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.

AstraZeneca is developing an experimental cancer drug sonesitatug vedotin that has reported a reduction in the risk of death by 42% in patients with advanced stomach and related cancers. The findings from their Phase 3 clinical trial was presented at the European Society for Medical Oncology (ESMO) Congress in Madrid on October 25.

The global CLARITY-Gastric01 trial compared the drug, also known as sone-ve, to chemotherapy selected by the physician in patients whose cancer had progressed after previous treatment.

The findings showed that patients who received sone-ve lived a median of 10.6 months, compared to 6.4 months among those undergoing chemotherapy.

The trial included 532 patients with advanced gastric cancer, gastroesophageal junction cancer or oesophageal adenocarcinoma whose tumours expressed the protein claudin 18.2 (CLDN18.2). The findings spark hope that the drug could offer another treatment option for patients whose disease has progressed despite early intervention.

Susan Galbraith, AstraZeneca's executive vice-president of oncology haematology research and development, said, “A 5-month improvement in overall survival is very clinically significant in a difficult to treat patient population,” according to Reuters.

How Does Sonesitatug Vedotin Work?

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Sonesitatug vedotin belongs to a class of treatments called antibody-drug conjugates (ADCs). These medicines combine an antibody that identifies a target on cancer cells with a drug that kills those cells, becoming a target-focused treatment.

Sone-ve targets CLDN18.2, a protein found on the surface of certain stomach and related cancer cells. The drug is designed to deliver its cancer killing properties to these cells.

The trial enrolled patients whose tumours showed CLDN18.2 expression in at least 25% of tumour cells. This limit could make the treatment relevant to a bigger group of patients than therapies that require higher levels of the protein.

Rui-Hua Xu, professor of medical oncology at Sun Yat-Sen University Cancer Center and the trial's principal investigator, said, “These are remarkable survival results for Sone-Ve in 2nd- and later-line metastatic gastric cancer, a disease where patients face a poor prognosis once initial therapy fails.”

He added that the treatment could be a shift in cancer care for patients whose tumours express CLDN18.2.

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More About The Trial's Findings

The results are promising but the drug did not meet the trial's other primary endpoint, which is survival without disease progression.

Progression-free survival measures how long patients live without their cancer worsening or dying. Median progression-free survival was 4.2 months with sone-ve and 3.8 months with chemotherapy.

Serious side effects related to the treatment occurred in 36.4% of patients receiving sone-ve, compared to 44.8% who did chemotherapy. However, side effects related to stomach were more frequent with sone-ve, affecting 11.1% of patients compared to 6.3% in the control group.

It is important to note that the findings are from a clinical trial and do not mean the drug is approved for routine use. Further regulatory review is needed before it can become a treatment option.

Furthermore, AstraZeneca is also studying sone-ve in early treatment, where it could be used before patients have exhausted multiple therapies.

The company said the findings support investigating the drug in a bigger population of patients with CLDN18.2-positive cancers. The next phase of research will help establish its role in treatment and whether the survival benefit can be maintained when used earlier.

A Chinese-Russian surgical team has reportedly replaced a damaged section of a paralysed patient's spinal cord with tissue from a brain-dead donor, executing the world's first human spinal cord transplant successfully.

However, with no evidence of neurological recovery, scientists have been questioning whether the procedure can restore movement so far. The 12-hour operation was performed at the Sklifosovsky Research Institute for Emergency Medicine in Moscow on October 14–15, according to Chinese surgeon Ren Xiaoping, one of the doctors who participated in the procedure. The patient had sustained a severe spinal cord injury three years ago.

Ren told the South China Morning Post, “It was our Guangxi University of Chinese Medicine Second Affiliated Hospital and the Russian team working together.”

Moscow Mayor Sergei Sobyanin announced the procedure on October 16, describing it as a significant development in spinal surgery. “A patient who was threatened with complete immobility had a chance to recover. Now he feels good,” he wrote.

However, feeling well after surgery does not mean that a patient has regained movement. The surgical team has not publicly released neurological evidence showing whether signals can travel across the transplanted section.

How Was The Spinal Cord Tissue Transplanted?

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According to Ren, surgeons removed the damaged section of the patient's spinal cord and replaced it with tissue obtained from a brain-dead donor. They used microsurgery and polyethylene glycol (PEG), a substance that can fuse cell membranes to join the tissues.

This technique addresses one of the central challenges of treating severe spinal cord injuries. The spinal cord carries signals between the brain and the rest of the body. When it is severely damaged, these signals cannot pass normally through the injury, causing paralysis and loss of sensation below the affected area.

But joining two sections of tissue is not enough. Nerve fibres must establish functional connections across the damaged area and the tissue that is transplanted must receive blood supply. The recipient's immune system may also attack the donor tissue.

These challenges become important when the injury is several years old. Repairing a recently damaged spinal cord is different from replacing tissue in a patient with a longstanding injury.

Scientists Have Raised Questions

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Scientists have raised concerns about the evidence about whether it can restore meaningful neurological function in humans.

Melissa Andrews, a neuroscientist at the University of Southampton, questioned the quality of the animal studies supporting the technique and warned about the risks involved, according to New Atlas.

Experiments involving PEG has shown some promise in animals but they do not prove that the technique can reconnect a human spinal cord successfully enough to restore movement.

The lack of publicly available evidence is another limitation. Details about the patient's injury, the precise location of the transplanted segment, neurological examinations after the procedure and changes in movement or sensation have not been disclosed. No peer-reviewed clinical report documenting the operation and its outcomes has been published.

Ren told New Atlas, “We have informed the patient of every potential risk and surgical outcome, and the patient's current condition is good.”

The operation is an experimental treatment, not proof that transplanting spinal cord tissue can reverse paralysis. Even if the patient survives the operation without major complications, recovery would depend on whether functional nerve connections develop and whether the brain can communicate with the body across the damaged region. Rehabilitation and long-term follow-up would be needed to assess any improvement.

Kerala's decision to switch from an expensive branded medicine for children with spinal muscular atrophy (SMA) with a much cheaper Indian-made alternative has sparked a dispute over the drug’s safety, regulatory procedures and parents' right to know what treatment their children receive.

Health Minister K Muraleedharan has defended the switch to Natco Pharma's generic risdiplam, which is sold as Natsmart. However, some parents and opposition leaders have questioned why bottles supplied to children at the Sree Avittom Thirunal (SAT) Hospital in Thiruvananthapuram were labelled “Physician's Sample” and “For Clinical Trials Only”.

The controversy has since expanded beyond the medicine's price. It now concerns how the drug reached the hospital and what evidence backs its use in children already receiving treatment.

Why Did Kerala Switch To The Generic SMA Medicine?

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SMA is a rare inherited disorder that causes progressive muscle weakness and wasting because of the loss of motor neurons. It can affect movement, swallowing and breathing. Its treatment may need to continue over a long period.

The branded risdiplam, Evrysdi, is manufactured by Swiss pharmaceutical company Roche. Its reported market price is around ₹6.2 lakh per bottle. Natco's generic alternative, Natsmart, is listed at ₹15,900 per bottle. The Kerala government has negotiated even a lower procurement price.

The difference could substantially reduce public expenditure. The state has been providing risdiplam free to eligible children through its KARE programme. Reports indicate that around 109 children are receiving treatment under the scheme.

The generic switch was intended to make treatment more affordable.. Public health expert B Ekbal has backed the decision, arguing that lower-cost medicines can expand access without compromising quality.

The debate is not over whether generic medicines should be used. Opposition leaders, including former chief minister Pinarayi Vijayan, say their objections concern the handling of the medicine that were labelled for clinical trials and the transparency of its distribution.

‘Clinical Trial’ Label Alarmed The Parents

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The controversy surfaced after families received bottles bearing the clinical trial and physician sample labels. Parents questioned whether their children had been given medicine intended for testing and whether they had adequately informed before.

Former Kerala health minister and CPI(M) leader K K Shailaja raised concerns about quality and the need for transparency and evidence before changing treatment.

“Just because a new company offers a price reduction doesn’t mean we can purchase everything. Besides price reduction, quality is what matters most. Some companies might lower prices just to push unsold products or for other interests,” she said, according to The South First.

The government says the labels indicate that they belong to sample stock and do not mean that the children were enrolled in a clinical trial.

Dr R Shankar, who heads the technical committee that evaluated the medicine, said, “If the concern is over the label, there was ‘physician’s sample’ written on it. It means it is a tested molecule. The container contains the same medicine.”

Hospital authorities said the disputed bottles were taken back after parents raised concerns. The minister has maintained that this was done to address their apprehensions, not because the government had concluded that the medicine was unsafe.

Muraleedharan has said the switch was based on an expert committee's recommendations and that the drug had received regulatory approval.

On October 24, he said, “People had concerns, but the doctors have addressed them. The treating doctors themselves have cleared the doubts.” He also said he would provide further clarification in the state Assembly on October 26.

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SMA Patient Says The Generic Medicine Worked For Her

Amid the concerns, SMA patient Seba P A has defended Natsmart, saying she has taken Natco's generic risdiplam since April through a patient assistance programme. “Taking Natsmart produces the same effect as when I was taking Evrysdi,” she said. “I have felt no issues due to the change in brand.”

Seba also said bottles supplied to her free of cost carried the same physician sample and clinical trial labels. She argued that the labels were intended to prevent the free medicine from being resold.

Is the Generic SMA Drug Safe?

Natsmart contains risdiplam, the same active pharmaceutical ingredient as Evrysdi. The Central Drugs Standard Control Organisation (CDSCO) has approved Natco's formulation for marketing in India.

They maintain that the generic medicine is suitable for patients and that the labels do not indicate an ongoing clinical trial involving the children.

However, questions have been raised about bioequivalence evidence, quality checks and the process followed before procurement. Bioequivalence studies are used to establish whether a generic formulation delivers an active ingredient into the bloodstream at a rate and to an extent comparable with the reference medicine.

The dispute therefore cannot be resolved by comparing prices or relying solely on individual patient experiences. Families need clear information about the product's approval, the evidence for its use in children, the significance of the labels and the safeguards in place to monitor adverse effects.