The following article is a part of conference coverage from the IDWeek 2021, being held virtually from September 29 to October 3, 2021. The team at Infectious Disease Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from the IDWeek 2021.
Among patients with HIV infection, those who switched from ritonavir-boosted darunavir (DRV/r) to doravirine (DOR) or were continued on DOR achieved sustained virologic suppression, superior lipid control, and a favorable safety profile, according to research presented at IDWeek, held virtually September 29 to October 3, 2021.
The DRIVE-FORWARD trial was a phase 3, doubleblind study that compared the effects of DRV/r (800/100 mg) with DOR 100 mg for the treatment of patients with HIV infection. The follow-up duration was 96 weeks. At week 48, DOR therapy was found to be noninferior to DRV/r in regard to viral suppression, with a superior lipid profile.
This current analysis used data collected during the 96-week open-label extension period, in which all patients were given DOR therapy. Efficacy and safety were assessed through week 192 among patients who continued DOR therapy (n=259) and those who switched from DRV/r to DOR (n=233).
Viral suppression (<50 HIV-1 RNA copies/mL) through week 192 was achieved by 81.1% of patients who continued DOR therapy and 80.7% of those who switched from DRV/r to DOR therapy. Of note, CD4 T-cell counts increased at week 96 by a mean of 47 cells/mm3 among patients who continued DOR therapy compared with 53 cells/mm3 among those who switched from DRV/r to DOR therapy.
Among patients who continued DOR therapy and those who switched from DRV/r to DOR therapy, 3.1% and 5.6% had virologic failure; 0.8% and 0.4% had genotypic resistance to DOR; and 0.4% and 0.4% had genotypic resistance to nucleos(t)ide reverse transcriptase inhibitors, respectively.
Drug-related adverse events occurred among 8.1% of patients who continued DOR therapy vs 9.0% among those who switched from DRV/r to DOR therapy; however, severe adverse events occurred among 6.6% and 6.9% of these patients, respectively.
Among patients who switched from DRV/r to DOR therapy, fasting LDL-cholesterol decreased by a mean of 7.0 mg/dL, non-HDL cholesterol decreased by 10.6 mg/dL. In addition, the ratio of total cholesterol to HDL-cholesterol decreased by 0.4, and triglycerides decreased by 15.8 mg/dL. The researchers noted that the impact of switching from DRV/r to DOR therapy on body weight was minimal, with a mean weight gain of 1.5 kg (3.3 lb).
According to the researchers, “[patients] who switched from DRV/r to DOR [therapy] maintained virologic suppression and demonstrated favorable safety [profiles] for 96 weeks.”
Disclosure: Some author(s) declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Cahn P, Molina J-M, Lombaard J, et al. The efficacy and safety of maintenance with doravirine plus two NRTIs after initial suppression in adults with HIV-1 in the DRIVE-FORWARD clinical trial: results from the study extension through 192 weeks. Presented at: IDWeek; September 29 to October 3, 2021.Poster 626.
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