Briefly: May + June 2020

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.”

Read more from the FDA announcement at bit.ly/2WFvbWo. Go to symtuza.com and positivelyaware.com/symtuza.

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.

Read the release at theratech.com/en/theratechnologies-signs-agreements-with-massachusetts-general-hospital-and-dr-steven-grinspoon. Go to positivelyaware.com/egrifta-sv.

Crixivan discontinued

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.