RESUMO
Background: People who inject drugs (PWID) are a key population for treatment with direct-acting antiviral medications (DAAs) to eliminate hepatitis C virus (HCV). We developed a Pharmacist, Physician, and Patient Navigator Collaborative Care Model (PPP-CCM) for delivery of HCV treatment; this study describes clinical outcomes related to HCV treatment (initial evaluation, treatment initiation, completion, and cure), as well as patient satisfaction. Methods: We conducted a single-arm prospective pilot study of adult PWID living with HCV. Participants completed baseline and six-month follow-up surveys, and treatment and outcomes were abstracted from electronic health records. Primary outcome was linkage to pharmacist for HCV evaluation; secondary outcomes included DAA initiation, completion, and cure, as well as patient-reported satisfaction. Results: Of the 40 PWID enrolled, mean age was 43.6 years, 12 (30 %) were female, 20 (50 %) were non-white, and 15 (38 %) were unhoused. Thirty-eight (95 %) were successfully linked to the pharmacist for initial evaluation. Of those, 21/38 (55 %) initiated DAAs, and 16/21 (76 %) completed treatment. Among those completing treatment who had viral load data to document whether they achieved "sustained virologic response", i.e. cure, 10/11 (91 %) were found to be cured. There was high satisfaction with 100 % responding "agree or strongly agree" that they had a positive experience with the pharmacist. Conclusion: Nearly all participants in this pilot were successfully linked to the pharmacist for evaluation, and more than half were started on DAAs; results provide preliminary evidence of feasibility of pharmacist-led models of HCV treatment for PWID. Clinicaltrialsgov registration number: NCT04698629.
RESUMO
BACKGROUND: Incidence of glandular cell cancers has risen. While atypical glandular cell (AGC) grade cytology results represent only a small percentage of all Pap test results reported annually in the US, a significant percentage represents a corresponding high-grade lesion on follow-up biopsy. The 2006 ASCCP consensus guidelines for AGC-grade cytology results include colposcopy, endocervical sampling, and high-risk (HR) HPV testing for patient management. OBJECTIVE: Determine HPV prevalence and genotype distribution in AGC-grade cytology specimens (n=53) compared to cytology specimens negative for intraepithelial lesion or malignancy (n=338). STUDY DESIGN: DNA extracted from residual, de-identified liquid-based cytology specimens, using QIAamp MinElute Media Kit was analyzed by PCR using Roche Linear Array HPV Genotyping and Detection Test Kits. Multivariate logistic regression compared HPV prevalence and genotype distribution between cases and controls to generate age-adjusted odds ratios (ORadj) and 95% confidence intervals (CI). RESULTS: HR-HPV DNA was found in 34.0% of cases and 7.4% of controls (ORadj=9.11; 95% CI: 4.08-20.33, p-value<0.001). Limiting analysis to HPV-16 and/or -18 resulted in finding HPV DNA in 20.8% of cases and 1.2% of controls (ORadj=40.10; 95% CI: 10.73-149.88, p-value<0.001). In contrast, prevalence of low-risk HPV DNA was similar between groups: 13.2% of cases and 17.2% of controls (ORadj=0.91; 95% CI: 0.35-2.31, p-value=0.834). CONCLUSIONS: AGC-grade cases contained a significantly higher rate of HR-HPV compared to controls, supporting earlier recommendations for HPV testing of AGC-grade cytology specimens. Our findings also suggest that follow-up genotyping of HR-HPV containing AGC cases for HPV-16 and/or -18 specifically would be useful in patient management.