The United States of America, as Represented by the Secretary, Department of Health and Human Services

Johns Hopkins University

The United States of America as Represented by the Department of Health

Centers for Disease Control and Prevention

Center for Disease Control and Prevention

Walid M Heneine

Thomas M Folks

William M Switzer

Jeffrey A Johnson

Jose Gerardo Garcia Lerma

Donald S Burke

Jennifer Brown

Robert Janssen

Ronald A Otten

Nathan D Wolfe

Paul Sandstrom

Shinji Yamamoto

Jonathan T Lipscomb

Eitel Mpoudi Ngole

Shambavi Subbarao

Margaret E Callahan

Paul A Sandstrom

Jan Pohl

Chou-Pong Pau

Aprille L Matthews

Shanmugam Vedapuri

Ivana Mabel Massud

Gerardo Garcia Lerma

Gerardo Garcia-Lerma

David M Sintasath

Xierong Wei

HaoQiang Zheng

Ae Saekhou Youngpairoj

Timothy Clyde Granade

Mpoudi Eitel

William Marshall Switzer

J Gerardo Garcia-Lerma

Disclosed is the use of a nucleoside reverse transcriptase inhibitor, a nucleotide reverse transcriptase inhibitor, and an integrase inhibitor after exposure to a potential human immunodeficiency virus (HIV) infection to inhibit or prevent an HIV infection. In some embodiments, a pharmacologically effective amount of emtricitabine (FTC), a pharmacologically effective amount of tenofovir alafenamide (TAF) or tenofovir disproxil fumarate (TDF), a pharmacologically effective amount of the integrase inhibitor elvitegravir (EVG), and optionally cobistat (COBI) are used to inhibit or prevent an HIV infection, wherein these agents are administered only after a potential exposure to HIV. In specific non-limiting examples, only one or two doses of the anti-retroviral viral agents are administered to a subject after the potential exposure to HIV.

HIV post-exposure prophylaxis

Disclosed are monoclonal antibodies that specifically bind emtricitabine (FTC). Methods are also disclosed for using these antibodies to detect FTC in samples. In some embodiments, these methods are of use for determining if a subject is complying with a therapeutic or prophylactic protocol. In other embodiments, methods are disclosed for determining the dose of FTC to administer to a subject.

Monoclonal antibody for the detection of the antiretroviral drug emtricitabine (FTC, 2',3&#x2032;-dideoxy-5-fluoro-3&#x2032;-thiacytidine)

Disclosed are compositions including primers and probes, which are capable of interacting with the disclosed nucleic acids, such as the nucleic acids encoding the reverse transcriptase, protease, or integrase of HIV as disclosed herein. Thus, provided in an oligonucleotide comprising any one of the nucleotide sequences set forth in SEQ ID NOS: 1-89, 96-122, and 124-141. Also provided are the oligonucleotides consisting of the nucleotides as set forth in SEQ ID NOS: 1-89, 96-122, and 124-141. Each of the disclosed oligonucleotides is a probe or a primer. Also provided are mixtures of primers and probes and for use in RT-PCR and primary PCT reactions disclosed herein. Provided are methods for the specific detection of several mutations in HIV simultaneously or sequentially. Mutations in the reverse transcriptase, protease, or integrase of HIV can be detected using the methods described herein.

Real-time PCR point mutation assays for detecting HIV-1 resistance to antiviral drugs

Disclosed are compositions including primers and probes, which are capable of interacting with the disclosed nucleic acids, such as the nucleic acids encoding the reverse transcriptase, protease, or integrase of HIV as disclosed herein. Thus, provided is an oligonucleotide comprising any one of the nucleotide sequences set for in SEQ ID NOS: 1-89, 96-122, and 124-151. Also provided are the oligonucleotides consisting of the nucleotides as set forth in SEQ ID NOS: 1-89, 96-122, and 124-151. Each of the disclosed oligonucleotides is a probe or a primer. Also provided are mixtures of primers and probes and for use in RT-PCR and primary PCR reactions disclosed herein. Provided are methods for the specific detection of several mutations in HIV simultaneously or sequentially. Mutations in the reverse transcriptase, protease, or integrase of HIV can be detected using the methods described herein.

Disclosed are compositions including primers and probes, which are capable of interacting with the disclosed nucleic acids, such as the nucleic acids encoding the reverse transcriptase or protease of HIV as disclosed herein. Thus, provided is an oligonucleotide comprising any one of the nucleotide sequences set for in SEQ ID NOS:1-89, and 96-104. Also provided are the oligonucleotides consisting of the nucleotides as set forth in SEQ ID NOS:1-89, and 96-104. Each of the disclosed oligonucleotides is a probe or a primer. Also provided are mixtures of primers and probes and for use in RT-PCR and primary PCR reactions disclosed herein. Provided are methods for the specific detection of several mutations in HIV. Mutations in both the reverse transcriptase and the protease of HIV can be detected using the methods described herein.

A process is provided for protecting a primate host from a self-replicating infection by an immunodeficiency retrovirus. Protection is achieved by administering to the primate host a combination of a pharmaceutically effective amount of a nucleoside reverse transcriptase inhibitor and a pharmaceutically effective amount of a nucleotide reverse transcriptase inhibitor prior to exposure to the immunodeficiency retrovirus. The administration is effective if provided in a single dose within 24 hours of the exposure. A regime of regular daily doses is also effective in providing protection against an immunodeficiency retrovirus becoming self-replicating after infecting a primate host. A process for controlling retrovirus transmission within a population includes the administration to a subpopulation at high risk for contracting an immunodeficiency retroviral infection the detailed combination prior to sexual exposure to a source of immunodeficiency retrovirus so as to preclude the immunodeficiency retrovirus from becoming self-replicating in a member of the subpopulation.

Inhibition of HIV infection through chemoprophylaxis

Disclosed are compositions including primers and probes, which are capable of interacting with the disclosed nucleic acids, such as the nucleic acids encoding the reverse transcriptase, protease, or integrase of HIV as disclosed herein. Thus, provided is an oligonucleotide comprising any one of the nucleotide sequences set for in SEQ ID NOS: 1-89, 96-122, and 124-141. Also provided are the oligonucleotides consisting of the nucleotides as set forth in SEQ ID NOS: 1-89, 96-122, and 124-141. Each of the disclosed oligonucleotides is a probe or a primer. Also provided are mixtures of primers and probes and for use in RT-PCR and primary PCR reactions disclosed herein. Provided are methods for the specific detection of several mutations in HIV simultaneously or sequentially. Mutations in the reverse transcriptase, protease, or integrase of HIV can be detected using the methods described herein.

Inhibition of HIV infection through chemoprophyalxis

Disclosed are compositions and methods related to the isolation and identification of the primate T-lymphotropic viruses, HTLV-3 and HTLV-4. The diversity of HTLVs was investigated among central Africans reporting contact with NHP blood and body fluids through hunting, butchering, and keeping primate pets. Herein it is shown that this population is infected with a variety of HTLVs, including two retroviruses; HTLV-4 is the first member of a novel phylogenetic lineage that is distinct from all known HTLVs and STLVs; HTLV-3 falls within the genetic diversity of STLV-3, a group that has not previously been seen in humans. The present disclosure also relates to vectors and vaccines for use in humans against infection and disease. The disclosure further relates to a variety of bioassays and kits for the detection and diagnosis of infection with and diseases caused by HTLV-3 and HTLV-4 and related viruses.

Primate T-lymphotropic viruses

Disclosed are the simian T-cell lymphotropic virus type 3 subtype D (STLV-3 subtype D), isolated nucleic acid molecules encoding STLV-3 subtype D polypeptides, such as STLV-3 subtype D envelope, protease, polymerase, tax, rex, and capsid polypeptides, isolated polypeptides encoded by such nucleic acids. Methods are also disclosed for detecting STLV-3 subtype D, for example by detecting a STLV-3 subtype D nucleic acid or polypeptide in the sample. Accordingly, probes, primers, and antibodies for use in detecting STLV-3 subtype D nucleic acids or polypeptides are disclosed. Therapeutic compositions which included isolated nucleic acid molecules encoding a STLV-3 subtype D polypeptides or isolated polypeptides encoded by such nucleic acid molecules are also disclosed.

Simian T-cell lymphotropic virus

Growing community of inventors

Atlanta, GA, United States of America

Walid M Heneine