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Preexposure prophylaxisdrugs can help reduce risk of developing HIV. Kuboo/Shutterstock
  • Preexposure prophylaxis (PrEP) drugs are approved for use in helping prevent HIV acquisition.
  • The US Preventive Services Task Force has released a new statement recommending PrEP for those at high risk of HIV.
  • Three forms of PrEP are currently available: two oral medications and an injection.
  • PrEP plays a significant role in helping reduce new HIV infections in the US.

While there’s no cure for human immunodeficiency virus (HIV), there are measures people can take to avoid developing the disease.

One involves taking drugs called preexposure prophylaxis (PrEP), which received Food and Drug Administration (FDA) approval in 2012.

A newly released statement from the US Preventive Services Task Force (USPSTF) recommends that clinicians prescribe the medication to persons at increased risk of acquiring HIV.

The recommendation was graded category A, meaning the panel believes “There is high certainty that the net benefit is substantial.”

This category also means that most insurance companies will cover the medications at no out-of-pocket costs for patients.

USPSTF is an independent volunteer panel of leading clinical experts working to improve the population’s health through evidence-based recommendations.

The latest statement builds on USPSTF’s PrEP recommendation from 2019 and is based on findings from a new systematic review.

Four years ago, USPSTF reviewed the evidence regarding the efficacy of PrEP in preventing HIV acquisition. At the time, PrEP came as an oral drug in two forms: containing tenofovir disoproxil fumarate (TFD) alone or a combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC).

Then, USPSTF found “convincing evidence” that PrEP offered “substantial benefit in decreasing the risk of HIV infection in persons at high risk of HIV acquisition.”

They recommended offering PrEP to people at high risk.

However, other antiretroviral drugs for HIV prevention have since become available and been approved: tenofovir alafenamide fumarate and emtricitabine (TAF/FTC) and an injectable medication called cabotegravir.

USPSTF wanted to conduct a more up-to-date assessment to review and compare these new medications to the older ones.

The panel looked at 32 studies, all of which found the drugs effective in preventing HIV infection compared to placebo or no PrEP.

Diving further into the results, oral TAF/FTC was found to be noninferior to oral TDF/FTC. The term “noninferior” means that one treatment is not unacceptably worse compared to another treatment.

Two reviewed studies also indicated that cabotegravir was more effective at reducing HIV infection risk than TDF/FTC.

In their report, the panel noted that further investigation is needed to determine the following:

  • Whether TAF/FTC is more beneficial than its TDF/FTC predecessor
  • Differences in intermediate outcomes (such as weight gain and changes in bone density) between older and newer PrEP regimens
  • The efficacy of TAF/FTC in groups aside from men who have sex with men
  • Long-term outcomes of taking injectable cabotegravir
  • The efficacy and safety of PrEP for pregnant and gender non-conforming individuals.

Recommendations and statements from organizations such as USPSTF can positively influence insurance providers’ plans and coverage costs — in turn, making treatments and drugs more affordable and accessible.

“Currently, PrEP is covered by most health insurance plans without out-of-pocket costs to patients,” said Lee Nguyen, PharmD, health sciences associate clinical professor at University of California, Irvine – School of Pharmacy & Pharmaceutical Sciences.

“I am hopeful that the US Preventive Services Task Force recommendations on HIV Preexposure Prophylaxis will improve insurance coverage,” he told Healthline — but added that “the process may be slow.”

“I really hope that any insurance companies who have chosen not to cover PrEP start now,” added Dr. Sarah Schmalzle, Infectious Disease Specialist at the University of Maryland Medical Center and Associate Professor at the University of Maryland School of Medicine.

“It’s such an important public health measure that allows individuals to take their health into their own hands.”

Those without health insurance needn’t remain at high risk: Nguyen explained there are other ways to obtain PrEP.

These include “Enrolling in the US Department of Health and Human Services’ Ready, Set, PrEP program or Gilead’s Medication Assistance Program for PrEP to get the medication for free.”

It was through studies around 15 years ago that scientists first learned two drugs — tenofovir and emtricitabine — could significantly reduce HIV acquisition risk, explained Professor Itzchak Levy, an infectious disease specialist and director of the HIV/AIDS Center at Sheba Medical Center.

He told Healthline that the two antiretroviral medications were initially available in one combined tablet named Truvada, developed and manufactured by the pharmaceutical company Gilead. Today, however, “there are a lot of generic medications that contain the same drugs.”

The most common brand name PrEP drugs are:

  • Truvada (TDF/FTC)
  • Descovy (TAF/FTC)
  • Apretude (cabotegravir)

“Truvada and Descovy are from a family of medicines called reverse transcriptase inhibitors, and Apretude is an integrase inhibitor,” said Nguyen.

Reverse transcriptase inhibitors interfere with the function of the HIV enzyme reverse transcriptase, preventing the virus from replicating. Meanwhile, integrase inhibitors stop another important HIV enzyme, integrase, from functioning properly.

It’s thought that PrEP — alongside increased testing and treatment — has played a vital role in helping reduce HIV infections in the US.

Ending the HIV Epidemic in the US, an initiative from the US Department of Health and Human Services involves PrEP as one of its key pillars. The aim is to have 50% of those who could benefit from PrEP taking the drug by 2025.

It’s important to note that although PrEP is highly effective in preventing HIV, it doesn’t protect against other sexually transmitted infections (STIs). As such, “Use of a condom is always recommended,” said Levy.

He added that regular HIV testing is also a must for those on PrEP — because “Taking [PrEP] while being infected will pose the risk of developing resistance to the virus.”

Potential side effects of PrEP

PrEP medications are considered safe, but can have minor side effects. These include:

  • Headaches
  • Nausea
  • Gastrointestinal concerns (such as stomach pain and diarrhea)
  • Fatigue

Fortunately, these usually aren’t long-lasting and should go away with time.

“Individuals with impaired or augmented kidney function may require dose adjustments, which is why seeing a healthcare professional is important,” added Nguyen. “[They] can assist with determining which of the PrEP medications is best for patients and their lifestyles.”

Various individuals qualify to take PrEP, as long as they are HIV-negative. “Those who will have the highest benefit are people at the greatest risk of infection, like men who have sex with men or transgender women that don’t use condoms,” said Levy.

“Over a million people in the US are eligible,” Schmalzle said. This number includes those who have engaged in vaginal or anal sex within the past six months and:

  • Have a sexual partner that has HIV (particularly if they have an unknown or detectable viral load)
  • Regularly have sex without a condom (especially if you’re unaware of your partner’s HIV status)
  • Have been diagnosed with an STI within the past six months.

STIs are important to consider because “Sexual infections tend to ‘travel in packs’ and increase the risk you’ll get another one,” explained Schmalzle.

Unfortunately, Levy noted that TAF/FTC (Descovy) is currently unsuitable for “cisgender women, as it has not been studied enough in this population.”

The USPSTF also said that “Persons who engage in transactional sex, such as sex for money, drugs, or housing, including commercial sex workers or persons trafficked for sex work” should be considered for PrEP (dependent on meeting specific criteria) as they “constitute a group at increased risk of HIV acquisition.”

Finally, Nguyen revealed PrEP can help prevent HIV acquisition among individuals who “Inject drugs and have an injection partner with HIV, or those that share injection equipment, such as needles or syringes.”

PrEP is a prescription drug, so you’ll need to speak to a doctor if you’re looking to start taking it.

“If you don’t have a doctor, PrEP consultation can be done at community health centers, sexual health clinics, or nonprofit/governmental health clinics,” said Nguyen. Visit locator.hiv.gov to find your nearest HIV service clinic.

Such centers may also be the best bet for those looking to take cabotegravir rather than TDF/FTC or TAF/FTC, as “The injection tends to be harder to get covered by insurance,” revealed Schmalzle.

She added that “Clinics specializing in sexual health or HIV care are more likely to have the approval process figured out and to give the injection.”

“It is essential that PrEP is taken as prescribed to ensure enough medicine is in the body to prevent replication of the human immunodeficiency virus,” stated Dr. Christine Horvat Davey, PhD, RN, assistant professor at the Frances Payne Bolton School of Nursing, Case Western Reserve University.

In injection form, PrEP (cabotegravir) is administered once every two months. Oral medications (TAF/FTC and TDF/FTC) are taken far more frequently.

“Most clinicians will strongly advise someone to take oral PrEP every day,” said Schmalzle. “Many studies have shown that how well you keep up a daily schedule greatly affects how likely PrEP is to work at preventing HIV.”

PrEP can also be taken “off-label” (when an approved drug is taken in a non-FDA-approved way). This involves taking oral PrEP “on-demand”, such as when an individual doesn’t regularly engage in “risky” sex.

Taking PrEP off-label requires “Taking two pills 2-24 hours before sex, one pill 24 hours after the first dose, and one pill 24 hours after the second dose,” Schmalzle said.

However, she added, “The safest bet is to take oral PrEP every day.”

A new statement from the US Preventive Services Task Force (USPSTF) recommends that clinicians prescribe the medication to persons at increased risk of acquiring HIV. The recommendation was declared category A, this means that most insurance companies will cover the medications at no out-of-pocket costs for patients.