Both trials are ongoing, although due to the strong interim findings it was recommended that the placebo arms be halted and that patients be offered active treatment. Maximum follow-up in Partners is 36 months (average greater than 1 year) and 3.7 years in TDF2 (average 12 months).
The preliminary analyses did not find any significant safety concerns associated with daily use of combination tenofovir/emtricitabine. Patients receiving the study drugs were more likely to report nausea, vomiting and dizziness, but details on serious adverse events were not provided.
Further information on Partners PrEP can be obtained from the University of Washington. Full data from CDC TDF2 are scheduled to be presented next week at the International AIDS Society conference in Rome.
Gilead Sciences Inc., announced earlier this week that it had signed a licensing agreement with the Medicines Patent Pool Foundation that would expand the number of developing countries from 95 to 111 in which generic versions of Viread and Truvada can be produced and sold, even though the drugs remain under patent in the United States.
Partners PrEP is funded by the Bill and Melinda Gates Foundation and the National Institutes of Health. The TDF2 study is being conducted by the CDC in partnership with the Botswana Ministry of Health. Gilead Sciences donated the study drugs for both trials.