Inside This Issue: Ryan White and ADAP report, HRSA funding opportunity, in-home HIV testing, PrEP, PACHA meeting summary, 2020 HIV drug guide, and COVID-19 update.
Ryan White HIV/AIDS Program
NASTAD Publishes 2020 RWHAP Part B and ADAP Report
In 2017, NASTAD’s National ADAP Monitoring Project evolved to include data not only for the National Ryan White HIV/AIDS Program (RWHAP) AIDS Drug Assistance Program (ADAP), but also for RWHAP Part B – the program under which ADAP falls. The newly published 2020 National RWHAP Part B and ADAP Monitoring Project Annual Report features comprehensive, longitudinal data spanning several domains of the RWHAP Part B program and ADAP, including budget, expenditures, service utilization, and client demographics. The report is divided into three sections described below and includes more than 40 tables and charts that summarize key data and trends.
- Section 1, “RWHAP Part B Program Funding and Structure,” provides an overview of Part B – the RWHAP component that ensures state and territorial health departments are funded to provide core medical and support services to eligible clients equitably across urban and rural regions – as well as extensive information on the Part B budget. The report’s Tables 1 through 5 provide extensive state-specific data on budgets.
- Section 2, “Effective and Comprehensive Care in Achieving an End to the HIV Epidemic,” describes jurisdictional and federal efforts under the Ending the HIV Epidemic (EHE) initiative launched by the Trump Administration in 2019. The data indicated that RWHAP clients served by Part B and ADAP have much higher retention in care and viral suppression rates than the overall population of people with HIV in the U.S.
- Section 3, “Expanding and Adapting Service Delivery in a Changing Healthcare Landscape,” describes opportunities to expand the reach and breadth of RWHAP Part B services, as well as the impact of policy changes on RWHAP Part B and ADAP. The data indicate that payments for client insurance premiums have grown significantly. In addition, viral suppression rates are highest among clients in states that expanded their Medicaid programs under the Affordable Care Act.
HRSA Funding Opportunity for RWHAP Emergency Relief Grant Program
HRSA’s HIV/AIDS Bureau recently published a Notice of Funding Opportunity (HRSA-21-055) for the RWHAP Part A HIV Emergency Relief Grant Program (ERGP). The ERGP provides direct financial assistance to eligible metropolitan areas (EMAs) or transitional grant areas (TGAs) that have been severely affected by the HIV epidemic. Eligible jurisdictions may use the grant funds to develop or enhance access to a continuum of high quality, community-based care for people with HIV. The goal is to provide optimal HIV care and treatment that will improve the health outcomes of people with HIV who are low-income, uninsured, and underserved. Applications for the grants are due by October 7, and awards are expected to be made by March 1, 2021. HRSA will hold a pre-application webinar on July 30 from 2 to 4 p.m. EDT. For additional information, contact: Chrissy Abrahms-Woodland, firstname.lastname@example.org; phone: (301) 443-1373.
HIV Testing and Treatment
New Information from FDA About OraQuick In-Home HIV Test
The FDA recently published a plain-language summary and fact sheet about the OraQuick In-Home HIV Test – a rapid, self-administered, over-the-counter (OTC) test. The In-Home HIV Test kit consists of a test stick to collect the specimen, a test tube (vial) to insert the test stick and complete the test, testing directions, two information booklets, a disposal bag, and phone numbers for consumer support. The summary and fact sheet are in a frequently-asked-questions format, and include information about the following:
- What the test kit is and how it works;
- The test kit’s components;
- How to perform the test;
- The reliability of test results; and
- Guidance on when to take an HIV test.
In related news, the Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) recently authorized its Minority AIDS Initiative (MAI) grantees to temporarily use grant funds to purchase HIV and hepatitis C self-test kits that can be mailed to clients receiving substance use disorder treatment. In a message to grantees, CSAT’s Dr. Kirk James explained that the temporary approval was made in response to the reduced availability of HIV and hepatitis C testing in traditional in-person settings because of the COVID-19 pandemic.
FDA Approves Dolutegravir for Treating Infants and Children with HIV
On June 12, the U.S. Food and Drug Administration (FDA) approved dolutegravir (Tivicay and Tivicay PD) tablets for suspension, in combination with other antiretroviral treatments, to treat HIV infection in children at least four weeks old and weighing at least 3 kilograms (6.6 pounds). Dolutegravir is an antiretroviral drug in the integrase inhibitor class. FDA first approved the drug for HIV treatment in adults and adolescents in August 2013.
“For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults,” noted Dr. Debra Birnkrant of FDA’s Center for Drug Evaluation and Research. “While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV.” Dr. Birnkrant also said that the once-daily dosing of dolutegravir could make it easier for children with HIV to adhere to their treatment, compared with more complex regimens. “Today’s approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”
Two Additional Companies Donate Dispensing Services to the Ready, Set, PrEP Program
By July 30, Albertsons Companies and Walmart will begin donating their dispensing services to HHS’s Ready, Set, PrEP program, which makes HIV pre-exposure prophylaxis (PrEP) medications available at no cost to qualified persons who lack insurance coverage for prescription drugs. Albertsons and Walmart join several other national and specialty pharmacies – including Avita Pharmacy, CVS Health, Health Mart, Rite Aid, and Walgreens – in donating dispensing services to Ready, Set, PrEP. These donating pharmacies together represent about half of the pharmacies in the U.S., according to HHS. They include more than 32,000 pharmacy locations in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as the capacity to distribute PrEP medications for free by mail order. The participating pharmacies have also agreed to help patients with medication adherence. The recent donation of dispensing services by Albertsons and Walmart “further expand access for patients by making PrEP medications available at groceries stores, even more pharmacies and retail stores, and by mail,” according to Dr. Brett Giroir, HHS’s assistant secretary for health.
To receive PrEP medication through the Ready, Set, PrEP program, patients must:
- test negative for HIV;
- have a valid prescription from their healthcare provider; and
- not have health insurance coverage for outpatient prescription drugs.
Before enrolling in the program, patients are also advised to talk with their healthcare provider – or find a provider at the HIV.gov Locator – to discuss whether PrEP is right for them.
AIDSinfo Updates Five Investigational HIV Drug Fact Sheets
HHS recently posted updated versions of fact sheets for five investigational HIV drugs to its AIDSinfo site. Although these drugs are currently being studied in clinical trials, the FDA has not yet approved them for HIV treatment or prevention. The fact sheets are available in three formats: plain-language “patient versions,” in English and Spanish, and a health professional version in English only. The patient versions include an overview of the drug and information about clinical trials studying the drug. The health professional version has more detailed, scientific information about the drug, including its pharmacology and any side effects that have been identified in clinical trials.
For each drug below, the first link is to the English-language patient version, followed by a brief description of its drug class, and links to the Spanish-language patient version and the health professional version:
- 3BNC117 – broadly neutralizing antibodies (Spanish, health professional)
- LC002 – therapeutic vaccine (Spanish, health professional)
- Peginterferon alfa-2b – immune modulator (Spanish, health professional)
- UB-421 – CD4 attachment inhibitor (Spanish, health professional)
- Vorinostat – latency reversing agent (Spanish, health professional)
Video Summary of June PACHA Meeting Now Available
The Presidential Advisory Council on HIV/AIDS (PACHA) held its 67th full Council meeting on June 1 and 2. Due to safety concerns related to COVID-19, the council members participated from home and presenters joined remotely for a virtual meeting. The topics discussed included:
- The impact of COVID-19 on the HIV response;
- The status of the Ending the HIV: A Plan for America initiative;
- Federal responses to the challenges in accessing HIV prevention and care access as a result of the COVID-19 pandemic; and
- Perspectives and lessons learned on HIV and COVID-19 from the President's Emergency Plan For AIDS Relief (PEPFAR).
Four videos from the June meeting – as well as recordings from past meetings – are available on PACHA’s YouTube channel.
TPAN 2020 HIV Drug Guide Available
TPAN recently published its 24th annual HIV Drug Guide. The heart of the Guide is the Find Your 2020 HIV Drug Here section – an A-to-Z listing of approved HIV drugs. For each medication and combination listed, this section provides information about the standard dosing, potential side effects and toxicity, potential drug interactions, drug manufacturer, wholesale price, and additional relevant information. The drug listings also include different perspectives on each drug and combination through physician and activist comments.
The Guide includes several other sections:
- 2020 HIV Drug Chart shows images of the different drugs and combinations, together with a summary of how the drugs are dosed;
- Getting the Most Out of Your Drug Guide has tips on using the guide to make informed HIV treatment decisions;
- The Waxing and Waning of HIV Drugs discusses how HIV regimens have changed over time, but their goal remains the same;
- Choice Options is a summary of the HHS treatment guidelines for people starting HIV therapy for the first time;
- HIV Life Cycle describes the different stages in HIV’s life cycle and drugs in development that would block or disrupt those stages;
- Picking Up the Tab is a guide to finding copay and patient assistance programs to help cover the cost of HIV medications; and
- What’s Cooking? is a look at experimental drugs in development, some of which may be approved soon.
Recent COVID-19 News and Research
FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
On June 15, FDA revoked an emergency use authorization (EUA) that had allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. FDA decided to revoke the EUA in response to emerging scientific data indicating that the two drugs are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. The agency also determined that “in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
In a separate notice, FDA also warned healthcare providers that chloroquine and hydroxychloroquine should not be combined with the antiviral drug remdesivir for the treatment of COVID-19. Remdesivir may be used for the treatment of hospitalized COVID-19 patients with severe disease – characterized by low blood oxygen levels, or the need for oxygen therapy or more intensive breathing support, such as a mechanical ventilator. FDA’s recent warning against co-administration of remdesivir and chloroquine or hydroxychloroquine is based on the results of a laboratory study indicating that chloroquine and hydroxychloroquine may reduce the antiviral activity of remdesivir.
MMWR’s Continuing Coverage of COVID-19
CDC’s Morbidity and Mortality Weekly Report (MMWR) continues to have extensive, ongoing coverage of COVID-19-related research – typically publishing several new reports each week and then archiving them on a page devoted to studies on COVID-19 and SARS-CoV-2. Reports published in recent weeks include the following:
- COVID-19 Outbreak Among College Students After a Spring Break Trip to Mexico – Austin, Texas, March 26-April 5, 2020
- Coronavirus Disease 2019 Case Surveillance – United States, January 22-May 30, 2020
- Potential Indirect Effects of the COVID-19 Pandemic on Use of Emergency Departments for Acute Life-Threatening Conditions – United States, January-May 2020
- Public Attitudes, Behaviors, and Beliefs Related to COVID-19, Stay-at-Home Orders, Nonessential Business Closures, and Public Health Guidance – United States, New York City, and Los Angeles, May 5-12, 2020
- Characteristics Associated with Hospitalization Among Patients with COVID-19 – Metropolitan Atlanta, Georgia, March-April 2020