At press time, information regarding the outbreak of COVID-19 continued to change rapidly. On March 20, the U.S. Department of Health and Human Services (HHS) released recommendations regarding the outbreak in its HIV treatment guidelines. See pages 8–9.
POSITIVELY AWARE on March 11 published a COVID-19 update for PLHIV online that included safer drug use information for people who use drugs. Go to positivelyaware.com/coronavirus.
The outbreak of COVID-19 and large-scale isolation policies and shutdowns to prevent it have caused a wave of event postponements and uncertainty in the HIV services and advocacy sector. Numerous major conferences, fundraisers, and non-profits have been affected.
Organizers of the 23rd International AIDS Conference, also known as AIDS 2020, announced that it is going virtual. AIDS 2020 is scheduled to be held July 6–10. Approximately 20,000 individuals from around the world have attended past conferences, an event that is both medical and community-oriented.
“We are acutely aware that there is not yet sufficient research on the impact of COVID-19 on people living with HIV. We are also conscious of the fact many delegates working in health and research are currently stretched and are providing essential support to their communities. We feel a special obligation to reducing any potential risk to both of these groups,” the organizers stated.
Go to aids2020.org for more information.
HIV2020, the alternative community conference organized by MPact that was to be held in Mexico City at the same time as AIDS 2020, has been cancelled, and alternatives are being explored. “Canceling HIV2020 as an in-person conference was a difficult but necessary decision, given the COVID-19 crisis,” says MPact Executive Director George Ayala. “The health, wellness, and safety of our communities must come first. MPact is working closely with the other HIV2020 organizers—NSWP, INPUD, ITPC, GNP+, ICSS, and Mexican advocates—to produce a series of community-led virtual sessions, drawing from the top scoring proposals we received. In addition, we will be conducting online consultations to solicit inputs from activists about steps the International AIDS Society could take to more meaningfully and consistently engage our communities in their decisions about the location, frequency, structure, and scale of future AIDS conferences. So stay tuned.” Go to HIV2020.org for future announcements.
On March 30, the Sero Project announced it was postponing its training academy on HIV decriminalization. “We have reluctantly, but unanimously, decided for the safety of our staff, advocates, and community members that we must postpone HIV is Not a Crime IV National Training Academy until 2021.” The academy, organized in collaboration with the Positive Women’s Network-USA, Positively Trans, THRIVE SS, and the U.S. PLHIV Caucus, is now scheduled for May 22–25, 2021, at Ohio State University. Go to seroproject.com.
The SYNChronicity conference (SYNC 2020) on HIV, HCV, STI, and LGBTQ health education, training, advocacy, and research is going virtual, June 23–25. SYNC 2020 is organized by HealthHIV, HealthHCV, and the National Coalition for LGBT Health. Go to sync2020.org.
The United States Conference on HIV/AIDS (USCHA) is scheduled to take place in San Juan, Puerto Rico October 10–13. NMAC said at press time that it will make a decision as to whether the conference will continue as scheduled, go virtual, or be postponed to Spring of 2021. Those who wish to attend should still continue to register and apply for scholarships, but there are no hard deadlines. NMAC will refund applications if needed. Go to uscha.life.
In April, the HIV Research for Prevention (HIVR4P) conference was postponed to January 17–21, 2021. Other deadlines related to the conference, to be held in Capetown, were also moved back.
The impact of COVID-19 on fundraising for some of the nation’s leading HIV service organizations has been far-reaching. The majority of HIV service organizations licensed to host Dining Out For Life in their respective cities (including TPAN in Chicago, the publisher of Positively Aware) have postponed their events, some to fall dates, others until further notice. Go to diningoutforlife.com.
The AIDS/Lifecycle, benefiting the Los Angeles LGBT Center and the San Francisco AIDS Foundation, was set to take place in late May and June and is one of the largest HIV-focused fundraisers in the country. Organizers announced on March 17 that the event would be cancelled in its traditional format and that they would pursue their goals through online fundraising.
“We are heartbroken that the AIDS/LifeCycle 2020 event won’t happen in the way we’ve all come to know and love this year, but we remain as committed as ever to [its] mission,” the organization stated on its website.
The postponement of in-person events like galas, sporting events, and volunteer gatherings has left many non-profits re-organizing how they will meet their fundraising needs. “We’re determined as ever to rally our community and ensure that people affected by HIV have the resources and services they need during this crisis,” said Bryant Dunbar, Director of Development at TPAN.” TPAN’s Ride for Life Chicago (formerly, the Ride for AIDS) currently holds to its schedule of September 12-13. “We are rolling out more virtual opportunities to make a difference, and we’re planning contingencies so that our riders and volunteers stay safe, as we work together to safeguard the health of thousands of people.” Go to rideforlifechicago.org.
Treatment as prevention (U=U) guidelines
U.S. treatment guidelines have made official what we already knew: the use of HIV therapy to successfully suppress viral load to undetectable prevents transmission to sex partners.
The magic of undetectable viral load in preventing HIV was initially debated with the release in 2008 of the Swiss statement (and naturally, there was evidence before then that led up to the statement). In 2011 interim results from the landmark HPTN 052 study showed a 96% reduction of HIV transmission within serodiscordant couples assigned to early antiretroviral therapy (ART). (Final study results found that there were no transmissions of the virus within the couple when the partner with HIV remained undetectable.)
The reality was confirmed with the international PARTNER study findings published in 2016, and Opposites Attract in 2017, again showing zero transmissions occurred between partners when the person with HIV was on ART and had suppressed viral load.
On December 18, 2019 the U.S. guidelines provided updated guidance on prevention with HIV therapy, stating “Clinical trials have shown that using effective antiretroviral therapy (ART) to consistently suppress plasma HIV RNA levels to [less than] 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), commonly known as Undetectable = Untransmittable or U=U.
“The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) has added a new section to help providers integrate TasP into their clinical practice. The key recommendations include:
• Providers should inform persons with HIV that maintaining HIV RNA levels [less than] 200 copies/mL with ART prevents HIV transmission to sexual partners (AII).*
• Persons starting ART should use another form of prevention with sexual partners for at least the first 6 months of treatment and until an HIV RNA level of [less than] 200 copies/mL has been documented (AII). Many experts recommend confirming sustained suppression before assuming that there is no risk of sexual HIV transmission (AIII).
• Persons with HIV who rely on ART for prevention need to maintain high levels of ART adherence (AIII). They should be informed that transmission is possible during periods of poor adherence or treatment interruption (AIII).
• Providers should inform patients that maintaining an HIV RNA level of [less than] 200 copies/mL does not prevent acquisition or transmission of other sexually transmitted infections (AII).”
* Indicates strength of recommendation based on evidence. AI is the highest rating.
The guidelines can be accessed at aidsinfo.nih.gov.
New pediatrics recommendation
The U.S. HIV treatment guidelines for children now recommends “rapid initiation of antiretroviral therapy (ART) for all children, not just those aged [less than] 1 year. Rapid initiation is defined as initiating therapy immediately or within days of HIV diagnosis.” In addition, the guidelines state, “The Panel [of experts producing the guidelines] acknowledges that, on a case-by-case basis, initiation of ART may be deferred based on a patient’s clinical or psychosocial factors.” The update was published April 14.
Read the update in its entirety at aidsinfo.nih.gov/guidelines/html/2/pediatric-arv/0.
Symtuza pediatric label change
The HIV single-tablet regimen Symtuza can now be used by children weighing at least 88 pounds (40 kg). All patients, whether adult or pediatric, must be taking HIV therapy for the first time (antiretroviral-naïve) or be switching from a stable regimen taken for at least for six months and have less than 50 viral load (undetectable) and no drug resistance to the darunavir and the tenofovir contained in Symtuza. Symtuza also contains emtricitabine and the booster medication cobicistat.
The U.S. Food and Drug Administration (FDA) updated the Symtuza drug label on March 4 to add the pediatric use.
“No clinical trials with Symtuza were performed in pediatric patients,” the FDA reported in its announcement of the label change. “However, the safety of the components of Symtuza was evaluated in pediatric subjects of 12 to less than 18 years of age through clinical trials GS-US-216-0128 (virologically-suppressed, N=7 with weight ≥40 kg) for darunavir co-administered with cobicistat and other antiretroviral agents, and GS-US-292-0106 (treatment-naïve, N=50 with weight ≥35 kg) for a fixed-dose combination regimen containing cobicistat, emtricitabine, and tenofovir alafenamide together with elvitegravir. Safety analyses of the trials in these pediatric subjects did not identify new safety concerns compared to the known safety profile of Symtuza in adult subjects.”
Egrifta and NASH
Theratechnologies, maker of Egifta SV, announced that it has entered into a long-term agreement with Massachusetts General Hospital and Dr. Stephen Grinspoon, chief of the hospital’s Metabolism Unit, to examine the use of the medication in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) in people living with HIV.
Dr. Grinspoon is a prominent researcher in metabolic complications in HIV. Egrifta SV (tesamorelin) is an injectable treatment for HIV-related excess belly fat.
“We feel privileged to collaborate with the Massachusetts General Hospital, the largest Harvard Medical School teaching hospital. The MGH will give us access to the talent, knowledge, and expertise of Dr. Grinspoon. We also look forward to working with Dr. Grinspoon since he is one of the world’s foremost experts on metabolic conditions related to HIV,” Theratechnologies stated in a February 4 press release announcing the agreement.
In that press release, Dr. Grinspoon said, “Tesamorelin appears to be an important therapeutic candidate for the treatment of NAFLD/NASH in people living with HIV based on data from a recently completed NIH-funded Phase II trial. I look forward to advancing this important work and finding ways to improve and extend treatment options for HIV patients with NAFLD/NASH.”
Dr. Grinspoon and his research team published results of tesamorelin in HIV-related NAFLD/NASH late last year in The Lancet HIV journal.
Who? Crixivan (indinavir sulfate) is an HIV medication from the protease inhibitor drug class. It was one of the first three protease inhibitors on the market, back in 1995–1996. It was these protease inhibitors, and others soon to follow, that most turned the epidemic around by bringing people back to strong health. Unfortunately, the early PIs were associated with large, complicated doses and side effects that were hard to tolerate long-term.
“I am writing to inform you that after careful consideration, Merck has decided to voluntarily discontinue the manufacture of Crixivan (indinavir sulfate) capsules for distribution in the United States,” announced Eliav Barr, Senior Vice President, Medical Affairs for Merck & Co., on March 12. “This decision, which was not made lightly, was based on the significant scientific advancements since Crixivan became available, changes to treatment guidelines, and declining demand. The discontinuation is not related to a product quality or safety issue.”
Today, the only HIV protease inhibitors in common use are darunavir (Prezista, Prezcobix, and Symtuza) and atazanavir (Reyataz and Evotaz).
Grants for Ending the HIV Epidemic
The U.S. Department of Health and Human Services (HHS) on February 26 announced $117 million in awards to expand access to HIV care, treatment, medication, and prevention services. The awards were determined through the department’s Health Resources and Services Administration (HRSA) as part of the Administration’s campaign, Ending the HIV Epidemic: A Plan for America, known as EHE. EHE aims to reduce the number of new HIV infections in the country by 90% by 2030. Read the announcement at hrsa.gov/ending-hiv-epidemic.
Philadelphia Safehouse update
In the continuing struggle to open the nation’s first safer consumption site, activists behind the proposed Safehouse, in Philadelphia, put their plans on hold at the end of February. A day later, however, the group lost the lease for the proposed location following resistance from area residents.
Safe injection sites prevent overdose deaths by allowing drug users to inject in a monitored facility. They also prevent the transmission of disease, including HIV. Sites exist in Canada, Australia, and Europe. As with syringe exchanges, the sites also provide people who use drugs with referrals to drug treatment programs, housing, and other services. See “Safer Drug Consumption Sites: An idea whose time has come,” by PA hepatitis editor Andrew Reynolds, at positivelyaware.com/articles/safer-drug-consumption-spaces.
The activists behind Safehouse, a non-profit organization, promised to continue moving forward in establishing a site. The group will also work more closely with community members and leaders in creating a safe haven. Safehouse leaders include former Pennsylvania Governor Edward G. Rendell; Jose Benitez, Executive Director of Prevention Point Philadelphia; and Ronda Goldfein, Executive Director of the AIDS Law Project of Pennsylvania. "A federal court has ruled that supervised injection sites are legal in Philadelphia," said Goldfein. "Safehouse is a life-saving public health approach and we are committed to opening in Philadelphia."
Prominent on the organization’s homepage is a quote from the American Medical Association: “Studies from other countries have shown that [overdose prevention services] reduce the number of overdose deaths, reduce transmission rates of infectious disease, and increase the number of individuals initiating treatment for substance use disorders without increasing drug trafficking or crime in the areas where the facilities are located.”
Go to safehousephilly.org.
First issued March 20, and updated as necessary by the U.S. Department of Health and Human Services in its Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Follow updates at aids.info.nih.gov. Also go to coronavirus.gov from the Centers for Disease Control and Prevention (CDC) and nih.gov/coronavirus from the National Institutes of Health.
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.
All persons with HIV
In current reports, individuals aged [greater than] 60 years and those with diabetes, hypertension, cardiovascular disease, pulmonary disease, or obesity 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 [less than] 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 (cdc.gov/coronavirus/2019-ncov/prepare/prevention.html), 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 (cdc.gov/coronavirus/2019-ncov/hcp/pediatric-hcp.html) and the general public (cdc.gov/coronavirus/2019-ncov/prepare/children-faq.html) is available from CDC.
CDC also provides information about COVID-19 prevention during pregnancy (bit.ly/covid19andpregnancy).
Persons with HIV should:
• Maintain on-hand at least a 30-day supply—and ideally a 90-day supply—of antiretroviral (ARV) drugs and other medications.
• Talk to their pharmacists and/or healthcare providers about changing to mail order delivery of medications when possible.
• Persons for whom a regimen switch is planned should consider delaying the switch until close follow-up and monitoring are possible.
To date, no drug has been proven to be safe and effective for treating COVID-19. Many drugs, including some ARV agents (e.g., lopinavir/ritonavir, boosted darunavir, tenofovir disoproxil fumarate/emtricitabine), are being evaluated in clinical trials or are prescribed for off label use for the treatment or prevention of COVID-19. Persons with HIV should not switch their ARV regimens or add ARV drugs to their regimens for the purpose of preventing or treating SARS-CoV-2 infection.
Clinic or laboratory monitoring visits related to HIV care:
• Together with their health care providers, persons with HIV and their providers should weigh the risks and benefits of attending, versus not attending in-person, HIV-related clinic appointments at this time. Factors to consider include the extent of local COVID-19 transmission, the health needs that will be addressed during the appointment, and the person’s HIV status (e.g., CD4 cell count, HIV viral load) and overall health.
• Telephone or virtual visits for routine or non-urgent care and adherence counseling may replace face-to-face encounters.
• For persons who have a suppressed HIV viral load and are in stable health, routine medical and laboratory visits should be postponed to the extent possible.
Persons with HIV and in opioid treatment programs:
Clinicians caring for persons with HIV who are enrolled in opioid treatment programs (OTPs) should refer to the Substance Abuse and Mental Health Services Administration (SAMHSA) website for updated guidance on avoiding treatment interruptions. State methadone agencies are also responsible for regulating OTPs in their jurisdictions and may provide additional guidance.
Persons with HIV who have fever or respiratory symptoms and seeking evaluation and care
Health care workers should:
Follow CDC recommendations (bit.ly/COVID19inhealthcaresetting), as well as state and local health department guidance on infection control, triage, diagnosis, and management.
Persons with HIV should:
• Follow CDC recommendations regarding symptoms.
• If they develop a fever and symptoms (e.g., cough, difficulty breathing), they should call their health care provider for medical advice.
• Call the clinic in advance before presenting to the care providers.
• Use respiratory and hand hygiene and cough etiquette when presenting to the healthcare facility and request a face mask as soon as they arrive.
• If they present to a clinic or an emergency facility without calling in advance, they should alert registration staff immediately upon arrival of their symptoms so that measures can be taken to prevent COVID-19 transmission in the health care setting. Specific actions include placing a mask on the patient and rapidly putting the patient in a room or other space separated from other people.
Persons with HIV in self-isolation or quarantine due to SARS-CoV-2 exposure
Health care workers should:
• Verify that patients have adequate supplies of all medications and expedite additional drug refills as needed.
• Devise a plan to evaluate patients if they develop COVID-19-related symptoms, including for possible transfer to a health care facility for COVID-19-related care.
Persons with HIV should:
• Contact their health care provider to report that they are self-isolating or in quarantine.
• Specifically, inform their health care provider how much ARV medications and other essential medications they have on hand.
Managing persons with HIV who develop COVID-19
When hospitalization is not necessary, the person with HIV should:
• Manage symptoms at home with supportive care for symptomatic relief.
• Maintain close communication with their health care provider and report if symptoms progress (e.g., sustained fever for [more than] 2 days, new shortness of breath).
• Continue their ARV therapy and other medications, as prescribed.
When the person with HIV is hospitalized:
• ART should be continued. If the ARV drugs are not on the hospital’s formulary, administer medications from the patients’ home supplies.
• ARV drug substitutions should be avoided. If necessary, clinicians may refer to recommendations on ARV drugs that can be switched (bit.ly/ARVswitch) in the U.S. Department of Health and Human Services (HHS) guidelines for caring for persons with HIV in disaster areas.
• For patients who receive ibalizumab (IBA) intravenous (IV) infusion every 2 weeks as part of their ARV regimen, clinicians should arrange with the patient’s hospital provider to continue to administer of this medication without interruption.
• For patients who are taking an investigational ARV medication as part of their regimen, arrangements should be made with the investigational study team to continue the medication if possible.
• For critically ill patients who require tube feeding, some ARV medications are available in liquid formulations and some, but not all, pills may be crushed. Clinicians should consult an HIV specialist and/or pharmacist to assess the best way for a patient with a feeding tube to continue an effective ARV regimen. Information may be available in the drug product label or from this document from the Toronto General Hospital Immunodeficiency Clinic (bit.ly/TGHIC-pdf).
Additional guidance for
Some Medicaid and Medicare programs, commercial health insurers, and AIDS Drug Assistance Programs (ADAPs) have restrictions that prevent patients from obtaining a 90-day supply of ARV drugs and other medications. During the COVID-19 outbreak, clinicians should ask providers to waive drug-supply quantity restrictions. ADAPs should also provide patients with a 90-day supply of medications.
Persons with HIV may need additional assistance with food, housing, transportation, and childcare during times of crisis and economic fragility. To enhance care engagement and continuity of ARV therapy, clinicians should make every attempt to assess their patients’ need for additional social assistance and connect them with resources, including navigator services when possible.
During this crisis, social distancing and isolation may exacerbate mental health and substance use issues for some persons with HIV. Clinicians should assess and address these patient concerns and arrange for additional consultations, preferably virtual, as needed.
Telehealth options, including phone calls, should be considered for routine visits and to triage visits for patients who are ill.
The CDC website provides information about COVID-19 for people with HIV (cdc.gov/coronavirus/2019-ncov/specific-groups/hiv.html).
The original guidelines also include information for pregnant women with HIV; persons with HIV in self-isolation or quarantine due to SARS-CoV-2 exposure (including information for health care workers); and investigational or off-label treatment for COVID-19 (“person with HIV should not be excluded from these trials”). The o