Summary

[Posted 31/May/2023]

AUDIENCE: Hematology, Infectious Disease

DETAILS: The U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.

This updated policy is based on the best available scientific evidence and is in line with policies in place in countries like the United Kingdom and Canada. It will potentially expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.

These final recommendations are consistent with the policy initially proposed in January. The FDA worked diligently to review and consider all comments submitted to the agency to finalize these recommendations as quickly as possible. "The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community," said Peter Marks, M.D., PhD., director of the FDA’s Center for Biologics Evaluation and Research. "The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place."

This policy eliminates time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Under the final guidance issued today, all prospective blood donors will answer a series of individual, risk-based questions to determine eligibility. All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.

Additionally, under these final recommendations, those taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred. Though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results. Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact. As stated in the guidance, individuals should not stop taking their prescribed medications, including PrEP, or PEP, in order to donate blood. The FDA remains committed to evaluating additional data and new technological developments as they become available to inform our donor eligibility recommendations.

The FDA has been evaluating alternatives to time-based deferrals for MSM and helping to facilitate the generation of scientific evidence that would support an individual risk based- assessment blood donor questionnaire. This scientific information has given the agency a solid foundation to support this new policy. The FDA strongly believes the implementation of an individual risk-based approach will not adversely affect the safety or availability of the U.S. blood supply.

The FDA carefully reviewed numerous data sources, including data from countries with similar HIV epidemiology that have implemented an individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, performance characteristics of nucleic acid testing for HIV and the FDA-funded Assessing Donor Variability And New Concepts in Eligibility study. The ADVANCE study examined the rates of HIV risk factors, such as anal sex and rates of HIV infection, as well as the usage of medications to treat or prevent HIV infection, among MSM study participants.

Copyright © FDA. All rights reserved.

Source: FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations. FDA. Published: May 11, 2023.

Summary

An Urgent Unmet Need!

[Posted 29/May/2026]

AUDIENCE: Dermatology, Oncology

KEY FINDINGS: Supportive oncodermatology, originally focused on the acute treatment phase, must evolve to address the long-term needs of the growing cancer survivor population. Preventive strategies, such as scalp cooling during chemotherapy, are vital, as existing treatments for established sequelae like PCIA and radiation-induced scarring have limited efficacy. While topical minoxidil and, more recently, oral minoxidil have shown promise for hair density improvements, and lasers are effective for telangiectasias, the management of many chronic dermatological sequelae remains largely extrapolated from other dermatological conditions rather than specifically validated for cancer survivors. Multidisciplinary follow-up programs are essential to address the complex functional, cosmetic, and psychological needs of these patients.

BACKGROUND: With the increasing effectiveness of modern oncological treatments, the population of cancer survivors is rapidly expanding. Consequently, clinical focus is shifting from the management of acute treatment-related toxicities to the long-term or late sequelae of cancer therapy. Among these, dermatological conditions—such as persistent alopecia, nail disorders, scarring, pigmentary alterations, and chronic radiation-induced skin changes—are highly visible, often persistent, and can significantly impair the quality of life, body image, and psychological well-being of survivors. While supportive oncodermatology is well-established for active treatment settings, structured care during the survivorship phase remains significantly underdeveloped.

DETAILS: This review defines "restorative oncodermatology" as the management of dermatological manifestations persisting for at least six months after the completion of anticancer therapy. Such conditions include both persistent toxicities that are slow to regress and true long-term sequelae resulting from treatment-induced tissue damage. Epidemiological data indicates that these issues are prevalent; for example, up to 59% of adult survivors of childhood cancer report chronic skin-related problems, and approximately 30% report visible scarring or disfigurement. Specific conditions addressed include persistent chemotherapy-induced alopecia (PCIA), which affects between 1% to approximately 40% of patients depending on the regimen , and radiation-induced scarring alopecia, where a threshold of approximately 36 Gy is associated with a 50% probability of severe alopecia. The article also explores the management of chronic nail changes, pigmentary alterations, hair growth disorders like hirsutism and hypertrichosis, and mucosal sequelae. Despite the high prevalence and impact of these dermatological sequelae, dedicated survivorship-oriented dermatological care is rarely implemented. There is an urgent requirement to improve knowledge in this field and provide specialized care, particularly for childhood and adolescent cancer survivors, who are especially vulnerable to the effects of these conditions on their physical appearance and identity development. Dermatologists must play a central role in long-term survivorship by performing surveillance for secondary skin cancers and delivering restorative treatments that help patients navigate life after cancer.

Copyright © Springer Nature. All rights reserved.

Source: Rapparini, L., Touhouche, T. A., Fattore, D., et al. Corrective and Restorative Dermatology in Cancer Survivors: An Urgent Unmet Need!. American Journal of Clinical Dermatology. 2026; 27, 515-535. Published: May, 2026. DOI: XXXX

Summary

[Posted 27/May/2026]

AUDIENCE: Infectious Disease, Family Medicine

KEY FINDINGS: A primary challenge in this specific outbreak is the nature of the causative agent, the Bundibugyo virus. Unlike the more common Zaire ebolavirus, there is currently no licensed vaccine or specific, FDA-approved treatment effective against the Bundibugyo strain. Consequently, the public health response relies entirely on traditional containment strategies. These include rapid case detection, patient isolation, meticulous contact tracing, the promotion of infection prevention and control practices, safe burial procedures, and robust community education to curb transmission chains. Researchers are currently evaluating whether existing therapeutic candidates or vaccine platforms could be adapted for emergency use, though clinical implementation remains under investigation.

BACKGROUND: In response to a burgeoning outbreak of Ebola virus disease caused by the Bundibugyo strain, the United States government has enacted new travel and entry protocols. The current outbreak, centered in the Democratic Republic of the Congo (DRC) and involving cases in South Sudan and Uganda, has prompted international health authorities to declare a public health emergency. As global travel remains a potential vector for the international spread of the virus, the U.S. government has taken proactive measures to bolster domestic defense against the introduction of the pathogen.

DETAILS: Effective May 2026, the U.S. Centers for Disease Control and Prevention (CDC) and the Department of Homeland Security have implemented stringent travel requirements. Foreign nationals who have visited the DRC, South Sudan, or Uganda within the 21 days prior to their arrival are temporarily suspended from entry into the United States. Furthermore, all U.S. citizens, nationals, and lawful permanent residents returning from these three countries must route their travel through specifically designated entry points, including Washington-Dulles International Airport, where they are subject to enhanced public health screening. These measures include health questionnaires, temperature checks using non-contact technology, and verification of contact information to facilitate monitoring for symptoms over a 21-day period following departure from the affected regions. While the current outbreak is significant—with reports indicating nearly 500 suspected cases and more than 130 deaths since the official declaration on May 15—the domestic risk to the United States is currently assessed by the CDC as low. As of late May 2026, no suspected, probable, or confirmed cases of Ebola have been reported within the United States. Authorities are maintaining a state of high readiness, with regional hospitals and state health departments prepared to manage and isolate any potential symptomatic travelers identified through the screening process.

Source: Centers for Disease Control and Prevention (CDC). Enhanced Ebola Airport Screening Begins at Washington-Dulles International Airport. U.S. Department of Health and Human Services. CDC. Published: May, 2026.

Summary

A Single-Centre, Open-Label, Phase 1b Trial

[Posted 26/May/2026]

AUDIENCE: Oncology, Ob/Gyn

KEY FINDINGS: The combination of fulvestrant, ipatasertib, and palbociclib showed preliminary signs of clinical activity and showed expected adverse events in heavily pretreated patients with HR+/HER2- metastatic breast cancer, warranting further evaluation in those with CDK4/6 inhibitor-refractory disease.

BACKGROUND: PI3K/AKT pathway activation is implicated in CDK4/6 inhibitor resistance. The use of AKT inhibition with continued CDK4/6 blockade after CDK4/6 inhibitor resistance remains unexplored. We evaluated the safety of ipatasertib and an antioestrogen with or without palbociclib in patients with treatment refractory HR+/HER2- metastatic breast cancer.

DETAILS: This single-centre, open-label, phase 1b trial was conducted at the Massachusetts General Hospital (Boston, MA, USA). Eligible patients were women older than 18 years with biopsy proven HR+/HER2- locally advanced, unresectable, or metastatic breast cancer; an Eastern Cooperative Oncology Group performance status of 0-2; disease progression on at least one previous therapy for metastatic disease; and measurable disease or bone lesions. Patients received 400 mg oral ipatasertib with standard 500 mg intramuscular fulvestrant dosing (ipatasertib and fulvestrant group) or with an aromatase inhibitor (oral anastrozole 1 mg per day, exemestane 25 mg per day, or letrozole 2.5 mg per day; ipatasertib and aromatase inhibitor group) on days 1-28 of each cycle. The ipatasertib and fulvestrant plus palbociclib group included a dose-escalation phase with patients assigned sequentially to escalating doses of ipatasertib and palbociclib using a standard 3 + 3 design starting at the recommended dose of palbociclib (125 mg on days 1-21) and the lowest dose of ipatasertib (200 mg on days 1-21). The primary endpoint was safety and progression-free survival was a key secondary endpoint. Safety was analysed in all patients who received at least one dose of ipatasertib and progression-free survival was assessed in all enrolled participants. This study is registered with ClinicalTrials.gov, NCT03959891 (active, not recruiting). Between June 5, 2019, and Feb 16, 2022, 77 patients were enrolled (19 assigned to ipatasertib and fulvestrant, 16 to ipatasertib and aromatase inhibitor, and 42 to ipatasertib and fulvestrant plus palbociclib). All patients were female (77 [100%]); 75 were White (97%) and two (3%) were Asian. The median age was 62 years (range 32-88) and 66 (86%) of 77 patients received previous CDK4/6 inhibitor (median number of previous lines was 3 [range 1-13]). The median follow-up was 12.5 months (IQR 7.6-19.7). The recommended phase 2 dose was established at 400 mg ipatasertib on days 1-21 with 100 mg palbociclib on days 8-28 and standard fulvestrant 500 mg. Median progression-free survival was 5.5 months (95% CI 3.8-7.4). Serious adverse events related to study treatment occurred in seven (17%) patients in the ipatasertib and fulvestrant plus palbociclib group and one (5%) in the ipatasertib and fulvestrant group, which were related to neutropenia, leukopenia, thrombocytopenia, and hyperglycaemia. Common grade 3-4 adverse events related to study treatment (occurring in >5% of patients) were neutropenia (30 [39%] of 77), leukopenia (15 [19%]), diarrhoea (14 [18%]), rash (seven [9%]), lymphopenia (three [4%]), and anaemia (four [5%]). Four deaths occurred during the study (one possibly treatment-related due to grade 5 hyperglycaemia in the ipatasertib and fulvestrant group and two due to infectious issues and one due to pulmonary complications in the ipatasertib and fulvestrant plus palbociclib group), deemed unrelated to study treatment.

Copyright © Elsevier Ltd. All rights reserved.

Source: Wander, S., Lloyd, M., Keenan, J. C., et al. Safety and Antitumour Activity of Ipatasertib Combined With Endocrine Therapy and A CDK4/6 Inhibitor in HR+/HER2- Metastatic Breast Cancer (TAKTIC): A Single-Centre, Open-Label, Phase 1b Trial. Lasers Oncology. 2026; 27(5), 580-591. Published: May, 2026. DOI: 10.1016/S1470-2045(26)00059-8.

Summary

A Randomized Controlled Comparative Study

[Posted 19/May/2026]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: Early active treatment with isotretinoin and FMRF is safe and better than isotretinoin monotherapy over 44 weeks regarding severity, reduced erythema, and improved surface roughness in moderate-to-severe acne vulgaris. This encourages early and effective treatment of acne to mitigate acne scarring and improve patients' quality of life.

BACKGROUND: Oral isotretinoin is the standard therapy for severe acne. However, scarring may persist. Fractional microneedling radiofrequency (FMRF) improves both inflammatory lesions and scars with minimal downtime. In this study, we compare isotretinoin monotherapy and concurrent isotretinoin and FMRF for active acne regarding clinical outcomes. The GAGS scores of isotretinoin and FMRF were significantly lower than those of isotretinoin monotherapy from weeks 12-44 (-79.69% vs. -60.34% at week 44, respectively; p < 0.001). Isotretinoin and FMRF showed significantly greater lesion count reductions than isotretinoin monotherapy at follow-up visits from weeks 12-44. Isotretinoin and FMRF showed significantly lower hemoglobin levels than isotretinoin monotherapy at weeks 32 and 44 (p = 0.029 and p < 0.001, respectively). Skin surface roughness improved substantially and persistently from week 12-44.

DETAILS: In this parallel two-group comparative study, patients received either low-dose isotretinoin monotherapy for 20 weeks (n = 34) or low-dose isotretinoin concurrently with 5 monthly FMRF sessions (n = 36). Outcomes were assessed at baseline and weeks 12, 20, 24, 32, and 44. The primary endpoints were Global Acne Grading System (GAGS) scores and inflammatory/non-inflammatory lesion counts. Secondary endpoints were hemoglobin indices and skin roughness.

Copyright © Wiley Periodicals LLC. All rights reserved

Source: Disphanurat, W., Leeyangyuen, P,, and Srisantithum, B. Efficacy of Low-Dose Oral Isotretinoin Combined With Fractional Microneedle Radiofrequency Versus Low-Dose Oral Isotretinoin Monotherapy in the Treatment of Moderate-To-Severe Acne Vulgaris: A Randomized Controlled Comparative Study. Lasers in Surgery and Medicine. 2026; 58(4): 321-330. Published: April, 2026. DOI: 10.1002/lsm.70120.

Summary

[Posted 11/May/2026]

AUDIENCE: All Healthcare Professionals

KEY FINDINGS:

• Hantaviruses are a family of viruses that cause serious illness and sometimes death in people worldwide.
• The viruses are spread by infected rodents through their urine, feces, and saliva.
• Some hantaviruses cause hantavirus pulmonary syndrome (HPS).
• Early symptoms of HPS in people resemble many other respiratory illnesses, making HPS difficult to diagnose at illness onset.
• Healthcare providers should test a person for hantavirus if they have HPS-compatible symptoms and have had contact with rodents.

BACKGROUND: Hantaviruses are spread by rodents' body fluids and excrement. People mostly contract hantavirus by breathing in the virus. Most hantaviruses found in North, Central, and South America can cause hantavirus pulmonary syndrome (HPS). Andes virus, which is found in South America, has reportedly had person-to-person transmission.

DETAILS: Different hantaviruses are found in the United States. Most of these cause HPS, which primarily affects the lungs. Non-HPS hantavirus infection can also occur, where patients experience non-specific viral symptoms, but no cardiopulmonary symptoms. The hantaviruses that are found throughout the United States are not known to spread between people.

HPS initially causes flu-like symptoms that can progress to more severe illness where people have trouble breathing. It's important for people with HPS to begin treatment as early as possible to improve their chances of recovery. HPS is fatal in nearly 4 in 10 people who are infected.

Exposure risks

Anyone who has contact with hantavirus-carrying rodents, or their droppings, urine, saliva or nesting material is at risk of HPS. Rodent infestation in and around the home remains the primary risk for hantavirus exposure. Even healthy individuals are at risk for HPS infection if they have contact with the virus.

Andes virus can cause HPS and is the only type of hantavirus that is known to spread person-to-person.

How it spreads

Each hantavirus has one primary rodent that carries the disease. The most common hantavirus that causes HPS in the U.S. is spread by the deer mouse.

People can contract hantavirus if they have contact with urine, feces or saliva of a rodent carrying the virus. This can occur when people:

1. Breathe in hantavirus-contaminated air when cleaning up after rodents.
2. Touch contaminated objects and then touch their nose or mouth.
3. Are bitten or scratched by an infected rodent.
4. Eat food contaminated with hantavirus.

Cases normally occur in rural areas where forests, fields, and farms offer habitats for rodents. The animals can get into homes and barns, where they may leave urine or feces.

Dogs and cats are not known to become infected with hantavirus in the United States. Pets may bring infected rodents to people or into homes.

Testing and diagnosis

Assessing patients for hantavirus can be difficult early in the infection because symptoms are non-specific and resemble many other viral infections like influenza, legionnaire's, leptospirosis, mycoplasma, and Q fever. Because hantavirus resembles these infections, a blood test is often the only way to officially diagnose it.

To diagnose hantavirus or HPS, clinicians should understand:

• Disease symptoms and rodent exposure history
• Testing guidelines to identify the virus
• How to request testing support from CDC if needed, and
• How to report cases to CDC

Clinicians with a patient experiencing symptoms compatible with HPS and a potential rodent exposure should contact their state, tribal, local, or territorial health department.

Testing

CDC uses an enzyme-linked immunosorbent assay (ELISA) to detect IgM antibodies and diagnose acute infections with hantaviruses. This diagnostic method is used to diagnose both HPS and HFRS. Diagnostic testing can be performed at:

1. CDC
2. State labs running the CDC-developed assay
3. State public health labs using other diagnostic assays
4. Commercial labs

The criteria to report hantavirus-positive cases are based on the national case definition, which includes clinical symptoms (HPS or non-HPS) and acute laboratory diagnostic results, such as:

1. IgM positive
2. IgG positive with rising titers
3. Immunohistochemistry positive, or
4. PCR positive

Treatment and recovery

There is no specific treatment for hantavirus infection. If HPS is suspected, the patient needs emergency medical care immediately, preferably in the intensive care unit, even before diagnosis.

Early intensive medical care is critical because patients who have sudden acute disease can rapidly become severely sick and die. If a patient is experiencing full distress, it is less likely the treatment will be effective.

Patient management should include:

1. Monitoring and adjustment of cardiac function
2. Carefully administering fluids
3. Providing supplemental oxygen
4. Intubating and ventilating if needed

Suspected HPS patients should receive appropriate broad-spectrum antibiotic therapy, even if you're still waiting for diagnosis. Care should also include fever reducers and pain relievers.

While HPS can be quite severe, it has a short duration of critical disease. The cardiopulmonary dysfunction seen in HPS is most likely due to circulating inflammatory mediators. Autopsies performed on fatal cases did not show significant tissue damage.

Initiating extracorporeal membrane oxygenation (ECMO) at the earliest sign of decompensation has an 80 percent survival rate in patients despite cardiopulmonary collapse.

Within 24 hours of initial evaluation, most HPS patients develop some degree of hypotension. They also experience progressive evidence of pulmonary edema and hypoxia, usually requiring mechanical ventilation.

Patients with fatal infections often appear to have severe myocardial depression that progresses to sinus bradycardia with subsequent electromechanical dissociation, ventricular tachycardia, or fibrillation.

In patients with HPS, poor prognostic indicators include a plasma lactate of greater than 4.0 mmol/L or a cardiac index of less than 2.2 L/min/m2.

Pulmonary edema and pleural effusions are common, but multiorgan dysfunction syndrome is rarely seen. However, HPS patients sometimes have mildly impaired renal function. Survivors frequently become polyuric during convalescence and improve rapidly.

Intravenous ribavirin, a guanosine analogue, has been tested in patients with HPS. However, it was not shown to be effective for treatment of HPS.

Without adequate treatment, most deaths occur in patients with HPS within 24 to 48 hours of the cardiopulmonary phase onset.

Related diseases

Some hantaviruses cause kidney symptoms more than lung damage. When this occurs, it is called hemorrhagic fever with renal syndrome (HFRS).

Source: Clinician Brief: Hantavirus Pulmonary Syndrome (HPS). CDC. Published: May 8, 2026.