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.

An experimental pancreatic cancer vaccine triggered an immune response against genetic mutations related to cancer in nearly 99% of patients according to a Phase 2 clinical trial. This has offered a new treatment strategy in tackling one of the deadliest cancers.

The vaccine, called camupepimut, is designed to train the immune system to attack cancer cells carrying mutations in the KRAS gene. The findings, published in Nature Medicine, come from a randomised trial led by researchers at Mayo Clinic.

KRAS mutations are found in approximately 90% of pancreatic ductal adenocarcinomas, the most common type of pancreatic cancer. These mutations help cancer cells grow and survive, making the gene an important target for researchers developing new treatments.

The trial included 144 patients with KRAS-mutated pancreatic cancer who had undergone surgery and chemotherapy. None had visible signs of cancer on imaging when they entered the study. Researchers randomly assigned 96 patients to receive the vaccine, while 48 were placed in an observation group.

Of the 90 vaccinated patients whose immune responses could be evaluated, 89, or 98.9%, developed increased T-cell responses against mutated KRAS. In more than 80% of these patients, the immune response was over nine times stronger than before vaccination.

How Does The Pancreatic Cancer Vaccine Work?

Also read: Top Neurologist Says Stroke Could Be First Sign of Undiagnosed Cancer: Red Flags to Know | Interview

Camupepimut is an investigational therapeutic cancer vaccine designed to target seven common mutations in the KRAS gene.

Unlike preventive vaccines that protect people against infections that can cause cancer, therapeutic cancer vaccines aim to help the immune system recognise and attack cancer cells.

The vaccine is designed to direct an immune response towards the body's lymph nodes, where immune cells are activated. It stimulates T cells, a type of white blood cell that can identify and destroy abnormal cells carrying specific mutations.

The researchers found that the vaccine activated both CD4 and CD8 T cells. These immune cells play different roles in recognising abnormal cells and coordinating attacks against them. Also, among patients who could be evaluated at least 46 weeks after starting vaccination, 95.5% continued to show a detectable KRAS-specific T-cell response.

"Historically, pancreatic cancer has been very difficult to treat with immunotherapy," said Ben George, a Mayo Clinic medical oncologist and lead author of the study.

"What is encouraging is that we were able to generate a strong immune response against KRAS mutations in nearly every patient we evaluated. In an exploratory analysis, patients with greater immune responses to the vaccine appeared protected with longer disease-free survival times."

Did The Vaccine Prevent Pancreatic Cancer From Returning?

Despite the strong immune response, the trial did not establish that camupepimut prevents pancreatic cancer recurrence.

There was no significant difference in survival without disease between the vaccinated and observation groups, which was the trial's primary outcome.

Median disease-free survival was 23.8 months among patients who received the vaccine, compared to 21.2 months in the observation group.

Researchers did, however, find a link between stronger immune responses induced by vaccines and longer periods without disease recurrence.

The researchers also identified possible differences in response based on patients' previous treatment. Those who had received radiation therapy developed weaker immune responses related to KRAS because radiation was associated with lower levels of lymphocytes, which are important immune cells.

These findings may help researchers identify which patients are more likely to benefit from the vaccine, but they are not yet sufficient to guide treatment decisions.

"We've shown that we can teach the immune system to recognize these KRAS mutations," Dr George said. "The next step is finding out whether doing that can change the course of the disease for patients."

Currently, researchers are planning a Phase 3 clinical trial to investigate whether camupepimut can improve outcomes for patients with pancreatic cancer.

India’s latest cancer drug price revision has reduced the maximum retail prices (MRPs) of several anti-cancer medicines. While the average price reduction comes around to be more than 50%, roughly one in four of the listed drugs still remain unchanged.

Also, the overall decline across all products is only 13.8%, according to an analysis by the Working Group on Access to Medicines and Treatments.

The analysis examined 643 anti-cancer drugs that were a part of the revised price list issued by the National Pharmaceutical Pricing Authority (NPPA). 484 products, or 75.27%, recorded a price reduction, while 159 products, accounting for 24.73%, remained unchanged.

Why Is Overall Price Reduction In Cancer Drugs Only 13.8%?

Also read: Top Neurologist Says Stroke Could Be First Sign of Undiagnosed Cancer: Red Flags to Know | Interview

Among products that became cheaper, the average price reduction was 50.78%. But when the combined listed MRPs of all 643 products were compared, the overall reduction was only 13.8%.

The difference between the two figures reflects the fact that many expensive cancer medicines have remained unaffected.

According to the working group’s analysis, the combined listed MRP of all 643 products fell from approximately ₹2.51 crore to ₹2.17 crore, marking a reduction of around ₹34.57 lakh.

However, the 159 products that recorded no price reduction accounted for 86.2% of the combined revised MRP value of the entire list.

“Of course, average can be misleading,” said KM Gopakumar, researcher with the Third World Network and co-convenor of the working group. “This weighted reduction gives us much more a realistic view.”

Expensive Cancer Drugs Remain Unchanged

Also read: Cancer Drug Prices Slashed For 543 Brands From Nov 9, But A Blockbuster Drug That Treats 21 Cancers Remains Untouched

The analysis found that several expensive cancer drug brands, including medicines manufactured by multinational pharmaceutical companies, retained their earlier MRPs. These include:

• Keytruda (pembrolizumab): The listed price remains ₹2,16,500 for a 100 mg injection.
• Tagrisso (osimertinib): The price remains approximately ₹4.16 lakh for a pack of 30 tablets.
• Avastin (bevacizumab): Roche’s 400 mg vial remains priced at ₹1,23,506.
• Alimta (pemetrexed): Eli Lilly’s 500 mg injection remains priced at ₹29,531.25.

The analysis also found that 110 of 122 products examined across 18 selected multinational pharmaceutical companies recorded no price reduction. Their average price reduction across all 122 products was just 1.3%.

On the other hand, several generic medicines recorded substantial cuts. For example, the price of a 400 mg bevacizumab vial sold as Bevacirel by Reliance Life Sciences fell by 83.27%, while Abbott Healthcare’s Bevacizab recorded an 86.26% reduction.

Call For Further Action

The Working Group on Access to Medicines and Treatments has urged the government to consider additional measures to improve access to expensive cancer medicines.

It has called for public health safeguards under Sections 92 and 100 of the Patents Act, which provide for compulsory licensing and government use of patented inventions in particular circumstances.

Such provisions can allow access to patented medicines under defined legal conditions when public health requirements warrant intervention.

The group has also questioned the trade margin framework, arguing that the margins remain high and that the government should disclose the calculations used to ascertain revised MRPs.

The NPPA introduced the latest intervention to address excessive trade margins and reduce the cost of cancer medicines.

Its October 28 list initially covered 543 brands, with subsequent updates expanding the coverage to 643 products.

The price revisions suggest that the overall impact remains limited because pricey drugs have not become cheaper. So patients who need expensive patented treatments, the latest price cuts may therefore offer little direct relief.

Barbados recently joined the list of 26 countries and territories that have been certified by the World Health Organization for eliminating mother-to-child-transmission (EMTCT) of HIV, syphilis or hepatitis B. 15 of these countries are in the Americas, which makes the region a global leader to achieve this feat.

The major public health milestone comes after years of sustained efforts to prevent mother-to-child-transmission of HIV.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said, “I congratulate Barbados on protecting a generation of children from HIV,” said “Barbados has shown what universal health coverage looks like in practice: free services for every pregnant woman, regardless of nationality, and care that respects her rights and privacy. With 15 countries and territories in the Americas now recognized, the region continues to show the world the way.”

How Did Barbados Prevent Mother-To-Child HIV Transmission?

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The Caribbean country's achievement was backed by widespread coverage of antenatal care, HIV testing and antiretroviral treatment.

“Barbados has shown that eliminating mother-to-child transmission of HIV is possible when women and children have access to quality health services without barriers,” said Dr Jarbas Barbosa, Director of the Pan American Health Organization (PAHO) and WHO Regional Director for the Americas.

“This achievement means that children are born free of HIV and that women living with HIV can access the care and treatment they need. It is a proud moment for Barbados, the Caribbean, and the global effort to end AIDS in children.”

During the three-year period, 98% of pregnant women received antenatal care, 98% were tested for HIV, and 98% of pregnant women living with HIV received antiretroviral treatment.

An essential step in Barbados' HIV elimination strategy is making HIV testing and treatment accessible to all pregnant women. Free HIV testing and treatment are available to all pregnant women regardless of race and nationality. These services are available through public clinics and hospitals.

“This is incredible for us, and it allows us to be able to see our children living their full, best lives. It allows mothers to be able to have the benefit of treatment during pregnancy, before treatment, but also, it means that we're able to ensure that we have a healthier population, and we're able to join the other countries around the globe that have also equally been able to achieve this historic milestone,” said Lisa Cummins, Minister of Health and Wellness of Barbados.

Additionally, pregnant women are offered voluntary and confidential HIV testing. Those who test positive are provided specialised care and treatment to reduce the risk of passing the virus to their babies.

Antiretroviral therapy (ART) is central to preventing mother-to-child HIV transmission. These medicines suppress HIV in the body, reducing the amount of virus in the blood. When an HIV+ pregnant woman receives ART, the risk of transmission to her baby can be reduced significantly.

Barbados also provides early testing and follow-up care for babies at risk of contracting HIV from their mothers.

Also read: 1 In 60 Adults In Fiji May Now Have HIV As Meth Use, Unsafe Injecting And Treatment Gaps Fuel Surge

How Does HIV Pass From Mother To Child?

HIV can be transmitted from a woman living with HIV to her child during pregnancy, childbirth or breastfeeding. This is known as vertical transmission or mother-to-child transmission.

Without preventive interventions, the risk of transmission can be significant. However, timely diagnosis, antiretroviral treatment during pregnancy and appropriate care around childbirth can substantially reduce this risk.

With effective treatment and appropriate medical support, women living with HIV can have children who are born without the infection.

The WHO certification recognises that Barbados has brought transmission down to a level at which it is no longer considered a public health problem. It does not mean that HIV has been eliminated from the country.