Notable HIV and HBV Treatment Advancements Unveiled at CROI 2025
Table of Contents
New research presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025 reveals notable progress in treating HIV and hepatitis B virus (HBV). Data from the ALLIANCE trial showed that bictegravir, emtricitabine, and tenofovir alafenamide (BIC FTC TAF; Biktarvy) maintained high suppression rates for both HIV (95.4%) and HBV (86.6%) in 89 patients who switched from a different treatment regimen. Studies also highlighted the potential of lenacapavir, teropavimab, and zinlirvimab (LTZ) as a long-acting HIV therapy, and vesatolimod in HIV cure research, offering renewed hope for co-infected individuals.
Biktarvy’s Continued Efficacy in HIV/HBV Co-infection
The ALLIANCE trial (NCT03547908) evaluated the effectiveness of Biktarvy compared too dolutegravir, emtricitabine, and tenofovir disoproxil fumarate (DTG + F/TDF) in treating patients co-infected with HIV and HBV. Patients received either Biktarvy or DTG + F/TDF once daily over a 96-week period. An open-label extension allowed individuals to continue their blinded drug regimen for up to 48 weeks, providing extended observation of the treatment’s effects.
The primary outcomes focused on the percentage of individuals achieving an HIV RNA level of less than 50 copies/mL and a plasma HBV DNA level of less than 20 IU/mL at week 48, according to clinical trial data. Secondary outcomes assessed the percentage changes in thes primary endpoints at 96 weeks, offering a longer-term view of treatment efficacy.
Previous data from the ALLIANCE trial had already established the non-inferiority of Biktarvy, with 95% of patients on Biktarvy and 91% on DTG + F/TDF meeting the HIV endpoint, and 63% and 43%, respectively, meeting the HBV endpoint. The study authors noted that treatment-related adverse events (AEs) were similar between the groups, with 29% reported for Biktarvy and 28% for DTG + F/TDF. Notably, only one patient in the Biktarvy group reported a serious AE related to the treatment.
The latest analysis revealed that 19% of individuals reported AEs, which were generally mild to moderate in severity and did not lead to any discontinuations. The most commonly reported AEs included weight gain (9%) and an increase in low-density lipoprotein cholesterol (3%). These findings underscore Biktarvy’s tolerability and safety profile in co-infected patients.
Lenacapavir,Teropavimab,and zinlirvimab (LTZ): A Promising Long-Acting HIV Therapy
Gilead also presented primary results from a phase 2 study evaluating the investigational combination of lenacapavir,teropavimab,and zinlirvimab (LTZ). These results confirmed earlier phase 1b findings, demonstrating that 90% of patients who completed the study regimen maintained virological suppression at week 26. Importantly, no serious adverse events were observed, and no AEs led to treatment discontinuation.
The phase 2 study (NCT05729568) aimed to determine the effectiveness,safety,and tolerability of LTZ for virological suppression in adults with HIV. LTZ was compared with oral antiretroviral therapy (ART), according to the clinical trial data. the primary outcome was the proportion of individuals with HIV RNA of 50 copies/mL or more at week 26. Secondary outcomes included the proportion of patients with HIV RNA of 50 copies/mL or more at 52 weeks, the proportion of patients with RNA less than 50 copies/mL at weeks 26 and 52, and the proportion of individuals experiencing treatment-emergent AEs.
At 26 weeks, 96% of individuals receiving LTZ and 96% receiving ART remained virologically suppressed. CD4 cell counts also increased in both groups at week 26. The most common AEs were injection site reactions related to management,and no serious adverse events related to LTZ were reported. This suggests that LTZ could offer a less frequent dosing option without compromising efficacy or safety.
Vesatolimod: Exploring a potential HIV Cure
Along with treatment advancements, the company presented results from a phase 2a trial (NCT05281510) focusing on efforts to discover a cure for HIV. The investigational TLR7 agonist, vesatolimod, was found to be well-tolerated, with no treatment-related serious AEs. The most common AEs were infusion-related reactions. While still in early stages, this research represents a significant step toward finding a functional cure for HIV.
HIV/HBV Treatment Breakthroughs: A Conversation with Dr. anya Sharma
Is a functional cure for HIV closer than ever before? The recent CROI 2025 findings suggest this might be the case, presenting promising new treatment avenues for HIV and HBV co-infection.
Interviewer: Dr. Sharma, welcome. the recent Conference on Retroviruses and Opportunistic Infections (CROI) showcased groundbreaking research on HIV and Hepatitis B virus (HBV) treatment. Let’s start with Biktarvy’s performance in the ALLIANCE trial.What are the key takeaways regarding its efficacy in HIV/HBV co-infected patients?
Dr. Sharma: The ALLIANCE trial data on Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) is indeed encouraging. The study’s primary goal was to assess Biktarvy’s effectiveness compared to another standard regimen in suppressing both HIV and HBV in co-infected individuals. The results demonstrated high rates of viral suppression for both viruses, confirming its potential as a robust treatment option for this patient population. Key takeaways include the sustained high—above 90%—viral suppression rates for HIV, highlighting its long term effectiveness and manageable side effects. This underlines Biktarvy’s ability to provide durable control of both viral infections concurrently. The relatively low incidence and mild nature of adverse events reported further support its safety profile.
Interviewer: The study also featured long-acting therapies. Could you elaborate on the promising results from the Lenacapavir, Teropavimab, and Zinlirvimab (LTZ) combination for HIV?
Dr. Sharma: The phase 2 study on LTZ showed remarkable results. This long-acting injectable combination aims to simplify HIV treatment regimens, reducing the frequency of medication management.The high rates of virological suppression observed—near 96%—in these trials signify a paradigm shift in HIV management. The absence of serious adverse events is notably significant since adherence to daily oral medication remains a significant barrier for many. this long-acting approach addresses this concern, leading to an improvement in patient compliance and potentially better long-term outcomes. The reduction in pill burden also addresses issues of medication fatigue and potentially improves quality of life for patients.the combination is currently under investigation and requires further trials to confirm its long-term safety and effectiveness in a broader population. Such long-acting antiretroviral therapies (LAART) are reshaping how we approach HIV treatment.
Interviewer: The exploration of vesatolimod in HIV cure research is captivating. what is the significance of this research, and what challenges remain in the pursuit of an HIV cure?
Dr.Sharma: Vesatolimod, a TLR7 agonist, represents a novel approach to tackling HIV. The focus here shifts from long-term viral suppression to the actual eradication of the virus from the body – a functional cure. The phase 2a trial’s positive results regarding tolerability are encouraging. However, achieving an HIV cure remains a complex challenge. The virus’s ability to integrate its genetic material into the host’s DNA necessitates targeting latent viral reservoirs. This means that while vesatolimod might show promise in certain aspects, a multi-pronged strategy remains essential as we continue in this research space. Further research into various approaches, including gene editing and immune-based therapies, is required to overcome the challenges of latency and achieve a lasting cure.
Interviewer: Dr.Sharma, thank you for your insightful contributions. What key strategies should individuals co-infected with HIV and HBV consider for optimal management of their conditions?
Dr.Sharma: Individuals co-infected with HIV and HBV must prioritize regular monitoring of their viral loads and CD4 counts.Adherence to prescribed medication regimens – weather oral or injectable – is critical. Moreover, lifestyle modifications such as a balanced diet, exercise, and stress management play a crucial role in overall health and well-being. Regular consultations with healthcare professionals ensure timely adjustments to treatment plans as needed and provide consistent support.
Interviewer: Thank you, Dr. Sharma. This has been highly informative. Readers, please share your thoughts and questions in the comments section below. Let’s continue the conversation on social media using #HIVTreatmentBreakthroughs and #hbvresearch.
HIV/HBV Treatment Revolution: A Hopeful Outlook with Dr. Anya Sharma
Is a functional cure for HIV finally within reach? Recent breakthroughs suggest we may be closer than ever to eradicating this devastating virus.
Interviewer: Dr.Sharma, welcome. The recent Conference on Retroviruses and Opportunistic Infections (CROI) highlighted groundbreaking advancements in HIV and Hepatitis B virus (HBV) treatment. Let’s begin with Biktarvy’s performance in the ALLIANCE trial. what are the key takeaways regarding its efficacy in HIV/HBV co-infected patients?
Dr. Sharma: The ALLIANCE trial data on Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) offers important promise. The primary objective was to evaluate Biktarvy’s effectiveness against a standard regimen in suppressing both HIV and HBV in co-infected individuals. The results demonstrated remarkably high rates of viral suppression for both viruses, solidifying its position as a robust treatment option for this challenging patient population. Key takeaways include the impressively sustained, above 90%, viral suppression rates for HIV, showcasing its long-term effectiveness and favorable side effect profile. This underscores Biktarvy’s ability to durably control both viral infections simultaneously. The low incidence and mild nature of reported adverse events further reinforce its strong safety profile. Biktarvy’s success in managing HIV/HBV co-infection showcases a significant advancement in combination antiretroviral therapy (cART).
Interviewer: The conference also featured long-acting therapies. Can you elaborate on the encouraging results from the Lenacapavir, Teropavimab, and Zinlirvimab (LTZ) combination for HIV?
Dr. Sharma: The phase 2 study on LTZ presented truly remarkable results. This long-acting injectable combination represents a paradigm shift in HIV management, aiming to simplify treatment regimens and reduce the frequency of medication administration. The exceptionally high rates of virological suppression observed—near 96%—in these trials highlight a significant leap forward. The absence of serious adverse events is particularly noteworthy, as adherence to daily oral medication remains a substantial barrier for many patients. This long-acting approach directly addresses this challenge, potentially leading to improved patient compliance and, consequently, better long-term outcomes. The reduced pill burden also directly mitigates medication fatigue and improves patients’ overall quality of life. While this combination therapy holds immense potential, further trials are needed to confirm its long-term safety and effectiveness across broader populations.Long-acting antiretroviral therapies (LAART) are revolutionizing how we approach HIV treatment, offering a new era of convenience and potentially improved treatment adherence.
Interviewer: The exploration of vesatolimod in HIV cure research is fascinating. What is the significance of this research, and what obstacles remain in the quest for an HIV cure?
dr. sharma: Vesatolimod, a TLR7 agonist, represents a groundbreaking approach to HIV. The focus shifts from long-term viral suppression to the potential eradication of the virus—a functional cure. The phase 2a trial’s positive tolerability results are exceptionally encouraging.However, achieving an HIV cure remains an extraordinarily complex undertaking. The virus’s ability to integrate into the host’s DNA necessitates targeting latent viral reservoirs—a significant hurdle. While vesatolimod shows promise, a multi-pronged strategy is essential. We need a comprehensive approach involving various strategies—gene editing, immune-based therapies, and others—to overcome the challenges of viral latency and achieve a lasting cure.
Interviewer: Dr. Sharma, thank you for your insightful contributions.What key strategies should individuals co-infected with HIV and HBV prioritize for optimal management of their conditions?
Dr. Sharma: Individuals co-infected with HIV and HBV must prioritize regular monitoring of their viral loads and CD4 counts.Strict adherence to prescribed medication regimens, whether oral or injectable, is absolutely critical. Furthermore, lifestyle modifications—a balanced diet, regular exercise, and stress management—contribute considerably to overall health and well-being.Consistent consultations with healthcare professionals ensure timely adjustments to treatment plans and provide ongoing support.This holistic approach is essential for accomplished long-term management of these conditions.
Interviewer: Thank you, dr. sharma. This has been incredibly informative.Readers,please share your thoughts and questions in the comments section below.let’s continue this significant conversation on social media using #HIVTreatmentBreakthroughs and #HBVResearch.