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 Ebola outbreak in the Democratic Republic of Congo (DRC) has crossed 4,000 cases, making it the second-largest Ebola epidemic ever recorded after the 2014-2016 West Africa outbreak.

According to the latest Health Ministry situation report, the DRC has recorded 4,053 cases and 1,850 deaths since the outbreak was officially declared in mid-May. Health officials believe transmission may have begun as early as January.

The outbreak is caused by the Bundibugyo strain of the Ebola virus, which has neither a vaccination nor any antiviral. However, two vaccine candidates by Oxford-SII and Moderna have entered clinical trials.

Africa CDC Calls for Intensified Response

Africa's public health agency has said the current response needs to be significantly expanded, announcing plans to shift from traditional contact tracing to an active, community-wide search for cases.

Dr. Wessam Mankoula, Acting Head of Emergency Preparedness and Response at the Africa Centres for Disease Control and Prevention (Africa CDC), said response teams will begin door-to-door case finding.

"I think the time for incremental action is over and we're starting now the phase for scaling up," he said.

He explained that community health workers would move from house to house to identify people showing Ebola symptoms rather than relying solely on contact tracing.

Africa CDC Director General Dr. Jean Kaseya also outlined plans for a village-centered response, with greater community involvement, expanded use of digital surveillance tools, and stronger interventions in camps housing people displaced by conflict.

Second-Largest Ebola Outbreak on Record

The outbreak has spread across 53 health zones in the provinces of Ituri, North Kivu, South Kivu, Haut-Uele and Tshopo.

Ituri, the epicentre of the outbreak, accounts for 86.9% of confirmed cases.

Africa CDC noted that, 11 weeks into the outbreak, the DRC has reported eight times more cases and six times more deaths than were recorded at the same stage of the 2014 West Africa Ebola epidemic, which ultimately infected more than 28,000 people and killed at least 11,000.

Is The Bundibugyo Virus Mutating?

Health officials are now examining whether changes in the virus could be contributing to the unusually severe outbreak.

Speaking at a press briefing, Dr. Jean Kaseya said he had discussed the situation with World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus.

"We plan studies to check if there is no additional issue, or maybe if the virus is not mutating, because the level of severity of this Bundibugyo outbreak is unprecedented," Kaseya said.

He cautioned against assuming scientists fully understand the virus.

"After many Ebola outbreaks, we cannot assume we know everything. In the DRC, we must listen to communities, act on what they tell us and build the trust needed to stop transmission."

Outbreak Shows No Signs Of Slowing

Medical charity Médecins Sans Frontières (MSF) said the response is expanding but is still not reaching communities quickly enough to interrupt transmission, The Guardian reported.

Philippa Boulle, MSF's Deputy Medical Director, warned that the outbreak continues to spread into new areas.

"New suspected cases are being reported almost daily in new locations, outside already identified transmission chains. To prevent further loss of life, the response must outpace the current rate of transmission," Boulle said.

Kaseya also highlighted shortcomings in surveillance, noting that only 10 contacts are being identified per Ebola patient, compared with the approximately 40 contacts typically expected during effective contact tracing.

The US Food and Drug Administration (FDA) has granted accelerated approval to Replimune's Tudriqev for the treatment of advanced refractory melanoma—a deadly form of skin cancer that continues to grow or spread despite treatment with standard immunotherapy drugs such as PD-1 inhibitors.

The approval comes after the FDA rejected the therapy twice over concerns related to the quality of clinical data.

The latest decision was supported by clinical trial results showing that 24% of patients responded to treatment, with responses lasting a median of 14.1 months. The FDA also considered input from clinical experts and patient advocates, who highlighted the urgent need for new treatment options for patients with refractory melanoma.

What Is Tudriqev?

Tudriqev is an oncolytic viral immunotherapy based on a genetically modified herpes simplex virus type 1 (HSV-1). The virus is engineered to selectively infect and destroy cancer cells while stimulating the body's immune system to recognize and attack the tumour.

The therapy is approved in combination with nivolumab for adults with unresectable melanoma that:

• Has spread or cannot be safely removed through surgery.
• Has progressed after treatment with a PD-1-blocking antibody-based regimen.

"For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. Clinicians managing these patients know this urgency firsthand," said Karim Mikhail, Acting Director of the FDA's Center for Biologics Evaluation and Research (CBER).

Also read: Narcolepsy: US FDA Approves First-Ever Pill That Targets Root Cause of Rare Sleep Disorder

How Does Tudriqev Work?

Tudriqev is injected directly into tumours, where the modified virus replicates inside cancer cells, causing them to rupture. At the same time, it activates the immune system to identify and attack cancer cells throughout the body.

When combined with nivolumab, an anti-PD-1 immunotherapy, Tudriqev may help restore an anti-tumour immune response in patients whose melanoma no longer responds to checkpoint inhibitor therapy.

How Is The Treatment Given?

Tudriqev is administered once every two weeks for eight consecutive doses.

• The dose is determined by tumour size.
• A lower concentration is used for the first injection, followed by a higher concentration for the remaining doses.
• Nivolumab is administered intravenously starting in week three of treatment.

Replimune has announced a list price of $450,000 per course of therapy, before rebates and discounts.

Clinical trial results

The FDA based its approval on an open-label, multiregional, single-arm trial involving 140 adults with Stage IIIB, IIIC, or IV unresectable melanoma whose disease progressed after at least eight consecutive weeks of prior anti-PD-1 therapy.

Among the 91 evaluable patients:

• 24% achieved an objective response.
• The median duration of response was 14.1 months.

A confirmatory Phase III study is currently underway to verify the drug's clinical benefit. Replimune expects results in 2030.

Safety and Side Effects

The most common side effects reported in more than 10% of patients included:

• Fatigue
• Fever (pyrexia)
• Infections
• Chills
• Musculoskeletal pain
• Nausea and Vomiting
• Diarrhoea
• Injection-site reactions
• Headache
• Cough
• Influenza-like illness
• Rash
• Shortness of breath (dyspnoea)
• Bleeding (haemorrhage)
• Oedema
• Abdominal pain

The FDA also warned of:

• The risk of accidental transmission of herpes infection to close contacts.
• Development or reactivation of herpes infection in treated patients.
• Injection-related complications.

About melanoma

Melanoma is the deadliest form of skin cancer and the fifth most common cancer in the United States. An estimated 105,000 new cases are expected to be diagnosed in the US in 2025, with the disease causing nearly 8,500 deaths each year.

Immune checkpoint inhibitors are the current standard treatment for advanced melanoma, but about half of patients either do not respond or eventually develop resistance, underscoring the need for new treatment options such as Tudriqev.

The US Food and Drug Administration (FDA) has approved Orzeyful (oveporexton), the first oral treatment for adults with narcolepsy type 1 that targets the underlying cause of the disorder rather than just managing its symptoms.

Developed by Takeda, Orzeyful is the first approved therapy to act on the orexin system, restoring the signaling lost in people with narcolepsy type 1. Existing treatments primarily help control symptoms such as excessive daytime sleepiness or cataplexy but do not address the disease mechanism.

What Is Narcolepsy Type 1?

Narcolepsy type 1 is a rare, lifelong neurological disorder that affects the brain's ability to regulate sleep and wakefulness. It impacts about 1 in 2,000 people in the United States.

The condition occurs when brain cells that produce orexin—a neurotransmitter essential for maintaining wakefulness, regulating sleep, and controlling muscle tone—are lost.

Common symptoms include:

• Excessive daytime sleepiness
• Cataplexy (sudden muscle weakness triggered by strong emotions)
• Sleep paralysis
• Hallucinations during the transition between sleep and wakefulness
• Disrupted nighttime sleep

Also read: FDA Approves Moderna's First mRNA Flu Vaccine, Marking A Milestone In Influenza Prevention

How Does Orzeyful Work?

Orzeyful is a twice-daily oral tablet that activates the orexin receptor, helping restore the missing orexin signaling in patients with narcolepsy type 1.

Unlike stimulants or sedatives that only relieve symptoms, the drug targets the biological cause of the disorder.

Clinical Trial Findings

The FDA approval was supported by two randomized, double-blind, placebo-controlled Phase III studies involving 273 adults with narcolepsy type 1 over 12 weeks.

Patients treated with Orzeyful 2 mg experienced:

• Improved ability to stay awake during the day
• Reduced excessive daytime sleepiness
• Fewer cataplexy episodes
• Improvements in sleep paralysis
• Reduced hallucinations during sleep-wake transitions
• Better nighttime sleep quality

Safety And Side Effects

The most commonly reported side effects were:

• Insomnia
• Increased urinary frequency
• Urinary urgency
• Increased saliva production

Read More: Ebola Outbreak: Moderna Begins First Human Trial Of Bundibugyo Vaccine As Cases Rise to 3,748

Few participants discontinued treatment because of side effects.

Orzeyful should not be taken with strong CYP3A inhibitors, and its safety and effectiveness have not been established in patients under 18 years of age.

The FDA has recommended scheduling the drug under the Controlled Substances Act. It can be commercially launched once the US Drug Enforcement Administration (DEA) completes the scheduling process.

Narcolepsy Treatment Landscape

According to an analysis by marketing firm Global Data:

• An estimated 735,082 people were living with diagnosed narcolepsy worldwide in 2024, with cases projected to rise to 761,297 by 2029.
• Generic medicines, with limited innovative therapies available, dominate the current narcolepsy treatment market.
• The development pipeline includes 28 drug candidates, comprising five Phase III and four Phase II assets, with no therapies currently in the pre-registration stage.
• More than 115 clinical trials have been conducted in narcolepsy over the past decade.