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HIV continues to have a disproportionate impact on certain populations, particularly racial and ethnic minorities, gay and bisexual men and other men who have sex with men and transgender women, the Kaiser Family Foundation said in its report, 

The HIV/AIDS Epidemic in the United States: The Basics

Black/African American and Hispanic/Latino communities are disproportionately affected by HIV compared to other racial/ethnic groups, 

. Blacks/African Americans represented 13% of the US population, but 41% of people with HIV in 2018, while Hispanics/Latinos represented 18% of the population and 23% of people with HIV.

HIV-related mortality rates have declined significantly since 1995, KFF found. The age-adjusted HIV death rate has dropped by more than 80% since its peak and by almost 50% since 2010.

“This is largely due to ART [antiretroviral therapy], but also to decreasing HIV incidence,” KFF said.

From 2010-2018, death rates decreased by 36.6% overall, 

“Early diagnosis, prompt treatment, and maintaining access to high-quality care and treatment have been successful in reducing HIV-related deaths and remain necessary for continuing reductions in HIV-related deaths,” the Centers for Disease Control researchers wrote in 

Still, more than 5,000 people died with HIV/AIDS as the underlying cause of death in 2019, KFF said.

In addition, while HIV is not a leading cause of death for Americans overall, it remains a leading cause of death for certain age groups. In 2019, HIV was the ninth leading cause of death for those ages 25 to 34, and the tenth for those ages 35-44, KFF found.

Most (66%) newly diagnosed cases of HIV occurred through male-to-male sexual contact, according to KFF, while 4% of diagnoses occurred among gay and bisexual men with a history of injection drug use. However, diagnoses attributable to injection drug use alone have declined significantly over time and accounted for 7% of new diagnoses in 2019.

In other positive news, the number of new HIV infections declined 73% between 1984 and 2019 and 9% between 2015 and 2019. Still, 34,800 people were newly infected with HIV in the U.S. in 2019, and declines were not seen among all populations, KFF found.

While US HIV treatment guidelines recommend initiating ART as soon as patient are diagnosed with HIV, only 66% of those diagnosed receive medical care, according to the CDC, and fewer (57%) are virally suppressed, KFF said.

Articles

While HIV continues to impact certain racial and ethnic minorities, the mortality rate in the US continues to drop.

HIV Mortality Rates Drop, But Minorities Impacted More

Among the top studies presented at the 18th European AIDS Conference (EACS 2021), October 27-30 in London, is the news that Gilead’s blockbuster HIV drug Biktarvy maintained virologic suppression after one year of treatment.

Here are the top three HIV treatment result studies presented at the conference:

1.) Ninety-seven percent of treatment-naïve adults and 96% of treatment-experienced adults achieved and maintained virologic suppression after one year of treatment with Gilead’s Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), the pharma maker said in a 

In addition, Biktarvy was generally well-tolerated and no resistance to the components of Biktarvy emerged.

2.) Merck reported that islatravir combined with doravirine, its antiretroviral treatment for HIV-1, continued to maintain viral suppression through 144 weeks in Phase 2b trials.

“We are encouraged by the Week 144 findings presented at EACS, which further support the potential of a two-drug doravirine/islatravir regimen for the treatment of HIV-1,” said Dr. Joan Butterton, vice president of Global Clinical Development, Infectious diseases at Merck Research Laboratories, in a 

 initial data from two Phase 3 clinical trials evaluating doravirine/islatravir in virologically suppressed adults with HIV-1 switching from a stable antiretroviral regimen.

3.) Implementation of the long-acting ViiV Healthcare’s Vocabria (cabotegravir injection) and Janssen’s Rekambys (rilpivirine long-acting injectable suspension) HIV regimen is “realistic and achievable in a variety of European healthcare settings,” Viiv said in a 

The study, initiated and conducted during the COVID-19 pandemic, evaluated perspectives of healthcare teams and people living with HIV.

The majority of healthcare teams across Europe agreed or completely agreed that long-acting cabotegravir and rilpivirine was acceptable, appropriate and feasible to implement, ViiV said. People living with HIV on the trial were also receptive to the regimen, with 97% feeling it was acceptable to come to clinic for an injection visit every two months.

Despite some initial concerns around implementing long-acting cabotegravir and rilpivirine, the CARISEL study interim findings showed that healthcare teams and people living with HIV continued to feel positive about the regimen as the study progressed,” said Dr. Laurence Slama, CARISEL investigator with Hôtel Dieu Hospital, Paris.

Among the top studies presented at the 18th European AIDS Conference in London is the news that Gilead’s blockbuster HIV drug Biktarvy maintained virologic suppression after one year of treatment.

Top 3 HIV Treatment Findings from European AIDS Conference 

The prescribing of generic drugs and biosimilars that are less expensive than their brand-name counterparts saved U.S. healthcare system almost $340 billion in spending in 2020 according to the Association for Accessible Medicines (AAM), a trade association for generic and biosimilar makers.

The AAM said that biosimilar drugs saved $7.9 billion in 2020, more than tripling the $2.5 billion saved in 2019. “This growth demonstrates prescriber and payer confidence in the safety and efficacy of FDA-approved biosimilars and their ability to provide greater access to treatments at a savings for patients,” Christine Simmon, executive vice president of policy and strategic alliances at AAM and executive director of the organization’s Biosimilars Council, told 

However, biosimilars were still less than 30% volume share in markets where they competed, Simmon noted. “As more biosimilars are approved and brought to market, patients and taxpayers will save billions while treating serious illnesses like cancer and Crohn’s disease,” she predicted.

The full promise of savings through biosimilar competition will only be realized if policymakers take steps to foster greater biosimilar adoption, Simmon added.

For example, the BIOSIM Act (H.R. 2815) would make changes to reimbursement to incentivize the use of biosimilars, Simmon told 

. “Currently, providers in Medicare Part B are reimbursed for administering biosimilars at the biosimilar’s average sales price (ASP), plus 6% of the brand-name biologic. The BIOSIM Act…would increase reimbursement for biosimilars by 2% to ASP+8% and would apply only when the biosimilar’s ASP is lower than the brand-name biologic’s ASP.”

The Increasing Access to Biosimilars Act (S. 1427/H.R. 2869), which directs the CMS to establish a voluntary, national demonstration project under Medicare Part B to evaluate the benefit of providing a shared savings payment for biosimilars, could also incentivize the use of biosimilars.

“Under this model, participating providers would receive a portion of the savings for prescribing a biosimilar with a lower ASP than the reference biologic,” Simmon said.

Meanwhile, the Ensuring Access to Lower-Cost Medicines for Seniors Act (H.R. 2846) would ensure that seniors are able to access and fully benefit from low-cost generics and biosimilars through the Medicare Part D program. “This bill…ensures that new generics and biosimilars are covered upon launch, provides that generics are placed only on generic tiers with lower cost-sharing and not higher brand cost-sharing tiers, and establishes a new specialty tier for biosimilars and specialty generics,” Simmon added.

Generic drug produced significant out-of-pocket savings for individual patients at the pharmacy counter, according to AAM. Almost all (93%) of generic drugs have copays under $20 (as compared to 51% of brand-name drugs) and the average generic copay is $6.61 compared to an average out-of-pocket cost of $55.82 for brand-name drugs, the trade group says.

Medicare recorded $109.6 billion in generic and biosimilar savings in 2020, while Medicaid saved $53.8 billion.

Three pieces of legislation that would provide incentives to prescribers and put generics and biosimilars in favorable formulary tiers would speed further prescribing and use of biosimilars, Christine Simmon told Managed Healthcare Executive.®

Biosimilar Growth Impressive But New Policies Needed, AAM Exec Says

More than half of advanced liver disease patients have had procedures canceled due to the COVID-19 pandemic, according to a 

The British Liver Trust survey of 121 patients found 54.6% of those with advanced liver disease have experienced cancellations.

“We know from speaking to patients on our nurse-led helpline and support groups that a wide variety of procedures have been delayed or cancelled, from routine scans, check-ups, blood tests, procedures such as liver biopsies, and cancer treatments,” Vanessa Hebditch, director of policy and communications at BLT, told 

For some patients, the delays and cancellations led to a deterioration in their condition. 

“We are very concerned. Liver disease is a public health emergency,” Hebditch said.

There are often very few symptoms in the early stages of liver disease, so people are usually diagnosed at a late stage when it’s too late for treatment, Hebditch explained. 

“Delays to diagnosis and treatment will lead to more people needing a liver transplant and, sadly, more liver disease deaths,” she added.

Procedure cancellations and delays have been caused by numerous factors, including a redeployment of nurses and doctors to other departments and a lower number of donor livers available for transplant, according to Hebditch. Additionally, there are concerns about the risks of treating people with liver disease in a face-to-face environment since many of them are extremely clinically vulnerable to COVID-19.

It will take some time before services return to pre-COVID levels and the backlog of treatments, scans and surveillance is addressed, Hebditch added. 

“There is currently a huge focus on cancer patients, which is absolutely right but we must ensure that other disease such as liver disease are not forgotten,” she said.

The survey also found 51% of advanced liver disease patients have been told they may require a liver transplant in the future. While some patients had their liver transplant delayed during the peak of the pandemic, transplant services have now returned to normal, according to Hebditch.

Half of patients surveyed also said they had to take time off work for liver-related hospital appointments, and 40% of respondents noted they have to travel more than 25 miles to their liver center/hospital for routine appointments.

Many liver disease patients also have to travel to hospitals for platelet transfusions and there are now new treatments that can be given orally, avoiding the need for a transfusion and an overnight stay, according to Hebditch.

“We also hope that one positive outcome from COVID-19 will be improved telemedicine and virtual appointments,” she said.

More than half of advanced liver disease patients have had procedures canceled due to the COVID-19 pandemic, according to a recent survey.


COVID-19 Cancels Liver Disease Patients’ Procedures

The U.S. healthcare system saved $338 billion in 2020 because of the prescribing of generic drugs and biosimilars that are less expensive than their brand-name counterparts, according to the Association for Accessible Medicines (AAM), a trade association for generic and biosimilar makers.

In a preview of its full-fledged report generic and biosimilar savings, the AAM said that biosimilar drugs saved $7.9 billion in 2020, more than tripling the $2.5 billion saved in 2019.

The biosimilar drug market continued to grow in 2020, with three new FDA approvals and six new product launches.

Americas patients deserve access to lifesaving medicines at more affordable prices, and biosimilars are making new access to care available for patients,” said Christine Simmon, executive director of the Biosimilars Council, which is part of the AAM. "Yet biosimilars were still less than 30% volume share in markets where they competed. As more biosimilars are approved and brought to market, patients and taxpayers will save billions while treating serious illnesses like cancer and Crohns disease.”

The AAM says the introduction of oncology biosimilarshas cut the growth rate of oncology spending roughly in half since 2019. “This reduction in growth, along with continued use of generic cancer medicines, contributed to a total of $18 billion saved on oncology medicines in 2020,” AAM said in a news release.

The generic drug industry is absolutely central to the affordability of health care in America, accounting for 9 out of 10 prescriptions,” said Dan Leonard, president and CEO of the AAM in the press release. “In the face of a pandemic that has upended life around the globe, generic and biosimilar medicines have been a constant, providing safe, effective and affordable treatments to the millions of patients who depend on them.”

The Association for Accessible Medicines said biosimilar drugs saved $7.9 billion in 2020, more than tripling the $2.5 billion saved in 2019.

U.S. Saved $338 Billion via Biosimilars and Generics

A drug used to treat advanced breast cancer may offer a new treatment option for 

, a rare blood cancer, according to a new study. The research was done in a mouse model, so the finding is preliminary and useful for guiding research, not treatment decisions.

The medication, Ibrance (palbociclib) may be able to prevent the scarring of bone marrow that existing treatments for myelofibrosis cannot, according to the study published in 

. The scarring disrupts the marrow’s production of blood cells and causes severe anemia that leaves patients weak and fatigued, and often makes blood clotting difficult, leading to an enlarged spleen, University of Virginia Health said in a 

Myelofibrosis occurs in approximately 1 to 1.5 of every 100,000 people, primarily those who are middle-aged or older. Patients with intermediate or high-risk cases typically survive only 16 to 35 months.

While Jakafi (ruxolitinib) is used to relieve patients’ symptoms, it does not offer significant reduction in bone marrow fibrosis and often loses its effectiveness with prolonged use, the researchers wrote. The new research suggests that pairing the drug with Ibrance may make for a superior treatment, UVA said.

“Current therapies only provide symptomatic relief without offering significant improvement of bone marrow fibrosis. So, there is a critical need to develop more effective therapy for myelofibrosis,” said Golam Mohi, Ph.D., the senior author of the study in the 

 and a researcher in the Department of Biochemistry and Molecular Genetics in UVA’s School of Medicine.

To that end, Mohi and other researchers identified CDK6, a regulator of cell cycle, as a new therapeutic target in myelofibrosis. “We demonstrate that CDK4/6 inhibitor palbociclib (Ibrance) in combination with ruxolitinib (Jakafi) markedly inhibits myelofibrosis, suggesting this drug combination could be an effective therapeutic strategy against this devastating blood disorder,” he said in the press release.

Ibrance, dampens the activity of bone marrow in patients with metastatic breast cancer, reduced bone marrow scarring in two different mouse models of myelofibrosis. It also decreased the abnormally high levels of white blood cells seen in myelofibrosis and shrank the mice’s enlarged spleens.

Combining the drug with Jakafi produced a number of positive outcomes, the researchers said. The combination restored the bone marrow and white blood cell counts to normal and dramatically reducing the size of the mice’s enlarged spleens.

The study results suggest support the clinical investigation of the palbociclib and ruxolitinib combination in patients with myelofibrosis, Mohi told 

®. “We are working with hematologists and oncologists at UVA Cancer Center to submit a proposal for clinical trial of this drug combination in myelofibrosis patients,” he said.

An Ibrance-Jakafi combination shows promise in a mouse model of myelofibrosis.