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Specialty Pharmacy Continuum • January/February 2022
CLINICAL
Data: What Works in HIV Prevention By Sarah Michienzi, PharmD, BCPS, AAHIVP, and Eric Wenzler, PharmD, BCPS, BCIDP, AAHIVP
C
omparisons have been made between the public health response to COVID-19 and the early days of the HIV epidemic.1 As with COVID-19, messaging regarding HIV risk and severity is of utmost importance. Many people do not believe they will contract the viruses; or if they do, they will not develop severe illness. Additionally, there is
not a one-size-fits-all approach to preventing infection with either virus. We know masking, handwashing, and physical distancing help prevent the spread of COVID-19.2 However, not all people are able to adequately physically distance due to factors such as crowded living environments and performing essential job functions. Similarly, we
know correct and consistent condom use and adherence to oral pre-exposure prophylaxis (PrEP) with emtricitabinetenofovir disoproxil fumarate (FTC/ TDF) or FTC-tenofovir alafenamide (FTC/TAF; Descovy, Gilead) are both highly effective in preventing HIV.3 However, not all people are willing to use condoms or able to negotiate for
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their use successfully. Additionally, not all people are able to adhere to daily medication, and some have contraindications to FTC/TDF and FTC/TAF. Achieving the goal of a 75% reduction in new HIV infections by 2025 and at least a 90% reduction by 2030, as set forth in the federal program “Ending the HIV Epidemic: A Plan for America,” requires a multifaceted approach that targets the highest-risk populations.4 The initiative calls for ramping up diagnosis, treatment, prevention, and outbreak response efforts. It is estimated that fewer than 25% of people who could benefit from PrEP are using it. Solutions to increase PrEP uptake and adherence/persistence are many. For example, data presented at the AIDS 2020 virtual meeting showed that a California Pre-Exposure Prophylaxis Assistance Program contributed to PrEP expansion by removing financial and structural barriers.5 Developing additional pharmacotherapeutic options for PrEP to meet the diverse needs of patients represents another potential solution.
The HPTN 083 Trial
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One such agent is the long-acting injectable integrase strand transfer inhibitor (INSTI), cabotegravir and rilpivirine (CAB/RPV; Cabenuva, ViiV Healthcare/ Janssen). The treatment was recently evaluated in the HPTN 083 trial (ClinicalTrials.gov Identifier: NCT02720094). The primary efficacy end point of this phase 2b/3, randomized, double-blind trial was incident HIV infections with CAB/RPV or oral FTC/TDF.6 The study was terminated early in May 2020 after reaching the prespecified stopping bound of accruing 25% of the end points in an interim analysis, which allowed for the final results to be presented at the AIDS 2020 meeting. The study continued unblinded, and all participants were offered CAB/RPV. To be eligible for inclusion in HPTN 083, subjects had to be cisgender men and transgender women who have sex
