We have come a long way in HIV prevention and treatment medications. No longer are we held hostage by handfuls of pills taken multiple times a day. Now, we have many options for treating and even preventing the spread of this virus. The latest advancements have come in the form of long-lasting injectable medications that last months!

Researchers and scientists are increasing the time needed between doses.

Currently, there are two PrEP usage methodologies: Daily and On-Demand. Those on DAILY PrEP take the medication as much as seven (7) to as low as four (4) days a week. Men who have chosen the ON-DEMAND option use a 2-1-1 system.

  • Take two pills (a double dose) between 2 to 24 hours before sex, then
  •  Take one pill 24 hours after the double dose, then
  •  Take one pill another 24 hours after that

HIV treatments are taken DAILY and usually require as few as ONE to THREE mediations. Those who are on a regular and successful regime cannot only entirely suppress the virus within their bodies but make them unable to pass it on to their sexual partners, even when a condom is not used. 

The approved formulation of cabotegravir for PrEP (sold as Apretude) is now the longest-acting HIV prevention method and long-acting cabotegravir plus rilpivirine (Vocabria and Rekambys) is the longest-acting complete HIV treatment regimen. (In North America and Australia, the two drugs are packaged together and sold as Cabenuva.)

Both PrEP and treatment involve intramuscular injections in the buttocks administered by a healthcare provider every other month. (A once-monthly dosing schedule for injectable cabotegravir and rilpivirine is approved in the U.S. and Australia but is not available in Europe.)

A longer-acting formulation of cabotegravir may offer an HIV pre-exposure prophylaxis (PrEP) and treatment option that could be administered once every four months, according to early study results presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2024).

Injectable medications can increase not only the number of gay males taking preventative steps towards remaining free of HIV but also assist those already living with the virus to have happy and healthy lives without fear of infecting their partners.

Injectable PrEP

On the 20th of December, 2021, The United States Food and Drug and Administration (FDA) approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Apretude is given first as two initiation injections administered one month apart and then every two months after that. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. 

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”

Who it’s good for

In general, injectable PrEP is an option for anyone who is also eligible for it in pill form. It is available for those who have previously taken PrEP, are currently using it, or are first-time users. However, it can significantly benefit those who have issues or concerns with their ability to take the medication as directed by their doctors, do not like taking daily pills, use/abuse illegal substances or alcohol, and or have mental healthcare issues. Black and Latino gay males are known to have much lower PrEP usage than their white counterparts. They may be good candidates for an injectable option.

Gay males of color

In 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015. However, there remains significant room for improvement. PrEP requires high levels of adherence to be effective, and specific high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty, and efforts to conceal medication, also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.

The CDC reports that the HIV epidemic continues and was more severe among Black and Hispanic/Latino gay and bisexual men in the United States between 2010 and 2019.

Although the number of new HIV infections declined among White gay and bisexual men between 2010 and 2019 (from 7500 to 5100), the number remained relatively stable among Black (from 9000 to 8900) and Hispanic/Latino (from 6800 to 7900) gay and bisexual men.

Gay and bisexual males of color experience large amounts of cultural stigma regarding HIV prevention and treatment. This can be exacerbated by taking a daily pill to prevent infection. With an injectable option, this has the potential to decrease stigma while increasing usage of this valuable medication.

Guys with adherence issues

Researchers have identified external factors that might interfere with PrEP uptake and could impact adherence. These external factors include both perceived and experienced stigma (being labeled as “sexually promiscuous” by taking PrEP or a fear of being mistaken as HIV-positive because of taking antiretroviral medications. External factors can also include structural barriers, such as having insufficient access to insurance to pay for PrEP (including the potential of losing insurance coverage for PrEP) or not finding a provider willing and able to prescribe it.

Gay and bisexual men who engage in unprotected chemsex (without condoms or PrEP) are at high risk of acquiring HIV. These men are known to have more significant issues of adherence challenges than those men who do not use illegal drugs. 

Elevated rates of alcohol and mental health-related issues among GBMSM also potentially hinder PrEP-taking efforts.

PrEP adherence can often be successfully achieved in the presence of alcohol-, substance use-, and mental health-related issues. Augmenting self-care and addressing pronounced addictions- and mental health-related concerns may enhance PrEP treatment among GBMSM. Injectable PrEP has the potential to be a significant assistance in decreasing the challenges these men have and increasing their ability to maintain a proper regimen over a long period.

Injectable HIV treatment

Injectable HIV treatments have been thoroughly tested to ensure that their effectiveness is comparable to traditional pill medications. It should be noted that they are NOT recommended for those new to HIV treatment. These people are advised to begin a pill-form regimen for a few months and to obtain an undetectable viral load before switching to an injectable schedule.

Those who have not yet achieved an undetectable viral load also are not eligible for injectable treatment options. They are also not suitable for people who have hepatitis B co-infection (who should take a drug combination that includes medications that are active against both HIV and hepatitis B).

The FACTS about injectable mediations

The first complete HIV treatment provided by long-acting injections is a combination of two medications. Cabotegravir belongs to the same class of drugs – integrase inhibitors – as the widely used HIV medication dolutegravir. The second medication is called rilpivirine and is already used for HIV treatment in tablet form. It is from a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Cabotegravir and rilpivirine can be taken either once a month or every two months.

To receive CAB/RPV, an individual must have a suppressed HIV viral load, which demonstrates qualified adherence to oral medication. CAB/RPV has not been studied in patients with a detectable viral load and should not be used by these patient groups. However, the CDC in 2019 estimated that only 56.8% of PLWH were virally suppressed or undetectable (CDC, 2021), suggesting less than half of all PLWH in the United States may qualify for CAB/RPV.

Before patients can receive CAB/RPV, healthcare providers must confirm if their patients have experienced failed HIV medication regimens in the past, meaning that the medication was not capable of maintaining HIV RNA levels below 200 copies/mL, a phenomenon observed in some cohorts of PLWH. Ensuring an accurate antiretroviral medication history, including a patient-centered discussion on all past antiretrovirals and reasons for failure or discontinuation, is paramount before starting a patient on CAB/RPV.

BEFORE YOU GO…

HIV has been a heavy brick around the necks of the homosexual male demographic for over four decades. Far too many of our brothers died from AIDS before these treatments were available. We now have successful ways to treat this virus and prevent its spread and infection. But all of these advancements mean nothing if we refuse to believe in the science or avail ourselves of the new methods to take these medications.

Get yourself educated about the facts regarding HIV treatments, prevention methods, and medications, and don’t let fear or stigma keep you from keeping yourself safe and healthy.

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