POSITIONS ON CALIFORNIA AND NEW YORK STATE HIV-RELATED LEGISLATION, 2017-2026

As a 501(c)3 charitable organization, the Beyond AIDS Foundation (BAF) is not primarily political, and an insignificant proportion of our income is devoted to activities that could be considered lobbying. Nevertheless, from time to time, we discover legislation that impacts the public health approach to HIV/AIDS and related diseases, and decide that an educational approach to legislators and their staff, from a perspective based on our expertise, could have a beneficial effect. Over the past decade, we have predominantly paid attention to state legislation in California, and to a lesser extent, New York State. Here are bills on which that our Board has expressed recommendations: 2017: BAF opposed California SB 239 (Wiener), which removed some criminal penalties for exposing others to HIV or other communicable diseases. When the bill passed the legislature, we asked for a veto, but it was signed. 2017/2019: BAF suppported California AB 1534 (Nazarian). This was to permit an HIV specialist to also be the patient's primary care provider. It passed but was vetoed in 2017. It was reintroduced in a different version in 2019 as AB 993, and again passed but was vetoed. The vetoes apparently were motivated by a concern that there would be separate billing for the same day of service. 2019: BAF asked unsuccessfully for amendments to California SB 159 (Wiener), which permitted temporary dispensing of pre-exposure prophylaxis (PrEP) by pharmacist. This bill passed and was signed into law. We supported a proposed New York bill to make HIV testing more routine. This was part of a preliminary initiative, which did not become serious legislation that year. 2024: BAF initially was "opposed unless amended" to California AB 2960 (Lee), which would have called for syphilis screening of all women (but not men) of childbearing age to help prevent neonatal syphilis. We pointed out that prenatal screening was more cost-effective for prevention of congenital syphilis, and for reducing syphilis as a whole, men needed to be screened as well. We changed to a support position after the bill was amended. The bill did not pass. BAF supported SB 1333 (Eggman), which permitted public health staff to disclose HIV information to providers for purposes of linkage to or coordination of care, but did not permit disclosures in the reverse direction from providers to public health. We requested an amendment to that effect, but instead were promised collaboration the following year on a new bill (see SB 504 below). The bill passed and was signed into law. BAF was supportive of New York S7809 (Hoylman-Sigal) to simplify patient informing requirements for opt-out HIV testing. 2025: This was an active year for involvement in California legislation. BAF initiated the concept that became California bill SB 504 (Laird), to permit disclosures of HIV case information without liability among public health workers. We were successful in obtaining inclusion of wording to permit providers to disclose HIV information to public health staff for purposes of reducing transmission. Prior to this bill, providers could only disclose HIV information at the time of case reporting. This bill passed and was signed into law. BAF also supported California SB 278 (Cabaldon), which allowed disclosure of HIV information from public health to providers and to Medicaid Managed Care and quality improvment staff for improvement of care (we unsuccessfully requested an amendment to allow communications from a provider to public health staff). This bill also passed and was signed into law. BAF supported California AB 309 (Zbur), which permitted indefinite continuation of authorization for pharmacists to dispense syringes and needles without prescription. This bill also passed and was signed into law. BAF supported California AB 554 (M. Gonzalez), which would have prohibited prior authorization or cost-sharing for HIV medications. This passed but was vetoed. Two additional California bills were supported by BAF but did not pass the Legislature: AB 551 (Krell) would have provided grants to emergency departments for reproductive health. SB 608 (Menjivar) would have prohibited age restrictions for purchase of OTC contraceptives, and would also have permitted condom distributions in schools for grades 7-12. 2026: At this writing, the BAF Board is following, and tentatively supporting, Califonia AB 1843 (Elhawary) to eliminate prior authorization for hepatitis C medications. This represents an expansion of our interest beyond HIV to another disease that can be transmitted by injections or blood.

BEYOND AIDS FOUNDATION PUBLISHES LETTER SUPPORTING PARTNER SERVICES FOR HIV

 

. Author manuscript; available in PMC: 2024 Aug 1.

Published in final edited form as: Sex Transm Dis. 2023 May 2;50(8):553–554. doi: 10.1097/OLQ.0000000000001824

Additional Public Health Benefits of HIV Partner Services and More Opportunities for Improvement

Ronald P Hattis ¹, Gary A Richwald ², Jeffrey D Klausner ³, Deanna Stover ⁴

 

PMCID: PMC10524523  NIHMSID: NIHMS1896091  PMID: 37155624

The publisher's version of this article is available at Sex Transm Dis

See the article "HIV Diagnoses through Partner Services in the United States in 2019 and opportunities for improvement" on page 74.

To the Editor:

As leaders of the Beyond AIDS Foundation,¹ a strong supporter of HIV partner services (including contact tracing, partner notification and testing, result-specific follow-up, and other appropriate services), we applaud the article by Williams et al.²

The article highlighted partner services as a means of detecting undiagnosed HIV infections. We would like to point out four additional public health benefits of HIV partner services, not mentioned in that article:

1. Most identified partners of a newly diagnosed person with HIV infection are likely not only to be undiagnosed but also to be recently infected. Initiating treatment for such individuals can both provide the earliest opportunity to prevent additional infections, and achieve the best clinical outcomes.³

2. One of the contacts may be the source of infection, likely an undiagnosed and untreated person with a high viral load, and capable of causing further infections. Testing and treating such an individual is a high priority for prevention.

3. Contacts who test negative for HIV infection have been exposed and may continue to be, without intervention. They, too, are a high priority for prevention. Increased attention to at-risk HIV-uninfected individuals, including safer sex counseling and referrals for PrEP, is consistent with CDC’s new “status neutral” initiative.⁴

4. Partner services can also be expanded or linked with other services for newly-diagnosed persons with HIV infection. Those individuals can be guided through the HIV Care Continuum aimed at viral suppression,⁵ and assisted to achieve other beneficial outcomes. An example is a pilot project in four counties of North Carolina. “Disease intervention specialists” went beyond usual partner services and linkage to care for persons testing positive for HIV or syphilis, by assisting access to primary care, housing assistance, Medicaid navigation, food insecurity, and other needs.⁶ Such expanded services could be implemented nationwide.

The Beyond AIDS Foundation conducted a survey of U.S. state and territorial HIV/AIDS directors or their designees found substantial discrepancies among jurisdictions in methods, content, and consistency of outreach for partner services and linkage to care. ⁵ As the Williams article noted,² partner services activities are currently required for all CDC-funded health departments, applying the shared guidelines for HIV, syphilis, gonorrhea, and chlamydia.⁷ However, our survey suggests that CDC does not monitor jurisdictions for details on whether and how this is done. We have recommended that uniform standards for public health outreach after newly reported diagnoses be established and written into CDC grant requirements, with appropriate compliance monitoring.⁵ CDC could require that a portion of grant funds be specifically designated for partner services.

State requirements can supplement federal grant stipulations. In New York State, for example, a law authored by one of our founding officers, the late Nettie Mayersohn, has required since 1998 that the names of any known sexual or needle-sharing partners be included as a part of reporting of new HIV diagnoses, and that local health departments perform contact tracing and partner notification along with HIV education, which may also be done by physicians.^8,9 Other states could consider similar legislation.

California, the state with the highest number of new HIV diagnoses in 2020,¹⁰ is missing from the Williams article because of incomplete data. That state delegates most public health functions to 58 counties and to 3 cities with public health departments. Some of the counties are rural with small populations and limited resources for partner services. Our unpublished 2013 survey, representing 95% of California’s public health jurisdictions, found that 5% were not performing any partner services for HIV or other STIs, and 66% were performing them but not for all four designated diseases.⁷ Then-current CDC guidelines were not being followed by 39%, and 27% were receiving no specific funding for the performance of partner services.

State public health departments have a responsibility to assure that essential public health programs, including partner services, are available and adequately maintained in all cities and counties. Partner services are valuable components of HIV prevention with multiple benefits, and policy changes could improve their uniformity, quality, and impact.

Footnotes

Conflict of Interest and Sources of Funding: None declared.

Contributor Information

Ronald P. Hattis, Loma Linda University School of Medicine, Loma Linda, CA; California University of Science and Medicine Colton, CA; Beyond AIDS Foundation, Redlands, CA.

Gary A. Richwald, Beyond AIDS Foundation, Redlands, CA; University of Southern California, Los Angeles, CA.

Jeffrey D. Klausner, Beyond AIDS Foundation, Redlands, CA; University of Southern California, Los Angeles, CA.

Deanna Stover, University of Southern California, Los Angeles, CA.

REFERENCES

• 1.Beyond AIDS Foundation. Available at: https://beyondaids.org. Accessed March 25, 2023.
• 2.Williams WO, Song W, Huang T, et al. HIV diagnoses through partner services in the United States in 2019 and opportunities for improvement. Sex Trans Dis 2023; 50:74–78. [DOI] [PMC free article] [PubMed] [Google Scholar]
• 3.National Institutes of Health. Early HIV diagnosis and treatment important for long-term outcomes October 21, 2022. Available at: https://www.nih.gov/news-events/news-releases/early-hiv-diagnosis-treatment-important-better-long-term-health-outcomes. Accessed March 25, 2023.
• 4.Centers for Disease Control and Prevention. Status neutral HIV prevention and care Available at https://www.cdc.gov/hiv/effective-interventions/prevent/status-neutral-hiv-prevention-and-care/index.html. Accessed March 25, 2023.
• 5.Hattis RP, Strydom RY, Gaio J, and Stover DC. HIV prevention practices and non-federal funding among U.S states and non-state regions: a survey of HIV/AIDS directors. AIDS Education and Prevention 2019; 31:82–94. [DOI] [PubMed] [Google Scholar]
• 6.Hurt CB, Morrison AS, Guy J, et al. Beyond disease intervention: exploring an expanded role for partner services in the MATRix-NC demonstration project. Sex Trans Dis 2022; 1:93–98. [DOI] [PMC free article] [PubMed] [Google Scholar]
• 7.Centers for Disease Control and Prevention. Recommendations for Partner Services Programs for HIV Infection, Syphilis, Gonorrhea, and Chlamydial Infection. MMWR 2008; 57:1–57. Available at: https://www.cdc.gov/mmwr/pdf/rr/rr57e1030.pdf. Accessed March 26, 2023. [PubMed] [Google Scholar]
• 8.Neidl BF. The lesser of two evils: New York’s new HIV/AIDS partner notification law and why the right of privacy must yield to public health. St. John’s Law Review 1999. 73;1191–1238. Available at: https://scholarship.law.stjohns.edu/cgi/viewcontent.cgi?article=1506&context=lawreview. [Google Scholar]
• 9.New York State Senate, Legislation. Section 2133, PBH chapter 45, article 21, title 2: contact tracing of cases of AIDS, HIV, related illness, or HIV infection Available at: https://law.justia.com/codes/new-york/2022/pbh/article-21/title-3/2133/. Accessed March 26, 2023.
• 10.Centers for Disease Control and Prevention. Statistics overview, HIV surveillance report, 2020. Available at: https://www.cdc.gov/hiv/statistics/overview/index.html. Accessed March 26, 2023.

PUBLIC HEALTH DEPARTMENTS HAVE OBLIGATION TO REACH OUT AND ASSIST PERSONS WITH NEWLY REPORTED HIV

INTRODUCTION: 

The Beyond AIDS Foundation recommends that the following services be routinely and consistently provided by public health departments upon receipt of a new HIV diagnosis (a positive laboratory test report or a report by a provider). These recommendations are consistent with CDC surveillance and prevention grant expectations, but currently adherence is not monitored as a condition for continued CDC funding. They both serve the interests of the patient and help to fulfill the public health goal of preventing further infections. 

A published survey of state and territorial HIV/AIDS directors conducted by our Foundation (https://guilfordjournals.com/doi/abs/10.1521/aeap.2019.31.1.82) demonstrated wide discrepancies in actual practices among U.S. states and territories and gaps in services in many locations. Such discrepancies and gaps, and the lack of monitoring for adherence to national guidelines by CDC, highlight the need for this policy.

We encourage concurrence with this policy by state and territorial HIV/AIDS directors and epidemiologists, city and county public health officials, federal, state, and local communicable disease-related agencies, local HIV/AIDS projects, state conferences of local health officers and of communicable disease controllers, and others. 

On another page of our Website, below this policy statement, we have provided more detailed guidelines as a reference to public health departments for developing their HIV outreach services after new HIV diagnoses are reported (https://www.beyondaids.org/articles/ApprovedPolicies032023.pdf).

POLICY: 

When a new HIV diagnosis is reported by a laboratory or a provider, surveillance by public health departments should either include or be seamlessly integrated with outreach and “case management” services to prevent further transmission: 

• Initiation and facilitation of the HIV Care Continuum (linkage to care, and encouragement of maintenance of treatment to reach undetectable viral loads). The achievement of undetectable viral loads both eliminates sexual transmission and achieves the best clinical outcomes, and is therefore a major public health objective. 
• Partner services (contact tracing and partner notification) with referrals of contacts for testing and counseling; best conducted by public health personnel 2 with or without the presence of the patient. Trusting the patient to notify partners is not consistently reliable, and should only be used as a last resort and when adherence can be verified 
• Referrals to other needed services (substance abuse or mental health treatment, housing, etc.) 
• Counseling/education on HIV infection and its prevention and treatment. This should include information that the patient does not yet have and is interested in receiving. Safe behaviors, protection of partners (e.g., condoms and PrEP), and the benefits of rapid treatment initiation are priority topics. 
• Obtaining information to accurately complete the morbidity reporting form. This is important to the local jurisdiction, state, and CDC for monitoring the epidemic, but does not in itself interrupt transmission or result in treatment, and therefore should not be the sole objective when following up on new reported diagnoses. 

These services can be provided by communicable disease investigators if they receive adequate training. Some jurisdictions may assign other staff, such as public health nurses or health educators. These staff may be assigned as case managers, so that there is consistent follow-up by a worker who has already established rapport and knows the patient. 

When a public health department receives a new positive HIV test result, there should be immediate outreach. If the test was ordered by a medical provider, there are advantages to contacting the provider first. The provider’s office can frequently provide information regarding reaching the patient, completing the morbidity reporting form, known partners, acute transmission risks such as history of needle sharing, comorbidities including mental illness and substance abuse, homelessness, and whether the provider can offer immediate initiation of therapy, has already made arrangements for referral or consultation regarding HIV care, or is willing to delegate referral for treatment initiation to the public health department or designee. 

Following the communication with the provider, or if there is no provider associated with the test, the public health department should make every possible effort to contact the patient directly. In-person meetings have the advantage of establishing trust and rapport. Virtual meetings may be next best, and in some cases, the only opportunity to see each other. 

The same four bulleted priorities listed above should be discussed with the patient, emphasizing rapid linkage to care and partner services. A follow-up contact a few weeks later, should help verify that linkage actually occurred. Subsequently, monitoring of periodic lab reports, particularly of viral load, should be done to determine whether the patient is maintaining treatment and that the viral load is approaching undetectable levels. The patient, medical provider, and in some cases the laboratory should be contacted if these test results are not being regularly reported. 

If a patient is found to live outside of the jurisdiction of the public health department, the appropriate department in the jurisdiction of residence should be informed of the case, so that services can be initiated.

BEYOND AIDS FOUNDATION PUBLIC COMMENT AT CHAC, THE ADVISORY COMMITTEE TO CDC AND HRSA

Following are the oral comments presented to CHAC on behalf of the Beyond AIDS Foundation, on April 20, 2021.  CHAC is the official advisory committee to the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA) concerning HIV, viral hepatitis, and sexually transmitted infections. A longer written document was also submitted.

_________________________________________________________________________

I am Ronald Hattis, Secretary and Past-President of the Beyond AIDS Foundation. This is a brief synopsis of our written testimony, which I hope committee members will read for the rationale and details of our recommendations. For over 3 decades we have promoted improved strategies for HIV prevention and control. Among our leaders are former major metropolitan STD and HIV directors, health officers, EIS Officers, PACHA members, and HIV and other I.D. specialists. We hope to renew ongoing direct dialog with both agencies, and hope for inclusion in future CDC consultations. 

 Our recommendations are based in part on findings of our survey of state and territorial HIV/AIDS Directors, published in 2019 in AIDS Education and Prevention (and provided to the committee). This revealed marked inconsistencies of policy and practices among jurisdictions. Our most important recommendations for CDC and HRSA, include: 

• That more oversight be provided and accountability required by both agencies regarding adherence to grant conditions. We recommend enhanced routine site visits for evaluation, education and guidance.  
  

• That CDC recommendations, and grant requirements, specify more standardized public health outreach to newly diagnosed patients and their providers, particularly for rapid linkage to care and partner services. 20% of states and territories did not routinely contact all diagnosed patients and 40% did not try to contact all known providers. 

• That CDC recommend, and include as a grant requirement, the monitoring of MISSED viral load results, none received in the past year for diagnosed patients, suggesting no active treatment. 

• That monitoring of genotype results become a CDC recommendation, with results forwarded to CDC for analysis. Only 38% of jurisdictions even received such results. 

• That all jurisdictions be encouraged to supplement CDC grants with their own money for HIV prevention. 28% of jurisdictions had no prevention funds other than their CDC grants.  That there be more joint screening efforts for HIV, STIs, and viral hepatitis, and more joint health education about their shared prevention measures, and that PrEP providers urge condom use to prevent other STIs.
  

• That HRSA grant recipients, be expected to attempt to contact patients to remind them of upcoming appointments, to follow up on missed appointments, and when possible, 2 to schedule HIV care on the same half day as primary and specialty care. Providers funded through other sources should be encouraged to act similarly.
  

• That PrEP costs be covered for uninsured patients, especially seronegative partners of Ryan White patients. HRSA efforts in this direction are appreciated.
  

• Finally, that training be made available nationwide to primary care providers on starting immediate HIV treatment. Presentations that I have used to provide such training are linked from our written testimony. 

I am honored to have had this opportunity to provide input today. I welcome any questions, now or after this meeting

OUR 2021 INPUT TO FEDS: MORE CAN BE DONE FOR BETTER HIV CONTROL

Ronald P. Hattis, MD, MPH, Secretary and Past-President

There are mixed effects from communicating virtually (Zoom, Gotomeeting, etc.) and by email, rather than in person, with national and state public health leaders. On the one hand, it has saved us money that we would have needed to spend for travel to Washington, Sacramento, and New York, etc. On the other hand, not meeting in person makes it more difficult to establish the interpersonal connections that can be very helpful to sway thinking and influence public policy. 

In the last few months, our Beyond AIDS Foundation (BAF) has remotely submitted input for the 2021-2025 National HIV/AIDS Strategy, which was not incorporated into the final plan, but which we are still promoting as activities to optimally implement it.  I also provided public comment on March 9, 2021 on behalf or BAF to the Presidential Advisory Council on HIV/AIDS (PACHA), which reintroduced our organization to PACHA (on which two of our Board members had previously served), but did not result in any immediate action.  For both of these initiatives, we made reference to the findings and recommendations of our published survey of state and territorial HIV/AIDS Directors, in which we had found much inconsistency and some missed opportunities to enhance the HIV Care Continuum (HCC).

The HCC refers to the various stages that patients have to move through before the HIV virus can be suppressed to undetectable levels, resulting in almost no sexual transmission. Those stages include screening to diagnose infected persons, linking infected (HIV positive) persons to care, initiating antiviral treatment immediately or as soon as possible, retaining treated patients in care, and suppressing the "viral load." There is dropout at each stage, and a major pubic health objective is to reduce the dropout rates so that the vast majority of patients can reach the ultimate goal of viral suppression, and consequently not passing the virus on to others. The concept is sometimes called "treatment as prevention," something to which I have a strong personal commitment, as one of the first people to advocate it, back in 1996. It was eventually adopted as a cornerstone of US HIV strategy, but not until 15 years later.

Beyond AIDS Foundation specifically advocates that state and local public health staff reach out to patients and providers as soon as a new positive HIV test is reported, to urge and help arrange linkage to a source of HIV care, to perform or arrange for partner services (contact tracing and partner notification). and to discuss other relevant concerns. In our survey, we found that most jurisdictions did this, but that some were not doing so routinely.  We also advocate that public health departments keep track of a specific reportable HIV test, the viral load, which measures virus in the blood. If test results show high levels of virus that are not dropping, we suggest that providers be contacted to see whether anything can be done to assist. If no viral load tests are reported for a year, there should also be outreach to find out whether the patient has dropped out of care or moved to another jurisdiction, either of which deserves follow-up. Over 40% of jurisdictions had on their own initiative started looking for such "missed viral load results" in diagnosed persons, even though CDC had not required this. We think that this practice should become universal and an expectation of CDC. When medical appointments for HIV patients are missed, providers should be expected to reach out to patients to persuade them to make new appointments, and if are no longer reachable, public health should be notified.

 We also recommend that all states and territories make genotype results, which indicate whether the virus is sensitive or resistant to various medications, reportable to public health.  In our survey, in 62% of jurisdictions these were not reportable. We also recommend that genotype results, or aggregate summaries, be forwarded to CDC so that there can be full national surveillance for the emergency of resistant strains. We also found that 28% of states and territories were relying entirely on CDC grants for HIV prevention. CDC money will often be the biggest source of funding for HIV prevention, but is usually not sufficient by itself, and should be supplemented by additional funding raised by states, local jurisdictions, and/or private sources.

Upcoming is another opportunity for our Foundation to capture the attention of some key federal public health leaders. We plan a brief BAF presentation during the public comment period at the April 20, 2021 meeting of CHAC, an advisory committee to CDC (Centers for Disease Control and Prevention) and HRSA (Health Resources and Services Administration) regarding HIV, STDs, and viral hepatitis programs. This may be our most important interaction with federal personnel, because most of the recommendations of our survey article were for CDC and to a lesser extent HRSA to consider some changes to what is expected in return for their grants.

Internally, this year we will be updating our Foundation's objectives and declarations, which are over a decade old. We will also be looking for opportunities for involvement "beyond AIDS." As the pandemic diverts staff from control of sexually transmitted infections, rates of some of those infections have risen, and there is a risk that HIV infections may as well. Ongoing prevention and control efforts for all these diseases should not suffer as the pandemic progresses into its second year.

A BRIEF HISTORY OF HIV THERAPY, AND NEW DRUGS FOR HIV, 2020-21

 A BRIEF HISTORY OF HIV THERAPY, AND NEW DRUGS FOR HIV, 2020-21

Ronald P. Hattis, MD, MPH

Prepared for Beyond AIDS Foundation as a resource to providers, updated 5/20/21

In 1987, AZT (now rarely used), a nucleoside reverse transriptase inhibitor (NRTI) originally studied as a possible anti-cancer remedy, became the first antiviral drug approved for AIDS by the FDA. Monotherapy helped temporarily, but typically resulted in the development of viral resistance. As more NRTIs were developed and over the next few years, combinations of two of them were found to be more effective than monotherapy, but still not adequate as a total regimen for treatment because of some eventual resistance and progression of disease. (Later, however, some duo combinations were found to be useful for pre-exposure prophylaxis or PrEP, see below).

Starting in 1996 (when protease inhibitors became available) and until very recently, the standard of care for “highly effective anti-retroviral therapy” (HAART) for HIV has been a combination of three drugs in one or more pills. These have included 2 NRTIs, or in the most highly recommended combinations of recent years, one NRTI plus the highly effective and chemically similar nucleotide reverse transcriptase inhibitor tenofovir disoproxil, approved in 2001.  An alternative form of tenofovir, alefenamide instead of disoproxil, was approved 15 years later and is discussed below. The term N(t)RTI is now sometimes used to refer jointly to the nucleosides and nucleotides.  Regimens that include N(t)RTIs all utilize either emtracitabine or the similar (and generically available) lamivudine, as these are considered to be the least toxic in the group. Those regimens that still include 2 N(t)RTIs combine one of these with either of those two forms of tenofovir, or with a less commonly used alternative, abacavir.

The third drug is selected from a separate class of antivirals. There are now several antiviral drug classes effective against HIV, but based on effectiveness and safety, one has become the class of choice to give with 2 N(t)RTIs as a complete regimen for treating HIV (and especially for starting treatment), This preferred class is the integrase strand transfer inhibitors, known for short as integrase inhibitors or INSTIs. Recently developed INSTIs (dolutegravir, bictegravir, and cabotegravir) have shown great effectiveness and negligible viral resistance, raising the prospect that they might be effective with only one other drug for treatment. This has already been approved for dolutegravir plus one NRTI, lamivudine. Cabotegravir has been approved in a long activing injection with one other drug, and has been proposed for use alone for PrEP, see below. This has influenced three of the new developments below. Unfortunately, INSTI drugs, and particularly dolutegravir and bictegravir, have been associated with weight gain.

Two drugs, ritonavir and cobicistat, are used solely as "boosters" to raise the level of another drug. All of the protease inhibitors are now given with a "booster," as is one of the INSTIs, elvitegravir.

In 2001, tenofovir disoproxil plus an NRTI, emtracitabine, were approved as the first drug combination (Truvada) for pre-exposure prophylaxis (PrEP). Unfortunately, tenofovir disoproxil has some mild toxicity to bone and kidney, which is a concern in particular when treating persons who are well and not infected. Fortunately, a pro-drug alternative lacking those bone and kidney side effects, tenofovir alefenamide, has been developed by the same company, and has been implemented both for treatment and for PrEP. That is one of the new developments discussed below. However, a countervailing consideration is that tenofovir disoproxil actually has some beneficial effects on lipids, which are reversed by switching to the alefenamide preparation. Also, tenofovir alefenamide has been associated with more weight gain than the disoproxil. So treatment choices should be individualized in patients with hyperlipidemia or obesity, and strong bones and kidneys.

1. Dovato (dolutegravir with lamivudine), was approved 4//8/19 as the first 2-drug combination sufficient for a complete treatment regimen. HHS treatment guidelines suggest that this be an approved starting regimen, except for patients with pre-treatment HIV RNA >500,000 copies/mL, or who are known to have active hepatitis B virus (HBV) coinfection; or who will initiate ART before results of HIV genotype testing for reverse transcriptase or HBV testing are available  (https://www.fda.gov/news-events/press-announcements/fda-approves-first-two-drug-complete-regimen-hiv-infected-patients-who-have-never-received; https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf)

2. Descovy (tenofovir alefenamide, the pro-drug of tenofovir not considered to be toxic to bone and kidneys but see above re lipids and weight gain, plus emtracitabine) was approved in 4/16 as part of treatment regimens, and 10/19 as the second combination for PrEP, a safer alternative to Truvada. Unfortunately, it has not been studied or approved for cis females exposed to sex by males. (https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic) 

3. Cabotegravir is a new integrase transfer strand inhibitor, given by injection. When combined with a long-activing injectable form of rilpivirine (a member of the non-nuclease reverse transcriptase inhibitors, one of the other drug classes, and previously approved for daily oral use), it has proven effective. This combination was approved by FDA as Cabenuva on January 21, 2021, as a complete 2-drug treatment regimen.  It is administered monthly, with the starting dose 50% higher than subsequent doses. Meanwhile, cabotegravir alone is being studied and is expected to be approved as the first single-drug and first injectable PrEP.  In a small study with females in sub-Saharan Africa, it was more effective than Truvada as PrEP. Cabotegravir for this use was given a "breakthrough therapy designation" by FDA in November 2020, meaning that the agency will collaborate closely with the manufacturer in hopes of reaching approval in the near future.  (https://www.who.int/news/item/09-11-2020-trial-results-reveal-that-long-acting-injectable-cabotegravir-as-prep-is-highly-effective-in-preventing-hiv-acquisition-in-women; https://jamanetwork.com/journals/jama/article-abstract/2771873) 

In addition, two entirely new types of drugs discussed below have recently been developed for patients with strains of HIV highly resistant to usual medications.

4. Trogarzo (ibalizumab-uiyk) is a new type of HIV drug for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). It was approved by the FDA on 3/6/18. It must be administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications. It is the first CD4-directed post-attachment HIV-1 inhibitor, and binds to CD4+ receptors on host cells, blocking the HIV virus from infecting the cells. Additional drugs requiring IV infusion are in the pipeline. (https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-treatment-patients-who-have-limited-treatment-options; https://www.prnewswire.com/news-releases/theratechnologies-announces-fda-approval-of-breakthrough-therapy-trogarzo-ibalizumab-uiyk-injection-the-first-hiv-1-inhibitor-and-long-acting-monoclonal-antibody-for-multidrug-resistant-hiv-1-300609280.html)

5. Rukobia (Fostemsavir) is a new fusion/entry inhibitor for treatment-experienced adults with failing HIV-1 therapy. It was approved by the FDA on 7/2/20, and is taken orally twice a day.  (https://www.usnews.com/news/health-news/articles/2020-07-07/rukobia-approved-for-patients-with-multidrug-resistant-hiv)

As of 2021, there is a robust pipeline of new drugs in development, some of which are in clinical trials. Both oral and injectable new medications will tend to have long half-lives and not require daily dosage.

ABSTRACT AND CONCLUSIONS/RECOMMENDATIONS FROM PUBLISHED BEYOND AIDS SURVEY, FEBRUARY 2019:
HIV PREVENTION PRACTICES AND NON-FEDERAL FUNDING AMONG U.S. STATES AND NON-STATE REGIONS: A Survey of HIV/AIDS Directors

AUTHORS

Ronald P. Hattis, MD, MPH; Richel Y. Strydom, MD, MPH; Josileide Gaio, MPH; Deanna C. Stover, PhD, RN, FNP, CNS, COHN-S

Published February 2019, AIDS Education and Prevention, Volume 31, No. 1 https://doi.org/10.1521/aeap.2019.31.1.82

Online abstract and journal information https://guilfordjournals.com/doi/abs/10.1521/aeap.2019.31.1.82?mobileUi=0

Corresponding author: Ronald P. Hattis, MD, MPH, Beyond AIDS Foundation, 404 New York St. #7718, Redlands, CA 92373, 909-838-4157, email: ronhattis@beyondaids.org.

Abstract and Conclusions provided here, including recommendations for CDC and HRSA:

ABSTRACT

We surveyed U.S. HIV/AIDS Directors or designees in states and non-state regions, regarding factors influencing HIV viral suppression: 1) non-federal prevention funding; 2) contacting newly-reported patients and providers, for care linkage and partner services; 3) follow-up of non-received viral load reports, to identify untreated patients; and 4) genotype/phenotype surveillance, to monitor drug resistance. The survey was conducted April-July 2015; 50 (87.7%) participated.  Of jurisdictions, 80% contacted all newly-reported patients; 60% contacted all providers. HIV resistance tests were reportable in 38%; 66% contacted providers and/or patients about missed viral loads. Non-federal funding was significantly associated with annual diagnoses (p=0.0001) and population (p=0.0002), but not with other factors studied. Many jurisdictions lacked non-federal funding (28%), or experienced unrestored reductions since 2008 (33%).  Jurisdictions’ funding and preventive practices varied greatly.  HIV viral suppression could be enhanced by restoring (or establishing) non-federal prevention funding, and by more standardized surveillance/outreach practices.

CONCLUSIONS AND RECOMMENDATIONS

(ENDORSED BY BOARD OF DIRECTORS, BEYOND AIDS FOUNDATION)

After several years of economic recovery, restoration of recession funding cutbacks for HIV prevention was overdue at jurisdictional and local levels. Federal matching of non-federal funds could incentivize this. Restored (or newly established) non-federal funding could help monitor and facilitate progression through the HCC, especially if used in part for outreach to patients and their providers after new diagnoses or if viral load results were not received for a year, and for collection and forwarding of viral resistance data to CDC. However, such services, which were not yet specifically funded routinely by CDC, showed no statistical association with non-federal funding,.

Public health practices relating to follow-up of newly reported HIV diagnoses and missed viral load results, and reporting of genotypes and phenotypes, varied widely among states and NSRs. CDC could revise guidelines to encourage a more uniform system of HIV surveillance and monitoring, based on HCC stages and goals.

Linkage to care and partner services were already endorsed by CDC, but inconsistently applied. They could become a required use of CDC prevention funding, with specifications regarding the types of outreach expected.

Public health tracking of non-received viral load results (an indicator of infected persons who may not be in treatment), with outreach to providers and patients, may facilitate two more stages of the HCC: retention in care and antiretroviral treatment. Despite lack of specific funding by CDC, a majority of jurisdictions already claimed engagement in this activity.  Patient progression through the HCC could be facilitated by making it a required use for CDC and/or HRSA funding. To make this a universal surveillance activity, jurisdictions that do not have mandatory laboratory reporting of all viral loads, regardless of result, would need to institute such reporting.

CDC considered genotype surveillance optional, did not collect phenotypes, and neither was reportable in most jurisdictions. Uniform reporting, with submission to CDC for nationwide analysis, could produce a more complete database for monitoring antiretroviral resistance.

CDC could require grant application objectives to address jurisdiction-specific shortfalls in these areas, and opportunities for improvement.

Surveys like this may prove valuable in increasing awareness among public health advocates about funding gaps and potentials for expanded surveillance and outreach within their jurisdictions. Such awareness could stimulate discussions about policy and any necessary political action.