CDC has reviewed and graded the evidence on lenacapavir as PrEP from two clinical trials, which demonstrated strong efficacy in preventing HIV infection among both females and males and found no serious safety concerns. On the basis of a high certainty of evidence for its efficacy and safety derived from the agency’s analysis, CDC strongly recommends lenacapavir, administered every six months as a subcutaneous injection, for HIV PrEP in all people weighing at least 35 kg who would benefit.