Is Long-Lasting, Injectable Medication the Future of HIV Therapy?

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Long-lasting medication to treat patients living with HIV/AIDS has been a goal of the medical field since the early days of the epidemic. Currently, most HIV therapies include daily medication involving multiple pills, which has proven to be expensive for the average patient, as well as potentially challenging for medication adherence. That could be changing, because an investigational, long-acting, injectable, 2-drug regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV is showing promise.

At the 2020 Conference on Retroviruses and Opportunistic Infections, ViiV Healthcare announced results from its 96-week global phase III FLAIR study. The results demonstrated the injectable therapy "continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC)." Also, compared to their previous, oral treatment, patients who participated in the study expressed a high level of treatment satisfaction at week 48, as well as week 96 (ViiV Healthcare).

Photo Source: Christian Today

"Our focus on creating innovative treatment options for people living with HIV is further supported by these long-term findings of a long-acting injectable HIV treatment regimen. The efficacy and safety data of cabotegravir and rilpivirine at 96 weeks, as well as a high level of treatment satisfaction for the long-acting regimen, further encourage us as we work to bring this treatment option to people living with HIV," said Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare.

"Seeing the longer-term data is really exciting. It confirms that the long-acting, two-drug regimen of cabotegravir and rilpivirine has maintained its efficacy and has the potential to be a generally well-tolerated alternative to the standard-of-care, daily, oral pill. For some people living with HIV, reducing their dosing schedules from 365 days per year to 12 may be a realistic option in the future," said Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London (ViiV Healthcare).

The use of cabotegravir has implications broader than HIV therapy, too. Injectable cabotegravir is also being evaluated for pre-exposure prophylaxis (PrEP). Whereas the aforementioned news of cabotegravir’s (in combination with and rilpivirine) initial effectiveness in treating patients is new to celebrate, questions still remain as it relates to its use in HIV prevention - one being its effectiveness in women living with HIV.

As it relates to PrEP, Molly Walker wrote in MedPage Today on May 19 that she worries this drug will be approved for only one HIV positive population.

"While results for the long-acting HIV prevention medication cabotegravir are promising in men who have sex with men (MSM), there is still no data on this drug in women, begging the question of whether this will be another HIV prevention option that ends up being approved for only one population," said Walker (MedPage Today).

Mitchell Warren is executive director of AVAC: Global Advocacy for HIV Prevention. He described the experience with another drug, F/TAF as 'completely dropping the ball early on in the process'. According to Walker, the experience with cabotegravir is not similar to F/TAF.

Thousands of women are getting cabotegravir injections and the same data safety monitoring board oversees both studies," he noted, adding HPTN 083 data has not been fully analyzed and yet to be peer reviewed. "It's still a long way from submission to the FDA and other regulators," said Warren.

Unlike F/TAF trials, the test trials for cabotegravir is almost 'fully enrolled' among women, which is promising. Warren also noted that if cabotegravir is effective in HIV positive women or at-risk women, it could be good news to those who still carry the social stigma of taking multiple pills a day.

"While PrEP has been "normalized" in the gay community, he added, the idea of carrying "a large pill bottle" still imparts a great deal of stigma for at-risk women," Warren said.

Warren emphasized that having more options with HIV medications is helpful to those around the world, citing that many women are comfortable getting injections every 3 months for contraception.

Cabotegravir is still in the testing stages, but the initial results of effectiveness in trail patients has been positive. The hope is that this new drug will be effective for both men and women, while also lessening the social stigma of taking large dosages of pills to treat and prevent HIV.

References:

• ViiV Healthcare (2020, March 9). ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting injectable treatment regimen in adults living with HIV-1. Retrieved from https://viivhealthcare.com/en-gb/media/press-releases/2020/march/viiv-healthcare-presents-positive-long-term-data-from-phase-iii-/#:~:text=Cabotegravir%20is%20being%20developed%20by,prior%20to%20long%2Dacting%20injection
• Walker, Molly (2020, May 19). HIV Injectable Tx May Work in Men -- But What About Women? MedPage Today. Retrieved from https://www.medpagetoday.com/hivaids/hivaids/86580.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

HIV Medications and the Treatment of Coronavirus

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor 

Over the past few months, numerous theories have been bandied about regarding the efficacy of certain HIV-centric drugs being potentially effective in treating novel coronavirus (SARS-CoV-2, or COVID-19). Moreover, stories continue to be published claiming that three drugs, in particular – ritonavir, lopinavir, and darunavir – may be used to “cure” COVID-19, a popular, yet untested idea because of the drugs’ effectiveness in treating certain other SARS (Severe Acute Respiratory Syndrome) strains (Journal of the American Medical Association, 2020). Again, these theories are untested.

Photo Source: Business Insider

Whenever a new pandemic arises, questions about why existing drugs aren’t being used to treat novel infections arise. Why, after over a century of medical innovations that, before the 19th Century, would’ve been labeled “Witchcraft,” are these pandemics catching us so frequently by surprise? The answer is that each virus is different; each straight of each virus family is different; not every drug that treats one strain of a virus will prove effective in another.

When I was first tasked with writing this piece, my prompt was:

There are lots of stories about coronavirus and the impact on HIV-positive folks. Yet, there are also lots of updates about HIV antiretrovirals being used to treat (and even cure) folks with the virus. So, does it stand to reason an HIV-positive person adherent to their therapy might be more protected?

So, I got down to some research. Sadly, the answer I’ve gotten from my own Infectious Disease doctor is:

There’s no real evidence to suggest that those specific HIV medications are 100% effective in treating COVID-19; there’s also no real evidence to suggest that people who are taking those medications and thus have them in their system are any more protected than anyone else.

The problem with novel viruses is that they often surface and retreat before any real, definitive testing can be completed. When a new one comes along, scientists rely upon things that have worked in the past to try to cobble together a workable solution in a short amount of time. Moreover, Janssen, maker of darunavir, released a statement on Monday, March 16th stating that there is “…insufficient evidence to suggest that…darunavir can effectively treat COVID-19,” and that “…HIV drugs are being considered as possible treatment options largely due to limited and ‘unpublished virological and clinical data’ that demonstrated they were effective in treating the SARS coronavirus” (Jagielski, 2020).

What is clear is that people living with HIV who have achieved viral suppression through adherence to a treatment regimen are shown to be generally healthier than people with higher levels of the HIV virus detectable in their blood. That doesn’t mean, however, that we are any more or less susceptible to opportunistic infections. Respiratory ailments, in particular, have historically been bad news for people living with HIV.

So, the verdict at this point is: “We don’t know what we don’t know, and therefore, should act with an abundance of caution.”

References:

• Jagielski, D. (2020, March 16). Johnson & Johnson Says There's Insufficient Evidence Its HIV Drug Can Treat COVID-19. Alexandria, VA: The Motley Fool: Investing. Retrieved from: https://www.fool.com/amp/investing/2020/03/16/johnson-johnson-says-theres-insufficient-evidence.aspx
• Young, B. E., Ong, S. W. X., Kalimuddin, S., et al. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. Published online March 03, 2020. doi:10.1001/jama.2020.3204 Retrieved from: https://jamanetwork.com/journals/jama/fullarticle/2762688

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Kudos to Janssen for its 2017 U.S. Transparency Report

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

On March 20th, Janssen Pharmaceutical Companies of Johnson & Johnson hosted a stakeholder meeting in Washington, DC to unveil its "2017 Janssen U.S. Transparency Report" and also promote a dialogue on value, access, and pricing transparency. It is the second time the company has released the comprehensive report, and as such the ADAP Advocacy Association extends its kudos to them for doing so. Patient advocacy groups are often left out of these conversations, yet patients are the people who have the most to gain from transparency. Numerous disease patient advocacy groups were also in attendance, including groups representing people living with diabetes, rheumatoid arthritis, and various mental health conditions.

(Editor's Note: This blog is not intended to be an endorsement of any product made by Janssen Pharmaceutical Companies of Johnson & Johnson but rather acknowledge their efforts to educate stakeholders on their corporate responsibility)

The transparency report highlights four key areas, including Janssen's ongoing investments in new medicines, value assessments, pricing and patient access, and resources for patients. An increasing amount of the public policy discussion has focused on drug pricing, so the information conveyed by Janssen in the report helps patient advocacy groups like ours (and others) refine their areas of interest. It is also important to gain insight into Janssen's work to develop new medicines considering the complexities of the current health care system.

The purpose behind the transparency report is spelled out in a letter from the company leaders, Jennifer Taubert, company group chairman, and Anastasia G. Daifotis, MD, chief scientific officer:

"We want this information to be useful to all our stakeholders: patients, families, caregivers, and advocates, who are asking questions about out-of-pocket costs for medicines and what resources are available to help them; health care professionals, who are increasingly being asked to consider the overall value of the medicines they prescribe; policymakers, who are working to make policy changes to help their constituents get the care they need; and others in the health care system, like payers, who consider value and price information when they make decisions about coverage and access."

The report can be downloaded online at Janssen.com/2017ustransparencyreport.

The stakeholder meeting also featured an interactive panel discussion on Innovation, Pricing & Patient Access, as well as another one on Moving to a Value-Based Approach. Each included representatives from Janssen Pharmaceutical Companies, but also independent experts who were asked to share their insight. The two panels offered good analysis on the oddities of the current health care system, and some tough questions from the audience about what needs to change.

The panels discussed numerous issues, including medication adherence, rebates, insurance discriminatory design, valued-based contracting, importation, among others.

Adam Fein, CEO of the Drug Channels Institute, outlined the problem with the "gross-to-net bubble," as he phrased it. For example, whereas the average net prices offered by Janssen declined by 4.6% last year, it is unlikely the reductions were passed along to consumers. Interestingly too, Fein noted that 9 out of 10 drugs on the market are relatively inexpensive with low-cost generics available. However, it is the 1:10 specialty drugs that are the true cost-drivers.

Dan Leonard, President of the National Pharmaceutical Council, addressed the question over value by noting sick people are currently subsidizing the healthy people. Leonard's analysis echoed the recent remarks by U.S. Food & Drug Administration (FDA) Commissioner Dr. Scott Gottlieb. Leonard also touched on how most insurance benefits are valued from the point of sale, except for drug costs due to the complexities of the existing market (i.e., rebates).

One of the more notable — and troubling — observations was shared by Janssen's own, Dr. Anastasia Daifotis. Upon answering a question from a stakeholder in attendance at the event, she said transparency is important because it sheds light on the rise in non-medical switching and how these patient decisions are being driven by budget and not appropriate patient care.

The ADAP Advocacy Association recognizes that the cost of pharmaceuticals is an important part of the broader conversation about the current health care system. In fact, many of the specialty drugs mentioned earlier in this blog directly impact the HIV/AIDS community, and unfortunately we've witnessed patient cost-sharing for these therapies increase under many insurance exchanges. We encourage more conversations like the one hosted by Janssen, and also to reserve a seat at the table for the patient perspective. It is imperative!