RESUMO
BACKGROUND: The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking. METHODS: We conducted a phase 3 trial at 25 U.S. sites. Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL were randomly assigned, in a 1:1 ratio, to receive either HSIL treatment or active monitoring without treatment. Treatment included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod. The primary outcome was progression to anal cancer in a time-to-event analysis. Participants in the treatment group were treated until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 months; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer. RESULTS: Of 4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer. With a median follow-up of 25.8 months, 9 cases were diagnosed in the treatment group (173 per 100,000 person-years; 95% confidence interval [CI], 90 to 332) and 21 cases in the active-monitoring group (402 per 100,000 person-years; 95% CI, 262 to 616). The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test). CONCLUSIONS: Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02135419.).
Assuntos
Neoplasias do Ânus , Infecções por HIV , Lesões Pré-Cancerosas , Lesões Intraepiteliais Escamosas , Conduta Expectante , Adulto , Neoplasias do Ânus/etiologia , Neoplasias do Ânus/patologia , Neoplasias do Ânus/prevenção & controle , Neoplasias do Ânus/terapia , Biópsia , Feminino , Infecções por HIV/complicações , Homossexualidade Masculina , Humanos , Masculino , Infecções por Papillomavirus/complicações , Lesões Pré-Cancerosas/etiologia , Lesões Pré-Cancerosas/patologia , Lesões Pré-Cancerosas/terapia , Estudos Prospectivos , Lesões Intraepiteliais Escamosas/etiologia , Lesões Intraepiteliais Escamosas/patologia , Lesões Intraepiteliais Escamosas/terapiaRESUMO
Vaccinations are an important part of primary care for people with HIV (PWH) and can protect against viral hepatitis and some sexually transmitted infections, as well as respiratory bacterial and viral infections. Vaccinations for influenza, COVID-19, herpes zoster (shingles), hepatitis B, meningococcal disease, mpox, and human papillomavirus are recommended for PWH. Additionally, the Advisory Committee on Immunization Practices has released recommendations incorporating the newer formulations of the pneumococcal pneumonia and respiratory syncytial virus vaccines. Additional considerations for the timing of vaccinations are de-scribed, including whether to delay vaccination until improvement of the immune status. Live vaccines (other than nonreplicating) are contraindicated for PWH with CD4+ counts less than 200 cells/µL or uncontrolled HIV.