This page includes the latest East Bay HIV updates, which include practice-changing studies and developments. Please click here to share feedback.
- This month’s East Bay HIV updates
- New HIV studies and guidelines (general)
- Prevention & testing
- Treatment & cure
- Upcoming events | latest resources | community bulletin board (separate page)
- East Bay COVID guide (separate page)
This month’s East Bay HIV updates
- Check out our new East Bay overdose prevention and safety plan toolkit! This toolkit includes a template and resources to help people write safety plans to reduce the risk of overdose when using substances. Thanks to our awesome presenters and everyone who joined us on April 27th and shared resources and insights!
- The Alameda County Health Care for the Homeless (ACHCH) and Community Assessment, Planning, and Evaluation (CAPE) teams released the first-ever Alameda County Homeless Mortality Report, a retrospective report on homeless deaths from 2018 to 2020 in Alameda County, including deaths from overdose, HIV, COVID, liver disease and other conditions.
- Two new studies on COVID among people living with HIV found that about 60% of PLWH with COVID remain asymptomatic, including during the Omicron surge. Viral loads among asymptomatic carriers were high, so we cannot rely on symptom screening alone. Universal masking, vaccinations and ventilation regardless of symptoms remain crucial strategies.
- The study from South Africa during the Omicron surge found an overall COVID+ prevalence rate of 23% among PLWH, with higher rates among people with CD4<500 and those who were SARS-COV-2 antibody negative (no vaccination or recent infection).
- The FDA has updated its approval so the Cabenuva (CAB-RBV-LA) oral lead-in is now optional and we can go direct-to-inject. Hopefully this gives you more confidence to offer this potentially life-saving option for people who cannot or have difficulty taking daily oral medications. Please click here for the updated Cabenuva prescribing info with optional lead-in, which may help you get insurance coverage. Apretude (CAB-LA PrEP) was approved already allowing direct-to-inject. These long-acting injectables are available now at specialty pharmacies, such as Community Walgreens, AHF, EBAC and AHS/Highland pharmacies.
New HIV/STD resources, studies and guidelines
General HIV updates
Current lists of open Bay Area HIV, hepatitis and COVID studies at UCSF are posted here.
The 2022 update of the East Bay HIV Strategic Plan is finished in English and Spanish! Many thanks to all of you who’ve provided excellent feedback and content for this year’s strategic priorities and activities. Mil gracias to Moisés Cruz Jáuregui for writing El Plan Estratégico 2022 en Español! Click here to download the plans and see more updates.
CROI 2022, the conference on the latest updates on global HIV research, took place February 13-16. Below are a few key resources and highlights:
- HIV.gov and NIH highlights on prevention, treatment and cure
- HIV.gov and NIH highlights on aging, cancer prevention and the future of HIV
- Clinical Care Options summaries and practice-changing highlights from CROI 2022 (requires free registration; offers free CME/CEU)
- View and download the original study abstracts on the CROI 2022 website.
- The March 2022 IAS-USA Topics in Antiviral Medicine issue includes CROI 2022 abstracts and is available here for free download.
HIV treatment and cure highlights from CROI 2022:
- Third case of documented HIV cure was highlighted in the IMPAACT study. All three known HIV cure cases had blood cancers and needed chemotherapy, radiation and transplant for cancer treatment. This case is unique because it’s the first woman of mixed race who received the treatment in the US (NYC), and got a cord blood transplant rather than an adult bone marrow or blood transplant. She has done clinically well, with no graft-versus-host-disease, unlike the other two cases who got bone marrow or adult stem cell transplants (Timothy Brown, treated in Berlin, and Adam Castillejo, treated in London). Her viral load remained undetectable 14 months after stopping ART, and she’s been in remission from AML for 4+ years. This treatment has a 30% risk of death, so it’s very risky not something that we can do for people who don’t need it for another condition, like a blood cancer. However, it does bring up potential mechanisms that can be studied for potentially safer ways to pursue cure treatments.
- The ANCHOR study showed that screening and treatment for anal dysplasia reduced anal cancer incidence by 57% over a median of just over 2 years. This is a reminder to continue/strengthen anal pap screening and HRA referrals! Some of you may know this SF-based study well, as you referred and/or participated in it. This study was stopped early because it quickly became clear that anal pap screening, HRA and treatment for HSIL (93% treated with electrocautery) was effective in preventing anal cancer. Over a median of 26 months, 30 anal cancers were detected, 9 in the treatment group and 21 in the observation group, for a 57% reduction. This will likely lead to guidelines updates recommending regular anal cancer screening with anal paps, HRA for dysplasia, and treatment (electrocautery or IRC) for HSIL.
HIV antiretroviral treatment (ART) studies:
- The CAB-RPV ATLAS-2M study found that injectable CAB-RPV given every 8 weeks was non-inferior to when it was given every 4 weeks over a period of 3 years with an >85% overall viral load suppression rate, leading to the FDA updated approval for giving it every 8 weeks.
- The DTG-3TC TANGO switch study found that in patients virally suppressed on a 3-drug regimen, switching to DTG+3TC was non-inferior at 96 weeks (almost 2 years) of follow-up.
- Several ART studies in resource-limited settings found that DTG-based regimens worked well in first, second and third-line regimens compared to NNRTI and PI-based regimens, and TDF did better than AZT in NNRTI treatment failure, even with K65R resistance mutations.
- A US-based study on DTG (dolutegravir or Tivicay) in pregnancy using a huge pregnancy data-set found that there was no increased rate of neural-tube defects associated with DTG use in the US, where folic acid is added to many food products containing grains (unlike in Bostwana, where they saw more neural tube defects). The IMPAACT group also found that DTG was better than EFV for sustained viral load suppression in pregnancy and post-partum, as well as associated with less stunting in infant growth.
- Studies on the new ART agents:
- Islatravir (ISL) long-acting translocation inhibitor (NRTTI) studies found that oral, long-acting injectable, treatment and PrEP versions were associated with lymphopenia (up to 30% reduction in CD4 counts) despite viral load suppression, so the FDA placed a clinical hold on these studies so the lymphopenia can be investigated.
- Lenacapravir (LEN) long-acting capsid inhibitor:
- The CALIBRATE study found that LEN given sub-cutaneously (SC) every 6 months along with daily oral ART had 85-90% viral load suppression after 1 year, similar to other first-line ART regimens.
- The CAPELLA study found that for people with multi-drug resistant HIV (resistance to at least 2 classes of HIV ART), adding LEN to their regimen led to 94% viral load suppression among those with 2 other active drugs and 79% in those with one other active drug at the 2-year follow-up mark.
- The FDA did not approve LEN for MDR HIV due to some issue with the glass vials it is stored in. The manufacturer is now addressing the glass vial problem and hopefully will re-submit for FDA approval for people with MDR HIV for whom there are few or no other treatment options.
More general HIV updates:
The Alameda County HIV Epidemiology and Surveillance Unit has released the new report “HIV in Alameda County, 2018-2020”, and its Executive Summary. The report and executive summary are available on the ACPHD website here.
The 2021 virtual Ryan White HIV Clinical Conference was held October 3-6, 2021. Please click here see our resource page for key takeaways and links to slides from the conference.
Another study shows worse COVID-19 outcomes for people living with HIV. People living with HIV in Spain with detectable HIV viral loads, chronic comorbidities, age over 75, and people of non-Spanish origin (e.g. migrants) had increased rates of severe outcomes from COVID-19. Earlier studies showed similar patterns and are summarized here.
HIV prevention and testing
The FDA has finally authorized a condom for anal sex, in addition to vaginal sex. While many of us have long advised people to use condoms for anal sex, the FDA finally has enough data to allow the ONE Condom to add anal sex to the product label, based on a study showing the failure rate, defined as slippage or breakage, to be less than 1% during anal sex.
Injectable long-acting PrEP (cabotegravir) is now FDA-approved! Cabotegravir PrEP (brand name: Apretude) is given as two initial injections administered one month apart, and then every two months thereafter. Health plans regulated by the California Department of Insurance are required to cover all PrEP drugs and related clinical services without cost sharing – including injectable PrEP. Processes for getting it covered are still getting worked out.
The CDC released its updated PrEP Clinical Practice Guideline on December 10, 2021. The update includes guidance for recommended initial and follow-up STD screening, revised HIV testing strategies, and recommended primary care practices for patients being prescribed oral or injectable PrEP. The Clinical Providers Supplement includes revised checklists, patient information sheets, and billing codes for both oral and injectable PrEP and includes guidance for counseling patients about adherent PrEP use.
Key revisions to the guideline include (from Demetre C. Daskalakis, MD, MPH, Director of the CDC Division of HIV Prevention):
- A new recommendation for providers to inform all sexually active adults and adolescents about PrEP. This is intended to increase awareness of PrEP more broadly.
- A recommendation that, in addition to taking a very brief history to identify persons with indications for PrEP, providers prescribe PrEP to anyone who requests it, even if they do not report specific HIV risk behaviors. This recommendation is intended to make PrEP available to people who may be apprehensive about sharing potentially stigmatized HIV risk behaviors with their provider.
- A recommendation for F/TAF (Descovy) as an FDA-approved PrEP option for sexually active men and transgender women at risk of getting HIV, based on recent data showing its effectiveness for these populations.
- A new section on prescribing bimonthly intramuscular injections of cabotegravir (CAB) for sexually active men and women who could benefit from PrEP, pending FDA data review and potential regulatory action.
A study of PrEP services at Kaiser Northern California from 2012 to 2019 showed that among those linked to PrEP care, people less likely to receive PrEP prescriptions included young adults ages 18-25, people with substance use disorders, people living in lower income neighborhoods, women, and among African American and Latinx people.
Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women: A study of 4,566 people including 570 (12%) transgender women, participants were randomized to receive TDF-FTC vs. CAB LA for PrEP. The results showed that CAB-LA was superior to daily oral TDF–FTC in preventing HIV infection. The study authors wrist that “strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure.”
STD studies and guidelines
A resurgence in STD cases: New CDC data show that during March-April 2020, reported STD cases dramatically decreased compared to the same time in 2019. However, a resurgence in gonorrhea and syphilis cases later in the year suggest overall STDs may have increased during 2020.
The CDC released their updated 2021 Sexually Transmitted Infections Treatment Guidelines. Click on this link to access the full guidelines and visit their provider resource page for copies of a summary wall chart and pocket guide.
HIV care, treatment and cure
The HRSA Ryan White HIV/AIDS Program Annual Client-Level Data Report 2020 was published December 2021. Click here for more HRSA HIV reports.
An international collaborative group has released the first Global Cure Strategy, which summarizes the priorities and recommendations for the next 5 years. The collaborative group included community members, scientific and industry experts. Key goals include understanding and measuring HIV reservoirs, identifying mechanisms of virus control, targeting the HIV provirus, developing ways to support immune control, cell and gene therapy, pediatric remission and cure, and the social, behavioral and ethical aspects of cure.
A case report has been published of a woman in Argentina who has undetectable HIV viral load after more than 8 years off ART, even with ultra-sensitive testing of multiple organs and reservoirs. It appears that her immune system may have cleared the HIV-1 virus, an extremely rare phenomenon.
The San Francisco 2017-2018 HIV Medical Monitoring Project (MMP) Report was released in July. Interview and medical record data from 361 participants were collected between June 2017 and May 2019 and features new data on long-term survivors and resiliency.
The CDC published data on August 5, 2021 from the 2019-2020 cycle of the HIV National Medical Monitoring Project (MMP). The MMP is an annual, cross-sectional survey that reports nationally representative estimates of behavioral and clinical characteristics of adults with diagnosed HIV infection (PLWH) in the United States.
- 79% of PLWH surveyed were retained in care
- 61% were virally suppressed
- 16% had symptoms of depression
- 21% had recent symptoms of anxiety
- 9% experienced homelessness
- The median HIV-related stigma score was 30.7 (0= lowest stigma and 100= highest stigma)
A separate MMP report on PLWH in the US showed that 25% had experienced discrimination in health care settings. People ages 18-29, transgender people, LGBTQ+ people and those who were experiencing homelessness or incarceration were significantly more likely to experience discrimination, and were more likely to have missed visits, not take ART or miss ART doses.
The authors conclude, “Interventions that address the sociocultural and structural factors associated with discrimination in all health care settings are needed to improve health outcomes among PWH and end the HIV epidemic in the United States.”