Newly Approved HIV Medications

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


US Pharmacist. 2020;45(10):17-25. 

In This Article

Abstract and Introduction


The available antiretroviral (ARV) drugs for the treatment of HIV have expanded since 2018. Novel types of ARVs with new mechanisms of action have been approved, including ibalizumab-uiyk and fostemsavir. There have also been approvals of combination tablets of previously available drugs, such as bictegravir/emtricitabine/tenofovir alafenamide and dolutegravir/lamivudine. Finally, there has been an expansion in approved indications for previously available ARVs themselves, such as emtricitabine/tenofovir alafenamide for use in pre-exposure prophylaxis.


The mainstays of antiretroviral (ARV) agents for treatment of HIV have largely consisted of the same handful of drug classes for years. HIV treatment was first attempted with nucleoside reverse transcriptase inhibitors (NRTIs), the first FDA-approved class of ARVs. Gradually, more and more classes were discovered and made available for treatment in various, often complex, regimens (Table 1).[1–3] After the approval of raltegravir in 2007, new HIV drug approvals were largely for repurposed available drugs and new combination drugs. This changed in 2018 with the approval of ibalizumab-uiyk, the first novel ARV in over a decade.[4] Ibalizumab-uiyk was quickly followed by a new nonnucleoside reverse transcriptase inhibitor (NNRTI), doravirine, later that year and a novel attachment inhibitor, fostemsavir, in 2020 (Table 2).[5–7]

While novel drugs are often the most exciting new drug approvals, ARVs have improved in other ways. Given the enormous pill burden of many HIV regimens, newly approved combination ARVs (Table 3) can make life much easier for patients. Use of such agents and limiting the necessary pill burden have demonstrated improved adherence and overall outcomes.[8,9] There have also been expansions in approved indications for previously available ARVs (Table 4), offering new options for certain patient populations and indications.[10–14]

Although their are many new approvals since 2018, this aricle profiles four of the newly approved medications and one new indication. These approvals were selected to demonstrate a sample of the wide variety of new agents becoming available, as well as emphasize some new options that offer a unique opportunity in the treatment of HIV.