Phase 3 HIV Treatment Switch Studies: Key Findings From Recent Clinical Trials

EP: 1.HIV Viral Suppression: Clinical Significance and Impact on Patient Outcomes

EP: 2.Changing Patient Demographics in HIV and Impacts of Polypharmacy on Treatment

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EP: 3.Phase 3 HIV Treatment Switch Studies: Key Findings From Recent Clinical Trials

EP: 4.HIV Therapy Without Integrase Inhibitor: Practical Advantages and Targeted Patient Populations

EP: 5.Long-Acting HIV Therapies: Real-World Data and Clinical Application

EP: 6.CD4 T-cell and Lymphocyte Monitoring: Clinical Significance in HIV Treatment

EP: 7.CROI 2025 Insights: Evolving HIV Treatment Landscape and Practice-Changing Developments

New Drug Combination - Doravirine and Islatravir

Key Themes:

• Novel Combination Therapy: A late-breaker study presented at the Conference on Retroviruses and Opportunistic Infections showed noninferiority of doravirine (nonnucleoside reverse transcriptase inhibitor [NNRTI]) plus islatravir (nucleoside reverse transcriptase translocation inhibitor [NRTTI]) compared with a standard bictegravir-based regimen.
• Patient Selection Criteria: The study enrolled patients suppressed for at least 3 months on bictegravir with T-cell counts greater than 50 and no prior virologic failure.
• Safety Monitoring: Special attention was given to effects on CD4 counts and lymphocytes, as earlier studies with islatravir showed potential toxicity.
• Hepatitis B Considerations: The new combination lacks anti–hepatitis B virus (HBV) activity, requiring HBV screening before switching.

Notable Insights From Dr Sharon Walmsley:

• The doravirine/islatravir combination maintained viral suppression in more than 90% of patients over 144 weeks.
• No cases of treatment resistance were observed in participants experiencing virologic failure.
• Unlike in earlier studies, no evidence of lymphopenia or CD4 cell count reduction was observed with the islatravir component.

Only 2% to 3% of patients discontinued due to adverse events, indicating good tolerability.