The Trump administration has revised the terms of a pilot effort that allows some drugmakers to offer rebates to certain hospitals and clinics for purchased medicines, a controversial move that may transform a key tenet of a federal drug discount program.

The anticipated pilot for the 340B Drug Pricing Program, which is slated to go into effect on Jan. 1, 2027, will allow pharmaceutical companies to provide “timely” rebates, rather than offering upfront discounts. The program targets specific drugs and pharmaceutical companies that are involved in the first two rounds of the Medicare Drug Price Negotiation Program.

“This revised pilot helps modernize program oversight by improving visibility into 340B transactions while helping preserve the program’s long-term sustainability for the patients and communities it was created to serve,” said Tom Engels, who heads the Health Resources and Services Administration, the government agency that oversees the program, in a statement.

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HIV infection remains a major global public health issue. In 2025, an estimated 40.9 million people were living with HIV, and approximately 1.2 million people acquired new HIV infections. In 2025, around 570,000 people died from AIDS-related illnesses worldwide.

Gut-associated lymphoid tissue is an early target of HIV. The virus severely damages the immune and epithelial cells in the gut’s lining, leading to an inflamed, leaky gut, a weakened defense system, and decreased nutrient absorption. The virus also disrupts mitochondrial function.

Even with strict adherence to antiretroviral therapy (ART), many people living with HIV have persistent gut inflammation caused by the virus. Previous research has suggested the bacterium Lactiplantibacillus plantarum—a common lactic acid bacterium found in the human gut, over-the-counter probiotics, and fermented foods—could quickly heal the chronically inflamed leaky gut associated with HIV.

Now, researchers have identified the metabolite that repairs gut damage caused by HIV infection and significantly improves the effectiveness of ART in the nonhuman primate model of HIV/AIDS.

The findings were published in Nature Microbiology in the paper, “Microbiota-derived 10-hydroxystearic acid activates PPARα to restore gut epithelial barrier integrity and enhance anti-retroviral therapy.”

“Current HIV therapies are remarkably effective at controlling viral replication, but they do not fully repair the profound damage HIV causes in the gut,” said Satya Dandekar, PhD, professor in the Department of Medical Microbiology and Immunology at UC Davis Health. “Our findings suggest that restoring the gut’s structural and immune health can enhance antiretroviral treatment and opens an entirely new avenue for achieving more durable control of HIV.”

For this study, the researchers identified metabolites produced by L. plantarum in the virally inflamed gut environment in the non-human primate model of HIV/AIDS. Among the hundreds of molecules created by L. plantarum, one metabolite, 10-hydroxystearic acid (10-HSA), emerged as the strongest candidate for repairing the gut barrier and reducing inflammation.

Using X-ray crystallography showed that 10-HSA directly binds to PPAR-alpha, a nuclear receptor that regulates key biological processes. This binding promoted inducing lipid metabolism, mitochondrial regeneration and subsequent epigenetic histone crotonylation, thereby promoting gut epithelial renewal.

The team also conducted two independent studies at the UC Davis National Biomedical Research Institute in non-human primates infected with simian immunodeficiency virus (SIV). The first study evaluated 10-HSA without ART, which led to intestinal repair, improved key markers of gut function, improved mitochondrial health, reduced inflammatory signaling and partially restored the gut microbiota.

When 10-HSA was given in combination with ART, the combined treatment showed faster clearance of viral burden than ART alone. The combination also promoted faster recovery of gut immune cells, reduced immune activation, restored epithelial barrier integrity and restored beneficial gut microbiota and microbial diversity.

“The findings suggest repairing the tissue damage caused by HIV may be as important as suppressing the virus itself with antiretroviral therapy,” said Dylan Kramer, PhD, a recent graduate from the Dandekar Lab. “By rebuilding the gut barrier, restoring mitochondrial function and reducing inflammation, 10-HSA helps create conditions that support stronger immune recovery and more effective antiviral therapy for HIV.”

The authors caution that the results are from preclinical models. The studies showed no adverse effects. The research supports testing the safety and effectiveness of 10-HSA in humans.

“Our research shows that host health, microbial health and viral control are deeply interconnected,” Dandekar said. She noted that treating the damaged gut ecosystem facilitates recovery of the immune system, leading to regained functions that have been lost during HIV infection. Additionally, treating the damaged gut during HIV infection can improve outcomes beyond what antiviral drugs can achieve alone.

“The restoration of gut barrier integrity and microbial balance through 10-HSA supplementation may represent a promising therapeutic strategy, with implications that extend beyond HIV to other chronic inflammatory diseases of the gastrointestinal tract,” Dandekar said.

The post Microbiota-Derived Metabolite Enhances HIV Therapy in Monkeys appeared first on GEN – Genetic Engineering and Biotechnology News.

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