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.

Amid reports of rare botulism cases in the UK, the country's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety warning for all botulinum toxin type A products, including Botox and other cosmetic injectables.

The regulator said cases of iatrogenic botulism—botulism caused by medical treatment—have been reported following both therapeutic and cosmetic use of botulinum toxin products when the toxin spreads beyond the intended injection site.

"Patients should seek immediate medical advice if they experience signs and symptoms," the MHRA said.

Why Are Botulinum toxin At Risk?

Botulinum toxin medicines are widely used for cosmetic procedures, such as reducing facial wrinkles, as well as for treating conditions including muscle spasms, excessive sweating (hyperhidrosis), and an overactive bladder.

While these medicines are considered safe when used correctly, the MHRA warned that, in very rare cases, the toxin can spread beyond the injection site and cause botulism—a serious and potentially life-threatening condition.

To improve awareness, the regulator has worked with manufacturers to update product information and patient leaflets to more clearly highlight the risk of iatrogenic botulism.

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Symptoms Can Appear Up to Four Weeks Later

The MHRA warned that symptoms may not appear immediately after treatment. They can develop within days or even up to four weeks after receiving a botulinum toxin injection.

Patients are advised to seek immediate medical attention if they experience:

• Difficulty swallowing
• Slurred speech or difficulty talking
• Difficulty breathing or shortness of breath
• Muscle weakness

Who Is at Higher Risk?

According to the MHRA, the risk of serious side effects may be higher in:

• People with underlying neurological disorders
• Those with a history of difficulty swallowing (dysphagia)
• Those with a history of aspiration (inhaling food or fluids into the lungs)
• Patients receiving high doses of botulinum toxin
• Procedures performed outside licensed indications or at unapproved injection sites
• Use of counterfeit or unlicensed botulinum toxin products

Health officials say early recognition of symptoms is critical, as prompt treatment can help prevent serious complications.

"While botulism is a rare infection, it can be serious. There are effective treatments available, and we recommend seeking immediate medical advice if you have had a recent treatment and are experiencing symptoms such as difficulty swallowing," said Dr. Martin Bewley, Consultant in Health Protection at the UK Health Security Agency (UKHSA).

Dr. Alison Cave, Chief Safety Officer at the MHRA, recommended that healthcare professionals and patients be aware of the symptoms of botulism and act quickly if they arise. Importantly, the expert "strongly urged the public to avoid unlicensed products and seek treatment only from appropriately qualified practitioners."

What Is Botulism?

Botulism is a rare but serious illness caused by a toxin produced by the bacterium Clostridium botulinum. The toxin attacks the nervous system and can lead to paralysis, breathing difficulties, and, in severe cases, death if not treated promptly.

Because it can rapidly affect the muscles involved in breathing, botulism is considered a medical emergency.

The US Food and Drug Administration (FDA) has approved a once-daily pill that can lower low-density lipoprotein (LDL), commonly known as "bad" cholesterol, a major risk factor for heart disease.

Developed by Merck, enlicitide, which will be marketed as Lipfendra, is the first FDA-approved oral PCSK9 inhibitor for reducing LDL cholesterol.

Lipfendra has been approved as an adjunct to diet and exercise to reduce LDL cholesterol in adults with primary hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).

The approval is based on two Phase 3 clinical trials showing that Lipfendra can reduce LDL cholesterol to 50–60 mg/dL or even lower in many patients.

"Results from these Phase 3 trials showed treatment with Lipfendra resulted in reductions across other atherogenic lipoproteins associated with atherosclerotic cardiovascular disease (ASCVD) risk, including non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB)," Merck said.

High LDL cholesterol is a major risk factor for atherosclerotic cardiovascular disease (ASCVD), the leading cause of death globally.

"In two Phase 3 trials, LIPFENDRA led to impressive reductions in LDL-C. Now, for the first time, patients have an oral PCSK9 inhibitor for LDL lowering," said Dr. Ann Marie Navar, lead author of the clinical trial and associate professor at the University of Texas Southwestern Medical Center.

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How Does Lipfendra Work?

Lipfendra is a 20 mg once-daily tablet that works by blocking PCSK9, a protein that regulates LDL receptors in the liver.

Normally, PCSK9 reduces the number of LDL receptors available to remove cholesterol from the bloodstream. By inhibiting this protein, Lipfendra allows more LDL receptors to remain active, enabling the liver to clear more LDL cholesterol from the blood.

Unlike statins, which lower cholesterol by blocking an enzyme the liver uses to produce cholesterol, Lipfendra targets the PCSK9 pathway. It is also the first oral medicine in this class, whereas existing PCSK9 inhibitors are administered as injections.

What Did the Clinical Trials Show?

The FDA approval was supported by two Phase 3 studies, including a 24-week trial involving 2,912 participants, which demonstrated significant reductions in LDL cholesterol.

The studies found that:

• Lipfendra lowered LDL cholesterol by up to 60%.
• Many participants achieved LDL levels of 50–60 mg/dL or lower.
• The drug also reduced non-HDL cholesterol and ApoB, two additional markers associated with cardiovascular risk.
• Side effects were similar to those seen with placebo.

The cholesterol-lowering effect was comparable to that seen with injectable PCSK9 inhibitors.

Merck is now conducting a cardiovascular outcomes trial to determine whether Lipfendra also lowers the risk of heart attacks, strokes and cardiovascular death, as injectable PCSK9 inhibitors have previously been shown to do.

Lipfendra: How Much Does It Cost?

Merck said Lipfendra will be available in the United States within the next few weeks. The company has set a list price of $315 for a 30-day supply, according to Merck spokeswoman Julie Cunningham.

Who Could Benefit From Lipfendra?

Lipfendra is intended for adults with hypercholesterolemia, a condition characterized by elevated LDL cholesterol that can lead to plaque buildup in the arteries.

The drug may particularly benefit:

• Adults with primary hypercholesterolemia.
• People with heterozygous familial hypercholesterolemia (HeFH).
• Patients who need additional LDL lowering despite diet, exercise or statin therapy.
• Individuals looking for an oral alternative to injectable PCSK9 inhibitors.

Breast cancer diagnosed shortly after pregnancy may be more aggressive. According to new research, some young mothers may face poorer outcomes despite having similar types of breast cancer tumors as other women.

A UCLA-led study, published in npj Breast Cancer, found that women diagnosed with hormone receptor-positive (HR+), HER2-negative breast cancer within the first three years after childbirth, especially during the first year, were more likely to have tumors with a higher risk of recurrence.

It therefore indicates that postpartum breast cancer is not simply breast cancer diagnosed after pregnancy but may be a biologically distinct disease.

Breast Cancer In New Mothers

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Researchers analyzed young women with HR-positive, HER2-negative breast cancer using the widely used 21-gene Oncotype DX Recurrence Score, a genomic test that helps predict the likelihood of cancer recurrence and whether chemotherapy may be beneficial.

They discovered that tumors diagnosed during the first three years after childbirth had significantly higher recurrence rates than tumors in women who had never given birth.

The highest scores were observed among women diagnosed within the first year after delivery.

"Our findings suggest that the first three years after childbirth represent a distinct biological window during which hormone receptor-positive breast cancers may behave more aggressively," the researchers observed.

The study also provides one of the first genomic definitions of this high-risk postpartum period rather than relying solely on clinical observations.

Can Childbirth Change Breast Cancer Outcome?

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Researchers believe that the answer to that question lies in what happens to the breast after breastfeeding comes to an end.

After pregnancy and lactation, the breast undergoes a natural process called mammary gland involution, during which the milk-producing tissue shrinks, and the breast returns to its pre-pregnancy state.

While this change is normal, it creates a temporary environment that features inflammation, weakened immune system, and extensive tissue restructuring.

According to a recent review published in Breast Cancer Research, these biological changes may unintentionally create conditions that help dormant cancer cells survive, grow, and spread. Researchers describe this postpartum remodeling as a "tumor-promoting microenvironment."

These processes may partly explain why postpartum breast cancers are often diagnosed at more advanced stages and have poorer outcomes than breast cancers in women of similar age who have not recently given birth.

Effect Of Delay In Childbirth

The findings hold importance as breast cancer rates among younger women continue to increase worldwide just when women are getting pregnant later in their lives. Previous studies have indicated that breast cancer detected after pregnancy behaves differently.

"The medical community has long recognized that breast cancers diagnosed after pregnancy can behave differently," UCLA researchers said. "With breast cancer rates among younger women increasing, scientists have been studying whether delayed timing of first pregnancy may help explain some of that trend."

Because pregnancy and breastfeeding naturally change breast tissue, warning signs like lumps or breast firmness can sometimes be mistaken for normal postpartum changes. This may delay diagnosis and allow cancers to progress before they are detected.