JULUCA▼

Why investigate DTG/RPV as a 2-drug regimen?

• The requirement for life-long ART for HIV infection has highlighted a need to minimise cumulative drug exposure[5-7]
• The potency, safety, and resistance barrier of DTG makes it an ideal core agent for 2DR[3], [8]
• The safety, tolerability, and efficacy of RPV make it an optimal partner[9]
• The SWORD-1 & -2 studies evaluated whether a 2DR of DTG + RPV once daily was as effective as a traditional 3 or 4 drug regimen for the maintenance of virologic suppression[1]

Study Design[1], [5]

*8% non-inferiority margin for pooled data. 10% non-inferiority margin for individual studies

Inclusion Criteria[1], [5],

*2NRTIs + NNRTI; 2NRTIs + INI; 2 NRTIs + PI

Patient Demographics[1], [5]

Data pooled across SWORD-1 and -2

Primary Endpoint Result

JULUCA—95% of Patients Maintained Virological Suppression[1]

Snapshot virological outcomes at Week 48 (pooled)

Non-inferiority was demonstrated in the pooled and individual analyses[1]

*Adjusted for age and baseline 3rd agent.

JULUCA—High Barrier to Resistance up to 48 Weeks

For patients switched to JULUCA, there was no increased risk of virological failure vs continued 3-drug regimen (<1% vs 1%, respectively)[1]

• One NNRTI mutation was identified (K101K/E) in a subject with documented poor/non-adherence; however, the virus remained susceptible to RPV[1]

One Subject with an Identified NNRTI Mutation After Poor/Non-Adherence Resuppressed on DTG + RPV at Week 45

• 41-year-old female participant randomised to DTG + RPV[5]
• Viral load history: pre-treatment >2 million copies/mL; at EVF/TDF/FTC initiation 968,000 copies/mL[5]
• Documented poor/non-adherence leading up to Week 36[5]

Virologic Withdrawals[1], [5],

• One subject on DTG + RPV meeting virologic withdrawal criteria had identified an NNRTI resistance–associated mutation (K101K/E)
• No INI resistance–associated mutations were identified

*Data pooled across SWORD-1 and SWORD-2.
**Confirmed virologic withdrawals – Current “retest” HIV-1 RNA ≥200 c/mL, prior ≥50 c/mL.

Adverse Events

No new safety signals were identified for DTG + RPV

• Patients switched to JULUCA had a median time on ART of 4.25 years[1]
• 87% of subjects were new to both DTG and RPV[5]

Adverse events (AEs) with onset through Week 52 (pooled)[6]

To learn more in relation to the safety and tolerability of JULUCA click here

*Two deaths in the study, both unrelated to study drug. DTG + RPV: Kaposi's sarcoma (n=1), continued 3-drug regimen: lung cancer (n=1).

Bone Markers

JULUCA—Significant Recovery in Bone Mineral Density (Dexa Sub-Study)[5]

• 1.29% and 1.32% improvement in hip and lumbar spine bone mineral density (BMD), respectively, compared with those continuing on TDF-based regimens[5]
• Significant decrease in all measured markers of bone turnover, compared with those continuing on TDF-based regimens[5]

Switching to JULUCA provides a robust option for maintaining virological suppression while preserving bone health.

Bone Health & HIV

Effect of DTG + RPV on Bone Mineral Density in SWORD Studies

JULUCA—Maintains Lipid Levels

Despite the majority of patients switching away from TDF-based regimens, lipid values remained stable at Week 48[1]

No clinically relevant difference in renal parameters in either treatment arm[1]

• Improvements in some renal biomarkers, suggesting a favourable effect on renal tubular function
• No change in eGFR in either group as measured by cystatin C