Hitting HIV Hard in America: New Steps in Prevention

As we head toward another US election season in 2020, access to health care remains a key issue in our country and rightfully so. Sometimes the focus is on prescription drug prices and spending, other times the discussion shifts to the opioid crisis, or the never-ending conversation surrounding health care reform.

Thankfully, from time-to-time, we also look at ways to eradicate and prevent disease and epidemics, shifting our focus from reactive care to preventative care. To that end, it was during President Donald Trump’s 2019 State of the Union address that the administration vowed to put resources toward the US HIV epidemic.

According to the Centers for Disease Control (CDC) Surveillance report on HIV, the number of estimated diagnosed and undiagnosed cases in the United States had reached a prevalence of more than 1.2 million people by the end of 2016. The recent Vital Signs analysis from the CDC also estimates that 1.2 million people are at high risk for HIV. This is important because pre-exposure prophylaxis (PrEP) therapy can play a critical role in slowing the spread of the disease.

PrEP therapy is a preventative treatment for HIV-naïve people who may be at high-risk for contracting HIV. The CDC has identified several high risk factors including, but not limited to:

• If you are having sex with a partner known to have HIV.
• If you are having anal sex or sex without a condom with a partner not known to have HIV.
• If you inject drugs with a partner with HIV or if you share needles or other injectable supplies.

For more information on PrEP and the other high risk factors associated with HIV, the CDC has put together a PrEP 101 Fact Sheet. Prevention and adherence to drug therapy can play a critical role in managing this epidemic.

Today in the United States, 2 drugs are approved for PrEP therapy: Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) and Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg), both manufactured by Gilead. In reviewing the specific prescribing information for the products, when used for PrEP, Truvada is approved to prevent HIV for all people at risk through sex or injection drug use.

Descovy has not been studied as extensively for PrEP because the clinical studies did not evaluate populations having vaginal sex, so Decovy has a more limited FDA-approved indication for PrEP. Specifically, Descovy is indicated to prevent HIV in people at risk through sex, but excludes people at risk through vaginal sex. In terms of which product is more optimal for PrEP therapy, Descovy does appear to have some advantages from an adverse effect (AE) profile perspective, according to a press release from Gilead.

“Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time,” said Daniel O’Day, Gilead Sciences chairman and chief executive officer, in the press release.

Both drugs share many similarities. They are chemically similar in that they contain a fixed-dose combination tablet with emtricitabine and either tenofovir disoproxil fumarate (TDF) for Truvada, or tenofovir alafenamide (TAF) for Descovy.

TAF is the more modernized prodrug of tenofovir and is more efficient at reaching the HIV cells, allowing its dose to be significantly less than TDF. The TAF component of Decovy is 25 mg and the TDF component of Truvada is anywhere from 150 mg to 300 mg depending on the dose. The lower dose of the tenofovir-TDF product causes fewer AEs. Other similarities include a once-daily dose for the PrEP indication.

Minimizing the need for a complex therapeutic regimen with once-daily dosing for PrEP therapy will likely help reduce that adherence barrier. Both drugs also showed comparable efficacy. According to the published information from Gilead on the DISCOVER clinical trial, results showed that out of 2694 patients who received Descovy once daily, 7 HIV cases were reported. Among 2693 patients who received Truvada, 15 HIV cases were reported.

It is important to note that adherence plays an essential role in the efficacy of PrEP therapy. PrEP therapy should be taken every single day.

According to the CDC, study results have shown that people who are adherent and take their medication every day have prevention rates up to 99%. This rate declines as fewer pills are taken on a weekly basis.

For example, if a person only takes 4 daily doses per week, the prevention rate drops to 96%. When the adherence drops down to only 2 doses per week, that prevention rate drops far more significantly to a 76% prevention rate.

It is important for pharmacists to consider key factors in adherence with the HIV population and provide proactive counseling if they see an opportunity to improve adherence. Factors that may affect adherence to PrEP therapy include the patient’s social situation, stigma associated with the HIV diagnosis, other comorbidities, lack of education, AEs from PrEP therapies, access to a trusted health care provider, younger age groups, cost of medication therapy, and insurance coverage for PrEP medications.

As for the last factors related to coverage and costs associated with PrEP therapy, political campaigns and the emphasis placed on health care initiatives are important. HIV was brought to center stage with a recent presidential initiative discussed during President Trump’s State of the Union address, aptly called “Ending the HIV Epidemic: A Plan for America,” in which the administration pledged to put resources towards the US HIV epidemic.

According to HIV.gov, the goal of the program is to reduce US HIV infection rates within the next 10 years. Specifically, they cite a 75% reduction in 5 years and a 90% reduction within 10 years. Through the use of new tools, such as improved medications to treat and prevent HIV along with data to help identify populations at-risk and areas with high new infection rates, the federal government has an opportunity to improve access to care and therapies, as well as respond to outbreaks to help end the HIV epidemic in the United States.

Two new federal programs are in various stages of implementation to meet the goals of “Ending the HIV Epidemic: A Plan for America” and the elimination of HIV transmission by 2030. First, a new initiative currently underway since December 2018 through the Department of Health and Human Services (HHS), called Ready, Set, Prep, which will provide HIV PrEP medications to uninsured high risk people at no cost, according to a press release from HHS.

The aim of this program is to prevent HIV through PrEP. The press release states, “Ready, Set, PrEP is a key component of the Ending the HIV Epidemic: A Plan for America initiative.”

The GetYourPrep.com website lists 3 requirements for people to be eligible for the program, including a valid prescription for a PrEP drug, a negative HIV test, and no current insurance coverage for these medications. In an effort to help defray some of the costs associated with the free drug program, Gilead has pledged to donate 2.4 million bottles of Truvada annually for up to 200,000 uninsured people per year until 2030.

In an effort to provide access to PrEP prescription care, the HHS press release states that, “CVS Health, Walgreens, and Rite Aid have donated their dispensing services to HHS. Beginning no later than March 30, 2020, as part of these donations, qualified patients can obtain the PrEP medications at the more than 21,000 combined CVS Health, Walgreens, and Rite Aid locations throughout 50 states, the District of Columbia, Puerto Rico, and the US Virgin Islands or through mail order—all at no cost to patients. These pharmacies represent about a third of all the pharmacies in the United States. CVS Health, Walgreens, and Rite Aid will also provide patient counseling and take steps to promote patient adherence to the regimen.”

The second initiative is also through the federal government via Affordable Care Act regulations, which require non-grandfathered, private health insurance plans to cover select preventative services without member cost share. In doing so, it provides Americans with certain preventable diseases, such as HIV, a pathway for greater access to and reduced or waived co-pays/coinsurance for HIV prevention.

The US Preventive Services Task Force (USPSTF) has created a draft recommendation for PrEP therapy. The recommendation comes with an “A” rating, which is indicative of meaningful preventative benefit to reduce the risk of HIV.

According to the USPSTF draft recommendation, a person with high risk of HIV is defined as “Persons at risk of HIV infection include men who have sex with men, persons at risk via heterosexual contact, and persons who inject drugs. Within these groups, certain risk factors or behaviors can place persons at high risk of HIV infection. It is important to note that men who have sex with men and heterosexually active persons are not considered to be at high risk if they are in a mutually monogamous relationship with a partner who has recently tested negative for HIV. In addition, all persons being considered for PrEP must have a recently documented negative HIV test result.”

Although the federal programs, Ready, Set, PrEP and the proposed USPSTF PrEP recommendation, mention providing affordable coverage for the medication associated with PrEP therapy, they have shortcomings in terms of providing for the ancillary services related to HIV treatment at no or reduced cost. These can include services such as lab testing and monitoring, which can be expensive for patients with HIV.

The list price for Truvada and Descovy as of January 1, 2020, is comparable at about $73.69 per pill. Therefore, an average 30-day supply is just over $2210 for a person without insurance or any discounts.

Annually, the cost of covering these PrEP therapies is nearly $26,900 per person. Truvada is anticipated to have a generic equivalent available by the end of the third quarter of 2020.

According to the Gilead 10Q SEC filing for first quarter 2019, “pursuant to a settlement agreement relating to patents that protect Truvada and Atripla, Teva Pharmaceuticals will be able to launch generic fixed-dose combinations of emtricitabine and TDF and generic fixed-dose combinations of emtricitabine, TDF and efavirenz in the United States on September 30, 2020.”

Although Teva will have the benefit of generic exclusivity for 6 months, as additional generic manufacturers enter the market after the exclusivity period, the generic pricing should become more competitive and affordable. With Gilead receiving FDA approval for its newer drug, Descovy, we can expect to see a massive effort to convert Truvada scripts to Descovy in advance of the generic Truvada launch. According to an article from Drugs.com, the Descovy patent for PrEP therapy may not expire until October 3, 2022.

So while it’s very promising to have several new federal programs aligned with eradicating and preventing HIV in the United States, this issue could become highly politicized in the months ahead. These discussions could spur many additional questions as to how taxpayers can afford to continue paying for all these medications and should we be doing more to shift our focus from reactive treatments for disease to preventative treatments and helping those at high risk.

Either way, these are great steps forward in helping Americans win the fight against HIV.

About the Author

Brandeis Seymore earned her Bachelor of Science Pharmacy degree from the Duquesne University School of Pharmacy and her Master of Pharmacy Business Administration (MPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. She has spent the past several years working as a senior clinical manager assisting employers with their pharmacy benefit management strategy. Prior to these experiences, she has held roles of increasing responsibility, most recently as a Strategic Account Executive to support client’s marketplace needs and demands.