Which HIV Treatment Regimens Are Recommended for Newly Diagnosed Patients?

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In 2015, after the landmark study known as START definitively answered the "when to start" treatment question, all the major HIV treatment guidelines came to a consensus: Starting treatment immediately, regardless of CD4 cell count, is more beneficial than waiting until CD4 cell counts drop.

For newly diagnosed patients, starting a treatment regimen can be a stressful decision, but providers can help by choosing what works best for patients. To guide that decision, here are the first-line regimens currently recommended by the U.S. Department of Health & Human Services (HHS) antiretroviral therapy guidelines, with basic information and considerations for each regimen.


Abacavir/Dolutegravir/Lamivudine (Triumeq)

Abacavir/dolutegravir/lamivudine (Triumeq) is a once-daily HIV medication recommended for adults and adolescents with HIV, but only for those who are HLA-B5701 negative. HLA-B5701 is a genetic mutation associated with abacavir (ABC, Ziagen) hypersensitivity.

The medication comes in tablet form, with each tablet containing: 600 mg abacavir (Ziagen), 50 mg dolutegravir (Tivicay, DTG) and 300 mg lamivudine (3TC, Epivir). The main component of the regimen is dolutegravir, which is part of the integrase inhibitors drug class and continues to show high potency, safety and limited drug interactions.

Abacavir/dolutegravir/lamivudine should be taken once a day, with or without food.

There can be serious, life-threatening side effects associated with abacavir/dolutegravir/lamivudine, including allergic reactions, lactic acidosis and severe liver problems.

See full prescribing information here for additional warnings and indications.


Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (Stribild)

Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF, Stribild) is recommended for adults and adolescents with HIV -- but only for those with estimated creatinine clearance (CrCl) greater than 70 mL per minute.

The medication is a once-daily tablet, which should be taken with food. Each tablet contains: 150 mg of elvitegravir (Vitekta), 150 mg of cobicistat (Tybost), 200 mg of emtricitabine (FTC, Emtriva) and 300 mg of tenofovir disoproxil fumarate (Viread, TDF).

Elvitegravir is part of the integrase inhibitor class, known for its potency and safety, while cobicistat is a booster drug that raises levels of elvitegravir in the blood. Together with emtricitabine and TDF, two nucleoside analog reverse transcriptase inhibitors (or "nukes"), the regimen is recommended as a first-line option for those starting treatment.

TDF, the older version of tenofovir, may cause kidney damage, so it's important to monitor patient creatinine levels.

See full prescribing information here for additional warnings and indications.


Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Genvoya)

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF, Genvoya) is much like Stribild, except TDF has been replaced with tenofovir alafenamide (TAF), an updated version of tenofovir that has shown better kidney and bone safety. It was the first regimen to contain TAF that was approved by the FDA.

E/C/F/TAF is recommended for adults and adolescents living with HIV, but only for those with estimated creatinine clearance (CrCl) greater than 30 mL per minute.

The medication is a once-daily tablet, which should be taken with food. Each tablet contains: 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of TAF.

See full prescribing information here for additional warnings and indications.


Dolutegravir (Tivicay, DTG) + Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC, Truvada)

As previously mentioned, dolutegravir is a strong integrase inhibitor that continues to show high potency, safety and limited drug interactions.

When paired with TDF/FTC, it is a very effective and complete HIV regimen, containing 50 mg of dolutegravir and 200 mg/300 mg of TDF/FTC.

Although this regimen contains two pills, it is a good alternative to the single tablet of abacavir/dolutegravir/lamivudine for those who may have abacavir hypersensitivity.

Dolutegravir + TDF/FTC is recommended for adults and adolescents with HIV, to be taken once a day, with or without food.

See full prescribing information for dolutegravir and TDF/FTC for additional warnings and indications.


Raltegravir (Isentress) + TDF/FTC

Raltegravir (Isentress) was the first integrase inhibitor approved by the FDA and continues to be an effective and well-tolerated HIV medication.

When paired with TDF/FTC, it makes for a complete HIV regimen, containing 400 mg of raltegravir and 200 mg/300 mg of TDF/FTC. The regimen is recommended for adults and adolescents with HIV, to be taken twice a day, with or without food.

While raltegravir + TDF/FTC is a strong option for those starting treatment, the two pills twice-a-day dosing (four pills total) may be a turn off for some.

See full prescribing information for raltegravir and TDF/FTC for additional warnings and indications.


Ritonavir (Norvir)-Boosted Darunavir (Prezista) + TDF/FTC

Out of the currently recommended regimens, ritonavir (Norvir)-boosted darunavir (Prezista) + TDF/FTC is the only protease inhibitor-based regimen. In fact, it's the only non-integrase inhibitor-based regimen recommended by the guidelines.

The regimen contains 800 mg of darunavir, 100 mg of ritonavir and 200 mg/300 mg of TDF/FTC. It is recommended for adults and adolescents with HIV and should be taken once daily, with food.

Although the regimen contains three pills, it's a strong option for those who may have resistance to integrase inhibitors or sensitivity to some of the other recommended first-line regimens. As an alternative, coformulations such as the already FDA-approved darunavir/cobicistat (Prezcobix) can reduce pill burden.

Darunavir can cause serious side effects, including liver problems, skin reactions or rash, so it's important for providers to routinely monitor liver function, particularly for patients coinfected with hepatitis B or C.

See full prescribing information here for additional warnings and indications.


Individualization

Although the guidelines currently recommend six great options for first-line HIV treatment, it's important to consider the individual needs of each patient.

The decision of what to start should be made in concert with patients, and "should be guided by factors such as virologic efficacy, toxicity, pill burden, dosing frequency, drug-drug interaction potential, resistance testing results, comorbid conditions, and cost," according to the guidelines.

Helping newly diagnosed patients adjust and adhere to daily medications is essential, so it's important to find the regimen that works best for each patient.

For patients who miss a dose, it is recommended that they take the missed dose as soon as they remember, unless it's almost time for the next dose, in which case they should skip the missed dose and wait for the next regular dose. Patients should never take two doses at the same time to make up for a missed dose.

See the full U.S. HHS antiretroviral therapy guidelines on "What to Start" for more information on each recommended first-line regimen, alternative and other regimen options, as well as advantages, disadvantages and considerations.


What's Next?

With new medications approved each year and more long-term data on current medications, the guidelines continue to be updated. This will no doubt be the case again this year, as a revision is expected sometime in June 2016.

Most notably, two more TAF-based medications were approved by the FDA earlier this year -- emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) and emtricitabine/tenofovir alafenamide (F/TAF, Descovy). As mentioned, TAF has shown a better kidney and bone safety profile than TDF, so it's expected that these new TAF-based medications will also be recommended.