In the heart of San Francisco’s Castro district, Pierre Cedric-Crouch, director of nursing for the San Francisco AIDS Foundation’s Magnet gay men’s health center, talks to a young gay man about whether he would be a good candidate for Truvada, a pre-exposure prophylaxis (PrEP) pill that prevents people from getting HIV. The young man admits he doesn’t always use condoms when engaging in sex, and he has questions about the drug’s potential side effects.
In the 1980s, a diagnosis of HIV used to mean AIDS or even early death. Today, thanks to advances in medicine, Truvada could potentially eliminate the 50,000 new cases of HIV infections diagnosed each year, yet the medication continues to be dogged by controversy.
Truvada combines two drugs that are part of the anti-retroviral cocktail that HIV-positive patients have taken for years. The medicines, tenofovir and emtricitabine, work together to block an enzyme called reverse transcriptase that allows HIV cells to multiply.
Produced by Gilead Sciences in Foster City, Truvada has been around for a decade, serving as one of the key drugs used in combination with others as a treatment for AIDS. In 2012, the U.S. Food and Drug Administration’s also approved Truvada as a medication that could prevent sexually-transmitted HIV transmission in the first place.
Public health officials say there are several reasons why Truvada isn’t more widely used. Some members of the gay community have labeled Truvada a “party drug,” and believe those at high-risk of contracting HIV won’t take it consistently enough to stave off infection. Others have financial concerns –even with insurance coverage, Truvada can prove costly. Finally, some of the people who may benefit the most from a pre-exposure prophylaxis – including teens, black gay and bisexual men, intravenous drug users, black heterosexual women, and trans women – may not even be aware of the drug’s existence.
Crouch notes that when taken once daily as prescribed by a doctor, Truvada has been shown to cut the risk of HIV infection by upwards of 90 percent. In November, he and his colleagues at the Magnet health center launched a pilot PrEP program, with 300 clients enrolled to date.
“Our goal is to make PrEP a priority and to minimize the rate of new infections,” Crouch says. “We know Truvada can drastically reduce the rates of HIV and our ultimate goal is to see HIV eradicated.”
While San Francisco public health officials, including Crouch, hope to cut new HIV infections in the city by 90 percent by the year 2020, they also realize they have their work cut out for them.
When Gilead Sciences reviewed records from about half of the U.S. pharmacies that dispensed Truvada between January 1, 2012, and March 31, 2014, they found that only 3,253 people had started the PrEP regimen during that period. This is in huge contrast to the Centers for Disease Control and Prevention’s (CDC) estimate that approximately 500,000 Americans are good candidates for PrEP.
Still, Crouch remains hopeful that increased outreach efforts will make a huge dent in infection rates.
“While we know that condoms are the best way to prevent HIV transmission, we also realize not everyone uses condoms all the time,” Crouch says. “All it takes is one episode of condomless sex or sharing a needle with a partner who is HIV-positive, to increase a person’s risk of contracting HIV.”
While public health officials have largely focused on gay men for Truvada use because they represent the biggest group of new HIV infections in the U.S., Crouch would also like to see the number of African-Americans on PrEP increase. The CDC notes that young African-American gay and bisexual men account for the highest number of new HIV infections among all gay and bisexual men.
“Currently, 30 percent of the people in our trial program are non-whites,” Crouch says. “I think the next level of PrEP outreach will be increasing efforts to target African-Americans, Latinos, and others who may not know Truvada is available, or how to gain access to treatment.”
Working to Increase Awareness Among At-Risk Groups
In the predominantly African-American neighborhood of Baldwin Hills in Southern California, the nonprofit AIDS Project Los Angeles (APLA), recently launched a program to reach black gay and bisexual men.
While HIV rates have stabilized or improved among most demographic groups, the new cases of HIV among young gay black men have increased. According to the CDC, gay and bisexual black men account for nearly one-fourth of the nation’s 50,000 new HIV infections each year.
“We’re not just working to increase awareness of PrEP, we’re continuing to combat the stigma that being gay still carries in the black community,” says Vallerie Wagner, chief operating officer for AIDS Project Los Angeles.
Although Wagner notes that Truvada is an “important tool in the overall HIV prevention tool kit” she also says it’s not necessarily the right choice for everyone.
“Taking Truvada every day is a commitment,” Wagner says. “The best candidates for PrEP are those who are having unprotected sex with any regularity, especially if they have a known HIV-positive partner.”
Across the state, health officials are working to spread news about Truvada to those who may need it the most. At the Black Brothers Esteem prevention and support group, part of the San Francisco AIDS Foundation, Dr. Hyman Scott, a provider with the 360: Positive Care Center at the University of San Francisco, recently held an event where he fielded questions about Truvada’s safety and effectiveness.
Public health officials say these kinds of ongoing conversations are crucial in order to reach people who may be good candidates for PrEP. At APLA, a PrEP navigator is available to meet one-on-one with HIV-negative patients to answer questions about Truvada, and then follow up to ensure they keep appointments for routine testing after they have started the medication.
Another group at increased risk for HIV infection is teens. The CDC says those between the ages of 13-24 account for the spread of 26 percent of all new infections within the United States, and more than half of the teens living with HIV are unaware they are affected. However, Truvada use has only been approved for those ages 18 and over, although it may be used as part of a treatment program for teens that have already contracted HIV.
The CDC is currently waiting for the results of Project PrePARE, a national clinical trial conducted by the Adolescent Trials Network, and funded by the National Institutes of Health, before concluding whether or not Truvada would be safe for adolescents. The trials include young gay, bisexual and transgender women, with a mix of both Latino and African-American teens. Researchers hope the study will also counter the racial disparities found in many clinical trials.
The Importance of Ongoing Monitoring
In order to be effective, Truvada must be taken on a daily basis, not intermittently, and once medication is started, patients need to schedule regular follow-up visits and tests with their doctor.
Brad Hare, director of HIV care and Prevention at Kaiser Permanente, San Francisco, says people on a PrEP regimen should be seen by a healthcare provider every two to three months, to be tested for liver and kidney function, HIV and sexually transmitted infections.
Hare says that Kaiser Permanente’s San Francisco Medical Center now has approximately 700 members who are taking Truvada. To date, there haven’t been any new cases of HIV infections.
Despite a significant increase of 200 members since this past December, Hare says about one-third of people referred to the program ultimately decide not to take PrEP.
“Some are worried about the potential side effects of Truvada,” Hare says. “The most common side effects are headache and upset stomach in the first few weeks of taking it, more serious side effects such as mild kidney and liver problems are extremely rare.”
Most health care providers recommend that Truvada be used in conjunction with condoms, since it doesn’t protect against sexually-transmitted diseases other than HIV. Yet for monogamous but serodiscordant couples (where one partner is HIV-positive and one is HIV-negative), Truvada offers an option for engaging in safe sex.
“Using Truvada allows the HIV-negative partner to feel more comfortable about having sexual relations,” Hare says.
Hare says PrEp is also a game changer for women.
“It’s the first HIV prevention method that a woman can use to take control of her infection risk,” Hare says. “With Truvada, women don’t have to negotiate condom use with their partners, or worry about risks their partners may be taking.”
For women who hope to get pregnant with an HIV-positive partner, Truvada offers the opportunity to have safe unprotected sex without worrying about contracting HIV. In studies, women took Truvada just until after conception, and gave birth to babies who were HIV-negative.
The High Cost of Care
The high cost of Truvada also proves to be a deterrent for many. Without insurance, PrEP costs approximately $1300 a month, not including office visits and lab work. Even those covered by the Affordable Care Act can incur high co-pays and deductibles under the bronze, gold and platinum plans.
“For a lot of people the co-pays can prove daunting,” says Wagner who recommends those interested in PrEP meet with an APLA’s eligibility specialist who can assist with health plan enrollment, as well as counseling regarding payment options for those who are underinsured or uninsured.
Most private insurance plans as well as Medicare and Medicaid cover PrEP.
If a prospective Truvada patient has a health plan with a high monthly premium, or drug co-pay, APLA’s eligibility specialist can help steer them to a plan that offers more affordable deductibles and prescription copays.
“Gilead also offers a copay assistance program to help cover the expense of Truvada,” Wagner says.
Gilead’s medication assistance program (MAP) provides the medication free to those without health insurance or drug prescription coverage. Their drug co-pay program provides assistance with out-of-pocket costs (including co-pays, co-insurance and deductibles) for people who have insurance. Both MAPS and copays for PrEP have limits on the amount of money a person earns each year to qualify for the program.
In addition, research conducted by organizations such as UC’s California HIV/AIDS Research Program is funding several PrEP projects in both Northern and Southern California. In the Bay Area, the outreach project is designed to offer high-risk young gay men of color free access to Truvada if they agree to participate in the study, while the Southern California research teams are offering Truvada free to high-risk gay men and transgender women through next year.
An Ambitious Plan to End Transmission of HIV
This past December, on World AIDS Day, public health officials unveiled a plan that aims to make San Francisco the first jurisdiction with zero new AIDS infections, zero stigma, and zero deaths.
In order to achieve that goal, the Getting to Zero Coalition knows that it has to expand PrEP outreach.
Scott Wiener, a member of San Francisco’s Board of Supervisors, has been candid about the fact that he uses Truvada. Wiener, who is openly gay, hopes that by going public with his decision to use PrEP, he can help to raise awareness, and encourage others to talk to their doctor about whether PrEP may be right for them.
“The word is starting to get out about Truvada and we’re continuing to see an uptake in the number of people starting PrEP,” Wiener says. “We know PrEP has the potential to stop the HIV epidemic in its tracks.”
While some critics view PrEP as a license for people to engage in risky behavior, and worry that the medication could lead to an increase in sexually-transmitted diseases, Wiener notes no studies have shown that using PrEP increases risky behavior.
“In order for PrEP to be successful, we need to accomplish three things,” Wiener says. “We need to raise awareness about the pill, remove the stigma so that people are able to openly talk about it, and finally, we need to expand access.”
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