Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose After community transmission of the novel virus that causes coronavirus disease 2019 (COVID-19) was detected in the State of Washington in February 2020, innovative measures, such as telehealth appointments, were needed to safely continue to provide optimal pharmaceutical care for patients with chronic conditions and cancer. Summary Prior to the COVID-19 pandemic, federal regulations limited the scope of telehealth pharmacist services. However, enactment of the Coronavirus Preparedness and Response Supplemental Appropriations Act, followed by guidance by the Centers for Medicare and Medicaid Services and the Department of Health and Human Services, allowed currently credentialed providers (including pharmacists) to continue to provide patient care services via telehealth with fewer restrictions. Our health system has numerous credentialed pharmacists across multiple ambulatory care clinics. In this article, we highlight our process of expediting the implementation of telehealth services. This process included obtaining authorization for the credentialed pharmacists to provide telehealth services, completion of training modules, implementation of new technology platforms, development of new workflows, and utilization of resources for providers and patients to facilitate successful completion of telehealth visits. We also highlight the consent and documentation components crucially important to the telehealth visit and share some of our successes, as well as identified limitations, in providing pharmacist services via telehealth. Conclusion In the setting of the COVID-19 pandemic, our institution was able to swiftly implement clinical pharmacist telehealth services for many patients, offering a safe and effective way to continue providing a high level of care. This article discusses our experience with and potential limitations of telehealth to assist other pharmacists seeking to implement and/or expand their telehealth services.

BackgroundThe U.S. Centers for Disease Control and Prevention (CDC) recommended a new regimen for treatment of latent tuberculosis (three months of weekly isoniazid and rifapentine) in late 2011. While completion rates of this regimen were reported to be higher than nine months of isoniazid, little is known about the completion rates of three months of isoniazid and rifapentine compared to nine months of isoniazid or four months of rifampin in actual use scenarios.MethodsWe conducted a retrospective cohort study comparing treatment completion for latent tuberculosis (TB) infection in patients treated with nine months of isoniazid, three months of isoniazid and rifapentine or four months of rifampin in outpatient clinics and a public health TB clinic in Seattle, Washington. The primary outcome of treatment completion was defined as 270 doses of isoniazid within 12 months, 120 doses of rifampin within six months and 12 doses of isoniazid and rifapentine within four months.ResultsThree hundred ninety-three patients were included in the study. Patients were equally likely to complete three months of weekly isoniazid and rifapentine or four months of rifampin (85% completion rate of both regimens), as compared to 52% in the nine months of isoniazid group (p < 0.001). These associations remained statistically significant even after adjusting for clinic location and type of monitoring. Monitoring type (weekly versus monthly versus less often than monthly) had less impact on treatment completion than the type of treatment offered.ConclusionsPatients were equally as likely to complete the three months of isoniazid and rifapentine as four months of rifampin. Four months of rifampin is similar in efficacy compared to placebo as isoniazid and rifapentine but does not require directly observed therapy (DOT), and is less expensive compared to combination therapy with isoniazid and rifapentine, and thus can be the optimal treatment regimen to achieve the maximal efficacy in a community setting.

Background A fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) is efficacious in treating chronic hepatitis C virus (HCV) infection; however, objective adherence to prescribed regimens in real-world clinical settings has not been well studied. Objective This study aimed to evaluate adherence and virologic outcomes in patients with chronic HCV infection treated with LDV/SOF using a novel digital medicine program that directly measures drug ingestion adherence. Methods This prospective, observational, open-label, single-arm pilot study was conducted at 2 clinical research sites and followed patients with HCV infection who were prescribed LDV/SOF along with an ingestible sensor. Patients were treated for 8 or 12 weeks. The main outcomes were ingestion adherence, medical interventions, virologic response, safety, and patient satisfaction. Results Of the 28 patients (mean 59 years, SD 7), 61% (17/28) were male, 61% (17/28) were non-Caucasian, and 93% (26/28) were treatment naïve. All 28 had genotype 1 HCV, and of these, 27 completed an 8- or 12-week treatment. Patients used the digital medicine program for 92% of the expected days; the overall mean ingestion adherence rate was 97%. Providers used the digital medicine program data for same-day medication therapy management in 39% (11/28) of patients. End-of-treatment response was achieved in all the available 21 of 28 patients. Sustained virologic response at 12 weeks or more was achieved in 26 of 28 patients; of the 2 patients who relapsed, one had less than 90% adherence and the other had greater than or equal to 95% adherence, lending insights into reasons for treatment failure. A total of 4 subjects reported nonserious adverse events, which were resolved. Conclusions Conclusions: The findings of this study suggest that digital medicines can be used for wirelessly observed therapy to support adherence to antiviral HCV therapy, reduce unnecessary medication wastage and retreatment costs, and potentially optimize sustained virologic response rates, especially in populations at high risk for nonadherence.

BackgroundReal-world data on adherence to new oral hepatitis C virus (HCV) therapies are limited. Suboptimal adherence can lead to unnecessary treatment failures. Usual methods to measure adherence are inaccurate, and do not allow for opportune intervention. The digital medicines program (DMP) consists of DigiMeds™ (medicines with an ingestible sensor), a wearable sensor patch that confirms ingestion, the Proteus Discover® mobile app, and secure web portal to allow for timely assessment of adherence, prevent missed doses, and maximize the likelihood of sustained virologic response (SVR), or cure. This study evaluated adherence and virologic outcomes in chronic HCV patients treated with sofosbuvir/ledipasvir (SOF/LDV) using the DMP.MethodsThis was a single-arm, prospective, open-label, pilot study at two sites. SOF/LDV tablets co-encapsulated with ingestible sensors allowed the DMP to record ingestion adherence rates (number of ingestions detected/number of expected ingestions). Other outcomes were medical interventions, SVR 12+ weeks after end of treatment, patient satisfaction, and safety.ResultsAll 28 subjects (age 59 ± 7 years [mean ± SD], 61% male, 39% Caucasian, 93% treatment-naïve) had HCV genotype 1; 27 completed treatment. Most (82%) had <$25,000 income/year, 46% had psychiatric comorbidities, and 32% had a history of drug abuse. The DMP was used for 92% of expected days; mean ingestion adherence was 94%. Providers used the DMP data for same-day adherence interventions in 39% of patients. SVR was achieved in 26 of 28 subjects (2 had failed prior therapy). One subject who did not achieve SVR had high adherence (≥95%), suggesting viral resistance; the other was non-adherent (<90%). Most (92%) agreed the DMP helped them feel more involved in managing their healthcare and easy to use in their daily routine; 85% agreed the DMP helped them understand the importance of taking medications regularly. Four subjects reported four nonserious adverse events of rash/pruritus, which resolved and were consistent with use of adhesives.ConclusionThese data suggest that the DMP may be used to support adherence to therapy through targeted, same-day adherence interventions, and optimize SVR rates, including in those with risk factors for nonadherence and in those who previously failed treatment.Disclosures M. Bonacini, Proteus Digital Health: Investigator, Research support. Y. Kim, Proteus Digital Health: Consultant and Employee, Consulting fee and Salary. C. Pitney, Proteus Digital Health: Research Contractor, Research support. L. McKoin, Proteus Digital Health: Research Contractor, Research support. M. Tran, Proteus Digital Health: Employee, Salary. C. Landis, Proteus Digital Health: Investigator, Research support.