8 JANUARY 2021 VOLUME 23 ISSUE 1

Media Coverage

• New Twist in the Gilead Patent Lawsuit Over Truvada and Descovy to Prevent HIV

  Who holds the patents on the meds Truvada and Descovy when they’re used as pre-exposure prophylaxis (PrEP) for the prevention of HIV? Is it the federal government or the drugs’ manufacturer, Gilead Sciences? That’s been the subject of heated discussion and lawsuits since early 2019. In the latest development, a federal judge ruled last week that the government cannot ignore Gilead’s claims that the government breached its contracts when it asserted patents on Truvada as PrEP.

  January 7, 2021

  PrEP

  POZ

• Many Health Plans Now Must Cover Full Cost of Expensive HIV Prevention Drugs

  Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

  January 6, 2021

  PrEP

  Medscape

• Many Primary Care Providers Still Don’t Understand PrEP

  Eight years into the pre-exposure prophylaxis (PrEP) era and two years into the federal government’s plan to end the HIV epidemic in the United States by 2030, about half of the primary care providers in one hard-hit Texas community still lack a basic understanding of PrEP eligibility, side effects and adherence.

  January 6, 2021

  PrEP

  POZ

• Why Are Parents Living With HIV Still Being Advised Not to Breastfeed?

  In many parts of the world where access to clean water, refrigeration, and medical care are limited, breastfeeding of infants is the standard of care for parents living with HIV. It has been consistently shown to promote the overall survival and well-being of HIV-exposed infants, with an extremely low risk of HIV transmission. Yet, in the United States and Canada, public health guidelines oppose breastfeeding for new parents living with HIV, out of concern for potential parent-to-child transmission.

  January 6, 2021

  General

  The BodyPro

• US Government Updates Pregnancy and Perinatal HIV Guidelines

  On December 29, the Department of Health and Human Services updated its HIV treatment and prevention guidelines for pregnant people and their infants. The update incorporates recent data on the safety of dolutegravir during pregnancy, allows for shared decision-making on breast feeding and adds a whole new section on pre-exposure prophylaxis (PrEP) for conception, pregnancy and breast feeding.

  January 5, 2021

  PrEP

  POZ

• Make ‘U=U’ Discussions a Standard Part of HIV Care, Researchers Urge

  An online survey of around 2,390 people living with HIV and on antiretroviral treatment (ART) found that the majority knew they could not transmit HIV to a sexual partner if they achieved and maintained viral suppression – a concept known as ‘Undetectable equals Untransmittable’ or U=U.

  January 5, 2021

  Treatment

  Avert

• NIH Restructures HIV Clinical Trial Networks; AIDS Director Touts Milestones

  The National Institutes of Health (NIH) wound down its latest seven-year HIV research cycle with a reflection on its successes and a rollout of new clinical trial priorities heading into 2021. On Nov. 30, the agency announced the clinical investigators and institutions that will lead four federally funded HIV/AIDS clinical trials networks over the next seven years.

  January 4, 2021

  General

  The BodyPro

• US Waits on Approval of Long-Acting HIV Treatment Cabotegravir and Rilpivirine as European Union Gives the Green Light

  The era of once-a-month HIV treatment has begun in the European Union—and it may soon commence in the US as well. Long-acting pre-exposure prophylaxis (PrEP) is also on the horizon.

  December 29, 2020

  Treatment

  The BodyPro

• How HIV Research Laid the Foundation for COVID Vaccines

  People are receiving COVID-19 vaccines less than a year after public health authorities discovered SARS-CoV-2, the deadly new coronavirus. How did it happen so quickly? In part, the world can thank decades of frustrating and often fruitless research to find a vaccine for Human Immunodeficiency Virus or HIV, the virus that causes AIDS. Many of the new technologies and approaches employed to create potent COVID-19 vaccines and therapies trace their origins to the desperate search, starting in the early 1980s, to slow the spread of HIV.

  December 24, 2020

  General

  Wall Street Journal

Published Research

• Recapitulation of HIV-1 Env-Antibody Coevolution in Macaques Leading to Neutralization Breadth

  Roark et al. report that the immediate and short-term evolutionary potential of the HIV envelope is constrained because of a number of essential functions, including antibody escape. Consequently, when introduced into humans as HIV or into rhesus macaque monkeys as chimeric simian-human immunodeficiency virus, homologous envelope glycoproteins appear to exhibit conserved patterns of sequence evolution, in some cases eliciting broadly neutralizing antibodies in both hosts.

  January 8, 2021

  Antibody Related Research

  Science

• In Silico and in Vivo Analysis of HIV-1 Rev Regulatory Protein for Evaluation of a Multiepitope-based Vaccine Candidate

  The results demonstrated that groups immunized with heterologous DNA+ MPG or HR9 CPP prime/rNef-Rev-Gp160-P24 polypeptide + LDP-NLS CPP boost regimens could significantly produce higher levels of IFN-γ and Granzyme B, and lower amounts of IL-10 than other groups. Moreover, higher levels of IgG2a and IgG2b were observed in all heterologous prime-boost regimens than homologous DNA or polypeptide regimens.

  January 8, 2021

  HIV Vaccine

  Immunological Investigations

• In Vivo Delivery of a Multiepitope Peptide and Nef Protein Using Novel Cell-Penetrating Peptides for Development of HIV-1 Vaccine Candidate

  The heterologous prime/boost regimens for both antigens could significantly direct immune responses toward Th1 and CTL activity compared to other regimens. Comparing the efficiency of Nef-Vpr-Gp160-P24 and Nef constructs, the Nef-Vpr-Gp160-P24 constructs delivered by CPPs showed promising results as an HIV vaccine candidate.

  January 8, 2021

  HIV Vaccine

  Biotechnology Letters

• Women Design Their Own Vaginal Microbicide Trial: Suggestions on How To Improve Adherence From Former Participants of HIV Prevention Trials

  Participants made concrete suggestions for improving microbicide trial design such as applicator use testing and real time feedback, improving education to participants about how trials answer their research questions, and improving transparency and clarity about study procedures. Participants also gave feedback on an innovative trial design with a non-randomised arm. Identifying HIV prevention products for women requires better understanding of the lives of women asked to join these trials, and application of that understanding to microbicide trial design.

  January 7, 2021

  Microbicides

  PLOS One

• Knowledge of PEP and PrEP Among People Living With HIV/AIDS in Brazil

  The knowledge about PEP and PrEP is low in Brazil. This may undermine secondary prevention efforts. Educational interventions to raise awareness of these prevention methods are needed among people living with HIV and who have HIV-negative sexual partners.

  January 7, 2021

  PrEP

  BMC Public Health

• Modulation of BRD4 in HIV Epigenetic Regulation: Implications for Finding an HIV Cure

  Our studies have reported a novel class of small-molecule modulators that are distinct from JQ1 but induce HIV transcriptional suppression through BRD4. Herein, we reviewed recent research on the modulation of BRD4 in HIV epigenetic regulation and discussed their potential implications for finding an HIV cure.

  January 7, 2021

  Cure

  Retrovirology

• A Qualitative Study To Identify Critical Attributes and Attribute-Levels for a Discrete Choice Experiment on Oral Pre-Exposure Prophylaxis (PrEP) Delivery Among Young People in Cape Town and Johannesburg, South Africa

  There is limited literature on qualitative research methods describing the step-by-step process of developing a DCE for PrEP in adolescents, especially in resource-constrained countries. We provide the process followed for the DCE technique to understand user preferences for daily and on-demand oral PrEP among young people in South Africa.

  January 6, 2021

  PrEP

  BMC Health Services Research

• Influence of Plasticizers on the pH-Dependent Drug Release and Cellular Interactions of Hydroxypropyl Methylcellulose/Zein Vaginal Anti-HIV Films Containing Tenofovir

  The films had similar or higher levels of TFV associated with genital epithelial cells (Ca Ski or HEC-1-A cells) but lower drug permeability compared to the free drug. These data confirm that films have the potential to achieve suitable mucosal levels of TFV with low systemic exposure. The films developed could protect women from HIV sexual transmission.

  January 6, 2021

  Microbicides

  Biomacromolecules

• A Qualitative Exploration of Women's Interest in Long-Acting Injectable Antiretroviral Therapy Across Six Cities in the Women's Interagency HIV Study: Intersections with Current and Past Injectable Medication and Substance Use

  Four primary categories of women emerged; those who (1) received episodic injections and had few LAI-related concerns; (2) required frequent injections and would refuse additional injections; (3) had a history of injection drug use, of whom some feared LAI might trigger a recurrence, while others had few LAI-related concerns; and (4) were currently injecting drugs and had few LAI-related concerns. Most women with a history of injectable medication would prefer LAI, but those with other frequent injections and history of injection drug use might not.

  January 4, 2021

  Treatment

  AIDS Patient Care and STDs

• Research Priorities to End the Adolescent HIV Epidemic in the United States: Viewpoint

  The investigators prioritized research in the following areas: (1) innovative interventions for youth to increase screening, uptake, engagement, and retention in HIV prevention (eg, pre-exposure prophylaxis) and treatment services; (2) structural changes in health systems to facilitate routine delivery of HIV services; (3) biomedical strategies to increase ART impact, prevent HIV transmission, and cure HIV; (4) mobile technologies to reduce implementation costs and increase acceptability of HIV interventions; and (5) data-informed policies to reduce HIV-related disparities and increase support and services for GBT youth and youth living with HIV. ATN’s research priorities provide a roadmap for addressing the HIV epidemic among youth. To reach this goal, researchers, policy makers, and health care providers must work together to develop, test, and disseminate novel biobehavioral interventions for youth.

  January 4, 2021

  General

  JMIR Research Protocols

• Sexually Transmitted Infections (STI) and Antenatal Care (ANC) Clinics in Malawi: Effective Platforms for Improving Engagement of Men at High HIV Risk With Voluntary Medical Male Circumcision Services

  Integrating VMMC recruitment and follow-up in STI and ANC clinics co-located with VMMC services can augment demand creation and targeting of men at risk of HIV, based on age and STI history. This approach can be replicated at least in similar health facilities with ANC and STI services in close proximity to VMMC service delivery.

  January 4, 2021

  Voluntary Medical Male Circumcision

  Sexually Transmitted Infections

• Men’s Sexual Experiences with the Dapivirine Vaginal Ring in Malawi, South Africa, Uganda and Zimbabwe

  Over half (59 percent) never noticed the ring; some attempting and failing to feel it during intercourse. A majority of men reported that the ring did not lead to changes in sexual positions, feelings, frequency or experience of sex, although some were initially afraid that the ring was a “magic snake” or “potion”. Male partners expressed strong opinions that ring use was a shared prevention responsibility that men should be engaged in, especially for maintaining trust and open communication in relationships. The ring was noticed by many male partners, particularly during women’s initial stages of ring use, although this led to few sexual problems or changes. Nevertheless, results suggest that risk of ring discovery should be discussed with women to mitigate any potential negative reactions or social harm. Strategies to increase male partner engagement will enhance support of this prevention method for women.

  January 2, 2021

  Microbicides

  AIDS and Behavior

• Change in Condom Use in Populations Newly Aware of HIV Diagnosis in the United States and Canada: A Systematic Review and Meta-Analysis

  HIV-infected individuals “aware” of their infection are more likely to use condoms, compared to HIV-infected “unaware” persons. To quantify this likelihood, we undertook a systematic review and meta-analysis of US and Canadian studies. Twenty-one eligible studies included men who have sex with men, persons who inject drugs, and mixed populations of high-risk heterosexuals. Risk ratios (RR) of “not always using condoms” with partners of any serostatus were lower among aware MSM, PWID and HRH; and, in aware MSM, with partners of HIV-uninfected or unknown status. Aware individuals had lower “condomless sex likelihood” with HIV-uninfected or unknown status partners and with partners of any serostatus. The association diminished over time. High risk of bias compromised evidence quality.

  January 2, 2021

  Male and Female Condoms

  AIDS and Behavior

• PrEP Use and PrEP Use Disclosure are Associated with Condom Use During Sex: A Multilevel Analysis of Latino MSM Egocentric Sexual Networks

  Participants who reported using PrEP or having more sexual partners were more likely to use condoms; however, participants who reported disclosing PrEP use were less likely to use condoms. Future longitudinal studies should characterize approaches to increase informed personal health choices and conversations about PrEP, condom use, and other HIV risk-reduction strategies using network methodologies.

  January 2, 2021

  Male and Female Condoms, PrEP

  AIDS and Behavior

• Trajectories of PrEP Adherence Among Young Women Aged 16 to 25 in Cape Town, South Africa

  Two adherence trajectory groups were identified: 52 percent with high early adherence that declined after month three and 48 percent with low adherence throughout. Adherence in the “consistently low” group was related to social support and logistical concerns, while the decrease in the “high declining” group corresponded to a change in the frequency of study visits from monthly to quarterly. PrEP support should be differentiated for those who need more frequent visits and adherence support initially versus later in PrEP use.

  January 2, 2021

  PrEP

  AIDS and Behavior

• HIV-1 p24-nef DNA Vaccine plus Protein Boost Expands T-Cell Responses in BALB/c

  The truncated form of p24-Nef was evaluated highly immunogenic specially when applied in prim-boost DNA/Protein regimen and could be investigated in other delivery systems and a proper animal model to achieve a therapeutic vaccine candidate against HIV-1.

  December 31, 2020

  HIV Vaccine

  Current Drug Delivery

• HIV-1 Accessory Proteins: Which one is Potentially Effective in Diagnosis and Vaccine Development?

  Generally, among accessory proteins, Nef, Vpu and Vif antigens were potentially more suitable vaccine antigen candidates than Vpr antigen. Human antibodies against all these proteins were higher in HIV-1 different groups than healthy group. Among them, Vpu was known as a potent antigen in diagnosis of treated from untreated individuals. The potency of accessory proteins as an antigen candidate in an animal model and a human cohort study are underway.

  December 31, 2020

  HIV Vaccine

  Protein & Peptide Letters

• The PrEP Cascade in a National Cohort of Adolescent Men Who Have Sex With Men

  AMSM PrEP use falls short of recommended levels. PrEP campaigns are needed to raise awareness by targeting key AMSM-subgroups that underestimate the appropriateness of use. Equally important, parents and health providers of AMSM should serve educational roles to help facilitate potential PrEP uptake, by motivating adolescents and giving them the skills needed to request, fill, and adhere to a prescription.

  December 30, 2020

  PrEP

  JAIDS

• The Effect of Depot Medroxyprogesterone Acetate on Tenofovir Alafenamide in Rhesus Macaques

  A high-dose DMPA treatment in macaques was associated with increased rectal TFV-DP levels, indicating a potential tissue-specific drug-drug interaction. The lack of detectable TFV-DP in the vaginal tissue warrants further investigation of PrEP efficacy with single-agent TAF products. DMPA did not affect systemic TAF metabolism, with similar PBMC TFV-DP in both groups, suggesting that DMPA use should not alter the antiviral activity of TAF.

  December 29, 2020

  Hormonal Contraceptives and HIV, PrEP, Treatment

  Antiviral Research

• Bictegravir Plus Tenofovir Alafenamide Nanoformulation as a Long-Acting Pre-Exposure Prophylaxis Regimen: Application of Modeling to Design Non-Human Primate Pharmacokinetic Experiments

  Using BIKTARVY equivalent dosages (from their NHP studies), we predicted that, following just one SC dose of nBIC-TAF in NHP, both BIC and tenofovir will have detectable and above in vitro efficacy levels for 28 days. Furthermore, the MBPK was able to provide a mechanistic explanation regarding the long-acting mechanism characterizing nBIC-TAF: nanoparticles stores in the SC space from which drugs slowly dissociate. Dissociated drugs in the SC space then buffer the plasma pool over time, yielding an extended-release effect in the plasma. Overall, we predicted for nBIC-TAF a promising long-acting pharmacokinetic in NHP, potentially usable as monthly PrEP. These results will help investigators to gain confidence for facing regulatory submissions at early stages.

  December 18, 2020

  PrEP

  Frontiers in Pharmacology

• Sexual Risk Compensation Following Voluntary Medical Male Circumcision: Results From a Prospective Cohort Study Amongst Human Immunodeficiency Virus-Negative Adult Men in Botswana

  We found no evidence of sexual risk compensation in the 3 months following VMMC.

  December 14, 2020

  Voluntary Medical Male Circumcision

  Southern African Journal of HIV Medicine

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