Newly Approved HIV Medications

Ian Villaluz, PharmD Candidate 2021; Glenn R. Grantner, PharmD, BCPS


US Pharmacist. 2020;45(10):17-25. 

In This Article

Dolutegravir/Lamivudine (Dovato)

Combination dolutegravir/lamivudine (DTG/3TC), an INSTI and NRTI, was approved in 2019. It is the first two-drug, fixed-dose complete regimen for the treatment of HIV-1 infection in treatment-naive adult patients. This contrasts with the traditionally required three-drug standard-of-care regimen options. This may offer opportunity in patients who cannot tolerate any of the more common three-drug regimen due to adverse effects or unavoidable drug interactions.[25,26]

The efficacy and safety of combination dolutegravir/lamivudine were demonstrated in two identical studies, GEMINI-1 and GEMINI-2.[27] These studies enrolled a total of 1,433 HIV-1–infected, treatment-naive adults who were randomized to receive a two-drug regimen, dolutegravir 50 mg plus lamivudine 150 mg, or a three-drug regimen, dolutegravir plus emtricitabine plus tenofovir disoproxil fumarate. The primary endpoint of achieving a viral load <50 copies/mL showed DTG/3TC to be noninferior—91% of the 716 two-drug patients and 93% of the 717 three-drug patients (treatment difference of -1.7%; 95% CI, -4.4% to 1.1%)—when the results of the two studies were pooled together. The pooled studies also showed that, numerically, fewer patients had drug-related adverse events in the two-drug regimen as opposed to the three-drug regimen (126 of 716 [18%] and 169 of 717 [24%], respectively). Due to noninferior efficacy and a similar tolerability profile, the Department of Health and Human Services was able to include fixed-dose combination DTG/3TC in the HIV/AIDS guidelines as a recommended initial regimen for most people with HIV.[27]

Combination dolutegravir/lamivudine is dosed once daily by mouth with or without food. The most common adverse reactions seen in patients are headache, nausea, diarrhea, fatigue, and insomnia. Despite being a two-medication combination tablet, there is no need to administer it with other ARV medications because it is a complete therapy regimen.[25–27]