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HIV Care in Europe
From the Conference to the Clinic: Applying New Data From EACS 2025 to HIV Care in Europe

Released: December 04, 2025

Karine Lacombe
Karine Lacombe, MD, PhD
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Key Takeaways
  • The risk of HBV reactivation with tenofovir-free ART regimens is low, but not zero.
  • Checking HBV serostatus is critical before switching to a tenofovir-free regimen, and people with chronic HBV should receive tenofovir-based ART.
  • Addressing weight gain and metabolic health in people living with HIV is not as simple as switching ART.

High Rates of HBV/HIV Coinfection in Europe
The use of oral antiretroviral dual therapies containing dolutegravir or injectable combinations of cabotegravir and rilpivirine represents a major therapeutic advance for people living with HIV. These combinations offer excellent efficacy, very good tolerance, and convenience appreciated by everyone. However, these regimens, which no longer contain tenofovir, could expose unprotected individuals to a risk of hepatitis B virus (HBV) acquisition or reactivation—a risk long overlooked since tenofovir was, until recently, the cornerstone of HIV treatment.

Indeed, due to similar transmission modes, the prevalence of HBV among people living with HIV is high. This is of particular interest to people living with HIV in Europe, as rates of HBV and HIV coinfection have reached approximately 6% in Western, Central, and Eastern Europe. This is more than 10 times higher than the median HBV prevalence among the general population globally, 0.5%. At EACS 2025, a full session was dedicated to estimating the risk of reactivation and management of acute HBV infection.

Elucidating the Risk of HBV Reactivation Without Tenofovir
The risk of HBV reactivation in patients receiving antiretroviral therapy (ART) without tenofovir was previously unknown. Initial results from the Swiss Cohort reported that among 190 patients with anti-hepatitis B core antibodies (anti-HBc) but no hepatitis B surface antigen, 5.3% had low levels (below the assay quantification limit) of detectable HBV DNA after a median of 1.3 years without major liver cytolysis.

A Spanish cohort study found that among 741 patients with isolated anti-HBc who switched to injectable cabotegravir plus rilpivirine, 4 had undiagnosed HBV infection before the switch. Of these 4, 2 experienced HBV reactivation treated with tenofovir, and 2 were switched back to tenofovir-containing therapy before acute hepatitis signs. 

To better describe the risk of HBV reactivation in patients with isolated anti-HBc, an Italian team assessed HBV DNA quantification using ultrasensitive methods. Before switching to cabotegravir plus rilpivirine, 75.8% of 66 participants showed very low–level HBV replication. Most continued to exhibit low-level replication, while two thirds of those without prior low-level replication became replicative after 48 weeks of treatment.

These findings highlight the necessity of checking HBV serostatus before switching to tenofovir-free regimens. People with chronic HBV infection should be excluded from such strategies except in therapeutic trials like the randomized Bi-Light trial in France.

Vaccination is essential for those without HBV immunity. EACS recommends vaccination for people with isolated anti-HBc, preferably with the new hepatitis B vaccine (recombinant), adjuvanted, which shows better immunogenicity.

For nonresponders to vaccination, the benefit of switching to tenofovir-free ART should be questioned, as tenofovir has proven effective for HBV "treatment as prevention." Annual HBV serology monitoring is advisable after switching, and possible HBV reactivation should be considered if transaminases suddenly increase.

What Is the Impact of ART on Weight Gain and Metabolic Health?
Another persistent concern for healthcare professionals in Europe is weight stabilization and weight loss in people who have become obese while on ART. The proportion of people with overweight/obesity is increasing rapidly in most European countries, with approximately 50% of people 16 years of age or older being overweight in 2022. Obesity significantly increases the risk of chronic diseases associated with HIV, such as cardiovascular disease and diabetes. Learning whether certain therapeutic strategies are more effective in addressing this issue is a top priority for the long-term health of people living with HIV.

First, the 96-week results of the randomized PASO-DOBLE trial in Spain were reported at EACS. To recap, 553 people with well-controlled HIV on triple therapy that included an integrase inhibitor were randomized to switch to either dolutegravir and lamivudine (DTG/3TC) or bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF). After 96 weeks of treatment, virologic efficacy was similar in both groups, as was mean adjusted change in weight, although the proportion of people with >5% weight gain was lower among those on DTG/3TC (24.1% vs 37.8%). 

The DO-IT trial randomized people living with HIV and obesity on integrase inhibitors to switch to 1 of 2 doravirine-containing regimens or continue their current therapy. After 1 year, all 3 study arms lost weight, and neither weight nor metabolic parameters improved more with doravirine-containing regimens vs integrase inhibitor–based therapy. The participants had been on integrase inhibitors for a median of 3.4 years before the switch, and it is unclear whether an earlier switch to doravirine as soon as weight gain is observed or within 1 year of starting an integrase inhibitor might be beneficial.

Finally, the phase III P052 trial evaluated a switch to a combination of doravirine and islatravir compared with continuing BIC/FTC/TAF. Here again, switching to doravirine and islatravir showed no impact on weight or other metabolic parameters compared to continuing BIC/FTC/TAF.

Overall, weight gain in people living with HIV is much more complex than a simple attribution to antiretroviral drugs, with lifestyle and genetic predisposition playing important roles. Addressing these factors will probably have a greater impact than changing ART, which risks destabilizing care for people who are benefiting from an effective and well-tolerated regimen.

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