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.

Leprosy will soon be a notifiable disease in India’s national capital, Delhi, in a move to boost surveillance, improve early diagnosis and treatment, the state health department has said.

The Delhi Health Department has submitted the proposal, under the Delhi Epidemic Diseases Act, for necessary approval. Once approved, Delhi will join states like Tamil Nadu, Maharashtra, Karnataka, and West Bengal that have already made leprosy notifiable.

“Leprosy is completely curable. Making it a notifiable disease will help us find hidden cases, stop transmission, and ensure every patient gets standard treatment with dignity. This is a critical step towards honoring our commitment to a leprosy-free Delhi and supporting India’s journey towards the interruption of its transmission by 2030,” Health Minister Pankaj Singh said, in a statement.

Why Notifying Leprosy Is Important?

More than 40 per cent of leprosy patients are managed by private health facilities in India, revealed a recent pan-India study. As a result, most go unreported to the National Leprosy Eradication Programme (NLEP).

Cases that go unreported continue to spike the risk of transmission. The variance in treatment protocols also raises the threat of drug resistance. WHO's Independent Evaluation of the NLEP program in India suggests that leprosy should be included in the list of diseases mandatory for notification.

According to the Ministry, the notification will mandate all government and private healthcare providers, including clinics, hospitals, and individual practitioners, to report every new leprosy case to the District Leprosy Officer.

Mandatory notification will

• boost surveillance
• boost targeted interventions
• lead to early diagnosis
• prompt early treatment with standard Multi-Drug Therapy (MDT)
• reduce disability risk
• prevent transmission through timely contact tracing and post-exposure prophylaxis (PEP),
• reduce stigma and discrimination by normalizing leprosy as a treatable medical condition,
• improve treatment compliance and reduced defaulter rates,
• boost ownership among all healthcare establishments toward the common goal of leprosy eradication.

The proposed notification will be issued following the advice of the Delhi Government as per the GNCTD Act 1991. Detailed reporting formats and guidelines will be shared with all health institutions and practitioners across the National Capital Territory of Delhi.

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What Is Leprosy?

Leprosy is also known as Hansen's disease. It is a chronic infectious disease that is caused by the bacterium Mycobacterium leprae. It affects the skin, peripheral nerves, upper respiratory tract mucosa, and eyes.

If it is not treated promptly, it could lead to permanent nerve damage, disabilities, and social stigma. However, the condition is fully curable with multidrug therapy, and early detection could prevent further complications.

Leprosy is also a neglected tropical disease (NTD), which occurs in more than 120 countries, with around 2,00,000 new cases reported every year.

The Prevalence Of Leprosy In India

India achieved the official elimination of leprosy as a public health problem (less than 1 case per 10,000 population) nationally in December 2005. However, the country still accounts for approximately 59 per cent of global annual new leprosy cases.

As per data from the Health Ministry, till March 2025, 31 states/UTs and 638 districts have achieved less than 1 case per 10,000 population of leprosy, with a prevalence rate of 0.57 per 10,000.

The NLEP now targets "Zero Transmission, Zero Leprosy" by 2027 through early detection, free multidrug therapy (MDT), and stigma reduction.

Under the NLEP, the government provides services such as free diagnosis and treatment (MDT) at all government health facilities, microcellular rubber footwears for patients, free assistive devices for leprosy patients, self-care kits for patients with ulcers, and reconstructive surgery for Grade 2 deformities with a welfare allowance of Rs 12,000.

All services under NLEP are available free of cost at all government health facilities.

The Supreme Court of India has urged the All India Institute of Medical Sciences (AIIMS) to set up an expert panel

to examine how brain death is certified in India.

The apex Court has sought to know whether additional tests, such as electroencephalogram (EEG) and angiogram, are needed to declare a person brain dead.

A bench of Justices Vikram Nath and Sandeep Mehta was hearing a petition filed by Kerala-based medic and activist S Ganapathy, alleging malpractices in brain death certification, Times of India reported.

Ganapathy alleged that patients who may not be brain dead are sometimes declared so to facilitate organ donation. The petition also questioned the reliability of the apnea test—the standard method used to confirm brain death—calling it subjective and claiming that the legal requirement of video graphing the procedure is often not followed.

What is Brain Death?

Brain death, technically referred to as brain-stem death, is the irreversible end of all brain activity.

In India, according to the Transplantation of Human Organs (THO) Act, 1994 (Subsection 6 of Section 3), 'brain stem death' refers to the stage at which all functions of the brain stem have permanently and irreversibly ceased.

This is to be certified by a 'Board of Medical Experts' consisting of:

(1) The medical superintendent (MS)/In-Charge of the hospital in which 'brain stem' death has occurred,

(2) a specialist,

(3) a neurologist or a neurosurgeon nominated by the MS, from a panel approved by the Appropriate Authority, and the doctor under whose care the 'brain- stem' death has occurred.

Amendments in the THO Act 2011 have allowed the selection of a surgeon/physician and an anesthetist, if an approved neurosurgeon or neurologist is unavailable.

“Brain stem death has to be certified by a panel of four independent doctors, including a neurologist or neurosurgeon, and confirmed twice with a minimum gap of six hours. The process is carried out with due diligence and seriousness,” Dr Manjari Tripathi, head of neurology at AIIMS, was quoted as saying.

“While the guidelines require the team of doctors to meet and declare brain death at least twice, we end up doing it sometimes three times for the patients. The current guidelines require various bedside tests for the declaration of brain death. It does not specify the need for tests such as an EEG or angiogram,” added Dr. Tripathi.

Experts said additional tests could add to the system burden. EEG is not routinely recommended for brainstem death certification, while an angiogram is used only in select cases where the apnea test cannot be performed. Globally, the apnea test remains the gold standard. These criteria are clearly laid down and cannot be altered, said experts.

Challenges To Brain Death Certification In India

The Indian Express reported that the lack of knowledge even among physicians is a significant challenge in India.

This leads to several patients never being officially declared and asked to be organ donors.

An AIIMS-led study, published in the journal Neurology India last year, found that more than half the doctors — including neurosurgeons, neurologists, and critical care specialists who are most commonly included in the certification process — did not receive any training on brain death certification at the time of their graduation.

The US Food and Drug Administration (FDA) has approved Merck's Idvynso (doravirine/islatravir), a new, once-daily pill for the treatment of HIV-1 infection in adults.

The two-drug single tablet replaces the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL).

The single tablet contains 100 mg doravirine and 0.25 mg islatravir. The FDA has approved it for adults on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

“IDVYNSO combines islatravir, a next-generation NRTI with multiple mechanisms of action, including translocation inhibition, with doravirine, an NNRTI with an established efficacy and safety profile,” said Dr. Eliav Barr, senior vice president and chief medical officer, Merck Research Laboratories, in a statement.

How Was The Pill Approved?

The approval is based on data from two randomized, active-controlled, noninferiority trials. In the double-blind Trial 052, participants were randomly assigned to stay on Glilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; 171 individuals) or switch to Idvynso (342 individuals).

Results showed that 1 per cent of participants in both groups had a viral load of ≥50 copies/mL at 48 weeks.

In the open-label Trial 051, participants were randomly assigned to stay on their oral antiretroviral therapy (ART) regimen (185 individuals) or switch to Idvynso (366 individuals).

Results showed that 1 per cent of participants who were switched to Idvynso had a viral load of ≥50 copies/mL at week 48 versus 5 per cent who continued on ART.

"As the only two-drug, non-integrase strand transfer inhibitor, tenofovir-free regimen, Idvynso expands therapeutic diversity beyond the currently available oral treatment options," Barr said.

"As the health needs of adults living with HIV change over time, Idvynso gives clinicians a new choice for HIV treatment."

What Is IDVYNSO? How Does It Work?

IDVYNSO is a fixed-dose combination of two medicines, doravirine with islatravir.

Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase.

Islatravir is a potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms, including:

• inhibition of reverse transcriptase translocation, resulting in immediate chain termination,
• induction of structural changes in the viral DNA (delayed chain termination).

Global Burden Of HIV

According to the latest data from UNAIDS, 40.8 million people globally were living with HIV in 2024. Of these, 39.4 million were adults (15 years or older) and 1.4 million were children (0–14 years).

While 1.3 million people became newly infected with HIV in 2024, 630,000 died from AIDS-related illnesses.

About 87 per cent of all people living with HIV knew their HIV status, and 5.3 million people did not know that they were living with HIV.