12 minute read
Rx options for hitting 75% prevention goal for new HIV infections
Data: What Works in HIV Prevention
By Sarah Michienzi, PharmD, BCPS, AAHIVP, and Eric Wenzler, PharmD, BCPS, BCIDP, AAHIVP
Comparisons 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
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 trialwas 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
with men, at least 18 years of age who met criteria for HIV risk, generally in good health, not diagnosed with hepatitis, and tolerant of gluteal injections. (Of note, cisgender women were not included in HPTN 083 despite the large number of heterosexual women in the United States who could benefit from PrEP. Safety and efficacy of CAB/RPV among cisgender women of sub-Saharan Africa were investigated in a similar study, HPTN 084,7 which showed that the treatment was superior to oral FTC/TDF for the prevention of HIV. Data on adolescents are forthcoming from HPTN substudies 08301 and 084-01.8)
Participants in the HPTN 083 trial were randomized 1:1 to a CAB/RPV or FTC/ TDF arm. In step 1, participants received daily oral CAB or FTC/TDF. This oral lead-in is required before administering the long-acting injectable CAB to ensure tolerability, because it has a long half-life once injected. Injections began in step 2. Participants received injections of CAB/ RPV (CAB arm) or matching placebo (FTC/TDF arm) at weeks 5 and 9 and every 2 months after that as well as oral FTC/TDF (FTC/TDF arm) or matching placebo (CAB arm) daily. The study planned for step 2 to last approximately 3 years, at which time injections would be discontinued.
Participants in the CAB/RPV arm would receive oral daily FTC/TDF for 1 year in step 3 to reduce the risk for HIV acquisition in the presence of subtherapeutic levels of CAB/RPV.
The primary efficacy cohort included 2,243 and 2,247 participants in the CAB/ RPV and FTC/TDF arms, respectively. Transgender women represented 12.4% of the total study population. There were study sites in the United States, Latin America, Asia, and Africa, and nearly 50% of the US participants were Black.
In 6,389 person-years of follow-up, with a median per-participant followup time of 1.4 years (interquartile range [IQR], 0.8-1.9), there were 52 HIV infections: 13 in the CAB arm and 39 in the FTC/TDF arm. Only 5 of the 13 HIV infections in the CAB arm occurred despite continuous on-time CAB/RPV injections. The others occurred after prolonged nonadherence to CAB/RPV (n=5) and during the oral lead-in phase (n=3). Of note, the pooled HIV incidence of 0.81 (95% CI, 0.61-1.07) per 100 person-years observed in the study was considerably lower than the target background HIV incidence of about 4.5%. Although designed as a noninferiority trial, CAB/RPV met the criteria for superiority, with a 66% reduction in HIV acquisition risk compared with FTC/TDF. Similarly, as noted, CAB/ RPV was shown to be superior to FTC/ TDF in women in HPTN 084.7
Overall, CAB/RPV was well tolerated in the HPTN 083 trial. Injection site reactions (ISRs) were the primary adverse event (AE), with 80.9% of participants in the CAB arm reporting an ISR. Most were classified as mild (grade 1) or moderate (grade 2), and lasted a median of 3 days (IQR, 2-5 days). There was a strong association
see HIV PREVENTION, page 21
A multifaceted approach is needed to reach the US goal of a
75% reduction
by 2030.
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accrediting organization. However, URAC changed its standard requirements in 2019, and programs now must be specific to disease states or medications, said Dr. Bonome, who was one of several pharmacy experts who presented best tips for successful clinical protocol programs at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually.
It turns out the best practices outlined during the ASHP session are the same ones that make any therapy successful, the speakers said: proper planning, thorough education, consistency, occasional reassessment and the ability to adjust when necessary. Protocols also should be specific to the disease or therapy, incorporate all members of the patient care team, and track outcome measures to demonstrate value, Dr. Bonome said.
“At the end of the day, specialty patients are special because of the disease state that they’re dealing with and because of the drugs that they’re taking,” she said. “Their unique needs need to be addressed.”
A Solid Start
The first step in establishing good protocols is identifying services and touch points to be provided, said Jenn Richards, PharmD, JD, CSP, the product development principal at URAC. An initial assessment is essential to determine the appropriateness of the therapy, based on factors such as diagnosis, comorbidities and medical history, Dr. Richards said. Assessments can be done by phone/video or in person, or information can be collected from the prescriber’s office through notes or a conversation, she noted.
Specifically, URAC accreditors look for key measures during the initial assessment, such as patient diagnosis, medication lists and prior allergies, Quintin Jessee, RPh, DPh, the vice president of specialty services and accreditation for D2 Pharma Consulting, told Specialty Pharmacy Continuum.
Understanding what makes these patients unique—as well as what is different about a particular disease state or drug—will help when deciding how to customize protocols, Dr. Richards said. Consider what information will ensure a medication is appropriate, such as other drugs the patient is taking, whether patients are comfortable injecting at home by themselves, or whether they have a caregiver at home, she continued.
Digital engagement technologies, such as text messaging, can help improve communications and patient outreach while taking some burden off staff during a challenging time, Dr. Jessee said.
Education is another important component and should be provided prior to the patient taking the medication, Dr. Richards said. Topics should include information about medication use and safety, side effects, and what to do in case of missed doses, she said.
It’s also important to boost patient literacy via education and counseling, Dr. Jessee said. Some of those discussions should focus on safety, including at-home medication storage, because many specialty medications need to be refrigerated or frozen, he continued.
Other conversations may need to
address patient requests or preferences for certain types of medications or formulations. Discussions over whether those requests are appropriate can be supported by reading material or demonstrations with medication in hand, Dr. Richards said. “The goal is to help the patient understand the nuances of the medication and overall health safety.”
Regular Checkups
Reassessments should be done regularly, such as during refills, lab tests and changes to patient health, Dr. Richards continued. “The goal here is to touch base with the patient enough to ensure you remain confident the medication continues to be appropriate and safe.”
Reassessment points may vary based on each drug or disease state, and pharmacies should rely on industry best practices or guidance from drug manufacturers, Dr. Jessee said. Some drugs with Risk Evaluation and Mitigation Strategy programs also include elements to ensure safe use, which will include specific touch points, he added.
Clinical interventions also are necessary and may arise because of issues for which you can prepare, such as particular disease states or drugs, Dr. Richards advised. Others may arise for unexpected reasons, such as changes in patient health, she said.
“Get to a place where you have covered a majority of the issues that can occur with these drugs, and how you’re going to handle that,” she said.
Interventions should be evidencebased, Dr. Richards continued. Documenting and reporting on interventions can ensure the entire care team has access to the data, and it supports the value of having pharmacists involved in treatment, she said. However, clinical interventions are a newer metric from URAC, and technology systems may not have an easy way to track them, Dr. Jessee cautioned. It’s important to determine a workflow to show this information, he said.
Working Together
Next, team collaborations should be planned, Dr. Richards said. Where will services be provided—in a pharmacy, clinic or other location, such as a longterm care facility or patient’s home with nursing support? What roles will the pharmacist, nurse, provider and others have? Also consider who will administer the medication, she said.
All of this should be documented in each step of the clinical protocol, Dr. Richards said. Consider resources such as time required for each patient, the number of people required to service all patients, and the use of clinicians and nonclinicians, she said. Doing so can minimize duplication of work and allow individuals to work at the top of their licensure, she added.
Avoid PA Pitfalls
One issue specialty pharmacy medications can run into is getting stuck in a prior authorization, step therapy or failed claim scenario, Dr. Jessee said. Electronic benefit tools and collaborations with insurers can speed up the resolution of these issues. Remember that infused products may require additional collaborations with provider offices, he continued.
Once these steps are completed, design methods for evaluating clinical protocols and decide which measures are needed to evaluate their effectiveness, Dr. Richards said.
In doing so, think what would be needed to determine whether the program is effective, how the data can best be captured, and define inclusion and exclusion criteria, she said. Metrics to be measured can be divided into clinical outcomes, such as laboratory values; financial outcomes, including projected savings from avoided hospitalizations; or quality-of-life outcomes. Make sure everything is clearly documented and that you outline a plan for how to analyze data and how often, she said.
Then, share the plan with internal and external stakeholders, including current or prospective clients and payors, Dr. Richards said. Before implementation, protocols should be approved by a clinical oversight body, she said, and plan to review and update the protocol at least annually.
A Transparent Launch
During implementation, ensure processes are documented, educate and train all members of the team, and communicate your launch to all stakeholders, Dr. Bonome said. During ongoing evaluations, check whether your measures are meeting goals or whether a change in protocol is required based on its effectiveness or any new clinical guidelines.
Pharmacists should note that some clinical management software systems are not accreditation-specific, and may be more challenging to extract reports about patient interactions, Dr. Jessee said. You may have to work with your information technology department or the software manufacturer to determine the best process to do this, he said.
“Tracking and documenting interactions has been the pain point.”
