This protocol addresses the management of HIV when an initial antiretroviral regimen has not achieved adequate virologic suppression, or when suppression has been lost, signalling virologic failure and the need to escalate to a structured next-line approach.
The previous line of treatment consisted of second-generation integrase strand transfer inhibitor (INSTI)-based combination antiretroviral therapy. This line is considered to have failed when plasma HIV RNA is not suppressed to below 200 copies/mL by approximately 8 to 12 weeks after initiation, or when the expected increase in CD4 T lymphocyte cell count of 50 to 150 cells/mm³ in the first year is not achieved. Confirmed virologic failure triggers escalation to this protocol.
The next step involves constructing a new antiretroviral regimen guided by current and prior drug-resistance testing. The approach prioritises including at least two fully active drugs, with at least one agent carrying a high resistance barrier — the specific regimen options, sequencing, and full composition are detailed in the complete protocol.
A new ARV regimen should preferably include two fully active drugs if at least one has a high resistance barrier, such as a second-generation INSTI or a boosted protease inhibitor (PI) (AI).
A new ARV regimen can also include a second-generation INSTI (i.e., dolutegravir [DTG]) plus a boosted PI (preferably boosted darunavir) without nucleoside reverse transcriptase inhibitors (NRTIs) if both are fully active (AI).
The goal of treatment for people with HIV with drug resistance who are experiencing virologic failure is to establish virologic suppression (i.e., HIV RNA levels below the lower limits of detection of currently used assays) (AI).
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