What is the recommended initial Highly Active Antiretroviral Therapy (HAART) regimen?

From the Guidelines

The recommended initial Highly Active Antiretroviral Therapy (HAART) regimen is a single-tablet regimen containing dolutegravir or bictegravir, due to their high rates of viral suppression, minimal toxicity, and low risk of drug interactions, as supported by the 2020 recommendations of the International Antiviral Society-USA panel 1.

Key Considerations

• The choice of initial HAART regimen should be based on the patient's individual needs and medical history, including any potential drug interactions or comorbidities.
• Baseline laboratory tests, including HIV viral load, CD4 count, resistance testing, HLA-B*5701 screening (if abacavir is being considered), and renal and hepatic function tests, should be performed before initiating therapy.
• INSTI-based regimens, such as those containing dolutegravir or bictegravir, are preferred due to their high efficacy, good tolerability, and convenience.

Recommended Regimens

• Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is a recommended single-tablet regimen for treatment-naïve patients, as it has been shown to have high efficacy and good tolerability 1.
• Triumeq (dolutegravir/abacavir/lamivudine) is another recommended single-tablet regimen, although it may not be suitable for patients with certain medical conditions, such as kidney or bone disease 1.

Important Notes

• Treatment should be initiated as soon as possible after diagnosis, regardless of CD4 count, to prevent disease progression and reduce transmission risk.
• Patients with hepatitis B virus coinfection should initiate ART that contains tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), lamivudine or emtricitabine, and a third component, as recommended by the International Antiviral Society-USA panel 1.

From the FDA Drug Label

HIV-1-infected subjects who were eligible for this trial were on a highly active antiretroviral therapy regimen (HAART) for at least 12 weeks. Both arms used an optimized background regimen consisting of greater than or equal to 2 NRTIs selected by the investigator Both arms used an optimized background regimen consisting of at least 2 antiretrovirals (NRTIs with or without NNRTIs).

The recommended initial Highly Active Antiretroviral Therapy (HAART) regimen is not explicitly stated in the provided drug labels. However, the labels mention that the subjects in the trials were on a HAART regimen for at least 12 weeks, and the trials used an optimized background regimen consisting of at least 2 antiretrovirals (NRTIs with or without NNRTIs) or greater than or equal to 2 NRTIs.

• The labels do not provide a specific initial HAART regimen.
• The trials used darunavir/ritonavir in combination with an optimized background regimen.
• The optimized background regimen consisted of at least 2 antiretrovirals (NRTIs with or without NNRTIs) or greater than or equal to 2 NRTIs 2 2.

From the Research

Recommended Initial HAART Regimens

The recommended initial Highly Active Antiretroviral Therapy (HAART) regimens are based on various studies that have evaluated the efficacy and safety of different combination therapies. Some of the key regimens include:

• Efavirenz/emtricitabine/tenofovir disoproxil fumarate: a once-daily, one-tablet regimen that has been shown to be effective in suppressing HIV-1 RNA and improving immunological recovery 3, 4
• Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate: a once-daily regimen that has been compared to efavirenz, emtricitabine, and tenofovir disoproxil fumarate in a randomized, phase 3, non-inferiority trial 5
• Tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat plus darunavir: a once-daily, 2-tablet regimen that has been evaluated in a retrospective review of antiretroviral-naive and treatment-experienced patients 6

Key Considerations

When selecting an initial HAART regimen, several factors should be considered, including:

• Efficacy: the ability of the regimen to suppress HIV-1 RNA and improve immunological recovery
• Safety: the potential for adverse events, such as liver dysfunction, rash, and changes in bone density
• Tolerability: the ability of patients to adhere to the regimen and manage any side effects
• Resistance: the potential for the development of resistance to the regimen, particularly in patients with a history of antiretroviral therapy

Regimen Options

Some of the key regimen options include:

• Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate): a once-daily, one-tablet regimen that is recommended as initial therapy for treatment-naive patients 3, 4
• TDF/FTC/EVG/cobi plus DRV: a once-daily, 2-tablet regimen that is considered safe, well-tolerated, and effective in suppressing HIV-1 RNA in antiretroviral-naive and treatment-experienced patients 6
• Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate: a once-daily regimen that has been shown to be non-inferior to efavirenz, emtricitabine, and tenofovir disoproxil fumarate in a randomized, phase 3, non-inferiority trial 5