies, which included 12,430 adult smokers, that evaluated e-cigarettes as smoking-cessation aids in the prestigious Cochrane Database of Systematic Reviews. Overall, Rigotti and her coauthors found increasing evidence that e-cigarettes containing nicotine are more effective at helping smokers quit for at least six months than nicotine-replacement therapy (such as skin patches and chewing gum), nicotine-free e-cigarettes and behavioral counseling.

Rigotti’s editorial appears in an issue of JAMA that also features a new study of e-cigarettes, which found that abstinence from smoking after three months was higher among participants using the devices than those who only received counseling. “We need more randomized trials because there is still a lot we don’t know,” says Rigotti. In particular, she calls for studies of new-generation “pod-type” e-cigarettes (the JUUL brand is one example), which deliver nicotine faster and in higher doses than the older devices studied in the JAMA article. She also calls for comparing e-cigarettes with other FDA-approved smoking cessation medications and for more research on the health effects of long-term use of e-cigarettes.

For now, FDA-approved therapies should be the first choice for patients who need to stop smoking, says Rigotti. “But what do you say to a smoker who has tried those treatments and failed? Or who isn’t willing to try them?” In that case, Rigotti believes it’s reasonable to discuss the potential benefits and harms of e-cigarettes with the patient. “In the debate about e-cigarettes,” she says, “we need to remember that there are millions of smokers who need help and could benefit.”

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