Long-Acting Injectable Cabotegravir plus Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
Authors: Rizzardini, Giuliano; Overton, Edgar T.; Orkin, Chloe; Swindells, Susan; Arasteh, Keikawus; Gorgolas Hernandez-Mora, Miguel; Pokrovsky, Vadim; Girard, Pierre-Marie; Oka, Shinichi; Andrade-Villanueva, Jaime F.; Richmond, Gary J.; Baumgarten, Axel; Masia, Mar; Latiff, Gulam; Griffith, Sandy; Harrington, Conn M.; Hudson, Krischan J.; St Clair, Marty; Talarico, Christine L.; Patel, Parul; Cutrell, Amy; Van Eygen, Veerle; D'Amico, Ronald; Mrus, Joseph M.; Wu, Sterling; Ford, Susan L.; Chow, Ken; Roberts, Jeremy; Wills, Angela; Walters, Nicola; Vanveggel, Simon; Van Solingen-Ristea, Rodica; Crauwels, Herta; Smith, Kimberly Y.; Spreen, William R.; Margolis, David A.
Abstract
Background: Long-acting (LA) injectable regimens are a potential therapeutic option in people living with HIV-1. Setting: ATLAS (NCT02951052) and FLAIR (NCT02938520) were 2 randomized, open-label, multicenter, multinational phase 3 studies. Methods: Adult participants with virologic suppression (plasma HIV-1 RNA <50 copies/mL) were randomized (1:1) to continue with their current antiretroviral regimen (CAR) or switch to the long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In the LA arm, participants initially received oral CAB + RPV once-daily for 4 weeks to assess individual safety and tolerability, before starting monthly injectable therapy. The primary endpoint of this combined analysis was antiviral efficacy at week 48 (FDA Snapshot algorithm: noninferiority margin of 4% for HIV-1 RNA >= 50 copies/mL). Safety, tolerability, and confirmed virologic failure (2 consecutive plasma HIV-1 RNA >= 200 copies/mL) were secondary endpoints. Results: The pooled intention-to-treat exposed population included 591 participants in each arm [28% women (sex at birth), 19% aged >= 50 years]. Noninferiority criteria at week 48 were met for the primary (HIV-1 RNA >= 50 copies/mL) and key secondary (HIV-1 RNA <50 copies/mL) efficacy endpoints. Seven individuals in each arm (1.2%) developed confirmed virologic failure; 6/7 (LA) and 3/7 (CAR) had resistance-associated mutations. Most LA recipients (83%) experienced injection site reactions, which decreased in incidence over time. Injection site reactions led to the withdrawal of 6 (1%) participants. The serious adverse event rate was 4% in each arm. Conclusion: This combined analysis demonstrates monthly injections of CAB + RPV LA were noninferior to daily oral CAR for maintaining HIV-1 suppression.
Gay Sex Workers in China's Medical Care System: The Queer Body with Necropolitics and Stigma
INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH
Authors: Yuk-ha Tsang, Eileen
Abstract
The struggles of China's gay sex workers-men who sell sex to other men-illustrate how the multi-layered stigma that they experience acts as a form of necropolitical power and an instrument of the state's discrimination against gay sex workers who are living with HIV. One unintended side effect of this state power is the subsequent reluctance by medical professionals to care for gay sex workers who are living with HIV, and discrimination from Chinese government officers. Data obtained from 28 gay sex workers who are living with HIV provide evidence that the necropower of stigma is routinely exercised upon the bodies of gay sex workers. This article examines how the necropolitics of social death and state-sanctioned stigma are manifested throughout China's health system, discouraging gay sex workers from receiving health care. This process uses biopolitical surveillance measures as most of gay sex workers come from rural China and do not enjoy urban hukou, thus are excluded from the medical health care system in urban China. Public health priorities demand that the cultured scripts of gendered Chinese citizenship must reevaluate the marking of the body of gay sex workers as a non-entity, a non-human and socially "dead body."