Methods of preventing hiv infections in humans

A pre-exposure prophylactic method, comprising:

• protecting a human subject from being infected with human immunodeficiency virus 1 (HIV-1) by orally administering a daily dose of a formulation to a human subject who is known to be HIV-1 negative, wherein the first administration occurs before the human subject is exposed to HIV-1 through sexual activity, and wherein the formulation comprises a therapeutically effective amount of:
• i. tenofovir or a tenofovir prodrug;
• and
• ii. emtricitabine, wherein the oral administration results in an area under the plasma concentration-time curve (AUC) of emtricitabine over a 24 hour interval of 10.0±3.12 μg-hr/mL, and wherein the human subject is prevented from becoming infected with HIV-1 following sexual activity with an HIV-1 infected person.

A method, comprising:

• (a) confirming that a human subject has not been infected with HIV-1;
• (b) following confirmation that the human subject has not been infected with the HIV-1 and before the human subject is exposed to HIV-1, orally administering a therapeutically effective amount of a formulation comprising:
• i. a therapeutically effective amount of a tenofovir prodrug;
• and
• ii. emtricitabine in an amount of 200 mg, wherein the oral administration results in an area under the plasma concentration-time curve (AUC) of emtricitabine over a 24 hour interval of 10.0±3.12 μg-hr/mL;
• (c) continuing to orally administer the formulation to the human subject while the subject is at risk for being exposed to HIV-1;
• and
• (d) confirming that the human subject remains seronegative for HIV-1 after several months of oral administration by testing the human subject for the presence of a HIV-1 infection.