Recommendation to Use Dolutegravir-Based Regimens for First- and Second-Line ART

The South African National Department of Health has updated their HIV regimen recommendations for patients aged older than 10 years and more than 35 kg.

Regardless of viral load (VL) patients over the age of 10 years and >35 kg who are taking enofovir/emtricitabine or lamivudine/efavirenz (TEE/TLE) to manage HIV can now be switched to tenofovir/lamivudine/dolutegravir (TLD) regimens, according to a new recommendation from the Southern African HIV Clinicians Society.

For adults, the new recommendation includes switching patients to TLD from a first-line regimen containing an NNRTI (either EFV or NVP), the authors noted. This was true regardless of suppressed or unsuppressed VL or regardless of whether there is a recent VL result, they noted. Additionally, patients who were formerly on a regimen of EFV or NVP and were interrupted, they can be restarted on a TLD.

The guidelines also recommend that adults can switch to a DTG from a second-line boosted PI-containing regimen if they are patients have had any 2 NRTIs + LPV/r or ATV/r who have a VL <50 copies/mL in the last 6 months can switch to TLD. Patients should continue to be managed per the current guidelines, the recommendation states, if they are on LPV/r or ATV/r-based regimens with a VL >50 copies/mL.

For children, the guidelines categorize treatment recommendations into 3 categories. First, children aged greater than 10 years and who weigh > 35 kg can be treated as adults. The guidelines also suggest that adolescent patients who are transitioning from ABC-based first-line regimens can be moved to TLD, regardless of VL.

All children who weigh between 20 and 35 kg and who are on ABC/ 3TC/ EFV who have VL <50 copies/mL in the last 6 months can switch to ABC/ 3TC/ DTG, the guidelines suggest. Patients in this weight class on ABC/ 3TC/ EFV who have VL >50 copies/mL for whom a regimen switch is necessary, should switch to AZT/ 3TC/ DTG with repeat VL at 3 months. Additionally, patients who are on ABC/3TC plus LPV/r or ATV/r with a VL <50 copies/mL in the last 6 can switch can switch to ABC/3TC/DTG, the guidelines said. Finally, patients should continue to be managed per standard South African National Department of Health guidelines if they are on LPV/r or ATV/r-based regimens with a VL >50 copies/mL in the previous 6 months.

And for children who weigh less than 20 kg are not currently eligible for DTG 50 mg tablets, unless recommended by an expert opinion, according to the guidelines.

If patients switch to DTG and continue with an unsuppressed VL, they should be considered for additional support, the recommendation continued. This additional care would be to identify any potential causes for this increased VL such as drug-drug interactions or poor drug absorption, they said.

All of these recommendations have been made with the assumption that there are no contraindications to DTG or TLD, the guidelines noted. The authors also noted that “first-line” and “second-line” terminology will becoming increasingly confusing, a topic that the WHO is currently addressing. But during this period, the authors noted, this terminology will continue to be the standard.

“Since this recommendation was first made, evidence from several trials (NADIA, VISEND and ARTIST) has been published or presented, that demonstrates that tenofovir with lamivudine can be safely and effectively recycled from a first- to a second-line regimen,” the authors wrote.