Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves First 2-Drug Regimen for HIV

FDA news release; 2017 Nov 21

The US Food and Drug Administration approved Juluca (dolutegravir and rilpivirine), the first 2-drug regimen to treat certain adults with human immunodeficiency virus type 1 (HIV-1). The approval was granted to ViiV Healthcare (Research Triangle Park, NC).

Indications: Juluca, a 2-drug combination of dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure, and no known substitutions associated with resistance to the individual components of Juluca.

Dosage and administration: Take 1 tablet orally once daily with a meal. Take an additional 25-mg tablet of rilpivirine with Juluca once daily with a meal for the duration of the rifabutin coadministration.

Safety and efficacy: Juluca’s safety and efficacy in adults were evaluated in 2 clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV regimen.

Adverse reactions: The most common adverse reactions in ≥2% of subjects were diarrhea and headache.


US Food and Drug Administration. FDA approves first two-drug regimen for certain patients with HIV. FDA Web site. November 21, 2017. Accessed November 27, 2017.

This Week's Must Reads

Seasonal Incidence of Symptomatic Influenza in US, Clin Infect Dis; ePub 2017 Dec 1; Tokars, et al

Sustaining Reduction Rates for Hospital-Onset CDI, Am J Infect Control; ePub 2017 Nov 21; Khoury, et al

Prevalence of Anal HPV Infection in Men with HIV, J Infect Dis; ePub 2017 Dec 4; Patel, Bush, et al

Inflammation, Coagulation & Risk in ART Initiation, Open Forum Infect Dis; ePub 2017 Nov 28; Baker, et al

FDA Approves Isentress for Tx of HIV in Newborns, Merck news release; 2017 Nov 29

Must Reads in FDA Actions

FDA Approves Isentress for Tx of HIV in Newborns, Merck news release; 2017 Nov 29

FDA Approves First 2-Drug Regimen for HIV, FDA news release; 2017 Nov 21

FDA Approves Two-Dose Hep B Vaccine , Dynavax news release; 2017 Nov 9

Shingrix Approved for Prevention of Shingles, GSK news release; 2017 Oct 23

FDA Approves Zika Virus Screening Test , FDA news release; 2017 Oct 5