National Updates

Antiretroviral (ARV) and Direct Acting Antiviral (DAA) Supply Chains

Concerns regarding potential disruptions to medical and pharmaceutical product supply chains due to COVID-19 cannot be discounted. NASTAD remains in close contact with the major manufacturers of brand-name ARVs and hepatitis C DAAs, none of which are currently reporting manufacturing concerns or supply shortages.

Many commercial and public payers, including ADAPs, have relaxed early fill or quantity limit policies to help people living with HIV and other chronic diseases maintain adequate supplies of prescription medication while practicing physical distancing. However, some issuers are requiring beneficiaries to switch to their PBM’s mail-order pharmacy service for 60- or 90-day supplies of medications typically dispensed every 30 days by a community pharmacy. This generally requires new prescriptions to be submitted by the beneficiary’s provider.

Additionally, many wholesalers have implemented “fair share” allocation processes to manage prescription drug inventories in response to COVID-19-related spikes in demand by pharmacies. To ensure that all pharmacies and direct purchasers, including ADAPs, receive their usual allocations to meet their average monthly dispenses, wholesalers may limit fulfillment of additional orders until all customers have received their usual monthly allocations. In turn, pharmacies may experience challenges meeting early refill and 60- or 90-day fill demands.

Many pharmacies have implemented their own protocols for ensuring access to essential prescription drugs while maximizing physical distancing. These include mail order delivery, courier delivery, curbside pickup, and designated pharmacy hours for highly vulnerable individuals.

NASTAD will continue to track pharmaceutical supply chain disruptions of significance to HIV and viral hepatitis programs. NASTAD members are strongly encouraged to contact Tim Horn regarding any supply chain disruptions or shortages.

Evaluation of HIV Treatments for COVID-19

There are no Food and Drug Administration (FDA)-approved treatments for COVID-19 or other coronaviruses. The FDA has issued two Emergency Use Authorizations (EUAs) for drugs that may be provided to hospitalized patients with severe disease. A number of agents are being evaluated, including some antiretroviral drug products typically used in the treatment and prevention of HIV, notably Kaletra (lopinavir/ritonavir), Prezcobix (darunavir/cobicistat), and tenofovir.

As per Interim Guidance for COVID-19 and Persons with HIV developed by the Department of Health and Human Services’ Antiretroviral and Opportunistic Infections Guidelines Panels, people living with HIV should not make changes to their antiretroviral therapy regimens for the purpose of preventing or treating COVID-19, except in the context of a clinical trial and in consultation with an HIV specialist. This guidance important, in part, to safeguard against supply chain disruptions for adults and children currently using these regimens for the management of their HIV.

The National Institutes of Health has released its COVID-19 Treatment Guidelines, to be updated frequently as published data and other authoritative information becomes available. The Infectious Disease Society of America has also launched Guidelines on the Treatment and Management of Patients with COVID-19, to be updated continuously.

COVID-19 Testing

As testing capacity for COVID-19 ramps up in both the public and private sectors, there may be particular considerations for individuals living with HIV and other chronic conditions. The Infectious Disease Society of America has released guidance for COVID-19 testing, including prioritization of testing for people living with HIV showing symptoms. Because availability of testing and access to testing sites varies by jurisdiction, clients should call their provider to advise on if a test is warranted and how to access one (see CDC guidance on COVID-19 testing). Drive-through testing sites are increasingly being used as a safe way to access testing while adhering to social distancing requirements.

Additional COVID-19 testing resources include:

Insurance Fraud and Scams

Fraudulent schemes related to COVID-19 have arrived and are being detected in many forms, including peddling fake cures, phishing e-mails, non-existent charitable organizations, price gouging, and insurance fraud.

Health Department Staffing Impact

NASTAD is aware that many HIV and hepatitis health department staff are being detailed to state and local COVID-19 efforts, putting an additional strain on already lean programs. Federal HIV and hepatitis partners – particularly those at CDC – are also being detailed away from their HIV and hepatitis posts. We are aware that a communication went out to CDC health department grantees from the Center for State, Tribal, Local, and Territorial Support (CSTLTS) entitled “Guidance for The Temporary Reassignment of State, Tribal, and Local Personnel During a Declared Federal Public Health Emergency.” The guidance details the process by which public health staff can be reassigned for emergency response and references additional CDC resources (available here). The Office of Management and Budget (OMB) has also released guidance with regard to federal grants and activities impacted by COVID-19 and flexibilities available to grantees as operations are affected. Both HRSA/HAB (available here) and CDC (available here) have released additional guidance on how each agency is implementing the OMB flexibilities for grantees.