Japan could become one of the first countries in the world to end the HIV epidemic, says the president of Gilead Sciences Japan, Kennet Brysting. The idea for now could seem a little too ambitious, but it is not entirely unrealistic, given that the availability of medicines that can prevent transmission of HIV. Drugs are not the cure, but control over the spread of virus to the point where the disease is no longer a major public health threat.

What Is The Role Of Preventative HIV Medicines?

Gilead's have two key drugs, Truvada and lenacapavir. These two are playing a crucial role in prevention. Truvada is taken as a daily pill, while lenacapavir requires two injections per year. It can make the virus undetectable in infected individuals and prevent transmission to those who are not infected yet. In trials, lenacapavir showed 100% efficacy in preventing HIV infections. This is why it is describe as "almost a vaccine".

In 2024, Japan also approved Truvada for HIV prevention, but the country has yet to approve lenacapavir for the same. Until now, people in Japan had been importing generic versions of Truvada or purchasing it from clinics that source it from overseas.

HIV In Japan

Up until now, Japan reported around 25,000 HIV infections, whereas 669 new cases were reported in 2023. For seven consecutive years, the number of new infections remained under 1,000. The downward trend thus shows that the virus has been controlled, however, getting to zero new infections remains the ultimate goal.

Brysting too acknowledged that simply having effective drug is not enough. What is important is to have a proper implementation, access and healthcare support to make sure that these treatments are widely available and effective.

What Are The Challenges In Implementation?

The biggest challenges is testing rates. There is a need to increase testing rates. At this very moment, around 86% people infective with Japan have been tested, but the goal is to increase it up to 95%, with an ideal goal of 100%. Without widespread testing, many infected people may not even know that they are infected and it could transmit the virus.

Another measure issue is the cost of preventative medication. While Japan's health insurance covers treatments for diseases, it does not cover preventative drugs. Those who purchase Truvada for prevention, pay around $470 per month. Some clinics in Tokyo offer generic alternatives too, which is cheaper, but they are not ideal.

Better Healthcare Support

Brysting expressed concern that individuals importing medications might not be consulting doctors regularly, which is essential for monitoring HIV status and overall health. Truvada users need to be tested for HIV initially and every three months, along with screenings for other infections and kidney function checks. Without proper medical supervision, there is a risk of misuse and inadequate protection.

Gilead is in discussions with Japanese authorities to improve access and insurance coverage for Truvada, and progress is being made. Japan has shown efficiency in approving critical medicines, as seen during the COVID-19 pandemic when Gilead’s remdesivir was approved in just three days.

What Is The Way Ahead?

Gilead at this moment is not only focused on HIV and hepatitis C, but also expanding into oncology with innovative treatments like CAR-T cell therapy, which strengthens a patient's immune system to fight cancer.

However, Japan’s strict approval processes can slow down drug availability. Phase 3 clinical trials often need to be conducted within the country, and Japan tends to approve medicines much later than other regions. For instance, Truvada was approved for prevention in Japan 12 years after the U.S. and nearly 20 years after its approval for treatment. inancial factors also play a role. The Japanese government adjusts drug prices annually, often reducing them, which can make long-term investment challenging for pharmaceutical companies.

Commonly known as the ‘morning-after pill’, emergency contraceptive pills will soon be sold with prominent warnings on packs.

The Union Health Ministry has proposed bringing levonorgestrel 0.75 mg and 1.5 mg emergency contraceptive tablets under Schedule K of the Drugs Rules, 1945, with mandatory warnings on their packaging and package inserts. The draft notification was issued on September 3 and is currently open to public objections and suggestions.

The proposed warnings are intended to make it clear that the pills are meant only for emergency contraception and that they are not a regular contraceptive method.

They will also indicate that they are not abortion pills and do not protect against HIV or other sexually transmitted infections. They would also warn that frequent use can lead to side effects and advise women seeking regular contraception to consult a healthcare professional.

What Do Emergency Pills Actually Do?

Levonorgestrel is a synthetic version of the hormone progesterone. When taken as emergency contraception, it primarily works by delaying or preventing ovulation, meaning it can prevent an egg from being released when sperm are present.

It is intended to be taken after unprotected sex or contraceptive failure, such as a broken condom. The World Health Organization recommends levonorgestrel emergency contraception as a single 1.5 mg dose, or 0.75 mg in two doses 12 hours apart. It works best when taken as soon as possible and can be used within 120 hours of unprotected intercourse.

Crucially, it does not terminate an established pregnancy. That is why it should not be confused with medication used for medical abortion.

Also read: Exclusive With Leading HIV Expert: What's Driving Rising HIV Cases Among India's Youth And How To Prevent It

Emergency Pills Cannot Protect Against STIs

One of the proposed warnings is meant to addresses a common misconception about emergency contraceptive pills prevents pregnancy, not sexually transmitted infections.

It is important to under stand that levonorgestrel does not protect against HIV, syphilis, gonorrhoea, chlamydia or other STIs. Sexually transmitted infections can be prevented by barrier methods like condoms, when used correctly.

The proposed Indian warning specifically states that emergency contraceptive pills “do not offer any protection against HIV or any sexually transmitted infections.”

Also read: 5 Reasons To Get Regular STI Testing If You’re 'Sexually Active'

Reason Behind The Move

The move follows recommendations from the Drugs Technical Advisory Board (DTAB) after an expert review of contraceptive use in India.

Minutes of the 67th Drugs Consultative Committee meeting recorded recommendations for the package warnings stating that levonorgestrel emergency contraceptives should not be used more than twice a month, that they do not protect against HIV or STIs, and that alternative contraception should be considered with a registered medical practitioner.

The latest draft notification also states that frequent use “may lead to side effects” and encourages women to seek medical advice. However, this does not mean emergency contraception is considered inherently unsafe.

The WHO says side effects like nausea, vomiting, fatigue and temporary menstrual changes are generally mild and can be resolved without treatment. It also states that emergency contraceptive pills do not cause any harm to fertility.

The concern is instead about using an emergency method as a substitute for regular contraception. Repeated use can lead to menstrual irregularities and side effects.

The proposal would place levonorgestrel 0.75 mg and 1.5 mg tablets under Schedule K, while retaining their availability without a prescription. The draft is therefore not supposed to make morning-after pills prescription-only.

India’s campaign to eliminate iodine deficiency has made a substantial progress. A recent Lancet Regional Health – Southeast Asia study has found that cases of goitre among school-going children have reduced significantly.

But the research has also highlighted that another thyroid concerns have surfaced among Indian children simultaneously. They include thyroid autoimmunity and thyroid dysfunction.

The nationwide study, conducted across eight centres, examined 8,903 school children between the ages of 10 to 18 years.

Researchers examined goitre, thyroid function, thyroid antibodies and iodine status as part of the ICMR-SALT-T 1 study.

Goitre Cases Have Gone Down After Decades Of Iodised Salt

India introduced universal salt iodisation in 1986 to tackle iodine deficiency, a major cause of goitre and other disorders that affect growth and brain development.

The new study found that 10.3% of children had goitre, a substantial decline from 23.5% in 2003 and 17.6% in 2012. Nearly 99% of the detected goitre cases were classified as grade 1.

The findings reflect the fact that India’s iodisation programme has helped extensively in eliminating iodine deficiency.

More than 90% of surveyed households reported using iodised salt, while 89% of 1,615 tested salt samples contained more than 15 parts per million of iodine.

The median urinary iodine concentration was 133.2 micrograms per litre, indicating adequate iodine nutrition at the population level.

India’s National Iodine Deficiency Disorders Control Programme continues to target household use of adequately iodised salt and regular monitoring of iodine levels.

Also read: Ashwagandha Gummies Linked To Liver Failure, Brain Damage In UK Woman: What Is The Risk With The Herb?

But Thyroid Autoimmunity Is Rising

Despite adequate iodine nutrition, 10.4% of the 5,726 children tested for thyroid antibodies were positive for anti-thyroid peroxidase, or anti-TPO, antibodies.

These antibodies are produced when the immune system mistakenly targets the thyroid. Their presence can be a marker of thyroid autoimmunity and may be associated with conditions like Hashimoto’s thyroiditis. But antibody positivity alone does not mean a child has thyroid disease.

Girls were about twice as likely as boys to test positive for anti-TPO antibodies. Children with goitre were also more likely to have the antibodies.

The study also found hypothyroidism in 13% of the 5,512 children for whom thyroid-function data were available.

In this condition, thyroid-stimulating hormone is elevated but thyroid hormone levels can remain within the normal range. Anti-TPO positivity was independently linked with a higher likelihood of hypothyroidism.

Also read: The Growing Burden of Autoimmune Disorders: Can Ayurveda Offer a Holistic Solution?

Does Iodised Salt Cause Autoimmunity?

Researchers note that previous studies conducted after the introduction of universal salt iodisation had raised questions about iodine excess and thyroid autoimmunity.

Excess iodine can affect thyroid function and has been proposed as one possible contributor to autoimmune thyroid disease.

But it is important to note that thyroid autoimmunity has multiple possible influences, including genetic, environmental, nutritional and lifestyle factors.

The new Indian study is cross-sectional, which means it captures thyroid and iodine status at one point in time. It therefore cannot determine whether iodine exposure caused the antibody findings.

The findings do not undermine the public-health value of salt iodisation. Instead, they suggest that India’s priorities may now need to include continued monitoring of iodine intake alongside thyroid function and autoimmunity.

After US President Donald Trump’s executive order to split MMR into three shots came out in August, he put forth a proposal recently for some childhood vaccines to be divided into five doses.

Trump recently said his administration plans to push vaccine makers to split some childhood vaccines into five separate shots, believing and claiming that giving smaller amounts at longer intervals could lead to a significant reduction in autism.

Trump made the claims on September 18 but did not specify which vaccines he wants divided into five doses, nor did he provide scientific evidence linking vaccination schedules to autism. He said the doses would be given at six-month intervals.

The proposal follows an executive order Trump signed in August, directing changes to federal childhood vaccine recommendations, including separating the combined measles, mumps and rubella (MMR) vaccine into three individual shots and administering them at separate visits.

What Is Trump’s Proposal?

Also read: Trump Nominates Dr Nicole Saphier As Third Surgeon General Pick

On Friday, the President Trump said that his administration is planning to recommend that certain childhood immunizations should be separated into five shots, each with a “small amount of the vaccine.” He added that these doses would each be given six months apart.

“Instead of a child going in and having a tremendous amount of different vaccines pumped into a big proportion of the body … we’re going to recommend that they do five doses marked one, two, three, four, five and that they be given in six-month intervals, so that a small amount of the vaccine gets pumped into the body,” Trump said.

He also said he expects that this could lead to a “massive reduction in autism.” However, it remains unclear which childhood vaccines would be affected or how such a five-dose schedule would be implemented.

HHS Secretary Robert F. Kennedy Jr., who was standing by Trump as he announced the vaccine changes, received a standing ovation Thursday at the conference of the anti-vaccine advocacy group Children’s Health Defense.

He praised Trump’s embrace of vaccine skeptics, stating, “You have a strong and steadfast friend at the White House” and said that he would “stay in this fight.”

Vaccine formulations and dosing schedules are established through clinical research and regulatory review. So, Trump’s proposal to divide an existing dose has sparked reactions.

No Evidence That Vaccines Cause Autism

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Decades of research have not established that childhood vaccines cause autism. The CDC's current vaccine-safety information says multiple studies have found no link between MMR vaccination and autism.

In August, Trump signed an executive order to change the federal government’s approach toward childhood vaccines, insisting that infants should receive fewer immunizations over a longer period.

He advised that the measles-mumps-rubella (MMR) vaccine be separated into three individual shots, despite little to no scientific evidence. Research also proves that there is no published scientific evidence showing a benefit from separating the combined MMR vaccine into three individual shots.

However, the CDC's current website reflects the Trump administration's position, stating it has not definitively ruled out every possible relationship between infant vaccines and autism. It also says that HHS is funding further research into biological mechanisms.

The strongest available evidence for MMR specifically continues to show no association with autism, according to the CDC's cited evidence reviews.

Would Splitting Vaccines Make Them Safer?

There is currently no evidence that splitting combination vaccines into smaller doses prevents autism. The CDC also says there is no published scientific evidence that separating MMR vaccine into individual measles, mumps and rubella vaccines provides a safety benefit.

Experts have also questioned the idea that simply dividing a vaccine dose would change its safety profile.

José Romero, a former senior CDC official, told The Washington Post that vaccines are formulated in a way, so the total dose produces the intended immune response.

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia told CNN that Trump’s plan would render vaccines ineffective and wouldn’t make them safer necessarily.

Offit said, “When you create a vaccine, you do a dose response curve, and you’re trying to give the least amount of vaccine that induces an immune response that’s protective. So, you don’t want to give too much, where you know you don’t need all that, and you don’t want to give too little, where it’s you know sub-immunogenic.”

He added, “What he’s suggesting would not work. He’s basically saying he wants to give vaccines in a manner in which they wouldn’t be protective.”