A subgroup analysis of data from a phase 3 clinical trial found that a fecal microbiota–based treatment for recurrent Clostridioides difficile infection (rCDI) was safe and effective in participants with mild-to-moderate immunocompromising conditions, researchers reported yesterday in Open Forum Infectious Diseases.

The data were from PUNCH-CD3-OLS, an open-label, prospective, single-arm study designed to evaluate the safety and tolerability of the fecal microbiota–based live therapeutic Rebyota (RBL) in a "real-world" population of rCDI patients. Rebyota was approved by the US Food and Drug Administration for preventing rCDI in adults following standard-of-care antibiotic treatment based on the results of the trial and other clinical trial data. But a 2024 clinical practice guideline noted that there was insufficient evidence to recommend RBL in mild or moderately immunocompromised adults with rCDI and recommended against its use in severely immunocompromised patients, owing to concerns about increased risk of infection.

Safety, efficacy results are similar across participants

For the study, a team led by researchers from Beth Israel Deaconess Medical Center in Boston analyzed treatment-emergent adverse events (TEAEs) and efficacy outcomes in 141 of 697 trial participants who received RBL and had immunocompromising conditions or were taking immunosuppressive medications. TEAEs within 8 weeks of treatment were reported by 44.7% of immunocompromised participants and 48% of non-immunocompromised patients. Most events were mild or moderate gastrointestinal disorders. 

Serious TEAEs within 8 weeks were reported by 4.3% and 3.8% of immunocompromised and non-immunocompromised participants, respectively. But no RBL-related systemic infections occurred.

In immunocompromised participants, the treatment success rate at 8 weeks was 75.7% and the sustained clinical response rate at 6 months was 88.7%, similar to results in the non-immunocompromised subgroup (73.3% and 91.6%, respectively).

The study authors say the safety and efficacy results in immunocompromised patients are consistent with those from previous studies in the RBL clinical trial program.

"This analysis provides important data regarding the safety and efficacy of RBL for rCDI in mildly to moderately immunocompromised patients, which can assist clinical decision-making in real-world care settings," they wrote.

Almost 20 years have passed since the US recommended the human papillomavirus (HPV) vaccine to prevent cancers and other diseases caused by HPV, and a new study shows a major drop in precancer incidence among women who were most likely to have been vaccine recipients. 

In a new study in Morbidity and Mortality Weekly Report, the authors say the first recipients of the vaccine have now been screened for cervical cancer, and precancer incidence has decreased 80% among screened women aged 20 to 24 years.

The study describes trends in incidence of precancerous lesions tracked by the Centers for Disease Control and Prevention (CDC) from 2008 through 2022. During that period, rates among women aged 20 to 24 decreased by 79% to 89%, while rates among women aged 25 to 29 years old decreased by 37%. 

Vaccination before sex initiation most effective

"The data are consistent with a considerable impact from the U.S. HPV vaccination program on cervical precancers, with the largest decreases in the youngest age group for which benefit of vaccination would first be observed," the authors wrote. 

The data are consistent with a considerable impact from the U.S. HPV vaccination program on cervical precancers.

During 2018 to 2022, all women aged 20 to 24 years would have been eligible for vaccination at the routine age—11 or 12 years—in 2006, the authors said. Vaccination at that age is more effective because it precedes exposure to HPV through sexual contact.

"Although some women in age groups 30–34 years and older would have been vaccinated, less impact is expected among women in this age group at this time because they were only eligible for catch-up vaccination, at ages when many women are already sexually experienced and therefore likely to have been infected with HPV," the authors noted.