TAF/FTC+DTG, TDF/FTC+DTG and TDF/FTC/EFV provide similar efficacy
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Tenofovir alafenamide with emtricitabine and dolutegravir, or TAF/FTC+DTG, and tenofovir disoproxil fumarate, or TDF, and FTC+DTG resulted in similar efficacy to TDF, FTC and efavirenz, or EFV, among people with HIV in South Africa.
The phase 3 results from the ADVANCE trial, which were presented at the International AIDS Conference and published previously in the New England Journal of Medicine, also showed low viral failure rates with the three regiments.
“These results support the current WHO treatment guidelines, reserving the TAF and DTG only for patients with osteoporosis or impaired renal function,” Simiso Sokhela, of the University of the Witwatersrand in Johannesburg, South Africa, said during the presentation.
Sokhela and colleagues performed an open-label, randomized 96-week trial to examine the efficacy and safety of TAF/FTC+DTG, TDF/FTC+DTG and TDF/FTC/EFV. The researchers included individuals aged 12 years and older who had received no ART in the preceding 30 days with a creatine clearance greater than 60 mL/min (or greater than 80 mL/min for individuals < 19 years) and HIV-1 RNA levels greater than 500 copies/mL. Exclusion criteria included pregnancy and tuberculosis.
The authors designated 96-week HIV-RNA levels of greater than 50 copies/mL and discontinuation or missing data as the primary treatment failure endpoint. They reported efficacy and safety data at 96 weeks.
Sokhela and colleagues analyzed results from 1,053 people living with HIV, of whom 99% were Black and 59% of whom were female. The mean age was 32 years.
The percentage of patients with HIV RNA levels of less than 50 copies/mL week 96 was 78.6%, 78.3% and 73.5% for TAF/FTC+DTG, TDF/FTC+DTG and TDF/FTC/EFV, respectively. In the on-treatment analysis, 96% of patients receiving TAF/FTC+DTG, 95.7% receiving TDF/FTC+DTG and 95.5% receiving TDF/FTC/EFV had HIV RNA levels of less than 50 copies/mL at week 96. Both DTG treatment arms showed non-inferior efficacy compared with the EFV arm.
The primary cause of treatment failures (84%) was discontinuation. The researchers observed similar rates of lab abnormalities and clinical adverse events among the three treatment arms.
“The biggest finding that is of concern to us was the mean change in weight for both men and women,” Sokhela said.
The weight gain across the various study arms at 96 weeks was 8.1 kg, 4.8 kg and 3.2 kg in the TAF/FTC+DTG, TDF/FTC+DTG and TDF/FTC/EFV groups, respectively, for women and 5.4 kg, 3.6 kg and 1.1 kg in the TAF/FTC+DTG, TDF/FTC+DTG and TDF/FTC/EFV groups, respectively, for men.
“The biggest finding of concern to us is the mean change in weight for both men and women,” Sokhela said, adding that it was a greater concern for women. “... We also noticed that the mass increases were largely fat over lean gain and were distributed in the trunk and limbs across all three arms of the study.”
According to Sokhela, the study reaffirms previous results and lays to rest questions regarding whether the weight changes increased with time.
“We are proving that the changes in weight are actually worsening with time,” she said. “We have a few patients who have developed metabolic syndrome, so we are right about the outcomes or implications of the weight gain. Even with pregnancies, we are predicting that there might actually be more instances of pregnancy-related adverse events because of the weight gain.”
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Sokhela S, et al. Abstract 10954. Presented at: International AIDS Conference; July 6-10, 2020 (virtual meeting).
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