The U.S. Department of Health and Human Services (HHS) has launched The HIV Challenge, a national competition to engage communities to reduce HIV-related stigma and increase prevention and treatment among racial and ethnic minority people. The HIV Challenge is part of a new partnership between the Office of the Assistant Secretary for Health (OASH) Office of Infectious Disease and HIV/AIDS Policy (OIDP) and the HHS Office of Minority Health (OMH).
Through this challenge, HHS is seeking innovative and effective approaches to increase the use of pre-exposure prophylaxis medication (PrEP) and antiretroviral therapy (ART) among people who are at increased risk for HIV or are people with HIV. The HIV Challenge is open to the public, and HHS will award a total of $760,000 to 15 winners over three phases. Phase 1 submissions are open from July 16, 2021, through September 23, 2021.
“HIV-related stigma is one of the reasons why prevention and treatment options, such as PrEP and ART, are underutilized,” said Assistant Secretary for Health, Rachel L. Levine, M.D. “The latest science shows that people living with HIV who take the proper medicine as prescribed and get and keep their HIV at an undetectable level do not transmit HIV to others.
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Long-term monitoring of people with HIV with an undetectable viral load has shown that viral suppression is rarely lost, enforcing the validity of ‘U=U’ (Undetectable equals Untransmittable) messaging, according to Italian research published in the online edition of AIDS. The study involved over 8000 HIV-positive individuals taking antiretroviral therapy (ART) and with viral suppression (a viral load below 200) at baseline. Regular monitoring of viral load (at least twice a year for most) showed that viral load remained suppressed 97% of the time.
However, some groups, including women, people who inject drugs and those with a past history of ART failing to control viral replication spent more time with a viral load above 200. The investigators suggest that people with these characteristics may need more support to maintain viral suppression.
“We found that in our population of people with HIV the ‘U’ status was maintained on average, for 97% of the following ten years of observation and the proportion of [time] spent in ‘U’ status showed a trend for an increase in recent years,” write the authors. “This data reassuringly suggests that U=U is an appropriate message to communicate to help decrease stigma and increase motivation to remain virally suppressed.”
Read the full article on aidsmap.com.
A press release from ViiV Healthcare:
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.”
Read the full press release (pdf file).
From the TheBodyPro…
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.”
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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.
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.
Read the full article on HIV.gov.
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.
Read the full article on HIV.gov.