Top HIV News of 2019

#6: NIH and Bill & Melinda Gates Foundation to Collaborate on Gene-Based HIV Cure

Advances in genetics research have led to the development of effective gene-based treatments for conditions including blindness and certain types of leukemia. Now, the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation have announced that $200 million will be invested over the next 4 years towards developing gene-based cures for both HIV and sickle cell disease.

Each organization will invest $100 million with the intention of making effective and affordable cures globally available, including in low-resource settings.

“This collaboration is an ambitious step forward, harnessing the most cutting-edge scientific tools and NIH’s sizable global HIV research infrastructure to one day deliver a cure and end the global HIV pandemic,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, part of the NIH, in a press release. “We are taking into account those with the greatest need at the foundation of this effort, to ensure that, if realized, this exceptional public health achievement will be made accessible to all.”

The collaboration will focus on 2 primary areas of coordination. The first area is to identify potential candidate cures for both diseases for pre-clinical and clinical evaluation, which will be co-funded by the 2 groups. The second area of collaboration is to define long-term opportunities to work with African partners in advancing viable options to late-phase clinical trials, for which funding will be determined based on progress.

Read the full article.

#5: Ending the HIV Epidemic by 2030—Is Trump's SOTU Promise Feasible? Public Health Watch

During February’s State of the Union (SOTU) address, President Donald Trump vowed to end the HIV epidemic in the United States by 2030.

It’s an admirable goal, however, some infectious disease experts working on the frontlines of HIV/AIDS research and treatment say achieving it may mean a political pivot on several key domestic policy positions, including those related to the Affordable Care Act (ACA), LGBT rights, and women’s health care.

“No force in history has done more to advance the human condition than American freedom,” the commander-in-chief said last week on Capitol Hill. “In recent years we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach. My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years. Together, we will defeat AIDS in America.”

Based on follow-up comments from the leadership at the US Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and Health and Human Services (HHS), it seems President Trump hopes to build on the work of predecessors Bill Clinton, who significantly expanded the NIH, effectively doubling the resources allocated to HIV/AIDS research to upwards of $3 billion annually; George W. Bush, who launched PEPFAR (the President’s Emergency Plan for AIDS Relief) and oversaw the country’s contribution to the Global Fund to Fight AIDS, TB, and malaria; and Barack Obama, whose administration developed the first-ever National HIV/AIDS Strategy and pushed for the passage of the ACA.

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#4: Second Patient Reported to Achieve Long-Term HIV Remission

The absence of viral HIV rebound was observed for 16 months following interruption to antiretroviral therapy at 17 months after a single allogenic CCR5-d32 hematopoietic stem cell transplant using a no irradiation approach with only mild graft-versus-host disease.

According to Reuters, Ravindra Gupta, a professor and HIV biologist who co-led a team of doctors treating the man described his patient as “functionally cured” and “in remission”, but cautioned: “It’s too early to say he’s cured.”

This documentation is similar to only that of the so-called “Berlin patient,” Timothy Ray Brown.

Details on this patient, referred to as the London patient, were presented in a late breaker oral abstract session at the Conference on Retroviruses and Opportunistic Infections (CROI 2019) and published in the journal Nature.

The Berlin patient was “cured of HIV” following 2 consecutive hematopoietic stem cell transplants (HSCT) with total body irradiation. However, it is unclear which aspects of treatment contributed to this only known case of HIV cure.

The London patient has been described as an HIV-infected male diagnosed with Hodgkin’s lymphoma who underwent allogenic HSCT using a homozygous CCR5d32 donor. The nadir CD4 count was 290 cells/mm and the baseline viral load was 180,000 copies/ml.

Antiretroviral therapy comprising tenofovir disoproxil fumarate/emtricitabine/efavirenz was started in 2012 and, during episodes of ART interruption, the investigators observed viral rebound and nucleoside reverse transcriptase inhibitor resistance.

The Hodgkin’s lymphoma was resistant to first-line chemotherapy and other treatment regimens.

An unrelated CCR5d32 homozygous donor was identified with 1 allelic mismatch at HLA-B gene.

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#3: California Signs SB 159 Into Law

In his December editor in chief letter, Jason C. Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS, discussed a big step in pre-exposure prophylaxis and post-exposure prophylaxis. Read an exerpt from this letter below:

Something novel in infectious diseases practice has occurred and, like many big changes, it is not without controversy. In October, Gov Gavin Newsom of California signed SB 159 into law.¹ This legislation allows pharmacists to dispense up to a 60-day supply of antiretrovirals for either pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) without a prescription, provided certain conditions are met. The law goes into effect in July.

Some conditions include limiting the supply of the drug to 60 days, requiring dispensing pharmacists to complete an approved education program, documenting a negative HIV test or negative in-pharmacy HIV test at the time of dispensing (waived for PEP), and notifying the patient’s primary care physician. It also requires the state Medicaid program, Medi-Cal, to cover the cost of the medication and forbids commercial insurance from requiring preau­thorization for dispensing.

Some controversy followed SB 159 as it made its way through the legislature, which led to some of those conditions. I first learned of the proposed law in March, when I attended a conference of the Infectious Diseases Association of California. During an open forum about the bill, pharmacist attendees expressed concerns about patients falling into and out of care without follow-up and the potential for busy pharmacists in community settings to assume responsibilities for which they are not ready.

Read the full letter.

#2: Descovy (F/TAF) Approved for PrEP But Not For Everyone

In October, the US Food and Drug Administration (FDA) approved emtricitabine 200 mg and tenofovir alafenamide 25 mg (F/TAF; Descovy) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection through sex, excluding those who have receptive vaginal sex. The approval was granted to Gilead Sciences.

F/TAF is not indicated in individuals at risk of HIV infection from receptive vaginal sex because the effectiveness in this population has not been evaluated.

F/TAF was evaluated in a randomized, double-blind multinational trial that included 5387 HIV-negative men and transgender women who have sex with men and were at risk for HIV infection. This trial assessed the safety and efficacy of the product and compared once daily F/TAF to emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg (F/TDF; Truvada).

The participants were followed for 48 to 96 weeks. The primary end point was the rate of HIV infection in each group and the trial concluded that F/TAF was similar to F/TDF in reducing the risk of acquiring HIV. The most common adverse reaction in individuals without HIV who were taking F/TAF in the trial was diarrhea.

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#1: FDA Approves Dolutegravir/Lamivudine

In April, the FDA issued an approval for dolutegravir and lamivudine (Dovato), as a complete regimen for treatment-naïve adults with HIV-1.

This marks the first FDA-approved 2-drug, fixed-dose, complete regimen for treatment-naïve adults with HIV, according to the press release.

"Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug," Debra Birnkrant, MD, director of the Division of Antiviral Products, said in the statement. "Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time."

The efficacy and safety of dolutegravir/lamivudine as a once-daily tablet were demonstrated in 2 identical, randomized, double-blind, controlled clinical trials, GEMINI 1 and 2. A total of 1433 adults with no prior antiretroviral treatment history were included. The trials showed that the regimen had a similar effect of reducing the amount of HIV in the blood when compared with a regimen of dolutegravir, emtricitabine, and tenofovir. The treatment was considered successful if the patient maintained low-levels (less than 50 copies/mL) of HIV RNA in their blood for at least 48 weeks.

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