Why ‘Fault in Our Stars' author John Green is obsessed with tuberculosis
'I was like respectfully, if that were true I would already know,' said Green, who is best known for young adult novels such as 'The Fault in Our Stars'. 'But I looked it up, and he was so totally right.'
It turned out that three of the assassins who plotted Archduke Franz Ferdinand's death – a crucial if chaotic moment in the build-up to war – were suffering from tuberculosis (TB). Historians have posited that they were prepared to die for their cause partly because they knew already that their days were numbered.
The tidbit is one of Green's favourites, but as his obsession with TB has grown, so too has his collection of anecdotes. Did you know that Ringo Starr first discovered percussion while recovering from TB in a sanatorium? Or that cowboy hats were created for the midwest sun after a hat-maker in the 1850s moved in search of cleaner air for his struggling lungs?
'I think we do underestimate the extent to which, not just tuberculosis but disease in general, has shaped human history,' said Green. 'Think of how different the world could be if Alexander the Great hadn't died of typhoid or malaria when he was still a young man… [or if] Louis XVI's son hadn't died of tuberculosis as the French Revolution was beginning.'
But while the intriguing history of the world's deadliest infection may have informed the title of Green's latest book, 'Everything is Tuberculosis', it was never the driving force for writing.
Instead, the story began with Henry Reider, an 'uncommonly charismatic' patient in Sierra Leone. The pair first met in 2019. Green was in the west African country on a trip related to maternal mortality when he visited a TB hospital – at the time, he had no idea that the curable disease still kills upwards of 1.2 million people every year, and infects another 10 million.
'I thought that TB was a disease of 19th century poets, not a disease of the present,' Green said, in his first interview with a British newspaper about the new book.
'Then I met this kid who looked to be about the same age as my son, who was nine at the time, and who had the same name as my son, Henry.'
But as Green toured the Lakka Government Hospital with Reider, he was in for a series of shocks. Henry Reider was not nine but 17 – he'd been stunted from severe malnutrition in childhood – and his experience with TB was 'devastating'.
Reider's father, distrustful of the health care system, had halted his son's treatment part way through a months-long course of drugs, allowing the infection to develop drug-resistance. Later, when the usual toxic cocktails of drugs failed him, bedaquiline – a safer treatment regimen that involves few tablets over a shorter period – was deemed too expensive.
'It was infuriating to me. You or I would receive the kind of personalised, tailored treatment that Henry was told was unaffordable without hesitation or question,' said Green. 'Meeting Henry and spending that afternoon with him really reshaped my understanding of illness.'
Reider's story forms the backbone of 'Everything is Tuberculosis', where Green argues that injustice is behind the continued presence of TB – a bacterial pathogen formally identified in 1882, but which has been killing people for centuries longer.
Although the airborne disease can infect anyone, today it is largely a disease of poverty. The World Health Organization (WHO) estimates 1.25 million people died from TB in 2023 – 81 per cent of fatalities were in south Asia and Africa, compared to just 1.4 per cent in Europe.
This has impacted everything from investment in vaccine and drug development, to the accessibility of expensive treatments and specialist doctors for patients. But it wasn't until Green spoke to a renowned TB doctor that the implications hit him: even with today's imperfect tools and knowledge gaps, the disease could be wiped out..
'I asked him, how many people would die of tuberculosis if everyone had the kind of health care that I have? And he said: 'none, zero'. And that shocked me, it means that every death from tuberculosis is optional.'
Drawing attention to this reality felt essential for Green. Still, he was unsure how the book would land.
'Every time I try to market the book, I feel almost apologetic – like I have to explain that it's a non fiction book about tuberculosis,' he said.
'[But] it feels like a natural progression, in the sense that I've been interested in illness for a long time… I wrote about cancer in 'The Fault in Our Stars', I wrote about OCD in 'Turtles All the Way Down'. And you know, this is also a book about a smart teenager who loves poetry.'
He hardly needed to be concerned. The response has been 'wildly unexpected': since it was published last month, 'Tuberculosis is Everything' has topped the New York Times bestseller list for non-fiction for a fortnight, while Green's US book tour sold out within days.
Green isn't entirely sure how he captured the public imagination, but he wonders if part of the explanation lies in the timing.
The book was published after Donald Trump's administration slashed the foreign aid budget and closed the USAID agency – an unprecedented move with huge ramifications for global health, including the fight against tuberculosis.
The US contributed roughly half of all international donor funding for TB last year, according to the WHO, which last month warned that efforts to curb the disease are now 'in peril' as health workers funded by USAID have been laid off, testing and surveillance services halted, drug development paused and access to treatment curtailed for millions.
'I never imagined that the cuts under the Trump administration would be this severe, and that they would lead to this scale of mass death. I was a little naive, I think,' said Green. 'It is absolutely devastating… it's a massive failure of global resource allocation, and a mark of shame on all of us.'
He added that it is disappointing to see the UK also reduce its aid budget, from 0.5 per cent of gross national income to 0.3 per cent in 2027.
In West Africa, Reider has recovered from TB, completed exams at the University of Sierra Leone, and launched a YouTube vlog. But Green fears for other patients – Reider's hospital is among those hit by the US aid cuts, and TB is not the only disease affected.
'A friend in Sierra Leone who has HIV called me and said: 'Look, there's two weeks left of medication, and after that they don't know'. I said Sarah [Green's wife] and I will make sure you and your mom have access to HIV medicine, of course. And he said: 'Thank you, but what about everyone else?
'The truth is, there is no way for individuals and philanthropy to set up and act at the scale that governments are acting. And so that question – 'what about everyone else?' – is a question that haunts me. I think it should haunt us all.'
But although Green is less optimistic about the promise of eliminating TB than when he finished writing the book, he has retained a sense of hope that the outlook can change – especially because cheaper diagnostics, better treatments and promising vaccine candidates are in the pipeline.
'If you think of the fight against tuberculosis as a very long staircase, we've walked a long way up that staircase since Hippocrates told his students not even to bother treating tuberculosis, because it would make them look like bad healers,' said Green.
'In the last eight weeks, we've fallen down the staircase and that's devastating. But when you fall down a staircase, you get up and start walking up the staircase again.'
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Forbes
6 hours ago
- Forbes
How AI Powered Med-Tech Can Scale Accessible Healthcare In India
Dr. Ashwini Kumar, Founder, CliniExperts. Helping Global Med-Tech Brands Navigate Indian Healthcare Landscape. In India, every eleven seconds, someone is diagnosed with tuberculosis. Every eight minutes, another case of cervical cancer claims a woman's life. These are more than just numbers; these are people with stories we cannot ignore. But what if technology could hear even what we cannot? Today, artificial intelligence (AI) is not just scanning slides or reviewing scans. It's doing something far more human—it's listening. It's noticing. It's learning from millions of data points and drawing conclusions with breathtaking speed. How AI-Enabled Innovation Is Rewriting The Rules Of Diagnosis Let's look at some of the tools that are already changing how we diagnose, detect and treat these critical health conditions: • Swaasa: A cough analysis tool developed for TB screening, capable of identifying distinct acoustic signatures of respiratory illnesses. It's enabling frontline health workers to screen large populations with nothing but a smartphone—no sputum, no X-ray. • qXR by An AI-driven chest X-ray solution designed to spot signs of TB, pneumonia and lung nodules quickly and reliably. Already deployed in government TB programs and mobile vans across India. • qTrack by A companion system to qXR that allows seamless integration of teleradiology workflows in underserved areas—scaling quality diagnostics to remote districts. • iBEX by Ibex Medical Analytics: A clinical-grade AI platform that supports pathologists in identifying breast cancer with high sensitivity, particularly useful in high-volume, resource-limited environments. • Arogya Arohan: An AI-based app that helps detect early oral cancers via smartphone images—vital for rural and underserved populations where regular screening is a challenge. • CerviSCAN: A visual AI-based cervical cancer screening platform, eliminating the need for complex lab-based pap smear testing in field settings. • TxGNN: An advanced graph neural network used in rare disease drug discovery and repurposing. With 49% higher precision in drug match identification, it's accelerating treatment development for conditions often left behind. • Watson For Oncology by IBM Watson Health: IBM's AI that assists oncologists by reviewing patient records and global literature to recommend personalized treatment plans—bringing world-class cancer expertise to every hospital. • Varian's AI-Enhanced Radiotherapy: AI integrated with imaging to optimize radiation dosage in real time, reducing side effects and improving outcomes. Each one of these tools acts as a second set of eyes, ears and clinical intuition—designed to empower doctors, not bypass them. As a result, AI is pushing 'early detection' into a new paradigm—preemptive healthcare. It's not just about catching diseases early; it's about forecasting risk, personalizing interventions and tracking real-time treatment responses. Whether it's adjusting radiation doses mid-session with Varian systems or designing treatment blueprints with Watson for Oncology, AI is becoming the quiet, indispensable co-pilot in some of medicine's most critical decisions. Where Do We Go From Here? For healthcare and technology leaders, the question is no longer whether to innovate—but how to innovate with intention. The gap between a promising AI prototype and meaningful patient impact is filled by decisions made today in boardrooms, clinics and policy circles. I believe India is uniquely positioned to lead this transformation, set an example for the world to follow suit and improve their healthcare at the same time. They possess a vast, diverse population, deep AI talent and a public health system ready for digital augmentation. But with great speed must come great scrutiny. As the tools evolve, so must the regulatory frameworks, validation mechanisms and ethical guardrails that govern them. Leading The Transformation First, build responsible partnerships. Companies must engage not only data scientists but also clinicians, regulators and public health experts from day one. Co-developing AI solutions alongside end users ensures that the final product is usable, explainable and implementable at ground zero. Second, treat regulatory strategy as an enabler, not a hurdle. Healthcare and tech leaders looking to invest in India's potential must understand India's CDSCO pathways, stay informed on global frameworks like the EU MDR for SaMD and invest early in local clinical validation. Working with experts who understand both innovation and compliance can mean the difference between a pilot that stalls and a product that scales. Finally, never lose sight of patient welfare. AI must serve people, especially the millions who rely on India's public health systems. Leaders should champion solutions that strengthen PHCs, rural diagnostics and community health—where these tools can save the most lives. Putting Patients At The Center If we embed transparency, ethics and real-world training into every stage of development, we will not just build smarter devices—we will build trust in the systems that deliver them. When innovation meets intention, technology becomes more than code. It becomes care. Because the real future of medicine isn't just AI. It's AI, access and accountability. And the entire med-tech industry will reinvent itself when we see innovation meet intention. Forbes Business Council is the foremost growth and networking organization for business owners and leaders. Do I qualify?


News24
15-07-2025
- News24
SA gets R520m to buy the twice-a-year anti-HIV jab... but there's a snag
SA has accepted an offer of just over $29 million from the Global Fund to Fight Aids, TB and Malaria to buy the twice-a-year anti-HIV jab, lenacapavir. . But there's a snag: the country isn't getting extra money from the fund to buy the medicine. It has to use cash from a grant that it has already been awarded and that was cut by 16% in June. South Africa has accepted an offer of just over $29 million (about R520 million) from the Global Fund to Fight Aids, TB and Malaria to buy the twice-a-year anti-HIV jab, lenacapavir, that research shows could help to end Aids in the country, says health department spokesperson Foster Mohale. But there's a snag. The country isn't getting extra money from the fund to buy the medicine; it has to use cash from a grant that it has already been awarded and that was cut by 16% in June. Moreover, the fund, at this stage, won't tell the health department – or any of the other eight countries it has selected for early roll-out – how much they're paying lenacapavir's maker, Gilead Sciences, for the product. Boitumelo Semete-Makokotlela, the CEO of the country's medicine regulator, the South African Health Products Regulatory Authority (Sahpra), told Bhekisisa it is aiming to have lenacapavir registered in South Africa before the end of the year. According to the national health department's head of procurement, Khadija Jamaloodien, the lenacapavir funds from the Global Fund will become available in October, when the rollout period of South Africa's next grant, known as Grant Cycle 7, kicks in. But rollout – likely in early 2026 – can only start once Sahpra has registered the medicine, the country's essential medicines list committee has reviewed and recommended lenacapavir, procurement processes are in place and health workers and clinics have all they need to hand the drug safely to patients. Two studies released last year showed the medicine completely protects young women from contracting the virus and works almost as well for men, transgender and gender-nonbinary people. In fact, a modelling study shows that if between two and four million HIV-negative people in South Africa use the jab every year over the next eight years, the medication could end Aids as a public health threat by 2032. Ending Aids as a public health threat means reaching a stage where fewer people are getting newly infected with HIV than the number of people with HIV who are dying (increasingly for other reasons than HIV, for example old age). According to the latest Joint United Nations Programme on HIV and Aids (UNAids) report, which was released last week, 170 000 people got newly infected with HIV in 2024, while there were 53 000 Aids-related deaths. The Global Fund money for South Africa is, however, not nearly enough to put two to four million people per year in South Africa on the lenacapavir jab (see price explanation below) – and even if it was, the country's health system won't be able to roll the medicine out that fast, scientists and policymakers say. Will the US help to pay for the jab? The fund's offer follows the body's announcement on 9 July, that it has the 'ambition' to finance enough lenacapavir for two million HIV-negative people – in the low- and middle-income countries it supports – over the next three years. But fulfilling this ambition will depend on whether the governments of wealthy countries give enough money to the fund in its next replenishment round. The US government's Aids fund, Pepfar, was originally going to help to pay to roll out lenacapavir in poorer countries. And, although some activists say it's still possible for the US administration to come on board (lenacapavir is mentioned in President Donald Trump's budget proposal for the next financial year, but is understood to be only for pregnant and breastfeeding women), it's not clear at all how this might happen after the Trump administration's drastic cuts to funding for HIV projects in countries like South Africa this year. The Global Fund's offer, however, is a way to get branded, 'bridging' doses from Gilead to South Africa while the world waits for cheaper generics to become available around 2027. 'We now stand at a moment of reckoning and a moment of choice,' Mitchell Warren, the executive director of the international advocacy organisation, Avac, told Bhekisisa at the 13th conference on HIV science in Kigali this week. 'While a lot of the choices over the last six months have been made by an American politician [Donald Trump] who doesn't care about the pandemic or science generally, our choice is to make decisions based on the science that we all now know. Which is that lenacapavir is our most potent opportunity.' Countries have to budget just under R600 per dose Jamaloodien, however, cautions further discussions with the Global Fund and Gilead will be needed about the governance around the pricing of the product. 'We have a transparent pricing system, guided by the Public Finance Management Act. Even if we procure medicine with Global Fund money, we have to follow the same rules that the Treasury requires us to follow with tenders, which includes revealing the price at which the medicine is bought,' Jamaloodien says. In a Global Fund letter sent in early July to the nine early rollout countries – South Africa, Zimbabwe, Eswatini, Lesotho, Zambia, Mozambique, Kenya, Uganda and Nigeria – the fund asked the governments to budget for $60 (about R1 076) per patient per year ($30, or R576, per six-monthly dose), to buy lenacapavir. But in the document, which Bhekisisa has seen, the fund makes it clear that the amount 'reflects the country contribution only, to be used for budgeting purposes, and should not be considered the product price'. Jamaloodien has confirmed to Bhekisisa that the health department did receive such a letter. The letter also states that the gap between the price that the fund pays Gilead per patient per year and the $60 that countries will pay for with their Global Fund grants, will be covered by private sector funding, which Hui Yang, the fund's head of supply operations, confirmed to Bhekisisa will be paid for by a $150-million (about R2.68 billion) donation of the UK-based Children's Investment Fund Foundation to the Global Fund. Furthermore, says Jamaloodien, South Africa's letter instructs the country to submit its first order, for planning purposes, by 30 September under an 'agreed procurement mechanism'. Why does Gilead not want to talk about LEN's price? Lenacapavir, also referred to as LEN for short, was registered for HIV prevention – also called PrEP – by the US medicines regulator, the Food and Drug Administration on 18 June, and is sold in that country for $28 218 (around R505 269) per person per year under the trade name Yeztugo. The US is the only country in which LEN has been registered so far as PrEP. For low- and middle-income countries such as South Africa, Gilead, however, said it will have a 'not-for-profit' price such as the one they negotiated with the Global Fund, but isn't allowing the fund to make it public. Several scientists and activists at the HIV science conference, have, however, told Bhekisisa the rumoured not-for-profit price that Gilead has negotiated with the Global Fund is $100 per person per year, and Avac, confirms it in its analysis of events. But neither Gilead or the Global Fund have confirmed this amount. If South Africa budgets for $60 per person per year, the $29.2 million that Global Fund says we can use to buy lenacapavir, translates to putting and keeping around 400 000 people on the medicine over three years (Global Fund grants run for three years at a time). Gilead argues that because the not-for-profit price is based on the actual cost of making lenacapavir, and shipping it to countries, it can't declare that cost. 'Gilead doesn't publicly disclose manufacturing costs for any of our medications,' Caroline Almeida, Gilead's head of public affairs, told Bhekisisa in Kigali. But activists don't buy this argument. 'Gilead's secrecy will obstruct civil society activism for lower drug prices and keep prices high in middle-income countries [such as South Africa] where Gilead negotiates prices directly,' the Health Justice Initiative and other activist groups said in a press release last week. Avac has identified 16 top lenacapavir markets, of which South Africa is – by far – the largest because of the country's high number of new HIV infections. The country's 170 000 new infections in 2024 is 13% of the 1.3 million new HIV infections around the world in 2024. And research released by Wits RHI on Tuesday in Kigali shows South Africans are open to using the jab: 56% of just over 1 700 participants in a survey in Tshwane, Mthatha and Gqeberha, who were already using public sector HIV prevention services, said they would take a lenacapavir shot. But for LEN to be affordable, activists argue, Gilead needs to be open about its price. 'Such secrecy undermines the power of buyers to negotiate affordable prices and violates the human rights of all people to access information and lifesaving tools,' activists said in last week's press release. Warren concludes: 'Pricing transparency has been a long-standing challenge, as companies try to balance their commercial pricing and marketing strategies with their global public health strategies. We clearly need a new model or compact for pricing that helps break the cycle of small thinking and limited impact.'


Business Wire
14-07-2025
- Business Wire
Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Gilead researchers and collaborators will present new Phase 3 PURPOSE trial data at IAS 2025 showing that twice-yearly lenacapavir (Yeztugo ®) was effective and well tolerated among a broad range of populations who need or want pre-exposure prophylaxis (PrEP) for HIV prevention, including pregnant and lactating women, adolescents and young people, and supports lenacapavir dosing recommendations for people in special situations, such as those taking medication to treat tuberculosis (TB) and other conditions. Researchers will also present new quantitative and qualitative data showing that participants in both Phase 3 PURPOSE trials indicated a preference for twice-yearly PrEP injections over daily oral medication. The new data, from the company's pivotal Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials that assessed the efficacy and safety of twice-yearly Yeztugo for PrEP, will be presented via poster sessions and during a Yeztugo-dedicated oral session at the International AIDS Society (IAS) 2025, the 13 th IAS Conference on HIV Science in Kigali, Rwanda on Thursday, July 17. The data presentations come less than a month after the U.S. Food and Drug Administration (FDA) approved Yeztugo as the first and only twice-yearly HIV prevention option. The data underscore Gilead's focus on intentional inclusion in the PURPOSE program to ensure broad and robust population data at the trials' primary analyses, as well as spotlight the community and organizational collaborations that guided the trial design and implementation process. 'It's a thrill to be back in Kigali with so many of the community, advocacy and research partners who helped make PURPOSE the most intentionally inclusive HIV prevention trial program ever conducted,' said Moupali Das, Vice President of Clinical Development, HIV Prevention & Pediatrics at Gilead Sciences. 'As the first and only twice-yearly PrEP option, Yeztugo continues to demonstrate efficacy and tolerability among diverse populations, and we're excited to highlight new data on this breakthrough HIV prevention option here at IAS 2025.' Yeztugo was Efficacious and Well Tolerated in Trials Among Pregnant and Lactating Women, Adolescents and Young People, and Can Be Administered in People Receiving Treatment for TB and Other Conditions Pregnant and lactating women—who face a heightened likelihood of acquiring HIV—have historically been excluded from HIV prevention trials. Based on input from community meetings in locations including Kigali, Gilead ensured that pregnant and lactating women were included in the Phase 3 PURPOSE 1 trial, which evaluated twice-yearly Yeztugo in cisgender women and adolescent girls in Sub-Saharan Africa. PURPOSE data presented at IAS 2025 show that Yeztugo was efficacious in pregnant and breastfeeding or lactating women, with no new cases of HIV reported among 184 participants in the Yeztugo group (there were a total of 509 pregnancies among 487 participants in PURPOSE 1). Data also show that Yeztugo was well tolerated by these women, that there were similar safety profiles between pregnant and non-pregnant women, and that there were no clinically significant differences in predicted Yeztugo exposure by pregnancy trimester or postpartum status. Additionally, exposure in breastfed infants was minimal. Young people aged 16-25 years are also at an increased likelihood of experiencing HIV acquisition globally, but, like pregnant women, are often not proactively included in Phase 3 HIV prevention trials. Gilead intentionally included this population in the PURPOSE 1 trial and the PURPOSE 2 trial, which evaluated twice-yearly Yeztugo among a broad and geographically diverse range of cisgender men and gender-diverse people. Data presented at IAS 2025 show that Yeztugo was efficacious in people aged 16-25 years, with zero reported HIV infections in young people receiving Yeztugo in PURPOSE 1 and two HIV infections among young people in PURPOSE 2. Additionally, there were no clinically significant pharmacokinetic differences between the 16-25-year-old group and adults aged over 25 years. Yeztugo was well tolerated across both trials among participants of all ages, with no new safety concerns identified. Globally, those at higher likelihood of HIV acquisition may also be vulnerable to TB, which can be treated by rifamycin-class drugs including rifampin and rifabutin. Yeztugo is a substrate of CYP3A, and strong CYP3A inducers such as rifampin, or moderate inducers such as rifabutin, may potentially lower Yeztugo plasma concentrations. Gilead will present modeling data showing supplemental Yeztugo dosing for strong and moderate CYP3A inducers to allow people receiving Yeztugo to receive rifamycin-containing TB treatment, if necessary. Yeztugo is also a moderate inhibitor of CYP3A and could theoretically increase levels of drugs such as statins for lowering cholesterol or PDE5 inhibitors for treating erectile dysfunction; dosing recommendations for these special situations will also be reviewed. Preference for Twice-Yearly Prevention Option Over Daily Oral PrEP New qualitative and quantitative self-reported data from PURPOSE 1 and PURPOSE 2 show significant preference for twice-yearly injectable PrEP compared with daily oral PrEP among study participants. More than 75% of study participants who were surveyed preferred twice-yearly injectable administration; of these, more than 50% reported a strong preference. Reasons given for favoring twice-yearly injectable PrEP versus daily oral PrEP include feeling more protected from HIV (69%) and feeling more confident about not missing a dose (77%). 'Certain groups—including pregnant and lactating women, adolescents and young people—are disproportionately affected by HIV, yet have long been underrepresented in HIV clinical trials,' said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and former President of the International AIDS Society. 'The PURPOSE program set a new standard for innovative, intentional inclusion by ensuring we would have safety and efficacy data in these populations from the outset. The results not only show that Yeztugo provides strong protection against HIV and was well tolerated in these groups, but also highlight the critical need for PrEP options that reflect people's preferences—reducing barriers to uptake and helping close persistent gaps in prevention.' Continued Global Regulatory Filings for Lenacapavir for PrEP, as Well as Milestone Partnerships On June 18, 2025, Gilead received FDA approval for Yeztugo as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. Gilead has also submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) application with the European Medicines Agency (EMA), both of which the EMA has validated and will review under an accelerated assessment timeline. Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada, South Africa and Switzerland. Additionally, now that lenacapavir has received FDA approval for PrEP, Gilead is preparing additional filings in countries that rely on stringent regulatory authority approvals for regulatory submission, including Argentina, Mexico and Peru. Gilead will continue to share updates on additional regulatory filings. Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. Last week, Gilead announced a strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria to supply enough doses of lenacapavir, at no profit to Gilead, to reach up to two million people over three years in countries supported by the Global Fund and that are included in Gilead's voluntary licensing agreements for lenacapavir. There is currently no cure for HIV or AIDS. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Yeztugo. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of the, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 'Breakthrough of the Year.' U.S. Indication for Yeztugo Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead has been recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's earnings; Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; the risk that physicians may not see the benefits of prescribing Yeztugo; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.