IAS 2025: Switching to dual ART after durable suppression on triple-drug ART in West and Central Africa

27 July 2025. Related: Conference reports, Antiretrovirals, Treatment strategies.

Simon Collins, HIV i-Base

An oral abstract presented at IAS 2025 reported non-inferiority at 96 weeks after switching to two different dual therapy ART compared to remaining on three-drug combinations in Côte d’Ivoire, Burkina Faso and Cameroon. [1]

Results of the French ANRS-sponsored MODERATO study were presented by Fatoumata Fadiga from the Programme PAC-CI-PRISME, Abidjan, Côte d’Ivoire.

From November 2020 to February 2023, the study randomised 480 adults to switch to either dolutegravir/3TC (n=160) or atazanavir/r/3TC (n=160) or to remain on TDF/3TC/efavirenz (n=149) or TDF/3TC/dolutegravir (n=11).

Important entry criteria included no history of viral failure, hepatitis B AgHbs negative and CD4 cell count >200 cells/mm³. The primary endpoint was viral suppression at week 96 using the FDA Snapshot approach with a 10% non-inferiority margin.

Baseline characteristics included 79% women, median age 50 years (range: 23 to 75) and approximate median CD4 of 800 (IQR: 500 to 900; range 200 to 2100). Overall, 44/618 people screened were excluded due to positive HBV status. Participants had been on ART for a median 9 years (IQR: 5 to 12; range 2 to 20).

At week 96, viral load was <50 copies/mL in 95% (304/320) vs 96.9 % (155/160) in the combined dual vs triple ART arms: adj diff –1.9% (95% CI: ­–5.5% to +1.7%), with viral failure reported in 10 (3.1%) vs 5 (3.1%) participants, respectively, and the difference driven mainly by missing data (n=6 vs 0).

There were no differences in grade 3/4 adverse events reported in 39 (12%) vs 15 (9%), respectively (p=0.36) or in CD4 changes (+70 vs +65, p=0.84). Results were also similar for both dual ART combinations but with 6 cases of hyperbilirubinaemia with ATZ and 7 cases of diabetes with dolutegravir (3 incidents).

However, adjusted median weight gain was significantly higher after switching to the DTG/3TC arm: +3.7 kg vs 0.55 kg on TLE (p<0.001). This is largely likely explained by switching away from EFV and TDF, as similar weight gains (though numerically low) in the ATZ/3TC arm.

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The baseline characteristics show this was a highly adherent population, with high CD4 counts and a long history of viral suppression on ART (>75% were <20 copies/mL), likely also diagnosed in early infection.

Although the study concluded that this supports the use of dual ART in sub-Saharan African countries, these results might only reflect a minority population in other settings, especially if access to CD4, viral load and HBV monitoring are more limited.

The most significant benefit is perhaps reassurance for people who are not able to take TDF that switching to dual ART will be okay. However, there were no benefits in terms of side effects, CD4 response or likely drug cost. Dual ART might even be more expensive given current low use and the economies of scale that have brought the annual price for TLD to less than US$45 in low-income countries.

Drug costs play a much lower proportion of overall care in low- compared to high-income countries. Last year at IAS a similar study vastly – and smugly – suggested inflated potential savings. [2]

However, it is important that dual ART with DTG/3TC is also now included as an option in the recently updated WHO guidelines. [3]

References

1. Fadiga F et al. First experience of dual antiretroviral maintenance regimen in West and Central Africa compared with continuing 3-drug current antiretroviral regimens (CARs): week 96 results from the MODERATO trial (ANRS -MIE 12372). AIDS 2025, 13-17 July 2025, Kigali. Oral abstract OAB0103.
   https://programme.ias2025.org/Abstract/Abstract/?abstractid=5282
   https://conference.ias2025.org/media-1144-art-strategies (webinar, with login)
2. Blick G. No confirmed virological failures (CVF) for 144 weeks when switching 2-/3-/4-drug ART to DTG/3TC in heavily treatment-experienced PLWHA with prior M184V/I and virological failures (VF) in the prospective SOLAR-3D study. IAS 2024 study. Co-chair choice. Berlin. Oral late-breaker abstract SS0403LB.
   https://programme.aids2024.org/Abstract/Abstract/?abstractid=11958
3. WHO. Overview of WHO recommendations on HIV and sexually transmitted infection testing, prevention, treatment, care and service delivery. (14 July 2025).
   https://www.who.int/publications/i/item/B09471-eng