Dolutegravir plus rilpivirine had good virologic, safety record in clinics before single tablet available

Before single-table dolutegravir/rilpivirine (DTG/RPV) became commercially available, clinicians who combined the two drugs (DTG+RPV) in practice found high rates of virologic control and frequent attainment of treatment goals, according to results of a 10-site US study. [1]

Only 5 of 66 people stopped DTG+RPV, and only two of them because of virologic failure.

In November 2017, DTG/RPV became the first single-tablet two-drug antiretroviral regimen licensed by the FDA. Intended as maintenance therapy for people already taking a suppressive regimen, DTG/RPV (Juluca) has now compiled two years of clinic-based experience. But before the single-tablet regimen became available, some clinicians gave DTG+RPV as separate pills for a variety of reasons. This study analysed that US experience.

This retrospective chart review involved 278 adults with HIV in care at 1 of 10 US sites and taking any DTG 2-drug regimen. Everyone began the 2-drug regimen before 31 July 2017 and had follow-up data at least to 30 January 2018. This report focused on 66 people (24% of 278) who took DTG+RPV.

Almost everyone starting DTG+RPV (94%) had antiretroviral experience, logging an average 15.5 years on treatment. Of these 66 people, 79% were men, 68% white, 23% black, and 14% Hispanic. Age averaged 56 years. More than one third of participants (39%) had documented comorbidities, and 26% had mental health issues. Almost half of the study group (49%) had taken four or more prior antiretroviral regimens.

Clinicians reported that people usually started DTG+RPV to avoid long-term toxicities (53%), to avoid toxicity or intolerance of other antiretrovirals (20%), or to simplify treatment (15%). All but one person took DTG+RPV once daily. The group averaged 1.6 years taking DTG+RPV at the time of this analysis.

CD4 count before DTG+RPV started averaged 666. Forty-six of 66 people (70%) had a viral load below 50 copies/mL when starting DTG+RPV, while the rest had a detectable load (averaging about 104,000 copies/mL). Of the 46 people who began DTG+RPV with an undetectable load, 45 (98%) still had an undetectable load at last follow-up. Among the 20 people with a detectable viral load when starting DTG+RPV, 12 (60%) attained and maintained viral suppression. Two people with an initially detectable load became undetectable then rebounded. Overall, 91% of participants achieved their goal with DTG+RPV, according to their clinician’s report.

Five of 66 people (8%) stopped DTG+RPV during follow-up, two because of virologic failure, two for further treatment simplification, and 1 because of toxicity/intolerance.

“Despite being used in a much more experienced population,” the researchers concluded, “real-world experience with DTG+RPV appears to be consistent with outcomes in phase 3 clinical trials”.