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.

The US Food and Drug Administration (FDA) has expanded the approval of Vertex Pharmaceuticals' Casgevy (exagamglogene autotemcel), making it the first gene therapy approved for children as young as 2 years with sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Earlier, the one-time CRISPR-based gene-editing therapy was approved only for patients aged 12 years and older. The expanded label is expected to make approximately 5,500 additional children in the US eligible for treatment, the company said.

Why The Expanded Approval Matters

The FDA said earlier intervention could help prevent irreversible organ damage and improve long-term health outcomes.

“With today’s decision, pediatric patients as young as 2 years of age can now access a critical additional treatment option to treat these debilitating, life-threatening diseases,” said Karim Mikhail, Acting Director of the FDA's Center for Biologics Evaluation and Research (CBER).

"Making this therapy available to younger patients opens a critical window for intervention and gives these children a meaningful chance at a healthier future," added Megha Kaushal, Acting Deputy Director of the FDA's Office of Therapeutic Products.

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Clinical Trial Results

The expanded approval is backed by clinical trial data in children aged 5 to under 12 years.

For sickle cell disease:

• All 8 evaluable patients experienced no severe vaso-occlusive crises (painful episodes) for at least 12 consecutive months within the first two years after treatment.

For transfusion-dependent beta thalassemia:

• Eight of nine evaluable patients achieved transfusion independence for at least 12 consecutive months.
• The median duration of transfusion independence was 20.1 months.

What Is Casgevy?

Casgevy is a one-time gene-editing therapy that uses CRISPR technology to modify a patient's own blood stem cells, enabling the body to produce healthier red blood cells.

Also Read: Popular Potato Chips Brand Recalled, Classified Under Highest FDA Risk Level Over Salmonella Contamination

For people with sickle cell disease, it aims to prevent painful vaso-occlusive crises. In beta thalassemia, it can eliminate the need for regular blood transfusions in many patients.

“These disorders carry a heavy burden for children and their families, affecting growth, development, and long-term health in profound ways,” said Kaushal, also a pediatric hematologist. “Grounded in the scientific evidence that earlier treatment reduces the risk of lasting end-organ damage, making this therapy available to younger patients opens a critical window for intervention and gives these children a meaningful chance at a healthier future.”

The FDA granted the expanded approval through its Commissioner's National Priority Voucher program, completing the review in 53 days.

Vertex said it has also submitted applications to expand Casgevy's use in the United Kingdom and Saudi Arabia, where regulatory reviews are currently underway.

A popular snack brand is currently under scrutiny after its multiple products were classified under the US Food and Drug Administration's (FDA) Class I recall. The move came after concerns over its product being contaminated with Salmonella surfaced.

Why Did The Product Get Recalled?

According to the FDA, the recall was initiated in May by Utz Quality Foods LLC after the company found out that a seasoning ingredient containing milk powder, sourced from California Dairies Inc. through a third-party supplier, may have been contaminated with Salmonella.

The recall affects a few varieties of its Zapp's and Dirty’s potato chips, including Zapp's Bayou Blackened Ranch, Big Cheezy, and Salt and Vinegar potato chips, as well as Dirty brand Salt and Vinegar, Maui Onion, and Sour Cream and Onion potato chips.

According to the FDA, Utz said the seasoning batches tested negative before being used in production, but the decision to recall the products was taken as a precautionary measure.

While no illnesses have been reported yet, the FDA's move indicates there is a reasonable probability that consuming these products could result in adverse health consequences and even death.

Also read: Cyclospora Parasite Spreads Across 17 US States: How To Prevent Parasitic Infection

What Does FDA’s Class I Recall Signify?

The FDA uses three categories to classify product recalls based on the level of public health risk. A Class I recall is usually reserved for products that pose the highest risk to consumers.

It is issued when there is a reasonable probability that consumption or use of the product will cause serious health problems or death.

What Is Salmonella & How Serious It Is?

Salmonella infection, known as salmonellosis, usually develops between six hours and six days after consuming contaminated food.

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Common symptoms of salmonellosis include:

• Diarrhea

• Fever

• Stomach cramps

• Nausea

• Vomiting

• Headache

Most healthy people recover within four to seven days without targeted treatment. However, it can become severe when the infection enters the bloodstream. Deemed as a medical emergency, this situation prompts urgent attention.

Those with weakened immunity systems, such as young children, older adults, and women who are expecting are at the greatest risk of developing serious complications from salmonellosis. In rare cases, the infection can become life-threatening.

The FDA has advised consumers not to eat the recalled potato chips. It has also said that anyone who has purchased the affected products should either discard them or return them to the place where they bought them for a refund.

The regulatory body has also said that consumers who experience symptoms of salmonellosis after eating the recalled products, especially those at higher risk for complications, should seek medical care immediately.

Although no infection cases linked to the recalled chips have been reported to date, health officials say the recall is intended to prevent potential cases before they occur.

Women diagnosed with polyendocrine metabolic ovarian syndrome (PMOS) should receive an annual NHS health review and be diagnosed earlier to reduce their long-term health risks, according to draft guidance released by the UK's National Institute for Health and Care Excellence (NICE).

The guidance, now open for public consultation, recommends yearly reviews to monitor symptoms, treatment and the risk of developing serious conditions such as type 2 diabetes and cardiovascular disease. Earlier diagnosis, NICE says, could help people access timely care and make lifestyle changes before complications develop.

PMOS, until recently known as polycystic ovary syndrome (PCOS), was renamed following an international consensus published in The Lancet. The new name better reflects the condition's endocrine, metabolic and ovarian features.

What Does The Draft Guideline Recommend?

Also read: PCOS Is Now PMOS: What The Name Change Means For Millions Of Women

NICE recommends that everyone diagnosed with PMOS should be offered an annual review covering:

• Menstrual irregularities
• Symptoms such as excess hair growth (hirsutism)
• Medication use
• Screening for long-term health risks, including diabetes and cardiovascular disease

The guideline also includes recommendations on fertility treatment, stating that eligible patients should be offered IVF in line with existing NHS fertility guidance. It also addresses the management of common PMOS-related conditions, including acne, hirsutism and obstructive sleep apnea.

Given the increased risk of metabolic and cardiovascular disease in people with PMOS, the guidance directs healthcare professionals to relevant NICE recommendations for managing these conditions.

Earlier Diagnosis A Key Priority

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The draft guideline highlights that PMOS remains underdiagnosed despite affecting an estimated one in eight women.

It recommends investigating PMOS in anyone with irregular or absent menstrual cycles alongside signs of excess male hormones, as these are common indicators of the condition.

The guidance covers girls aged over 10, as well as adult women, trans men and non-binary people who are not receiving gender-affirming hormone therapy or surgery.

People with suspected PMOS should be offered blood tests to measure hormone levels and, where appropriate, pelvic ultrasound scans. The guideline also states that PMOS should not be ruled out after menopause and notes that the condition may be more prevalent among women of Black, Asian and mixed ethnic backgrounds.

Marie Anne Ledingham, consultant clinical adviser for women's and reproductive health at NICE, said the guidance is intended to improve consistency of care and ensure people receive appropriate long-term monitoring.

"PMOS is a common but often overlooked condition that can have a major impact on health and well-being. Recommending a simple annual review is an important step towards ensuring people get the ongoing care and monitoring they need," Ledingham said, in a statement.

Mental Health And Fertility Addressed

The draft guidance recognizes that PMOS affects far more than reproductive health. It is associated with an increased risk of depression, anxiety, eating disorders, fatty liver disease, obstructive sleep apnoea, pregnancy complications and fertility problems.

For people planning a pregnancy, NICE recommends advice on achieving and maintaining a healthy weight, balanced nutrition, regular exercise, good sleep and mental wellbeing to improve reproductive outcomes.

The guidance also stresses that eating disorders should not be overlooked or dismissed based solely on a person's weight.

Laser Hair Removal Not Recommended

While the draft guideline includes recommendations to manage hirsutism, it does not support routine NHS funding for laser and light-based hair removal therapies. NICE concluded that these treatments are not cost-effective, estimating they could cost the NHS "up to £100 million annually" in England if routinely funded.

The draft guideline is open for consultation until August 11, 2026, with the final NICE guidance on PMOS expected to be published in December 2026.