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Dolutegravir/Rilpivirine as Simpler Maintenance After Heavy Pretreatment
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21st International AIDS Conference (AIDS 2016), July 18-22, 2016, Durban, South Africa
Mark Mascolini
Once-daily dolutegravir/rilpivirine maintained viral suppression and improved metabolic markers in all 38 people switching from complex antiretroviral regimens after 19 years of multidrug treatment experience [1]. Liver function, kidney function, and lipid profiles all improved after the switch.
Clinicians at Madrid's Ramon y Cajal University Hospital noted that people with a history of several virologic failures often end up taking complex antiretroviral regimens with a high risk of side effects and drug-drug interactions with non-HIV medications. They are conducting an ongoing cohort study of such patients who trade their multidrug antiretroviral combination for the integrase inhibitor dolutegravir plus the nonnucleoside rilpivirine at a dose of 50/25 mg once daily.
All study participants had several virologic failures with diverse regimens and a resulting array of resistance mutations. But people could not enter the study if they had resistance to integrase inhibitors or to rilpivirine. Everyone had an undetectable viral load with their current regimen. Follow-up visits are scheduled for 4, 12, 24, and 48 weeks after the switch to dolutegravir/rilpivirine.
The study group included 38 people, 13 of them (34%) women, 26 (68%) who injected drugs, and 27 (70%) with HCV infection. Median age stood at 53.4 years, median nadir CD4 count at 179, and median current CD4 count at 592. The group had spent a median of 19.4 years taking antiretrovirals and had an undetectable viral load for a median of 6.7 years.
Proportions of cohort members who had taken a nonnucleoside, a protease inhibitor, or an integrase inhibitor were 90%, 97%, and 62%, and proportions in whom regimens based on those classes failed were 68%, 71%, and 8%. The group had a median of 3.8 nucleoside mutations, 2.0 nonnucleoside mutations, and 4.2 protease inhibitor mutations. The current regimen included a median of 4.3 pills. At the time of the switch to dolutegravir/rilpivirine, 85% of participants were taking a regimen combining nucleosides, a nonnucleoside, and a protease inhibitor, and 53% were taking drugs from those three classes plus an integrase inhibitor.
Four weeks after the switch, all 38 study participants maintained a viral load below 37 copies. Forty-eight weeks after the switch, 35 of 35 still had an undetectable viral load. Three people stopped dolutegravir/rilpivirine, one because of gastrointestinal toxicity, one because of an interaction with omeprazole, and one because of the physician's decision. CD4 counts remained stable after people started dolutegravir/rilpivirine.
Total bilirubin, AST, ALT, alkaline phosphatase, and gamma-glutamyl transferase all improved significantly after the switch to the two-drug regimen. Triglycerides and total cholesterol (but not HDL or LDL cholesterol) also improved significantly with dolutegravir/rilpivirine. Estimated glomerular filtration rate by CKD-EPI dropped significantly from 85 to 76 mL/min 4 weeks after the switch (P = 0.0002) and stayed at that level through 48 weeks.
The researchers concluded that a switch to dolutegravir/rilpivirine in people with heavy antiretroviral experience and current viral suppression is safe and effective.
Reference
1. Diaz A, Casado JL, Dronda F, et al. Dolutegravir plus rilpivirine in suppressed heavily pre-treated HIV-infected patients. 21st International AIDS Conference (AIDS 2016). July 18-22, 2016. Durban, South Africa. Abstract TUPDB0106.
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