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Double oral administration of emtricitabine/tenofovir prior to virus exposure protects against highly pathogenic simian/human immunodeficiency virus infection in macaques.

In the absence of any effective vaccine against human immunodeficiency virus (HIV), current anti-retroviral drugs may be suitable for pre-exposure prophylaxis (PrEP). Previous large clinical trials showed that PrEP reduced HIV infection in high-risk populations. Emtricitabine/tenofovir (FTC/TDF) may be a suitable agent for PrEP. FTC/TDF PrEP efficacy was evaluated using a highly pathogenic simian/human immunodeficiency virus (SHIV) in a non-human primate model of AIDS, the SHIV-KS661c/cynomolgus monkey model. Double oral administration of FTC/TDF (20/30 mg/kg), at 24 h and a few minutes prior to exposure, completely protected 2/3 monkeys from infection. Interestingly, a single oral administration 2 weeks before viral exposure moderately rescued CD4 cells, although the data did not reach statistical significance. These results are consistent with previous primate studies and with recent clinical data.