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.

Even as the US faces major outbreaks of Cyclospora and Salmonella infections, the Food and Drug Administration (FDA) has finalized safety guidance for operations handling ready-to-eat (RTE) fresh-cut produce.

The guidance incorporates public comments received on the October 2018 draft and replaces the FDA’s 2008 guidance on fresh-cut produce.

“This guidance represents the agency’s current thinking on the issues related to preventing contamination in fresh-cut produce,” the FDA said.

The agency also encouraged the industry to continue advancing food safety practices, including through best-practice documents tailored to specific commodities and processes.

The FDA’s guidance targets manufacturers and processors of fresh-cut produce and recommends measures such as sanitation controls, supplier verification and refrigeration amid ongoing outbreaks of cyclosporiasis and salmonella linked to fresh produce.

What Does the FDA Guidance Include?

The FDA recommendations are not legally binding and are aimed at manufacturers and processors of products such as chopped lettuce, sliced cantaloupe, diced onions, shredded carrots, coleslaw mixes and fruit salads.

Fresh-cut produce can include a single commodity, such as cut lettuce, sliced cantaloupe, diced celery, diced onions and shredded carrots, or combinations of two or more produce items, such as coleslaw mixes and fruit salads.

The FDA has focused on contamination with pathogens including salmonella, cyclospora, E. coli and listeria.

Fresh-cut produce processors should assess whether these pathogens pose potential hazards that require preventive measures, including supply-chain controls, the FDA said.

The recommended measures include:

• Using safe water
• Washing fruits and vegetables with antimicrobial solutions
• Training personnel
• Improving facility design
• Implementing sanitation controls
• Verifying suppliers
• Maintaining appropriate refrigeration

Why Is Fresh-Cut Produce at Risk?

Fresh-cut produce can be particularly susceptible to contamination because pathogens may be introduced at multiple points, including during growing, transportation, manufacturing, commingling with other products or at retail.

The opportunity for contamination can increase at each stage before the food reaches consumers.

Fresh-cut produce also does not undergo a kill step to eliminate pathogens that may be introduced during these processes, and most products are sold ready to eat.

The guidance provides recommendations and examples of how Preventive Controls for Human Food can be implemented to protect fresh-cut RTE produce from biological hazards.

Cyclospora and Salmonella Outbreaks

The guidance comes as the US investigates outbreaks linked to contaminated lettuce and jalapenos that have sickened thousands of people.

The cyclospora outbreak linked to iceberg lettuce from Taylor Farms has spread to 15 states, with Michigan hit the hardest.

“Americans should feel confident in eating fresh produce, including leafy greens at this point,” Diamantas said during an appearance on CNBC. The FDA said it remains confident that iceberg lettuce linked to the cyclospora outbreak had been effectively removed from the market following the July 17 recall.

The US Department of Health and Human Services also said Tuesday on X: “Cyclospora: contained, American food: safe.”

However, the FDA and CDC say the investigation into the cyclospora outbreak remains ongoing.

Separately, Taylor Farms said Monday that it was recalling prepared foods containing jalapenos from retailers in several states because of potential salmonella contamination.

Statins are widely used to lower “bad” LDL cholesterol and reduce the risk of heart attacks and strokes.

A new study published in The Lancet Healthy Longevity found that stopping statins in adults aged 75 and older with no history of cardiovascular disease did not increase the risk of death over three years compared with continuing treatment.

However, LDL cholesterol rose by around 50% among those who stopped taking the drugs.

Stopping Statins Did Not Increase Death Risk

The study found no significant difference in deaths or major cardiovascular events, including heart attacks and strokes, between older adults who stopped statins and those who continued treatment.

Researchers cautioned that the findings do not mean older adults should routinely stop taking statins.

“The decision to continue or stop statin treatment later in life should be individualized and made through shared decision-making between patients and clinicians,” the researchers said.

Further trials are needed to confirm the findings and assess the long-term effects of stopping statins.

“The benefits of statins increase over time in younger adults and it remains unknown whether stopping the medication could increase the risk of cardiovascular disease and death after the three-year follow-up period in older people,” said the researchers from Bordeaux University Hospital and Université de Bordeaux, France.

What Did the Trial Find?

The randomized controlled trial enrolled 1,160 adults aged 75 and older with no history of heart disease or stroke at general practices in France. Participants were randomly assigned to stop or continue their statin medication.

After three years:

• 7.2% (35/484) in the statin discontinuation group had died.
• 7.9% (48/604) in the continuation group had died.
• There was no significant difference in major cardiovascular events, including heart attacks and strokes.
• LDL cholesterol rose by 50%, from 115 mg/dL to 171 mg/dL, among those who stopped statins.
• LDL cholesterol showed no change among those who continued treatment.
• Physical and mental quality of life remained unchanged in both groups.

What Does This Mean for Patients?

The study involved people taking statins for primary prevention—those at risk of heart disease or stroke but without established cardiovascular disease.

The researchers stressed that the findings should not be interpreted as a recommendation to stop statins.

Instead, the decision should be based on the individual patient’s circumstances and discussed with a clinician.

Why Are Findings Important?

Evidence on the benefits of statins for primary prevention in older adults remains limited because many statin trials exclude people older than 70 or 80.

A 2013 Cochrane meta-analysis of 18 trials found a 14% reduction in deaths from all causes among adults taking statins for primary prevention of atherosclerotic cardiovascular disease. However, the median age of participants was 57.

The new findings also differ from observational studies from Denmark and Italy published in 2021. Those studies reported about a 30% higher risk of fatal and nonfatal cardiovascular outcomes after statins were discontinued in older adults.

Unlike those cohort studies, the new research was a randomized controlled trial, but it only followed participants for three years.

How Statins Work

Statins work by reducing the amount of cholesterol produced by the liver, helping slow the buildup of fatty plaque in the arteries.

They are prescribed both for people at risk of cardiovascular disease (primary prevention) and those with established cardiovascular disease (secondary prevention).

The new study does not establish that stopping statins is safe for all adults over 75. Longer-term research is needed to determine whether discontinuing treatment could affect cardiovascular risk or mortality beyond three years.

The U.S. Social Security Administration (SSA) has expanded its Compassionate Allowances (CAL) program by adding 14 serious and rare medical conditions, helping eligible patients to have their disability claims fast-tracked.

The announcement, made on August 11, brings the total number of conditions covered under the programme to 314. According to the SSA, more than 1.2 million people with severe disabilities have been approved through the fast-paced process since CAL was introduced.

Which Conditions Have Been Added To CAL?

The newly included conditions range from rare genetic and neurological disorders to aggressive cancers. They include:

• Aicardi Syndrome
• Baraitser-Winter Syndrome
• Bohring-Opitz Syndrome
• CASK-Related Gene Disorders
• Lafora Disease
• Warburg Micro Syndrome
• Hepatosplenic T-Cell Lymphoma
• Primary Cardiac Sarcoma
• Primary Intracranial Malignant Melanoma
• Metastatic Uveal Melanoma
• Malignant Migrating Partial Seizures of Infancy
• OPHN1 Syndrome
• Beare-Stevenson Cutis Gyrata Syndrome
• Adenylosuccinate Lyase Deficiency, neonatal form and Type 1

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What Is The Compassionate Allowances programme?

For people with severe disabilities, applying for Social Security Disability Insurance (SSDI) or Supplemental Security Income (SSI) can become another burden at a time when they are already dealing with a life-changing diagnosis.

The CAL programme, established in 2008, is designed to reduce the waiting time. When a person applies for disability benefits with a qualifying condition, the SSA can identify the diagnosis and move the claim through an accelerated determination process. In some cases, decisions can take days rather than months due to red tape.

The programme is particularly important for patients whose illnesses may prevent them from working while simultaneously creating significant medical and financial expenses.

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How Can This Expansion Help?

Rare diseases and aggressive cancers can progress rapidly, leaving patients and families with little financial breathing room. A conventional disability determination can involve gathering medical records and reviewing evidence before a decision is made.

“The Compassionate Allowances initiative cuts through red tape and allows us to deliver support to individuals who experience life-changing diagnoses and need help fast,” SSA Commissioner Frank J. Bisignano said.

The agency said it uses technology to identify potential CAL conditions and, where available, receives electronic medical records through its Health IT programme to help adjudicators make faster decisions.

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What Does This Change Mean For Patients?

The most important factor patients must note is that CAL is not a separate benefit or extra payment. It is a faster route through the existing SSDI and SSI disability determination process. Patients must still meet Social Security's definition of disability and other eligibility requirements.

There is also no separate CAL application. Patients should apply for SSDI or SSI and ensure their qualifying diagnosis is clearly documented. The SSA system can then flag eligible claims for accelerated processing of their claims.

For families facing rare, devastating diseases, that difference can be significant. Faster access to existing disability benefits can help bridge the gap between a diagnosis that changes someone's ability to work and the financial support they need to manage life after it.