emtricitabine--tenofovir-disoproxil-fumarate-drug-combination and Acquired-Immunodeficiency-Syndrome

Antiretroviral preexposure prophylaxis (PrEP) for persons at high risk of human immunodeficiency virus infection is a promising new prevention strategy. Six randomized trials of oral PrEP were recently conducted and demonstrated efficacy estimates ranging from 75% to no effect, with nonadherence likely resulting in attenuated estimates of the protective effect of PrEP. In 1 of these trials, the Partners PrEP Study (Kenya and Uganda, 2008-2011), participants (4,747 serodiscordant heterosexual couples) were randomized to receipt of tenofovir (TDF), coformulated TDF/emtricitabine (FTC), or placebo. Intention-to-treat analyses found efficacy estimates of 67% for TDF and 75% for TDF/FTC. We applied multiple methods to data from that trial to estimate the efficacy of PrEP with high adherence, including principal stratification and inverse-probability-of-censoring (IPC) weights. Results were further from the null when correcting for nonadherence: 1) among the strata with an estimated 100% probability of high adherence (TDF hazard ratio (HR) = 0.19, 95% confidence interval (CI): 0.07, 0.56; TDF/FTC HR = 0.12, 95% CI: 0.03, 0.52); 2) with IPC weights used to approximate a continuously adherent population (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.15, 95% CI: 0.04, 0.52); and 3) in per-protocol analysis (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.16, 95% CI: 0.05, 0.53). Our results suggest that the efficacy of PrEP with high adherence is over 80%.

Topics: Acquired Immunodeficiency Syndrome; Adult; Age Factors; Anti-HIV Agents; Double-Blind Method; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; Heterosexuality; HIV Infections; Humans; Incidence; Kenya; Male; Medication Adherence; Models, Statistical; Patient Satisfaction; Pre-Exposure Prophylaxis; Research Design; Sex Factors; Socioeconomic Factors

In 2019, the U.S. Food and Drug Administration (FDA) approved emtricitabine and tenofovir alafenamide (Descovy) as another option for HIV pre-exposure prophylaxis (PrEP) prevention for high-risk adults and adolescents. With the introduction of this new PrEP, millions of current users on emtricitabine and tenofovir disoproxil fumarate (Truvada), another PrEP medication currently used to prevent HIV transmission, have options of whether to continue their current treatment regime or transition to new treatment options. The objective of this study was to conduct a descriptive analysis to characterize user-generated social media conversations on Reddit associated with FDA-approved PrEP prevention treatment options. Key themes identified were associated with perceptions, knowledge, and attitudes associated with the transition of use of different PrEP medications. Data were collected retrospectively and prospectively from the Reddit platform for posts with keywords filtered for HIV, PrEP, and FDA-approved PrEP prevention treatment from October 2020 to December 2020. We chose the Reddit platform based on prior studies that have identified PrEP user conversations and insights on access challenges for specific AIDS communities, such as gays and men who have sex with men (MSM). Reddit posts were then manually annotated using an inductive content coding approach for key themes regarding the transition of use and other emergent themes from user-generated content. Formal coding of text data was conducted with refined codes, and sub-codes created. A total of 3,120 posts were analyzed from Reddit resulting in 315 posts that were coded for PrEP and 105 posts (33.33%) specific to user discussions regarding the transition of PrEP prevention. Overall, users expressed interest in drug switching to Descovy, particularly in the context of poorer adherence or concerns about existing side effects associated with Truvada. Other major themes included discussions about the cost of Descovy, apprehension about side effects in comparison to Truvada, insurance coverage changes, and discussions about the donation of Truvada to other users after transitioning. Among these discussions, topics related to sexual minorities, including MSM, reported concerns when considering a switch in their HIV prevention regime. Understanding the changing public perception associated with the introduction of new HIV prevention is important in the context of market access, patient safety, pharmacovigilance,

Topics: Acquired Immunodeficiency Syndrome; Adolescent; Adult; Anti-HIV Agents; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Homosexuality, Male; Humans; Male; Retrospective Studies; Sexual and Gender Minorities

Topics: Acquired Immunodeficiency Syndrome; AIDS Vaccines; Anti-HIV Agents; Clinical Trials as Topic; Coronavirus Infections; COVID-19; Delayed-Action Preparations; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Humans; Injections, Intramuscular; Pandemics; Pneumonia, Viral; Pyridones; Time Factors

We evaluated the relationship between 2 types of social relationships, ie, (1) external support for use of HIV pre-exposure prophylaxis (PrEP) and related study supplies and (2) participants' disclosure of PrEP use and condom use and HIV PrEP adherence among daily-dosing regimen participants in HIV Prevention Trials Network (HPTN) 067, an open-label trial of oral tenofovir (TFV) disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg.. Using HPTN 067 survey data, we developed scales examining (1) Low Perceived External Support for PrEP: low perceived support by others for PrEP use or perceived negative reactions to the pill case (scoring ranges from 0 to 2) and (2) Participant-Staff Disclosure Challenges Scale, which identifies challenges to sharing nonuse of PrEP or condoms to study staff (scoring ranges from 0 to 4); these scales are the primary independent variables. Adherence, the dependent variable, was determined using log-transformed plasma TFV concentrations. generalized estimating equation (GEE) linear regression was used to assess the association between both scales and adherence.. Participants (n = 161) included HIV-uninfected women in South Africa, and men who have sex with men and transgender women, in Thailand and the United States. In multivariable analyses, higher scores in the Participant-Staff Disclosure Challenges Scale were significantly associated with lower PrEP adherence [exp(β) = 0.62, 95% CI: (0.46 to 0.84); P = 0.002] as were increased days since the last PrEP dose [exp(β) = 0.73, 95% CI: (0.65 to 0.83); P ≤ 0.001].. Given the association with adherence, study staff-participant interactions and participants' disclosure of PrEP challenges may be worthwhile intervention targets for improving PrEP adherence in confirmatory studies.

Topics: Acquired Immunodeficiency Syndrome; Adult; Anti-HIV Agents; Condoms; Directly Observed Therapy; Disclosure; Drug Therapy, Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; Homosexuality, Male; Humans; Male; Medication Adherence; Middle Aged; Pre-Exposure Prophylaxis; Risk-Taking; Sexual and Gender Minorities; Social Networking; South Africa; Surveys and Questionnaires; Tenofovir; Thailand; United States; Young Adult

Toxoplasmosis is an important cause of enhancing brain lesions in patients with acquired immunodeficiency syndrome (AIDS), and it is typically associated with low CD4-lymphocyte counts. Extensive toxoplasma encephalitis when the CD4-lymphocyte count is above 100 cells/µl is unusual. Cavitary lung lesions are also not typically associated with toxoplasmosis. Here, we present a case of toxoplasmosis associated with extensive brain masses and cavitary lung lesions, both of which improved with directed toxoplasmosis therapy, in an AIDS patient with a CD4 cell count of 120 cells/µl.

Topics: Acquired Immunodeficiency Syndrome; AIDS-Related Opportunistic Infections; Anti-Infective Agents; Antibodies, Protozoan; Antiprotozoal Agents; Brain; CD4 Lymphocyte Count; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Heterocyclic Compounds, 3-Ring; Humans; Leucovorin; Magnetic Resonance Imaging; Male; Middle Aged; Oxazines; Piperazines; Polymerase Chain Reaction; Pyridones; Toxoplasma; Toxoplasmosis, Cerebral; Treatment Outcome

Topics: Access to Information; Acquired Immunodeficiency Syndrome; Adenine; Anti-HIV Agents; Deoxycytidine; Drug Combinations; Drug Therapy, Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Humans; Organophosphonates; Organophosphorus Compounds; Publishing; Tenofovir; United States; United States Food and Drug Administration

Topics: Acquired Immunodeficiency Syndrome; Cost-Benefit Analysis; Deoxycytidine; Drug Combinations; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Humans; Organophosphorus Compounds

Topics: Acquired Immunodeficiency Syndrome; Anti-HIV Agents; Deoxycytidine; Dideoxynucleosides; Drug Approval; Drug Combinations; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Humans; Lamivudine; Organophosphorus Compounds; United States; United States Food and Drug Administration