96-week study results published today show that 79 percent of treatment-naïve HIV-1 infected adults taking PREZISTA (darunavir) 800 mg (two 400 mg tablets) with 100 mg ritonavir once daily reached an undetectable viral load (<50 copies/mL) at week 96, compared with 71 percent of patients taking lopinavir/ritonavir 800 mg/200 mg once daily (or 400 mg/100 mg twice daily), both with a fixed dose of emtricitabine and tenofovir disoproxil fumarate.
Results from the study, known as ARTEMIS, were published today in AIDS, the official journal of the International AIDS Society. The study compared the efficacy and safety of the protease inhibitors (PIs) darunavir/r and lopinavir/r in treatment-naïve adults with HIV (those who have never taken HIV medication before).
At 48 weeks, the primary objective of ARTEMIS was reached when darunavir/r was demonstrated to be non-inferior to lopinavir/r for virologic response (confirmed HIV RNA <50 copies/mL). The difference between the treatment arms was not significant at week 48. The pre-planned safety and efficacy analysis at 96 weeks was a secondary endpoint. At 96 weeks, the study showed darunavir/r was non-inferior to lopinavir/r for virologic response. The estimated difference in virologic response between the treatment groups was eight percent and statistically significant (95 percent confidence interval 1.9; 14.8) per data published in AIDS.
“This study offers the medical community long-term efficacy and safety data for once daily darunavir in treatment-naïve adult patients,” said Dr. Mark Nelson, Consultant Physician and Deputy Director of HIV Research at Chelsea and Westminster Hospital, London.