Category Archives: News

April 8th, 2020- Partnership-level correlates of IPV among men who have sex with men (MSM) and transgender women (TW) in Peru were analyzed in a recent publication. This analysis aimed to improve understanding of factors associated with intimate partner violence (IPV) and explore its role in sexually transmitted infection (STI) acquisition. Dr. Steve Shoptaw, CHIPTS Director, and Dr. Jesse Clark, CHIPTS Combination Prevention Core Scientist, were co-authors.

Read more about the article’s findings here, or download the PDF version below.

[Download not found]

This article originally appeared on aidsinfo.nih.gov. To see the full article, click here.

This interim guidance reviews special considerations for persons with HIV and their health care providers in the United States regarding COVID-19. Information and data on COVID-19 are rapidly evolving. This guidance includes general information to consider. Clinicians should refer to updated sources for more specific recommendations regarding COVID-19.

Guidance for all Persons with HIV

• In current reports, individuals aged >60 years and those with diabetes, hypertension, cardiovascular disease, or pulmonary disease are at highest risk of life-threatening COVID-19, the illness caused by the virus known as SARS-CoV-2.
• The limited data currently available do not indicate that the disease course of COVID-19 in persons with HIV differs from that in persons without HIV. Before the advent of effective combination antiretroviral therapy (ART), advanced HIV infection (i.e., CD4 cell count <200/mm³) was a risk factor for complications of other respiratory infections. Whether this is also true for COVID-19 is yet unknown.
• Some people with HIV have other comorbidities (e.g., cardiovascular disease or lung disease) that increase the risk for a more severe course of COVID-19 illness. Chronic smokers are also at risk of more severe disease.
• Thus, until more is known, additional caution for all persons with HIV, especially those with advanced HIV or poorly controlled HIV, is warranted.
• Every effort should be made to help persons with HIV maintain an adequate supply of ART and all other concomitant medications.
• Influenza and pneumococcal vaccinations should be kept up to date.
• Persons with HIV should follow all applicable recommendations of the U.S. Centers for Disease Control and Prevention (CDC) to prevent COVID-19, such as social distancing and proper hand hygiene. These recommendations are regularly updated.
• Information on COVID-19 prevention in children with HIV for pediatric health care providers and the general public is available from CDC.
• CDC also provides information about COVID-19 prevention during pregnancy.

See additional guidance and recommendations here.

New emerging evidence from a systematic review of the safety of PrEP for pregnant and postpartum women has been released in a new publication co-authored by CHIPTS members Dvora Davey, Thomas Coates, and Steven Shoptaw, Director of CHIPTS.

The abstract summary of the publication can be found below, alongside the full publication available for download here- [Download not found]

Introduction: HIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.

Methods: We used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that
assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.

Results and discussion: We identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.

Conclusions: Expanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.

This article originally appeared on niaid.nih.gov. To see the full article, click here.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has stopped administration of vaccinations in its HVTN 702 clinical trial of an investigational HIV vaccine. This action was taken because an independent data and safety monitoring board (DSMB) found during an interim review that the regimen did not prevent HIV. Importantly, the DSMB did not express any concern regarding participant safety.

The Phase 2b/3 study, named HVTN 702 or Uhambo, began in 2016 and is taking place in South Africa. It was testing an investigational prime-boost vaccine regimen based on the only vaccine regimen ever to show protection from HIV—the regimen tested in the RV144 clinical trial in Thailand led by the U.S. Military HIV Research Program and the Thai Ministry of Health. For HVTN 702, the vaccine regimen was adapted to the HIV subtype Clade C most common in southern Africa, where the pandemic is most pervasive.

“An HIV vaccine is essential to end the global pandemic, and we hoped this vaccine candidate would work. Regrettably, it does not,” said NIAID Director Anthony S. Fauci, M.D. “Research continues on other approaches to a safe and effective HIV vaccine, which I still believe can be achieved.”

The HVTN 702 study enrolled 5,407 HIV-negative volunteers at 14 sites across South Africa. The study population consisted of sexually active men and women aged 18 to 35 years. The study volunteers were randomly assigned to receive either the investigational vaccine regimen or placebo injections. Study participants received six injections over 18 months. As with all NIAID-sponsored HIV prevention trials, the safety of HVTN 702 study participants was closely monitored throughout the trial, and participants were offered the local standard of care for preventing HIV, including access to oral pre-exposure prophylaxis (PrEP).

Read more here.

This report originally appeared on hiv.gov. To view the full report, click here.

On Friday, 1/24/20, the CDC published a major funding opportunity designed to advance Ending the HIV Epidemic: A Plan for America. The plan was announced by President Trump during the State of the Union last year; and Congress recently approved funding for the initiative, which is being coordinated by the Office of the Assistant Secretary for Health. The resources will be infused into communities most impacted by HIV and provide a major boost to the bold initiative to reduce new HIV infections by 90% by 2030.

This five-year funding program is titled “Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States (PS20-2010).” First-year awards are expected to total approximately $109 million.

This funding opportunity can help end this epidemic by infusing communities with the resources, technology, and expertise needed to strengthen HIV prevention and treatment. To achieve maximum impact, the funding targets geographic areas that account for more than half of new HIV diagnoses, and states with a substantial rural burden. In recent months, each of these jurisdictions has developed a comprehensive Ending the HIV Epidemic plan, informed by consultations with diverse stakeholders and community-level input.

The new funding opportunity includes three components:

1. Component A (up to 32 awards) will help state, local, and territorial health departments scale up four strategies that can end the epidemic: diagnosing all people with HIV as early as possible; treating people with HIV rapidly and effectively to reach sustained viral suppression; preventing new HIV transmissions with proven interventions, including PrEP and syringe services programs; and responding quickly to potential outbreaks to get needed prevention and treatment services to people who need them.
2. Component B (up to 8 awards) will fund health departments to use routinely collected HIV surveillance data to calculate CD4-based HIV incidence estimates. These estimates will help communities plan, implement, and evaluate prevention and treatment programs.
3. Component C (up to 8 awards) will allow health departments to scale up innovative HIV prevention services in STD clinics.

Details about the funding opportunity are available on CDC’s website. Applications are due on March 25, 2020 and the anticipated award will begin on June 1, 2020.

For more information about CDC’s role in Ending the HIV Epidemic, visit www.cdc.gov/endhiv.

You can also learn more about Ready, Set, PrEP, the new nationwide program that provides PrEP medications at no cost to thousands of individuals who qualify.

Read more here. 

This report originally appeared on nih.gov. To view the full report, click here.

The HHS Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission (the Panel) is pleased to announce the release of the updated Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.

Key updates to the guidelines include the following:

• The Panel has updated the recommendations on the use of dolutegravir (DTG) in pregnant women and women who are trying to conceive based on data available as of August 2019. Restrictions on the use of DTG during the first trimester and in women who are trying to conceive have been removed. DTG is now a Preferred antiretroviral (ARV) drug throughout pregnancy and an Alternative ARV drug for women who are trying to conceive.
• In a number of sections, the Panel emphasizes the importance of patient counseling and recommends supporting informed decision-making regarding the use of DTG and other ARV drugs for women who are pregnant or who are trying to conceive. A counseling guide has been added to summarize the content that should be discussed with patients; this new section is titled Appendix D: Dolutegravir Counseling Guide for Health Care Providers.
• In Recommendations for Use of Antiretroviral Drugs During Pregnancy, the Panel has updated the definitions for the Preferred and Alternative categories of ARV drugs recommended for use in pregnancy and in women who are trying to conceive. In addition, the Panel recommends that all pregnant women and women who might conceive should take at least 400 mcg of folic acid daily.
• A new section was added to Teratogenicity with data about the association between integrase strand transfer inhibitors (INSTIs) and birth defects. This section was also updated to include recent data about an increased rate of microcephaly in HIV-exposed but uninfected children with in utero efavirenz exposure.
• Combination Antiretroviral Drug Regimens and Maternal and Neonatal Outcomes was revised and reorganized to focus on data regarding preterm birth, fetal growth restriction, miscarriage, and stillbirth that has been published since 2015. This section also discusses data about hypertensive disorders of pregnancy and maternal HIV.
• Lack of Viral Suppression now states that, after reviewing a woman’s full treatment history and drug resistance test results, a clinician may consider using an INSTI as part of a new regimen for a pregnant woman who is experiencing virologic failure on an ARV regimen that does not contain an INSTI.
• Older ARV drugs that the Panel does not recommend for use in pregnant women or women who are trying to conceive because of unacceptable toxicities, inferior virologic efficacy, high pill burden, pharmacologic concerns, and/or limited data about use in pregnancy have been moved to a new section in Appendix B titled Archived Drugs; data about these drugs will no longer be reviewed by the Panel.

For a complete list of updates, please see What’s New in the Guidelines. Additions and revisions are highlighted in yellow throughout the PDF version of the guidelines.

To view or download the guidelines, go to the Perinatal Guidelines section of AIDSinfo’s website. The guideline tables and recommendations can also be downloaded as separate PDF files.

This report originally appeared on nih.gov. To view the full report, click here.

The HHS Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) has just released an updated version of the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.

Key updates in this version of the guidelines include:

• Antiretroviral Therapy to Prevent Sexual Transmission of HIV: Clinical trials have shown that using effective antiretroviral therapy (ART) to consistently suppress plasma HIV RNA levels to <200 copies/mL prevents transmission of HIV to sexual partners. When ART is used to prevent HIV transmission, this strategy is called treatment as prevention (TasP). The Panel has added a new section to the guidelines to help providers integrate TasP into their clinical practice.
• The latest data on neural tube defects (NTDs) in infants born to women who received dolutegravir (DTG) around the time of conception have shown that the prevalence of NTDs is lower in these infants than initially reported. Based on the new data, the Panel has revised some recommendations related to the use of DTG in individuals who are of childbearing potential and who are trying to conceive, those who are sexually active and not using contraception, and those who are using effective contraception.
• What to Start: The Panel has added DTG plus lamivudine to the list of Recommended Initial Regimens for Most People with HIV, except for individuals who have pre-treatment HIV RNA >500,000 copies/mL, who are known to have active hepatitis B virus (HBV) coinfection, or who will initiate ART before results of HIV genotype testing for reverse transcriptase or HBV testing are available.
• Cost Considerations and Antiretroviral Therapy: A new sub-section on cost sharing that describes how varying cost-containment practices may impact the out-of-pocket payments for patients with Medicaid, Medicare, and Ryan White (AIDS Drug Assistance Program) coverage has been added. To help clinicians better understand the different ART-related pricing systems in the United States, a new table titled Table 19a. Insurance and Health Program Prescription Drug Pricing and Access was created.
• Acute and Recent (Early) HIV Infection: Bictegravir/tenofovir alafenamide/emtricitabine has been added as a treatment option for persons with acute or recent HIV infection in cases where ART will be initiated before genotypic drug resistance testing results are available.
• Initiation of Antiretroviral Therapy: The Panel recommends that ART be started immediately or as soon as possible after diagnosis to increase the uptake of ART, decrease the time required to achieve linkage to care and virologic suppression for individual patients, reduce the risk of HIV transmission, and improve the rate of virologic suppression among persons with HIV.
• Laboratory Testing for Initial Assessment and Monitoring of People with HIV Receiving Antiretroviral Therapy: The Panel previously recommended monitoring fasting lipid profile and fasting glucose before and after initiating ART. This section now includes a new recommendation that allows for random (nonfasting) tests.
• Tuberculosis/HIV Coinfection: This section now includes newly published data on short-course regimens in the treatment of latent tuberculosis infection and new drug-drug interaction data for antiretroviral drugs and rifampin and rifapentine.

For a complete list of guideline updates, please see What’s New in the Guidelines. Additions and revisions are also highlighted in yellow throughout the PDF version of the guidelines.

To view or download the guidelines, go to the Adult and Adolescent Antiretroviral Guidelines section of AIDSinfo’s website. The guideline tables and the boxed recommendations can also be downloaded as separate PDF files.

This article originally appeared on nih.gov. To view the full article, click here.

Efforts to prevent new HIV transmissions in the United States must be accompanied by advances in addressing HIV-associated comorbidities to improve the health of people already living with HIV, National Institutes of Health experts assert in the third of a series of JAMA commentaries. Previous commentaries detailed the proposed Ending the HIV Epidemic: A Plan for America, which aims to reduce new HIV transmissions in the United States by 75% in five years and 90% in 10 years, and discussed the challenges posed by the emerging opioid injection epidemic in rural areas.

Assuming the aspirational goals of Ending the HIV Epidemic are achieved, at least one million people in the United States still will be living with the virus. With effective antiretroviral therapy (ART), people with HIV can expect a near-normal lifespan.

Read more. 

This report originally appeared on hhs.gov. To view the full report, click here.

The U.S. Department of Health and Human Services (HHS) today launched Ready, Set, PrEP, a national program that makes medications for pre-exposure prophylaxis (PrEP), taken daily to prevent HIV, available at no cost to people without prescription drug insurance coverage.

Although more than one million people at risk for HIV in the United States could benefit from PrEP medications, only a small fraction get them. The Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force  recommend PrEP for individuals at risk of acquiring HIV. When taken as prescribed, PrEP is highly effective at reducing an individual’s risk of acquiring HIV.

Ready, Set, PrEP is a key component of the Ending the HIV Epidemic: A Plan for America (EHE) initiative. EHE aims to reduce the number of new HIV infections in the United States by 75% in five years and by 90% in 10 years. By increasing awareness of PrEP and its access, the Ready, Set, PrEP program can provide thousands of people a safe, effective way to prevent HIV and bring our nation one step closer to ending the HIV epidemic.

Read more.