Lauren Santye, Assistant Editor

	Beth Wallace provides advice to patients with leiomyosarcoma, as well as to women with cancer in general.

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Cancer patient Beth Wallace provides advice to patients with leiomyosarcoma, as well as to women with cancer in general. 

What Advice Would You Give to Patients?

A fixed-dose combination of bictegravir and emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was non-inferior to boosted protease inhibitor (bPI)-based regimens in virologically suppressed adults with HIV, according to a recently-published phase 3 study. 

Included in the phase 3 study 1878 were 577 virologically-suppressed adults with HIV who were receiving boosted atazanavir (ATV) or darunavir (DRV) plus abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF), according to a press release.

The participants were randomized 1:1 to either continue their bPI regimen or switch to open-label co-formulated BIC/FTC/TAF once daily. At week 48, switching to BIC/FTC/TAF was found to be non-inferior to continuing bPI treatment, with 1.7% of patients in each arm having HIV-1 RNA ≥50 c/mL.

There were 92.1% of patients in the BIC/FTC/TAF arm who had HIV-1 RNA ≥50 c/mL, and 88.9% in the bPI arm, according to the release.

“These data demonstrate the potential of BIC/FTC/TAF to match the efficacy of a boosted protease inhibitor regimen while also offering a high barrier to resistance and fewer interactions with other drugs,” said lead author Eric Daar, MD, in the release. “The findings, along with data from 3 other phase 3 studies in both treatment-experienced and treatment-naïve patients, suggest that the investigational regimen of BIC/FTC/TAF may be appropriate for a broad range of people living with HIV.”

There were no reports of patients in the BIC/FTC/TAF arm developing treatment-emergent resistance. Only 1 participant on DRV/ritonavir plus ABC/3TC developed a treatment-emergent NRTI mutation associated with abacavir.

In the BIC/FTC/TAF arm, there were no reports of renal adverse events (AEs) leading to discontinuations or cases of proximal renal tubulopathy. The incidence of grade 3 or 4 AEs were 4% in the BIC/FTC/TAF arm compared with 6% in the bPI arm, according to the report. Incidence of grade 3 or 4 laboratory abnormalities were 6% for the BIC/FTC/TAF arm versus 29% for the bPI arm.

The most common AEs in both arms were headache, diarrhea, nasopharyngitis, and upper respiratory tract infection.

“The combination of unboosted integrase inhibitor with the FTC/TAF backbone has the potential to further evolve HIV triple therapy with convenient dosing in a single-tablet regimen,” Norbert W. Bischofberger, PhD, executive vice president of Research and Development and chief scientific officer at Gilead, said in the release. “We look forward to the opportunity to offer patients this next-generation therapy as part of our TAF-based portfolio of treatments for HIV.”

A New Drug Application for BIC/FTC/TAF was filed on June 12, 2017, and the treatment was granted Priority Review. The FDA set a target action date of February 12, 2018. Additionally, a marketing application for BIC/FTC/TAF is under review in the European Union and was validated by the European Medicines Agency on July 13, 2017, according to the release. 

Articles

Bictegravir Combo Treatment Non-inferior to Boosted Protease Inhibitors in HIV?

Achieving National HIV/AIDS Strategy (NHAS) target goals could prevent an estimated 200,000 deaths over 20 years, according to a study recently published in the 

The primary goals of the NHAS are for 90% of HIV-positive individuals to know their diagnosis, and for 80% of those patients to achieve virologic suppression via antiretroviral therapy (ART) by 2020.

In the study, Massachusetts General Hospital (MGH) analysts found that meeting the goals of NHAS would save more than 2 million years of life over the next 2 decades.

“If nearly everyone with HIV in the US were in care, on medication, and virally suppressed, we would stop the epidemic in its tracks,” said senior author Rochelle P. Walensky, MD, MPH, chief of the MGH Division of Infectious Diseases. “Achieving the NHAS goals would bring us one step closer to that goal.”

The NHAS was released in 2015 to better align US HIV/AIDS policies with the Joint United Nations Programme on HIV/AIDS 90-90-90 target, which states that by 2020, 90% of all individuals living with HIV will know their status, 90% of HIV-positive individuals will receive sustained ART, and 90% of all individuals receiving ART will achieve viral suppression.

If the NHAS targets are met, 72% of HIV-positive individuals would successfully achieve virologic suppression compared with current estimates of 49%.

An estimated 1.1 million individuals in the United States are living with HIV, and 1 of every 7 are unaware of their status. According to the CDC, men who have sex with men (MSM) and bisexual men are most affected, particularly African Americans.

For the study, MGH investigators sought to identify the expected return on investment for the programs required to achieve NHAS goals, and to highlight the impact that failing to achieve the goals would have on illness and death. A separate analysis was conducted on the impact of NHAS among black MSM.

The investigators used a mathematical model to assess the cost efficacy of HIV/AIDS prevention, and compared the forecasted results of continuing at the current pace of HIV diagnosis, linkage to and retention in treatment, and viral suppression to achieving NHAS goals. They projected both the clinical benefits and costs over a 20-year period.

The findings showed that if the United States remained at its current pace, then 750,000 deaths from HIV/AIDS would occur over 20 years. Contrastingly, if NHAS goals were achieved, it would reduce total deaths to 551,000, preventing approximately 200,000 deaths.

Among the black MSM patient population, achieving NHAS targets would reduce the number of deaths from 110,000 to 65,000.

“Achieving NHAS goals is entirely feasible,” said co-author Kenneth Freedberg, MD, MSc. “One of the biggest barriers is retaining patients in care, but our projections would be enough to reach these goals. This study is only the latest contribution to the large evidence base demonstrating conclusively that we have it in our clinical and economic power to bring the HIV/AIDS epidemic in the US to a halt. Now is the time to do so.”

Over the next 20 years, meeting NHAS targets would cost an estimated $645.7 billion compared with $525.3 billion under the current pace; however, the number of lives saved would result in a cost effectiveness ratio of $68,900 per quality-adjusted life year (QALY). According to the authors, this is well within the US cost effectiveness standard of 100,000/QALY.

Findings from the separate analysis of the black MSM population revealed that achieving the NHAS targets would produce a ratio of $38,300/QALY.

The authors noted that reducing the cost of ART could lead to even greater cost effectiveness because almost 75% of costs are attributable to ART.

“Achieving NHAS won’t be cheap, but it would be affordable and cost effective,” Freedberg said. “It would make good public health and economic sense to first focus NHAS implementation on black MSM, since they are at considerably higher risk than the general population. Overall, fully implementing NHAS could avert more than 200,000 deaths and prevent more than 250,000 HIV infections over the next 20 years.”

Achieving National HIV/AIDs target goal could prevent an estimated 200,000 deaths over 20 years, according to a study recently published in the Journal of Infectious Diseases. 

Meeting National HIV/AIDS Strategy Goals Could Save 200k Lives

	Beth Wallace was always one to advocate for herself in different areas of her life, but when it came to her health, she left it to the doctors. Here, she discusses the importance of education and being your own advocate. 

The Importance of Being Your Own Advocate

No patient is prepared to hear they have cancer. The process can be confusing, with many unsure of the right questions to ask. As a result, patients can get overlooked and slip through the cracks of care.

In the session, The Rx for Patient Satisfaction at the 2017 National Association of Specialty Pharmacy (NASP) Annual Meeting and Educational Conference, cancer survivor Emily Wallace described her journey with Hodgkin’s lymphoma.

Wallace pinpointed March 2013 as where her story began. Growing up in a basketball family, staying active was second nature. But she soon started to feel lethargic all the time, even having to leave work to take naps.

In addition to fatigue, Wallace noticed large bruises on her legs, thighs, and especially her calves, with no explanation. It wasn’t until a few lumps started to emerge on her neck that she sought out a physician.

Wallace was eventually sent to a specialist, but it wasn’t until she googled the physician’s name that she learned she was being sent to an oncologist. At the cancer center, Wallace underwent lots of blood work and when the results came back, she was told she had a rare blood disease called Gardner-Diamond syndrome, which affects only 150,000 people worldwide.

Although Wallace received medication that caused her bruises to disappear right away, the lumps persisted. When she asked what was going on, she was told by her oncologist, “Oh, I get cysts all the time. Don’t worry about it.” As a result, Wallace continued to take her pills, and the lumps and lethargy continued.

In November 2015, Wallace was back at home to attend her grandfather’s funeral. While in the shower, she felt a golf ball sized lump underneath her armpit. Wallace went back to her primary care physician to get checked out.

“She starts feeling on me and says, ‘I’m not trying to freak you out but I think you have lymphoma,’” Wallace said in the session. “She did the CT scan and some X-rays, and 2 days later I was diagnosed with stage 3 Hodgkin’s lymphoma, and 4 days later I had my first chemotherapy. Everything happened in a 2.5-year span, super slow, then all of a sudden it was super fast.”

Wallace underwent 12 rounds of chemotherapy, each of which were a little different.

“Obviously, I got sicker each time, but I also had different faces each time as well,” Wallace said. “In a small cancer center, I was expecting to have a nurse that would go with me throughout my journey but that didn’t happen. I only had the same nurse twice, [and] my oncologist was only there 6 out of the 12 times as well.”

While undergoing chemotherapy treatments, Wallace said she felt extremely isolated. Her parents lived 6 hours away, and her mom was diagnosed at the same time with having terminal intestinal cancer, when in fact, she had suffered a ruptured appendix.

Since her mom had her own recovery, Wallace only saw her the first chemotherapy session and didn’t see her again until 2 weeks after her last session. Wallace’s father came down every 2 weeks and her friends filled in for the other sessions. One friend had been diagnosed with leukemia at age 17, so he had a better understanding of the questions to ask.

“It was kind of like I was more so alone,” Wallace said in the session. “The biggest person in that cancer center was the receptionist. The day that I was diagnosed, she came up to me and said ‘Hey, I’m a cancer survivor as well. I had Hodgkin’s lymphoma too. I’m 22 years in remission.’”

“That was my hope right there, and she was kind of my rock. And I mean, yes receptionists are great but that probably shouldn’t have been the person that I was going to at all times.”

Wallace was working full-time as a social worker while she was sick because she needed her insurance. Being a social worker, she had the opportunity to go to therapy herself but it was something she rejected at first. After a few months, she submitted.

“That was probably the best decision I ever made because that therapist used to be a nurse practitioner oncologist,” Wallace said during the session. “She did everything that I needed that probably should have been happening weekly in the cancer center that wasn’t happening.

Wallace is currently 27 months in remission, but has switched oncologists twice. She emphasized the need for patients to seek a second opinion and have a strong support network because of the life-changing impact of a cancer diagnosis.

“Although I’m here, I’m able to talk about my journey, it still isn’t easy,” Wallace said. “It still isn’t easy to look back. And it’s just not fair for somebody, I think, to have to go through what I went through, especially in the day and age that we are in now.”

Wallace has been in remission since June 2015. She is a social worker in Lincoln, Nebraska, working in a preventative program with families to stay out of the CPS system.

“I want to applaud Emily’s courage to share her story with all of you because I think it takes an immense amount of courage, but it’s her courage that fuels our fire to be health care practitioners in oncology,” said NASP President Mike Agostino during the session.

Ann Fish-Steagall, BSN, RN, OCN, also spoke during the session to illustrate what a specialty pharmacy could have done to have improved Wallace’s journey.

“Patient care is still my passion all these many years later,” said Fish-Steagall, who has been an oncology nurse for more than 30 years. “At ASCO (American Society of Clinical Oncology) this year, I got more professional satisfaction at one preliminary session than I have in my 30 years of being an ASCO member, and that was an evaluation study that patient management truly makes a difference in patients’ lives.”

The study was large for its type, comprising 766 patients who were followed and accrued over a 4-year period, and have now been followed-up with at a median of 7 years. Fish-Steagall noted that there was a large range in ages of the study participants, so there were no biases by age.

“This was a randomized study for patients to follow-up with their provider using a web-based patient reported outcomes application versus the good old standard way of, you have a problem [and] you need your physician, you call and leave a message,” Fish-Steagall said in the session. “As you heard Emily tell her story, there can be gaps. There can be gaps in having their calls returned, maybe there’s no particular person in a cancer center or practice for a patient to use as a lifeline.”

During the study, the participants used either their standard method of follow-up or the web-based application. If they had a new symptom associated with their disease or therapy or they had a worsening symptom, the nurse at their practice was pinged by email to get in touch with that patient. According to Fish-Steagall, 77% of what was reported by the patients required nurse follow-up.

For those patients who received follow-up from the nurses due to their web-based reporting, they were on therapy an average of 2 months longer. Furthermore, they had an overall survival advantage of 5 months, which translated into an 8% survival benefit.

“This study really validates for me, as an oncology nurse, that when we take really good care of patients we have much better outcomes,” Fish-Steagall said.

What Can Specialty Pharmacy Do to Improve Outcomes?

“As a specialty pharmacy, we are an extension of the practice,” Fish-Steagall said. “We don’t intend to replace the physicians or nurses in a patient’s practice, but we are an extension of that practice. As we move towards 2020, we know that oral specialty drugs are going to overtake oncology—–they’re very expensive, these patients have extremely complex situations, diseases, [and] comorbidities. They require a lot of handholding so that their care can be coordinated between specialists amongst other physicians.”

There are also many patients who must travel long distances to cancer centers, and there can be large gaps in their care.

Patient outcomes can be improved in specialty pharmacy through URAC accreditation.

“The newest version of URAC referred to as 3.0 has been a giant leap from the previous accreditation standards,” Fish-Steagall said. “It is a very rigorous accreditation to say the least, but one of the things that I really was impressed with was that for a pharmacy accreditation standard, they have focused a lot of attention on patient management.”

URAC was founded in 1990 to do utilization review/management. Over the years, URAC has expanded and now offers many accreditations in the health care setting; specialty pharmacy is just one of them.

There are multiple standards in accreditation; however, the number one standard is a patient-centered strategy, according to Fish-Steagall. URAC believes it is “our duty as health care providers in a specialty pharmacy setting to make sure that it is the right drug, the right choice, and that it is an appropriate drug considering concurrent medications that patient has.”

Additionally, Fish-Steagall believes education is equally as important.

Pharmacy law says that you should offer counseling to patients; however, it does not say that a pharmacist must do mandatory counseling.

“We feel that—–especially for oncology patients––one of the things that removes barriers to adherence and improves compliance in quality of life for patients is to do intense education before that drug is ever shipped to them,” Fish-Steagall said in the session.

Patients only retain approximately 10% of information given at any one setting. To combat this, nurses need to follow-up on that education, according to Fish-Steagall.

“Did the patient hear the pharmacist? Did they take note of how to take their medication? Do they take the right dose, do they take it with or without food? It’s amazing to me how often we follow-up not just once but on multiple occasions, and realize that patients have reverted to taking medication just the way they want to take it…without consideration for the original instructions they were given,” Fish-Steagall said. “It’s a nurse’s job to make sure that a patient stays on track, continues to take their medication appropriately, and then to really mitigate those side effects that drug may cause.”

Fish-Steagall believes the role as a specialty pharmacy health care provider is 2-fold: to keep the patient on medication for as long as it is working for them, and do it in a manner that ensures the patient has the best quality of life they possibly can while undergoing that therapy.

One question often asked is how a physician may take this interference.

“I have to say, in my experience, the majority of the time the physician is very happy that we picked up on it,” Fish-Steagall said. “They recognize that it is the pharmacies duty to know that drug inside and out, especially as new therapies are launching every week, every month, it seems. It’s very hard for physicians, especially in a community practice who may not see highly orphaned indications that often. They may not really understand the mechanism of action, they may not really understand the side effects of the drug. So, for us to be that content expert, to reach out to those providers and make sure that they have all the information needed to safely take care of the patient, makes us a good partner.”

Documentation and being aware of who is on that patient’s caregiving team is also important, explained Fish-Steagall.

“I want our pharmacists and our nurses to treat that patient as if they had just walked into a hospital room and they were taking care of that patient at the bedside, or they were walking into an outpatient clinic and they were seeing that patient face-to-face,” Fish-Steagall said. “The documentation should be no different than if we were in any other clinical setting.”

If a patient falls into the high-risk category, URAC requires specialty pharmacies to assess every patient for barriers to compliance, as well as distress.

Specialty pharmacies are also beholden to the manufacturer to report any changes in side effects, according to Fish-Steagall.

“If you are involved in any of these patient management programs that are sponsored by the manufacturer, then you know that in today’s world we are not only a part of that health care team we are also an agent of the manufacturer,” Fish-Steagall said. “Therefore, it causes us to have to report adverse events in the same manner that the manufacturer does to the FDA.”

Fish-Steagall noted that although it is important to document and report appropriately, it is also important to realize that these are just a byproduct of good patient management.

“There is no way, especially in oncology, for a nurse or a pharmacist to improve that patient’s quality of life throughout therapy without learning of adverse events and then reporting them,” she said.

Another aspect of URAC requirements are care plans. URAC recognizes that care plans should be designed by the nurse with the patient, and the patient should come up with goals that are acceptable to him or her.

“We have to demonstrate this in documentation as a URAC standard,” Fish-Steagall concluded. “So, our care plans become a permanent part of the patients record within the specialty pharmacy.”

Consistency among caregivers can be an important factor for patients undergoing treatment for cancer.


The Rx for Patient Satisfaction

New findings from a phase 3 study showed a fixed-dose combination of bictegravir and emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was non-inferior to boosted protease inhibitor (bPI)-based regimens in virologically suppressed adults with HIV.

 arm who had HIV-1 RNA ≥50 c/mL, and 88.9% in the bPI arm, according to the release.

A New Drug Application for BIC/FTC/TAF was filed on June 12, 2017, and the treatment was granted Priority Review. The FDA set a target action date of February 12, 2018. Additionally, a marketing application for BIC/FTC/TAF is under review in the European Union and was 

validated by the European Medicines Agency on July 13, 2017

The investigational regimen may be appropriate for a broad range of HIV-positive patients. 
