ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.
Lynn Baxter, Head of North America, ViiV Healthcare, said: “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-ofits-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission.”
The era of once-a-month HIV treatment has begun in the European Union—and it may soon commence in the U.S. as well. Long-acting pre-exposure prophylaxis (PrEP) is also on the horizon.On Dec. 21, the European Commission authorized use of the long-acting injectable HIV treatment regimen of cabotegravir and rilpivirine (LA-CAB+RPV) for combination antiretroviral therapy in the European Union. These two drugs are the first long-acting injectable HIV treatments to enter clinical use. The authorization comes after the European Medicines Agency recommended authorization on Oct. 16.
Cabotegravir is an integrase strand transfer inhibitor (INSTI), and rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). The combination regimen is administered by intramuscular injection monthly or every two months. It is indicated for maintenance treatment of adults with HIV who meet the following criteria:
Undetectable viral load (HIV RNA less than 50 copies/mL) on current antiretroviral regimen.
Virus that has not exhibited NNRTI or INSTI resistance.
No history of virologic failure while on an NNRTI- or INSTI-containing regimen.
“I continue to be surprised by the level of enthusiasm by many of our patients for getting their medicines by monthly injection, or injections every two months,” said Susan Swindells, M.B.B.S., the lead investigator of the Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study, which was pivotal in the drug regimen’s eventual approval in Europe. “Taking one pill once a day does not seem that difficult in theory, but for many patients it is a challenge—and, importantly, a daily reminder of the fact that they have HIV. Having this alternative to offer is a great benefit for interested patients.”
As 2020 draws to a close, we asked David Alain Wohl, M.D., a professor of medicine in the Division of Infectious Diseases at the University of North Carolina and a highly respected HIV clinician-researcher, to take stock of the year’s most momentous research developments and other critical events. In this exclusive series of articles, Wohl calls attention to 10 such developments that have tremendous short-term implications for our day-to-day efforts to improve HIV prevention, treatment, patient care, and policy in the U.S., and analyzes each development with his trademark wit and clinical savvy.
“Looking for something we can rely on. There’s got to be something better out there,” Tina Turner sings in her 1980s pop hit “We Don’t Need Another Hero.” That song jumps into my head when I think about new HIV therapies, but in my mind, it’s framed as a question: Do we need another hero?
For those with few antiretroviral options, who are downing multiple pills to keep multidrug-resistant virus from replicating, the answer would be yes: We do need another antiretroviral hero.
Fortunately, the number of people living with HIV who are heavily treatment experienced and have few remaining antiretroviral options is fairly small. Among over 27,000 HIV-positive people in the U.S. who were treatment experienced and in care at one of the HIV clinics contributing to the U.S. Centers of AIDS Research Network of Integrated Clinical Systems (CNICS) cohort from 2000 to 2017, just 916 had limited treatment options (LTO)—a status defined as having two or fewer available antiretroviral classes, as well as two or fewer active drugs per class as determined by resistance testing. After 2007, the proportion of people with LTO fell; it has since remained less than 1% of the cohort’s antiretroviral experienced patients.
Still, for that 1%, things can be rough. Many are straddled with antiretroviral regimens that include pharmacological boosters, inconvenient dosing, and side effects. Some may even still fail to achieve virologic suppression. Therefore, U.S. Food and Drug Administration (FDA) approval of fostemsavir (brand name: Rukobia), an HIV attachment inhibitor, in July is welcome news to these patients and their providers.
The SASH study (Impact of Poor Sleep and Inflammation on the Adenosine Signaling Pathway in HIV Infection) seeks to understand how sleep can affect the health of people living with HIV.
Study participants complete questionnaires before and after getting a watch-like device similar to a Fitbit. Subjects wear the device for two weeks, to track their sleep patterns. Subjects also answer a few questions in a diary each morning about their sleep.
The study involves two visits to Montefiore Hospital. Each visit is about one hour in length. Participants will receive up to $100. Parking vouchers and/or bus fare will also be provided.
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While current antiretroviral treatments for HIV are highly effective, data has shown that people living with HIV appear to experience accelerated aging and have shorter lifespans—by up to five to 10 years—compared to people without HIV. These outcomes have been associated with chronic inflammation, which could lead to the earlier onset of age-associated diseases, such as atherosclerosis, cancers, or neurocognitive decline.
A new study led by researchers at Boston Medical Center examined what factors could be contributing to this inflammation, and they identified the inability to control HIV RNA production from existing HIV DNA as a potential key driver of inflammation. Published in The Journal of Infectious Diseases, the results underscore the need to develop new treatments targeting the persistent inflammation in people living with HIV in order to improve outcomes.
Getting a flu vaccine during 2020-2021 is more important than ever because of the ongoing COVID-19 pandemic. When you get vaccinated, you reduce your risk of getting sick with flu and possibly being hospitalized or dying from flu. This season, getting a flu vaccine has the added benefit of reducing the overall burden on the health care system and saving medical resources for care of COVID-19 patients.
People with HIV—especially those who have a very low CD4 cell count or who are not taking antiretroviral therapy—are at high risk for serious flu-related complications. For this reason, it is especially important that people with HIV get a flu shot annually. (The nasal spray flu vaccine is not recommended for people with HIV.)
In addition to getting a flu shot every year, people with HIV should take the same everyday preventive actions CDC recommends of everyone, including avoiding people who are sick, covering coughs, and washing hands often.
Initial data from a large NIH-supported clinical trial offer a detailed look at the health status of people aging with HIV around the world. With 7,770 participants enrolled in 12 countries across five continents, the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE ) is evaluating the ability of a statin medication, pitavastatin, to reduce the risk of heart disease among people with HIV. By leveraging data collected from this diverse group of study participants, researchers also are learning more about the long-term health effects of HIV. They report their initial findings in an August supplement for The Journal of Infectious Diseases.
For women, accelerated reproductive aging—a natural process that eventually leads to menopause—may heighten risk for heart disease and stroke. Among women with HIV in the REPRIEVE study, more advanced reproductive age was associated with two risk factors for cardiovascular disease: high waist circumference and high blood levels of hemoglobin. Women living in sub-Saharan Africa or Latin America and the Caribbean were more likely to experience accelerated reproductive aging than those living in high-income countries.
The initial REPRIEVE findings also provide insight into the relationship between HIV and heart disease among transgender people, about which little is known. Transgender people are disproportionately affected by HIV, and studies have suggested that hormone use as part of gender-affirming therapy may increase cardiovascular disease risk. By collecting data on gender identity and use of gender-affirming therapy, the REPRIEVE investigators aim to address this knowledge gap. Notably, their initial analysis revealed that high waist circumference was more common among transgender women, particularly those who were receiving gender-affirming therapy.
Highlights from the Ryan White Clinical Conference on HIV.gov…
The promise of long-acting injectable formulations of HIV medications to maintain viral load suppression is closer to reality, according to Constance A. Benson, MD, Professor of Medicine and Global Public Health at University of California San Diego. She shared her assessment during a session at the 2020 Ryan White HIV/AIDS Program Clinical Conference, held online earlier this month for over 600 physicians, nurse practitioners, physician assistants, and other key clinical decision makers in HRSA’s Ryan White HIV/AIDS Program-funded clinics and programs.
What is the AHEAD Dashboard?
AHEAD is a data visualization tool created to support the efforts of local health departments towards reaching the goals of the Ending the HIV Epidemic: A Plan for America (EHE) initiative.
Who Can Use the AHEAD Dashboard?
AHEAD allows jurisdictions, community organizations, and other stakeholders to monitor progress towards meeting the goals of EHE and use data to inform national and jurisdictional action.
AHEAD graphically visualizes data and targets for jurisdictions to track their progress on the six EHE indicators:
• Knowledge of Status
• Linkage to HIV Medical Care
• Viral Suppression
• PrEP Coverage
Over the next year, AHEAD will add additional features and expanded data sets to further to encourage progress towards EHE initiative goals.
Explore the AHEAD Dashboard today and view our progress towards ending the HIV epidemic in America