New data on HIV-1 treatment, including Biktarvy and the new combined regimen of renacapavir, was published at Croi 2025

The Gilead Science (CROI) 2025 presentation at the conference on retrovirus and opportunistic infections was presented with a phase 2 study of twice the annual study combination of HIV and hepatitis B virus (HBV) and co-infectious diseases (HBV) with combinations of victigugravir, emtrabin, and tenophobiangin; promising results of phase 2 studies and broadly neutralizing antibodies (BNABs).¹

HIV can lead to a lifelong burden of medication compliance. | Image credit: ©Corona borealis -stock.adobe.com

Data from these presentations demonstrates ongoing research into HIV treatment and ultimately provides treatment for infected patients. It affects more than 1 million individuals in the United States alone, and HIV remains a major health burden for affected patients and their families despite major advances in pre-exposure prevention (PREP) availability and treatment options. As the existence of HIV care in a particular setting continues to evolve and expand, it is essential for pharmacists to recognize new treatments in their clinical trial pipeline.²

Bictegravir, emtricitabine, and Tenofovir alafenamide (biktarvy)

At Croi, investigators presented new data from the Alliance (NCT03547909). This is an ongoing phase 3 trial investigating victalvir and ibortegravir 50 mg (DTG) and 200 mg/tenfovir disproxyl fumarate (TDF) 300 mg. Adults who have started treatment with f/tdf; and DTG+F/TDF, HIV-1 and HBV co-infection. Approximately 5% to 15% of HIV patients also suffer from chronic HBV infection, and investigation into treatment of co-infection is important as it speeds up progression to harmful liver outcomes.^3,4

In the Open Label Expansion Phase of the Alliance, the first randomized clinical trial to assess TDF-based and TDF-based regimens in adults with treatment with HIV/HBV co-infection, the results at 48th week show that Biktarvy induced high rates of HBV (95.4%) in HIV-1 (95.4%) and HBV (86.6%) in HBV (86.6%) in HBV (95.4%). Weeks of treatment with DTG + F/TDF. During the previously performed 96-week randomised phase, the investigators showed the efficacy of both regimens in co-infected patients.^1,5

Importantly, regarding the endpoints of HBV, researchers observed normalization of alanine transaminase (ALT), a key enzyme found in the liver. This was announced to be inspired by MD, PHD, PHD, All in All in All in All in All in secluse and in secluse and eclession from All Allise in co-infectious disease patients who reported abnormal ALT levels prior to switching from DTG + F/TDF to Biktarvy, according to Anchalee Avihingsanon.⁶

“This is very important because if you switch this patient and they still have an abnormal ALT, it means they will increase. [risk] After liver inflammation, liver fibrosis, cirrhosis, and liver cancer, Avinganon described the percentage of adverse events (TEAE) that extends to treatment.⁶

Renakapaville and bnabs

Investigators also presented data from the Phase 2 Open Label Study of Lenacapavivir (LEN) (NCT05729568) using BNABS (Teropavimab). [GS-5423, TAB] and zinlirvimab [GS-2872, ZAB](LTZ) as a combination regimen that is twice as long-acting for HIV-1 patients per year. Recently, the FDA has allowed LTZ to designate breakthrough therapy. This makes the regimen ready for rapid review and prompt investigation into the possibility of FDA approval to become the first long-acting combination regimen with double dosages per year.^1,7

In a phase 2 trial, researchers looked at results when adults who were virologically suppressed switched to LTZ every six months, whereas they remained on a stable baseline antiretroviral regimen (SBR). The primary endpoints of the exam have been met. This was the proportion of patients with HIV-1 RNA above 50 copies/ml at week 26, as determined by the FDA-defined algorithm. At week 26, 96% of participants who received LTZ (n = 51/53) and 96% who received SBR (n = 26/27) remained virologically suppressed, a key indicator of efficacy. Furthermore, CD4 counts increased from baseline to 26 weeks in each cohort.¹

“From now on, I think this is a regimen that should taste very good for patients who really want long-acting therapy to alleviate the burden of having to take the medication frequently.” “Our hope is that advanced strategies can be applied to individuals struggling with daily pill adherence.”⁸

Importantly, there were no serious AEs associated with treatment with LTZ and no infusion responses associated with either of the BNABs. Ogbuagu noted that while pharmacists can play a role in patient education about what they expect regarding the injection site, they can also counsel them on ways to make the injection experience more tolerant. According to Ogbuagu, pharmacists can treat injection site responses to prescribe pain relief measures and topical treatments.^1,8

“We intend to present the data for the year in a short order. [from this trial] To demonstrate that we are inducing much longer-term efficacy and safety, and then the open label stage [will begin]Ogbuag explained.⁸

reference

1. Gilead Science. Gilead presents new HIV treatment and treatment data at CROI 2025. News release. Released on March 12th, 2025. Accessed on March 19th, 2025. https：//www.gilead.com/news/news-details/2025/gilead-presents-new-hiv-treatment-and-cure-research-data-at-croi-2025-invinving-an-investigational-long-opce-twice-twice-incting-ficting-twice-ficting-ficting-ficting-ficting-ficting-ficting-ficting-ficting-ficting-ficting-ficting-twice

2. KoS, Mathew D, Pao M, Goetz H. The role of pharmacists in HIV care continues to expand. The age of pharmacies. Released on December 21, 2023. Accessed on March 19th, 2025. https://www.pharmacytimes.com/view/the-role-of-pharmacists-in-hiv-care-continues-to-Expand

3. ClinicalTrials.gov. Safety and efficacy of naive, HIV-1, and hepatitis Bictegravir/emtrictabine/Tenofovir Alafenamide and of olutegravir + emtricitabine/Tenofovir Disoproxil fumarate in alliances, naive, HIV-1, and hepatitis B. National Library of Medicine. Updated March 19, 2024. Accessed March 19, 2025.

4. ClinicalInfohiv.gov. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV: Considerations for antiretroviral use in people with co-infectious diseases. Last updated: September 12, 2024. Accessed March 19, 2025. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-audholescent-arv/

5. AvihingsanonA, Lu H, Leong Cl et al. Bictegravir, emtricitabine, and tenofovirarafenamide, ivorteravir, emtricitabine, and tenofovir deproxyl fumarate for the initial treatment of HIV-1 and hepatitis B co-infection (alligation): double-blind, multiventricular, randomized comparison, phase 3 non-tumor trials. Lancet HIV. 2023; 10 (10): E640-E652. doi:10.1016/s2352-3018(23)00151-0

6. Interview with Anchalee Avihingsanon, MD, and PhD. The age of pharmacies. Recorded on Zoom on March 19, 2025. Accessed March 19, 2025.

7. ClinicalTrials.gov. Studies of GS-5423 and GS-2872 in combination with the capsid inhibitor lenacapavir in virologically suppressed adults with HIV-1 infection. National Library of Medicine. Last updated: January 13th, 2025. Accessed March 19, 2025. https://clinicaltrials.gov/study/NCT05729568

8. Interviews with Crazy, MBBCH, FACP, and FIDSA. The age of pharmacies. It was recorded on Zoom on March 18th, 2025. Accessed March 19, 2025.