Taken every 2 months, the long-acting injectable drug cabotegravir (CAB-LA) prevented more HIV infections than daily oral pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC), according to newly announced results from a major Phase 3 study. The results were released originally in May due to the overwhelmingly positive data on CAB-LA for PrEP, but researchers presented their final data in early July at the 23rd International AIDS Conference (AIDS 2020).
The data show that the experimental drug is superior to the current standard-of-care PrEP regien, which may open the door for a new biomedical HIV prevention option aimed at those who would prefer a shot six times a year over taking a daily pill.
“The HPTN 083 results demonstrating the superiority of CAB to TDF/FTC have the potential to transform the landscape of HIV prevention for cisgender MSM and transgender women,” said HPTN 083 protocol chair Raphael J. Landovitz, M.D. “We know that some people have difficulty with or prefer not to take pills, and an injectable product such as long-acting CAB [cabotegravir] could be a very important option for them. We want to thank the study participants and research staff, as this study would not have been possible without their dedication and commitment.”
The Centers for Disease Control and Prevention (CDC) understands that its partners in HIV prevention are facing unprecedented challenges and demands as we continue to battle the COVID-19 pandemic together.
While some clinics and HIV prevention providers have adapted to changing circumstances by offering expanded phone triage and telehealth services, other clinics that provide pre-exposure prophylaxis (PrEP) services have had to reduce hours, eliminate or reallocate staff resources, or temporarily close.
CDC has developed guidance for providing PrEP when facility-based services and in-person patient-clinician contact is limited. For programs experiencing disruption in PrEP clinical services, CDC offers the following guidance for clinics to consider in the context of local resources and staff availability.
Beginning April 1, 2020, patients enrolled in the U.S. Department of Health & Human Services (HHS) Ready, Set, PrEP program will fill their prescription for pre-exposure prophylaxis (PrEP) medication at no cost at their choice of Avita Pharmacy , CVS Health , Health Mart , Longs Pharmacy Solutions , Rite Aid , and Walgreens locations or through mail.
Ready, Set, PrEP is a nationwide program led by HHS and an essential component of the Ending the HIV Epidemic Initiative. Ready, Set, PrEP provides PrEP medications to individuals who qualify, increasing access to PrEP medications, reducing new HIV infections, and bringing us one step closer to ending the HIV epidemic in the United States.
Recognizing the importance of expanded access to HIV PrEP medications, these pharmacies are donating their dispensing and mailing services at over 24,500 pharmacy locations nationwide. This represents about a third of all the pharmacies in the United States, with locations in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. The donation provides a valuable service to those using PrEP and results in substantial cost savings to the federal government.
When most respondents in a population don’t know about a particular medication, that means that the word is not getting out. Although efforts may have gotten better since 2013, the reality is that most women still are not considered in the marketing of PrEP especially among people that have some high-risk activities within their lifestyle.
The parallels of this lack of knowledge continue a legacy of female bias when it comes to sexual health topics. The female condom is one example of a tool that was meant to empower women to protect themselves. However, the commitment by the health community to engrain it in our cultural sexual education failed and it is always seen as an option that men and women don’t fully embrace.
Both relationship-specific and structural factors influence whether coupled gay men living in New York City choose to use pre- and post-exposure prophylaxis (PrEP/PEP) for HIV prevention. Some men – particularly those in monogamous relationships – felt that discussing PrEP and PEP in the context of a relationship could threaten the relationship by raising issues of trust, while others felt that it had the potential to enhance sexual health and satisfaction.
Stigma from the gay community and healthcare providers around promiscuity also presented barriers to PrEP uptake. This qualitative research was conducted by Stephen Bosco, Dr Tyrel Starks and colleagues at City University New York and published in the Journal of Homosexuality.
Gay and bisexual men accounted for 66% of all new HIV diagnoses in the US in 2017. It is estimated that 35-68% of these infections happen within the context of a long-term relationship. This indicates that coupled gay men have the potential to benefit significantly from biomedical prevention strategies, such as PrEP (taken on an ongoing basis) and PEP (taken shortly after a suspected infection). However, only 7% of the potential 1.1 million gay and bisexual men who could benefit from PrEP were prescribed it in 2016. Black and minority men in the US remain most at-risk for HIV infection, while also having the lowest rates of PrEP uptake.
Facebook has quietly started removing some misleading ads about HIV prevention medication, responding to a deluge of activists, health experts and government regulators who said the tech giant had created the conditions for a public-health crisis.
The ads at issue — purchased by pages affiliated with personal-injury lawyers and seen millions of times — linked drugs designed to stop the spread of HIV with severe bone and kidney damage. Lesbian, gay, bisexual and transgender advocates long have said such claims are “false,” pointing to multiple studies showing the class of medication, known as PrEP, is safe.
After initially declining to disable the ads, Facebook began on Friday retroactively labeling some of them as rule violations in its archive, limiting their visibility. The company’s third-party fact-checkers concluded the ads were misleading and lacked context, according to a copy of an email sent by those fact-checkers to LGBT groups that was shared with The Washington Post, which first reported on the matter earlier this month.
The change in course at Facebook drew praise from LGBT organizations that had worked since September to stop the spread of HIV misinformation on the social media platform. But many activists said they remain uneasy that it took so long to get Facebook’s attention in the first place — and worried the company’s policy on such ads in the future remains unclear.
“The removal of select ads is a strong first step given the findings of Facebook’s own fact-checking agency and the dozens of organizations that spoke out,” said Sarah Kate Ellis, the leader of GLAAD. She added the “time is now for Facebook to take action on other very similar ads which target at-risk community members with misleading and inaccurate claims about PrEP and HIV prevention.”
Facebook spokeswoman Devon Kearns confirmed that the company had taken action against some of the ads. “After a review, our independent fact-checking partners have determined some of the ads in question mislead people about the effects of Truvada,” she said, referring to the name of the drug. “As a result we have rejected these ads and they can no longer run on Facebook.”
Pre-exposure prophylaxis (or PrEP) medications are prescription medications that people take daily to significantly reduce their risk of acquiring HIV through sex. PrEP can stop HIV from taking hold and spreading throughout the body. Two medications are FDA-approved for use as PrEP: TRUVADA and DESCOVY. When taken daily, PrEP is highly effective for preventing HIV from sex.
The Ready, Set, PrEP program makes PrEP medication available at no cost for qualifying recipients. To receive PrEP medication through this program, you must:
Lack prescription drug coverage
Be tested for HIV with a negative result
Have a prescription for PrEP
Talk to your healthcare provider or find a provider at HIV.gov Locator to find out if PrEP is right for you. If PrEP is a good option for you, click below to apply.
Research says that men who have sex with other men make up 67% of new HIV infections. Then on top of that, 25 percent of Latino men who have sex with other men (MSM) will be infected with HIV in their lifetime. And, 50 percent of Black MSM will experience the same. That’s compared to 12.5 percent of white men. That said, men of color are less likely to use the HIV preventive drug pre-exposure prophylaxis or PrEP. Why is this?
As NBC writes, researchers believe the problem lies in accessibility issues to health care. Studies show health care providers are not prescribing Black and Latino men to PrEP. In addition, men of color are less aware of PrEP’s very existence. The CDC’s study found that 95% of white men, 87% of Latino men, and 43% of Black men are knowledgeable about PrEP. Then even worse, only 58% of white, 44% of Latino, and 43% of Black men said they discussed the preventative medication with a physician.
As Kanny told Reuters Health,“This type of research is critical to finding—and correcting — missed opportunities to offer PrEP to people at risk of HIV, particularly among African American and Latin gay and bisexual men.”
He said further: “It’s important for providers to take sexual histories of gay and bisexual men and to discuss PrEP as an option for HIV prevention with those who could potentially benefit from it,” said Kanny. “These discussions also help to destigmatize PrEP use, which is particularly important for increasing PrEP use among African American and bisexual men.”
PrEP, or pre-exposure prophylaxis, is an HIV prevention method in which people who do not have HIV take medicine on a daily basis to reduce their risk of getting HIV if they are exposed to the virus. Descovy for PrEP should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections.
The safety and efficacy of Descovy for PrEP were evaluated in a randomized, double-blind multinational trial in 5,387 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection. The trial compared once daily Descovy to Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg), a daily fixed dose combination of two drugs approved in 2012 to prevent the sexual acquisition of HIV; participants were followed for 48 to 96 weeks. The primary endpoint was the rate of HIV-1 infection in each group. The trial showed that Descovy was similar to Truvada in reducing the risk of acquiring HIV-1 infection.
According to the Centers for Disease Control and Prevention, over 1.1 million people 13 years old and over are living with HIV, and nearly 14 percent of them are undiagnosed.
While studies from world health organizations continue to expand deeper realities unseen in the epidemic, transgender men are often excluded from the conversation — especially when it comes to PrEP, an HIV prevention strategy that when practiced routinely makes it impossible to contract HIV. Today, the only FDA-approved drug to be used as PrEP is Truvada, a once-daily pill.
Now, thanks to researchers at The Fenway Institute, a groundbreaking study is the first of its kind to investigate PrEP and other biological/psychological factors (like alcohol or substance abuse, depression, relationship status, needle sharing, and more) specifically among transgender men who have sex with men (MSM).
The study, which was published in the Journal of the International AIDS Society, was conducted online from November 2017 to December 2017 and included 857 trans MSM (aged between 18 to 60, though the majority of them were under 30), all of whom were surveyed by researchers to determine their PrEP use and HIV risk factors.