High Hopes, Major Obstacles for PrEP and Ending HIV/AIDS as We’ve Known It

Susan Ladika

The incidence of HIV infections has held steady for most of the decade, but experts say the number of new infections could drop dramatically if currently available medications reached those who are most at risk, particularly black and Hispanic gay and bisexual men. Some are even putting “end” and “AIDS epidemic” in the same sentence. “We essentially have tools to end the epidemic at this point even without a cure,” says Carlos Malvestutto, MD, the medical director of the Family AIDS Clinic and Education Services program at Nationwide Children’s Hospital in Columbus, Ohio.

Gilead says 200,000 of the 1.1 million Americans at high risk of contracting HIV are taking Truvada, its pre-exposure prophylaxis (PrEP) pill.

Carlos Malvestutto, MD

For people who are already infected with HIV, antiretroviral therapy can suppress the virus to such a low level that it can’t be passed on. But government and public health officials and the pharmaceutical industry are talking up pre-exposure prophylaxis (PrEP) as perhaps the most potent weapon against ending the spread of HIV/AIDS. It consists of a daily pill that combines antiviral medications and prevents infection with HIV in those who are exposed to the virus. In this country, Gilead’s Truvada, a combination of two antivirals, emtricitabine and tenofovir disoproxil fumarate, has had the PrEP market to itself. In October, the FDA approved another Gilead product, Descovy, for PrEP. Descovy swaps out tenofovir disoproxil fumarate for tenofovir alafenamide and may have advantages over Truvada for people with kidney disease or osteoporosis.

Greg Millett

There’s no question that PrEP can prevent HIV infection. Access to PrEP has already helped cut the rate of new infections significantly in big cities. However, “PrEP is not reaching the population who needs it most. We haven’t been able to scale up proven interventions,” says Greg Millett, vice president and director of public policy for amfAR, the Foundation for AIDS Research, a high-profile HIV/AIDS advocacy organization that also funds research. Part of the problem, Malvestutto says, is the stigma still associated with the disease, particularly among the highest-risk population groups and in parts of the South, which has the highest rate of new infections. While people may be offered HIV testing, “they would rather not know,” he says. They are often concerned about what it would mean if the word got out that they were HIV positive. Bridget Calhoun, associate dean of health sciences at Duquesne University in Pittsburgh, says that some health care providers resist prescribing PrEP because “they don’t want to encourage risky behavior.” 

The National Institute of Allergy and Infectious Diseases (NIAID) supported a 2010 clinical trial called iPrEx, which was the first to establish the effectiveness of PrEP. It found that daily use of Truvada reduced the risk of acquiring HIV infection among men who had sex with men. For those who took the drug on a daily basis, the risk of acquiring HIV was 92% lower than those in the placebo group. But the main challenge was getting participants to take the medication daily. Overall, the risk was reduced by 44% because many failed to take the drug regularly. Because of the adherence challenges, NIAID is supporting research to find a longer-acting form of PrEP.

Patients resist PrEP—both sticking with it and refusing to start it in the first place—for a raft of interconnected reasons, ranging from distrust of health care providers to lack of health insurance coverage to marginalization of at-risk groups. “Without stable access to health insurance, access to PrEP is lost,” Millett says. And prophylaxis of any kind is a hard sell: You are asking people to do something—in the case of PrEP, taking a pill daily—to prevent an infection or disease that may not happen. 

Meanwhile, the opioid epidemic has created a new wave of people who are injecting drugs, says Millett, and intravenous drug use and the sharing of needles is one of the primary ways that HIV is transmitted. A recent outbreak of HIV infections in rural West Virginia has been linked to drug users sharing contaminated needles. PrEP is not routinely offered to IV drug users, notes Malvestutto.

Large racial disparity

Expense is also an obstacle for PrEP acceptance. Truvada’s list price is more than $20,000 per year, although payers often pay far less because of discounts and rebates. Gilead has come under fire because generic versions of the drug sell for about $60 a year in Africa. Several companies have tried to introduce generic versions of Truvada in the United States and Gilead has sued. Every case has ended in a settlement that has been kept secret.

This spring, Gilead announced a generic version of Truvada will be available next year. The company also announced it was donating up to 2.4 million bottles, each containing a month’s supply of Truvada, to the CDC annually for those who lack insurance. Some have criticized Gilead because Descovy has not been tested for those who have vaginal intercourse. 

Last year, CDC researchers reported research findings that showed that only 7% of the 1.1 million Americans who were at high risk of HIV infection in 2016 were prescribed PrEP. Presumably that percentage has increased, and earlier this year, Gilead said 200,000 Americans were taking Truvada for PrEP purposes. Still, the vast majority of Americans who might benefit from PrEP are not taking it.

The CDC researchers also highlighted another problem with PrEP: the glaring racial disparity of the prescription patterns. Although black men and women accounted for about 40% of the Americans for whom PrEP might be indicated, just 11% of the prescriptions were written for black Americans.

Southwest Care Center in Santa Fe, N.Mex., offers PrEP. It was founded in 1996 as a clinic for people with HIV/AIDs.

Government action at the federal and state levels may spur wider acceptance of PrEP. In June, the U.S. Preventive Services Task Force recommended HIV screening for everyone between the ages of 15 and 65. Part of that recommendation is that PrEP be prescribed for those who are at high risk of contracting HIV. Because it is a USPSTF recommendation, under the ACA, private health plans must start covering PrEP without copay beginning no later than 2021. This won’t help Americans without insurance coverage, but for those who do, it will remove one more barrier to PrEP. In California, Gov. Gavin Newsom signed a bill last month that allows specially trained pharmacists to dispense PrEP without a prescription. 

During this year’s State of the Union address, President Donald Trump announced a goal to eliminate the HIV epidemic within 10 years. This effort includes using PrEP to prevent new infections. The initial phase focuses on the areas of the country that account for more than half of new diagnoses, particularly urban areas and the South, which has a disproportionate number of cases in rural areas. 

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