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  • FDA Approves Xocova (Ensitrelvir): The First Oral COVID Pill You Take After Exposure — Before You Get Sick

    FDA Approves Xocova (Ensitrelvir): The First Oral COVID Pill You Take After Exposure — Before You Get Sick

    COVID-19 is still killing tens of thousands of Americans every year — and for the first time, there is now an FDA-approved oral medication that household contacts of infected individuals can take before symptoms develop to significantly reduce their risk of getting sick.

    On June 1, 2026, the U.S. Food and Drug Administration approved Xocova® (ensitrelvir), an oral antiviral developed by Japanese pharmaceutical company Shionogi, for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents 12 years of age and older. It is the first and only oral option approved for preventing COVID-19 after exposure to an infected individual — a distinct and previously unaddressed clinical need.

    What Xocova Is — and How It Differs From Paxlovid

    The distinction between Xocova and Paxlovid (nirmatrelvir/ritonavir) is essential to understand, because they serve different purposes at different points in the COVID-19 timeline.

    Paxlovid is taken after a positive COVID test and symptom onset, to reduce the severity of illness in high-risk individuals who are already sick. It is a treatment for active disease.

    Xocova is taken after exposure to an infected individual, before the person becomes infected or symptomatic — a pre-symptomatic intervention window that previously had no oral pharmacological option in the United States. It is a prophylactic medication, not a treatment for existing infection.

    Mechanistically, both drugs target the same SARS-CoV-2 main protease (3CL protease) — a key enzyme the virus needs to replicate. By blocking this enzyme, Xocova prevents the virus from reproducing efficiently in newly exposed individuals, reducing the probability that a household exposure leads to established infection.

    According to the SCORPIO-PEP trial data published in the New England Journal of Medicine: in the primary endpoint analysis of 2,041 SARS-CoV-2-negative participants, only 2.9% of those in the ensitrelvir group developed symptomatic COVID-19 by day 10, compared with 9.0% in the placebo group — a 67% reduction in risk.

    Xocova (Ensitrelvir) Key Data Detail
    FDA approval date June 1, 2026
    Developer Shionogi (Japan)
    Indication Post-exposure prophylaxis (PEP) of COVID-19
    Age indication Adults and adolescents 12 years and older
    Phase 3 trial SCORPIO-PEP (NCT05897541)
    Primary endpoint result 67% lower risk of symptomatic COVID-19 (2.9% vs. 9.0%)
    Secondary analysis (all participants) 57% risk reduction
    Dosing regimen 375mg on Day 1 (3 tablets); then 125mg on Days 2–5 (1 tablet each)
    Duration 5 days
    Most common side effects Headache, diarrhea, cough (15.1% vs. 15.5% placebo)
    Prior approved COVID post-exposure option None (bamlanivimab withdrawn due to Omicron resistance)
    U.S. COVID cases Oct 2025 – May 2026 3.8–12.4 million (CDC estimate)
    U.S. COVID deaths Oct 2025 – May 2026 13,000–42,000 (CDC estimate)

    How the Trial Worked — and What the Results Mean

    The SCORPIO-PEP trial enrolled 2,387 individuals aged 12 and older who had tested negative for SARS-CoV-2 at enrollment and were living in a household with a confirmed COVID-19 case. Participants were randomized 1:1 to receive ensitrelvir or matching placebo for five days.

    According to AJMC, ensitrelvir was well tolerated — adverse event rates were nearly identical between the ensitrelvir group (15.1%) and placebo group (15.5%), with the most common events being headache, diarrhea, and cough. No serious safety signals were identified.

    A notable feature of the trial population: more than 99% of household contacts already had SARS-CoV-2 antibodies at baseline — meaning nearly the entire study population had pre-existing immunity from prior infection, vaccination, or both. TechTimes noted that the drug performed equally well in this highly immune population, confirming that Xocova’s benefit does not depend on immunological naivety. This is clinically significant: it means the medication is likely to work in 2026’s real-world population, nearly all of whom have some prior COVID immunity.

    Who Should Take Xocova — and When

    The critical timing parameter for Xocova is not yet formally defined by the FDA label as a specific hour cutoff, but the clinical logic — and the trial design — centers on initiating treatment as soon as possible after a confirmed household exposure, ideally within 24 to 72 hours.

    The populations with the most to gain include:

    • Adults 60 and older, who remain at highest risk of severe COVID outcomes
    • Immunocompromised individuals (transplant recipients, patients on chemotherapy, people with HIV, those on long-term immunosuppressive therapy)
    • Adults with significant comorbidities — heart disease, diabetes, chronic kidney disease, chronic lung disease, obesity
    • Residents and staff of long-term care facilities, where up to 47% of household-level contacts develop COVID following exposure to an infected person, according to Shionogi’s prescribing data
    • Adolescents 12 and older in high-risk households

    Anyone in one of these groups who has a confirmed household contact with COVID-19 should contact their healthcare provider immediately to discuss Xocova eligibility. The drug closes a therapeutic gap that has existed since bamlanivimab/etesevimab — the only prior authorized COVID post-exposure option — was withdrawn after proving ineffective against Omicron variants.

    “The approval for COVID-19 PEP was based on data from the SCORPIO-PEP trial, which demonstrated favorable safety and efficacy in uninfected pediatric and adult patients who had been exposed to an infected individual, reducing the risk of symptomatic COVID-19 by 67%,” AJMC reported.

    COVID-19 in 2026 — Why This Still Matters

    The approval arrives at a moment when COVID-19 has become background noise for many Americans but remains a significant cause of illness, hospitalization, and death. The CDC estimates that between October 1, 2025, and May 23, 2026, there were 3.8 to 12.4 million new COVID cases in the United States, resulting in 800,000 to 2.3 million outpatient visits, 120,000 to 240,000 hospitalizations, and 13,000 to 42,000 deaths. Long COVID — which produces lasting neurological, cardiovascular, and respiratory complications — adds a further layer of risk that prevention reduces. Preventing even a percentage of those infections among the highest-risk population represents a meaningful public health gain.

    Frequently Asked Questions

    What is Xocova (ensitrelvir) and what was it approved for?

    Xocova (ensitrelvir) was FDA-approved June 1, 2026, by Shionogi, as the first and only oral medication for post-exposure prophylaxis (PEP) of COVID-19. It is approved for adults and adolescents 12 and older who have had contact with a confirmed COVID-19 case.

    How is Xocova different from Paxlovid?

    Paxlovid is taken after a positive COVID test and symptom onset to reduce disease severity. Xocova is taken after exposure but before infection or symptom onset, to prevent the exposed person from developing COVID at all. They target the same viral enzyme but are used at different clinical moments.

    How effective is Xocova?

    In the Phase 3 SCORPIO-PEP trial, Xocova reduced the risk of symptomatic COVID-19 by 67% compared to placebo in household contacts who were initially SARS-CoV-2-negative, with a secondary analysis showing 57% risk reduction across all participants.

    How do you take Xocova?

    Xocova is a 5-day oral regimen: 3 tablets taken as a single dose on Day 1, then 1 tablet per day on Days 2 through 5. It should be started as soon as possible after a confirmed household exposure. Contact your healthcare provider immediately if you have been exposed.

    Who qualifies for Xocova?

    The FDA approval covers adults and adolescents 12 and older following contact with a confirmed COVID-19 case. People most likely to benefit include adults 60 and older, the immunocompromised, those with significant comorbidities, and long-term care residents and staff. A healthcare provider should assess individual eligibility.

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  • “Transformative Advance” in Cancer Treatment Emerges in Dallas — New Pill Shows Rare Survival Jump in Pancreatic Cancer Patients

    “Transformative Advance” in Cancer Treatment Emerges in Dallas — New Pill Shows Rare Survival Jump in Pancreatic Cancer Patients

    For decades, a pancreatic cancer diagnosis was among the most devastating words a patient could hear from their physician. The five-year survival rate for metastatic pancreatic cancer — cancer that has spread to other organs by the time it is caught — has historically hovered around 3%. Standard second-line chemotherapy for patients whose cancer had stopped responding to first-line treatment offered a median overall survival of just 6.7 months. These were not numbers that inspired hope. They were numbers that ended conversations about the future and began conversations about end-of-life planning.

    That calculus may be changing. In one of the most significant oncology results of the decade, Revolution Medicines presented Phase 3 trial data for daraxonrasib on May 31, 2026 at the American Society of Clinical Oncology annual meeting in Chicago — the most important cancer research gathering in the world. The results were extraordinary: compared to standard chemotherapy, daraxonrasib nearly doubled overall survival for metastatic pancreatic cancer patients who had already received prior treatment, extending median overall survival from 6.7 months to 13.2 months. It reduced the risk of death by 60%. One-third of patients on the drug achieved at least a 20% reduction in tumor size. For a cancer that has been called “undruggable,” this is a scientific watershed.

    The Molecular Breakthrough: Targeting KRAS for the First Time

    Understanding why daraxonrasib is historically significant requires a brief excursion into cancer genetics. The KRAS gene — Kirsten rat sarcoma viral proto-oncogene — is mutated in approximately 92% of pancreatic cancer cases, making it the most consistently mutated driver gene in this disease. For over four decades, KRAS was classified as literally undruggable: the protein it produces lacks the obvious binding pockets that most targeted therapies need to attach to and inhibit. Multiple generations of pharmaceutical researchers attempted to develop KRAS inhibitors and failed.

    Daraxonrasib belongs to a new class of drugs called pan-RAS inhibitors — molecules engineered to target the RAS protein family in an entirely new way, blocking its activity regardless of which specific RAS mutation is present. The RASolute 302 Phase 3 trial enrolled 500 participants with solid tumors harboring activating RAS mutations, with 300 mg selected as the Phase 3 dose after dose-escalation established the therapeutic window. The drug is administered orally once daily — an important practical advantage over intravenous chemotherapy that requires hospital infusion visits.

    Why This Matters Especially for Dallas and Texas

    The Dallas–Fort Worth metroplex is home to one of the most formidable oncology ecosystems in the United States. UT Southwestern Medical Center’s Harold C. Simmons Comprehensive Cancer Center, Baylor Scott & White Health, Texas Health Resources, and the UT Health San Antonio MD Anderson Cancer Center Network collectively serve the cancer care needs of tens of millions of Texans. Texas Cancer Registry data show pancreatic cancer among the leading causes of cancer death in the state for both men and women. In Tarrant and Dallas counties combined, hundreds of new pancreatic cancer diagnoses are made each year — the majority of them late-stage, given that pancreatic cancer is notoriously asymptomatic until it has already advanced.

    “This achievement exemplifies the strength of UT Southwestern as a premier institution for interdisciplinary patient care, discovery-driven research, and the development of breakthrough therapies,” said Dr. J. William Harbour, Chair of Ophthalmology at UT Southwestern, reflecting the institution’s broader commitment to breakthrough oncology. UT Southwestern’s Simmons Cancer Center is already offering novel whole-liver chemotherapy delivery for rare eye cancers — the first program in Texas and the surrounding region to do so — illustrating how Dallas’s premier academic medical center is positioned to rapidly adopt next-generation treatments as they receive regulatory approval.

    The ACS Cancer Statistics 2026: The Bigger Picture of Progress

    Daraxonrasib arrives at a moment of genuine, documented progress in cancer outcomes across the board. The American Cancer Society’s Cancer Statistics 2026 report records that the five-year relative survival rate for all cancers combined has reached a historic milestone of 70% during the 2015–2021 period — up from 49% in the mid-1970s. Since the cancer death rate’s peak in 1991, it has declined by 34%, with approximately 4.8 million cancer deaths prevented as of 2023. Prostate cancer death rates have decreased 53% since 1993. Colorectal cancer mortality is down 55% from its 1980 peak. Breast cancer death rates dropped 44% between 1989 and 2023. Metastatic melanoma five-year survival has more than doubled.

    For distant-stage cancers — the most advanced, metastatic presentations — the relative survival rate has doubled from 17% in the mid-1970s to 34% in the most recent data period. Dr. Marc Siegel, Fox News senior medical analyst, attributed the improvement to “more awareness of cancer risks and symptoms, much better screening, earlier diagnosis leading to earlier treatments,” and specifically to advances in targeted therapy and immunotherapy. Daraxonrasib, if it receives FDA approval following the Phase 3 data, would represent precisely this kind of targeted advance — a drug designed for a specific molecular driver that is present in a specific tumor type, delivering outcomes that chemotherapy’s blunt-force approach never could.

    The One Critical Warning: Funding Threats to Future Progress

    The ACS 2026 report is explicit about a threat that must be named alongside the good news: “continued progress is threatened by proposed federal cuts to cancer research and health insurance.” The breakthroughs driving today’s improved survival rates — daraxonrasib, immune checkpoint inhibitors, CAR-T therapies, cancer vaccines — are the downstream product of decades of federal investment in basic science through the National Institutes of Health and the National Cancer Institute. Cutting that foundational research funding now, as multiple federal budget proposals have contemplated, would not produce savings — it would produce future deaths, from cancers that a funded scientific community would have learned to cure.

    For Dallas-area patients with pancreatic cancer, the immediate clinical question is access. Daraxonrasib is not yet FDA-approved — Revolution Medicines is expected to file for approval based on the Phase 3 data in the second half of 2026. Patients with pancreatic cancer harboring RAS mutations who have already received first-line chemotherapy should discuss clinical trial eligibility with their oncologist at UT Southwestern, Baylor Scott & White, or Texas Health Resources. Revolution Medicines’ clinical trial locator identifies open enrollment sites for ongoing RAS-inhibitor trials. This is the most important oncology news in pancreatic cancer in decades. Dallas’s world-class cancer infrastructure puts its patients in the best possible position to access it.

    RELATED ARTICLES ON MEDICALDAILY.COM

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  • Are Birth Control Pills Safe Long-Term? What to Know About Birth Control Pill Risks

    Are Birth Control Pills Safe Long-Term? What to Know About Birth Control Pill Risks

    Are birth control pills safe to take for years, or does long-term use gradually increase health risks? Overall, evidence suggests that the pill is safe for many healthy users when properly prescribed and monitored, but it carries specific risks and benefits that should be reviewed regularly.

    How Do Birth Control Pills Work?

    Birth control pills contain synthetic estrogen, progestin, or both, which prevent pregnancy by stopping ovulation, thickening cervical mucus, and thinning the uterine lining. When taken at the same time every day, they are highly effective, though missed pills can reduce protection.

    Combined pills (estrogen and progestin) are most common, while progestin-only pills are often used when estrogen is not advisable, and each type carries its own profile of birth control pill risks.

    Are Birth Control Pills Safe to Take Long-Term?

    Decades of research indicate that many healthy, nonsmoking people can safely use birth control pills for years when they are regularly evaluated by a healthcare professional.

    Safety depends on age, smoking status, blood pressure, migraine history, weight, and existing conditions like diabetes or clotting disorders. Long-term pill use is not a one-time decision; it requires periodic reassessment as health and risk factors change.

    What Are the Long-Term Birth Control Pill Risks?

    Long-term use can involve both mild side effects and a small increase in serious complications. Common, usually manageable effects include nausea, breast tenderness, mood changes, and irregular spotting, particularly in the first months.

    More serious birth control pill risks include blood clots, stroke, heart attack, and some cancers, especially with estrogen-containing pills and in people who have additional risk factors.

    Do Birth Control Pills Increase the Risk of Blood Clots?

    One of the most discussed birth control pill risks is venous thromboembolism (blood clots in the legs or lungs). Estrogen increases clotting tendency, raising clot risk slightly compared with non-users, though the absolute risk for healthy young nonsmokers remains relatively low.

    Smokers, people over 35, those with obesity, inherited clotting disorders, or prolonged immobility face higher risk and may need alternative methods.

    Do Birth Control Pills Increase Cancer Risk?

    Hormonal exposure can influence cancer risk, and birth control pill risks here are nuanced. Some studies link current or recent combined pill use to a small, temporary increase in breast and cervical cancer risk.

    At the same time, long-term pill use clearly lowers the risk of ovarian and endometrial cancers, with protection lasting years after stopping, and may modestly reduce colorectal cancer risk.

    Can Birth Control Pills Cause Other Health Problems Over Time?

    Other potential long-term birth control pill risks include higher blood pressure, worsening of migraines (especially with aura), changes in cholesterol, and rare liver issues, according to the World Health Organization.

    Some users report mood changes, altered libido, or weight fluctuations, though research results vary. Because responses to hormones are individual, persistent or severe side effects should prompt a discussion about changing formulations or methods.

    Do Birth Control Pills Affect Fertility in the Long Run?

    Long-term pill use does not permanently damage fertility. Most people resume ovulation within weeks to a few months after stopping, and many conceive within a year if no other fertility problems exist.

    Temporary cycle irregularity can occur after long-term use, but if periods or conception do not return after several months, evaluation is recommended to look for other causes unrelated to prior pill use.

    Is It Bad to Take Birth Control Pills Every Day Without a Break?

    Continuous or extended-cycle regimens, where withdrawal bleeding is skipped or minimized, are increasingly common and are considered safe for most healthy users.

    They do not appear to add major new birth control pill risks beyond those already linked to combined pills. Breakthrough bleeding or spotting is common with continuous use, especially early on, but is usually not harmful unless bleeding patterns change suddenly.

    How Long Is Too Long to Be on Birth Control Pills?

    There is no fixed maximum number of years that fits everyone. Instead, clinicians weigh birth control pill risks against benefits at regular intervals, often yearly.

    A healthy nonsmoker in their 20s may safely use combined pills for many years, while someone in their 40s who develops high blood pressure or migraines with aura might be advised to switch to progestin-only or nonhormonal methods.

    Who Should Avoid Long-Term Use of Certain Pills?

    Combined estrogen-containing pills are generally unsuitable for people with a history of blood clots, certain heart or liver diseases, migraines with aura, uncontrolled high blood pressure, or some hormone-sensitive cancers.

    In these cases, progestin-only methods or nonhormonal contraception are usually safer choices. An accurate personal and family history is critical to assessing individual birth control pill risks, as per the Centers for Disease Control and Prevention.

    How Can Someone Lower Birth Control Pill Risks?

    Lifestyle plays a key role in keeping long-term use safer. Not smoking, staying active, managing weight, and controlling conditions like hypertension, diabetes, and high cholesterol can reduce cardiovascular and clotting risks associated with the pill.

    Regular checkups, blood pressure monitoring, and age-appropriate cancer screening help catch problems early, and alarming symptoms such as chest pain, severe headaches, sudden leg swelling, or shortness of breath warrant immediate medical attention.

    Long-Term Birth Control Pill Risks and Informed Choices

    Over time, birth control pill risks must be balanced against reliable pregnancy prevention, cycle control, and treatment of conditions like endometriosis, PCOS symptoms, and heavy or painful periods.

    For many people, the benefits outweigh the risks when the pill is chosen thoughtfully and reviewed regularly. For others, changing health factors make it safer to shift to progestin-only or nonhormonal methods as they age or develop new conditions.

    By keeping an open, ongoing dialogue with a healthcare professional, individuals can navigate birth control pill risks while maintaining effective contraception and supporting overall health.

    Frequently Asked Questions

    1. Can long-term birth control pill use affect bone health?

    Most standard-dose combination pills do not significantly weaken bone density in healthy adults, but very low-dose or progestin-only methods may need closer monitoring in teens or those at high osteoporosis risk.

    2. Is it safe to use birth control pills while recovering from surgery?

    Because surgery and immobility increase clot risk, many providers advise stopping estrogen-containing pills several weeks before major surgery and using another contraceptive temporarily.

    3. Do birth control pill risks change during perimenopause?

    As people age and cardiovascular risks rise, combined pills may become less suitable; doctors often reassess pill use in the late 30s and 40s and may recommend switching methods.

    4. Can someone with a family history of breast cancer safely use birth control pills?

    Some individuals with a family history can still use the pill, but they usually need a personalized risk assessment, careful choice of formulation, and strict adherence to recommended cancer screenings.



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