According to the latest report by UNAIDS, a U.N. agency exclusively responsible for AIDS, the number of new HIV infections worldwide totaled about 1.5 million in 2021, more than a million more than the global target.

UNAIDS, which declared to terminate AIDS by 2030, puts its foremost priority on HIV prevention efforts and has stressed the need for countries to urgently shift to the massive implementation of HIV (human immunodeficiency virus) prevention by placing a higher priority on it politically and economically.

Korea also implements PrEP (pre-exposure prophylaxis) therapy, a representative HIV prevention method.

Currently, the only PrEP drug available is Truvada (emtricitabine/tenofovir disoproxil fumarate), which has received health insurance benefits since June 2019. However, controversy over the effectiveness of PrEP therapy has been constantly raised in Korea due to unreasonable reimbursement standards and low access to treatment limited to “infected people’s sex partners.”

Against this backdrop, Korea Biomedical Review met with two experts – Dr. Lisa Sterman, Global Executive Director for HIV Prevention at Gilead Science, and Professor Choi Jun-yong of the Department of Infectious Diseases at Severance Hospital – to look at the limitations of HIV/AIDS treatment and prevention services in Korea and listen to success stories to increase the effectiveness of domestic PrEP therapy.

KBR: We are curious about what effects Covid-19 might have had on HIV/AIDS.

Choi: According to data from the Korea Disease Control and Prevention Agency (KDCA), the number of new HIV infections decreased in 2020 and 2021. The number of yearly new HIV infections has increased by totaling 1,000 or more but has begun to decline since 2020. The drop was partly due to the social distancing system and the resultant fall in outdoor activities. It is still not uncertain whether the new HIV infections decreased or infected people remain the same undiagnosed amid reduced tests.

As the work of KDCA or regional public health centers concentrated on Covid-19 quarantine and management, the work on managing HIV infection has relatively considerably dropped or been suspended. Before the pandemic, the HIV test rate at public health centers accounted for a considerable share. Still, the outbreak of Covid-19 drastically reduced the number of tests at public health centers. Anonymous HIV testing was suspended for the past three years and has just been resumed.

Besides, epidemiological investigations, which were actively conducted in the early stages of the Covid-19 pandemic, might have worked to reduce new HIV infections. During the epidemiological investigation, personal information, such as the details of the card use and the place of visit of the survey subjects, was exposed. The high-risk HIV group might have recognized that personal information and sexual orientation could be revealed and felt a great sense of crisis. They might have been afraid of social stigma. There were some criticisms of the gay community in Itaewon, Seoul, at the time. Therefore, in the early days of Covid-19, external gatherings and sex life decreased, and the number of new HIV infections decreased.

KBR: Covid-19 is becoming endemic. Now seems to be the right time to raise awareness about infectious diseases. What do you think are the most urgent task in the management of HIV/AIDS infection?

Choi: The strategy to prevent the spread of HIV has standards that have already been agreed upon by many countries. Above all, we need to detect HIV infections early. Through periodical tests, we should find infected people and begin treatment. According to the “U=U (Undetectable = Untransmittable)” concept, if we treat infected people properly to a level where HIV viruses are no longer detected, the contagion is reduced and no longer spreads. For uninfected high-risk groups, we should implement PrEP therapy. In other words, if we appropriately implement the three methods -- “early diagnosis,” “early treatment,” and “PrEP” -- we can effectively reduce new HIV infections as some African countries and the city of San Francisco, U.D., have done.

Such efforts had progressed before the outbreak of Covid-19 according to plan. However, the pandemic outbreak has suspended part of the three efforts. We should resume the suspended activities as planned as soon as possible. The number of high-risk people who receive PrEP has increased than before. Still, it has not reached a satisfactory level, and the prescriptions of PrEP are being made only to a significantly smaller number of people compared to foreign countries. We should spread PrEP more broadly.

KBR: You talked about the case of San Francisco. We understand Dr. Sterman led the efforts and made a success. Could you explain in detail?

Sterman: In San Francisco, we have conducted various campaigns concerning PrEP, active treatments for prevention, and the spread of the U=U concept. As a result, HIV prevention and recognition through PrEP have improved much. We had already attained the goal of reducing yearly new HIV infections from more than a thousand to lower than a hundred before the Covid-19 outbreak.

PrEF is used widely, with more than 10,000 people practicing it in San Francisco. In the early phase of introducing PrEP, we tried to raise awareness of PrEP through the HIV high-risk group and provide information for them. We strived to provide online information and increase the awareness of PrEP as soon as possible through word of mouth among community members.

In San Francisco, PrEP is called “rocket science” because it is fast, simple in the procedure, and easily accessible. Above all, many clinics exclusively responsible for PrEP are opened. In the U.S., “nurse practitioners” operate some primary medical institutions or clinics exclusively responsible for PrEP. These nurse practitioners conduct tests and provide counsel. In addition, many video contents provide information that easily explains how to self-test the method through YouTube.

We have prepared various measures to conduct examinations remotely without visiting the hospital for HIV testing every three months. We provided self-test kits by mail for remote examination by subjects seeking a prescription for PrEP therapy. Or they can visit the clinic in person for an examination. Even in that case, they can directly receive it with a tablet device and test themselves without meeting inspectors. People can also pre-order prescriptions and receive drugs by mail or from a designated pharmacy. The spread of PrEP therapy has increased because it can be quickly and conveniently prescribed anytime and anywhere. Also, in the U.S., you can use Descovy in addition to Truvada as a PrEP therapy, which reduces concerns over kidney function tests.

Most of all, money does not matter when it comes to PrEP therapy in the U.S. Most are prescribed free of charge, and Gilead Science provides full support for periodic payments. For example, if people prescribed PrEP therapy can’t afford to pay for the drug, they can go to the pharmacy and get a card instead of paying for it. They can contact a doctor or pharmacist and ask for registration if that is also difficult. Gilead will pay them free of charge. The same is valid with treatments or PrEP.

The most important achievement of PrEP therapy was that it gave relief to the daily lives of the high-risk HIV population. Before the introduction of PrEP therapy, the daily lives of high-risk groups were always surrounded by anxiety and danger, and various restrictions were created. Since its introduction, they have become more secure and able to live their lives and have a safer sex life. I think a society with less fear can become safe and stable.

KBR: Listening to the example of the United States, we became curious about the domestic situation. What is the detailed process of prescribing PrEP therapy in Korea?

Choi: Currently, PrEP therapy is prescribed by infectious medicine specialists. Suppose you want to be prescribed PrEP therapy. In that case, the high-risk group can go to the hospital they want, receive a medical request, visit a university hospital, and get tested for HIV. To prescribe PrEP therapy, the high-risk group must be HIV-negative. This is because HIV-infected people can develop resistance if they take PrEP therapy. Afterward, PrEP therapy is prescribed after various evaluations, such as kidney function. High-risk groups who take PrEP are tested for HIV at least once every three months to maintain PrEP therapy. In addition, physicians determine every year whether it is necessary to continue PrEP therapy.

Currently, the insurance benefits of PrEP therapy are limited to “partners of HIV-infected people.” If you are not a partner of an HIV-infected person, you can only receive a non-reimbursable prescription. If you're prescribed benefits, take the prescription and receive the drug at a pharmacy inside the hospital (in-house pharmacy) or a pharmacy outside the hospital (out-house pharmacy). If you receive drugs at an out-house pharmacy, your payment will be reduced by about 50 percent to an in-house pharmacy. You will pay about 120,000 won ($8.35) per month. In uncovered cases, the drug cost is quite expensive and reaches about 400,000 won a month. Not many people can pay this much drug cost for prevention that is not for treatment.

The Korea Medical Assistance Foundation provides a support program to refund 50 percent of the drug cost to those prescribed PrEP therapy. Suppose people submit a prescription formulation receipt to the person in charge. In that case, they will receive a 50-percent refund of the drug fee they paid. People can receive PrEP therapy at a lower cost through these support programs. High-risk groups prescribed with insurance benefits receive support through this program and can take PrEP therapy for about 60,000 won a month. However, it is also not easy for healthy people to come to the hospital continuously and pay 60,000 won per month to continue PrEP therapy.

KBR: Many point out that the current reimbursement criteria are unreasonable.

Choi: Yes, it is. The high-risk group by reimbursement criterion is not the real high-risk group. The current criterion defines the high-risk group as “partners of HIV-infected people.” However, according to the U=U concept, infected people’s partners are instead safe from infections. The criterion is set wrongly. HIV-infected people have the premise that they are already aware of the infection, diagnosed, and being treated. If they receive treatment, the risk of transmission is very low enough to be close to zero, according to the concept of U=U. Men who have sex with men (MSM) and are sexually active are in the high-risk group because they do not know whether their partners are infected. PrEP therapy should be widely distributed to prevent HIV prevention is not being correctly implemented, as I see it. The academic society also points out the limitations of PrEP therapy’s reimbursement criterion and calls for introducing a positive HIV prevention policy to spread PrEP. Still, their assertions are also not accepted well.

I think there must be a reason why HIRA does not receive society's opinions well. In Korea, no insurance benefits have been recognized to prevent diseases other than PrEP therapy. Some say it is unfair to apply the reimbursement because it is for prevention, not treatment. The application of insurance benefits is bound to occur within a limited budget. We need a budget to promote PrEP therapy. Although efforts to promote awareness of PrEP therapy are essential, there should first be an agreement on who should pay for the prescription of PrEP therapy. If it is difficult to expand the scope of PrEP therapy benefits with health insurance finance due to various reasons and differences of opinion, making a separate budget could also be a way. For example, they can make a separate budget at the KDCA, which directly purchases and distribute PrEP therapy drugs. Taiwan adopted this method to distribute PrEP therapy.

Most regrettable are those who misunderstand insurance benefits for PrEP as concentrating benefits on a few immoral groups. However, this is a mistaken idea. From a long-term perspective, PeEP is an effective way of HIV prevention. If Korea distributes it broadly, people can be protected from HIV/AIDS risks. It may be somewhat strange in international standards not to actively implement the spread of PrEP therapy.

KBR: Dr. Sterman, you have long been engaged in HIV/AIDS-related activities and must have run into ideological barriers in various countries. What are your suggestions for Korea’s HIV prevention policy?

Sterman: It is necessary to accept opinions from HIV/AIDS experts based on their research results and hands-on experience on a transparent basis. It should also be recognized that political ideology and religion are separate from medicine. Recognition and prejudice against a specific group should also be separated from medicine. People discriminate against people, but viruses do not discriminate against people. You have to realize that viruses can infect anyone. HIV is no different from lung disease, cancer, and chronic diseases. It is just one of several diseases that should be prevented to reduce social costs in advance. Religious beliefs or political ideologies should not be involved in determining disease prevention policies.

There are much data on the clinical usefulness and cost-effectiveness of PrEP therapy. There are also many clinical results showing that the HIV prevention effect of PrEP therapy exceeds 90 percent. Even studies show that PrEP therapy does not promote promiscuous sex life. So far, not many of the preventive drugs and vaccines we’ve used have shown this much effect. It is self-contradictory if we agree that infectious diseases should be controlled through prevention but not use them even though we have excellent preventive measures. If we approach this issue from the perspective that everyone is safe from disease, lives an everyday life, and is responsible for the future of society, I think we can take a step further in increasing access to PrEP therapy. Prevention against diseases that threaten our lives and health should be applied without discrimination against any disease.

KBR: Talking about cost-effectiveness, there must be a basis to persuade the government to put the national budget into it. We are curious whether there are study results on PrAEP’s cost-effectiveness.

Sterman: PrEP therapy has demonstrated high cost-effectiveness through various cost-effectiveness analysis models. Although we have already developed many HIV treatments, and it has become much easier to treat than before, it is much simpler to prevent it in advance than treat it later. There is also a conclusion that HIV prevention through PrEP therapy is far more cost-effective than HIV treatment and other follow-up responses. Comparing precautions against other diseases with PrEP therapy can also be a basis to consider when emphasizing the importance or necessity of PrEP therapy. For example, if you have a family history of colorectal cancer, taking a screening test for colon cancer would be a wise choice for health. Likewise, there should be a social awareness that high-risk HIV groups should be tested for HIV periodically.

Choi: I published a paper on the cost-effectiveness of domestic PrEP therapy using mathematical modeling in Scientific Reports, Nature’s online open-access journal, years ago. The modeling study showed that PrEP therapy is cost-effective in Korea. It demonstrated that the widespread use of PrEP therapy in sexually active HIV high-risk groups resulted in cost-effectiveness.

Again, “early diagnosis,” “early treatment,” and "PrEP therapy" are effective HIV prevention strategies to control the spread of HIV infection. While the number of people infected with HIV continues to decline worldwide, the number of new HIV infections in Korea is being maintained or continues to increase. Everyone in the country hopes to see fewer new HIV infections. It is possible with the introduction of PrEP therapy. PrEP therapy is, in a way, the HIV vaccine that has been developed. Active and early diagnosis and the spread of PrEP therapy will help reduce the number of HIV-infected people in Korea. Despite the research results showing this, there must be a flaw in not actively implementing it.