New medications get their recommendation; plus, pregnancy updates and more
Enid Vázquez @ENIDVAZQUEZPA
Updated HIV Guidelines

HIV treatment guidelines from the U.S. Department of Health and Human Services (DHHS) were updated in October. A one-page section called “What’s New in the Guidelines” lays out the changes for you. Some highlights:

Pregnancy: Last year, preliminary data from Botswana showed a possible connection between dolutegravir and birth defects in infants whose moms were on the medication around the time of conception. The guidelines now provide guidance, including a table, on the use of dolutegravir and other INSTIs (integrase strand transfer inhibitors) in patients who could become pregnant. Dolutegravir (brand name Tivicay) is also found in Juluca and Triumeq. The other INSTIs on the market are raltegravir (Isentress and Isentress HD), bictegravir (found in Biktarvy), and elvitegravir (found in Genvoya and Stribild).

At the same time, there is new information on why dolutegravir may be the only treatment option for some people experiencing virologic failure (when viral load is no longer undetectable). Information on this option includes pregnancy considerations.

Note: There were reassuring data presented at the International Congress on Drug Therapy in HIV Infection, held in Glasgow in October. Read Keith Alcorn’s report, “Neural tube defects and integrase inhibitors: studies show no further evidence of increased risk,” at aidsmap.com.

What to use when starting HIV treatment: Three medications approved by the FDA last year are now rated “recommended initial regimen for most people with HIV” (the highest recommendation there is): Pifeltro when taken with Descovy, along with the single-tablet regimens Biktarvy and Delstrigo. Pifeltro is the brand name of the non-nucleoside reverse transcriptase inhibitor doravirine. Biktarvy contains the INSTI bictegravir plus emtricitabine (FTC) and tenofovir alafenamide (TAF). Like Biktarvy, Delstrigo is a single-tablet regimen. It combines doravirine with lamivudine (3TC) and tenofovir DF (TDF).

Genvoya and Stribild have been downgraded from that highest recommendation and are now “recommended initial regimens in certain clinical situations.” According to the guidelines, this change was made due to the many drug interactions associated with cobicistat, the booster medication found in Genvoya and Stribild, and because the primary drug in these single-tablet regimens, elvitegravir, has a lower barrier to drug resistance than bictegravir or dolutegravir.

The combination of dolutegravir and 3TC (brand names Tivicay and Epivir) may now be considered when abacavir, TDF, or TAF “cannot be used or are not optimal.” This two-drug therapy is expected to receive FDA approval as a single-tablet regimen later this year. Look for its drug page in the POSITIVELY AWARE Annual HIV Drug Guide in the upcoming March+April issue.

A review of data on Trogarzo (ibalizumab), approved by the FDA last year, has also been added. According to the guidelines, “Patients with ongoing detectable viremia [detectable viral load] who lack sufficient treatment options to construct a fully suppressive regimen [get to undetectable viral load] may be candidates for the recently approved CD4 post-attachment inhibitor ibalizumab.”

More new information: There are also updates on HIV/HCV co-infection; drug-related adverse events; drug interactions; drug resistance testing; average monthly cost of the most commonly used HIV medications; and use of treatment when there are kidney or liver problems.

Go to aidsinfo.nih.gov.

HIV meds during pregnancy

Late last year, the FDA made several changes related to the use of HIV drugs during pregnancy.

Rilpivirine (brand name Edurant, found in Complera and Odefsey) has been shown to have lower exposure levels during pregnancy, which possibily makes it less effective at controlling the virus. Therefore, pregnant women taking rilpivirine who have undetectable viral load should have their viral load monitored closely to make sure it remains undetectable. The FDA reported that the lower rilpivirine levels are not, however, considered clinically relevant.

Genvoya and Stribild are not recommended during pregnancy due to “substantially lower exposures” with elvitegravir and cobicistat (both found in Genvoya and Stribild) during the second and third trimesters. Switching to an alternative HIV therapy during pregnancy is recommended.

Moreover, Tybost (cobicistat) taken with either darunavir (Prezista) or atazanavir (Reyataz) is also not recommended in pregnancy, for the same reason. Note, there are co-formulated medicines with these drugs, Prezcobix and Evotaz.

Updates to perinatal HIV treatment guidelines

Updated in December were the U.S. HIV perinatal treatment guidelines. As with the adult and adolescent guidelines, there’s an introduction to the changes. Go to aidsinfo.nih.gov. Among the highlights:

Dolutegravir (Tivicay, found in Triumeq and Juluca): Dolutegravir is not recommended during the first trimester of pregnancy or in someone trying to become pregnant. It is recommended after the first trimester, when it is actually a preferred medication from the drug class of integrase strand transfer inhibitors (INSTIs). Counseling points about whether or not to switch to a different HIV regimen are provided for those who are in their first trimester.

The concern about using dolutegravir during the first trimester come from a surveillance study in Botswana suggesting a possible increased risks of neural tube defects (NTDs) in infants born to mothers taking dolutegravir at the time of conception. “However,” the guidelines state, “other data from this study and others support the safety and efficacy of dolutegravir when it is initiated during pregnancy.”

Not recommended during pregnancy: The following medications were added to the list of HIV drugs not recommended for use during pregnancy: Evotaz, Prezcobix, and elvitegravir/cobicistat (found in Genvoya and Stribild).

Not enough data for use in pregnancy: New HIV medications that do not have enough data at this time to be recommended for use in pregnancy are bictegravir (found in Biktarvy), doravirine (Pifeltro, found in Delstrigo), and ibalizumab (Trogarzo).

Hepatitis C: Due to the low level of testing for hepatitis C in babies exposed to that virus in utero, medical providers are urged to counsel parents about the important of testing exposed children for hep C during the first few years of life.

Recommended medicine for infants: It is now recommended that infants exposed to HIV in utero who are at a higher risk of becoming infected be treated with the triple drug combination of zidovudine plus lamivudine plus raltegravir.

Other recommendations have been added based on higher or lower risk of infection to an infant.

Genvoya now for dialysis

Thanks to new 48 week safety data on Genvoya in patients with end stage renal (kidney) disease (ESRD), the FDA updated the drug’s label in December. Adults with ESRD (creatinine clearance, or CrCl, below 15 mL per minute) who are receiving chronic hemodialysis can now take Genvoya, but on the days of dialysis, it must be taken after the dialysis is over. Previously, individuals needed a CrCl of at least 30 mL per minute to receive Genvoya. Genvoya is not recommended, however, for those with ESRD who are not on dialysis, nor for individuals with severe renal impairment (estimated CrCl between 15 to below 30 mL per minute). Genvoya is the only single-tablet regimen that can be given to people with ESRD on chronic dialysis.

New off-patent nuke co-formulation

The FDA in November approved a co-formulation of lamivudine and tenofovir DF, or 3TC/TDF, for HIV therapy. The new Temixys was approved based on bioavailability data showing that it has similar exposure levels as the two brand name drugs it is based on, Epivir (lamivudine) and Viread (TDF). There is already another new co-formulation on the market, Cimduo, which like Temixys also uses the 3TC/TDF combination. Lamivudine is often used interchangeably with emtricitabine for treatment of HIV, which in combination with TDF is sold under the brand name Truvada; however neither Temixys nor Cimduo are approved for use in PrEP. Because Cimduo and Temixys are based on drugs that have gone off patent, they should be lower in cost.

Two-Drug Single-Tablet Regimen Coming

ViiV Healthcare, an offshoot of pharmaceutical giant GlaxoSmithKline devoted solely to HIV, filed a New Drug Application (NDA) with the FDA back in October for a combo pill of two of its HIV meds already on the market: dolutegravir (brand name Tivicay) and 3TC (brand name Epivir). The two meds would be contained in one pill as a single-tablet regimen, meaning that’s all someone would take.

Two-drug therapies have certain advantages, and these two meds have some advantages as a single regimen. Look for its drug page in the upcoming POSITIVELY AWARE Annual HIV Drug Guide, the March + April issue. FDA approval is expected sometime this year.

Two Years with Biktarvy or Symtuza

At two years (96 weeks)of taking Biktarvy, individuals in Study 1490 continued to have non-inferior results compared to those taking Tivicay plus Descovy. The Phase 3 study results were presented at the International Congress on Drug Therapy in HIV Infection in Glasgow in October. Biktarvy is one of the newest single-tablet regimens (STRs) for HIV on the market, and quickly gaining ground in sales for a variety of reasons.

Also presented at Glasgow were two-year data with Symtuza, another new STR on the market. The Phase 3 AMBER study found that 85% of people put on Symtuza maintained an undetectable viral load at week 96—this was 308 of the 362 individuals taking Symtuza. U.S. HIV treatment guidelines recommend darunavir (contained in Symtuza) for people with suboptimal adherence, who may develop drug resistance as a result, and for individuals who need to start treatment right away before drug resistance test results are in.

Landmark report documents challenges of older adults living with HIV in San Francisco

“Older adults living with HIV in San Francisco face staggeringly high rates of mental health issues and levels of loneliness, as well as experience a dire need for regular social connections and health care coordination,” according to a landmark new report by the ACRIA Center on HIV and Aging at GMHC [formerly Gay Men’s Health Crisis] in New York City, released in October. This is the first report from the multi-site Research on Older Adults with HIV (ROAH) 2.0 project. The report “demonstrates in stark terms that living with HIV as an older adult presents a unique set of challenges—and requires a complex set of coordinated solutions,” says a GMHC press release.

“Though most participants reported that their HIV is well managed and that their health is ‘excellent’ or ‘good,’ 41% reported that their health is ‘fair,’ ‘poor,’ or ‘very poor.’ They also reported a high burden of physical symptoms and diseases other than HIV,” GMHC continued. “Furthermore, survey participants said that they contend with hunger, low income, and burdensome housing costs. Many also said they lack ways to get help with the activities of daily living or care should they fall sick or be injured.”

Go to bit.ly/2Sloaop to read the report.

New Era, New Leader for Black AIDS Institute

Raniyah Copeland is the new CEO of the Black AIDS Institute

The Black AIDS Institute (BAI) starts the new year with a new CEO. Longtime staff member Raniyah Copeland became BAI’s new president and CEO on January 1, succeeding founder Phill Wilson.

Copeland’s selection was announced following a 10-month national search from among 20 candidates. In 2015, Wilson had announced he would step down from BAI at the end of 2018. Copeland joined the organization in 2008 as training and capacity building coordinator; most recently, she had been serving as Director of Programs.

“I have grown from planning the details of one of our largest programs to leading the strategic direction of all of BAI’s programming, including our newest entry into providing HIV direct services,” Copeland says. “In my tenure with the Institute I have had the pleasure of developing seasoned and meaningful relationships with significant individuals and institutions from federal leaders, to community organizers, and key funders. I have led our growth to currently having the largest staffed and skilled programs team we have had in 10 years.”

Copeland earned a Bachelor of Arts degree in African American Studies at the University of California, Berkeley, and has a Master’s in Public Health from Charles Drew University of Medicine and Science. She is married to Bryce Copeland, a business manager for Sony Pictures Entertainment. They are the parents of two children.

“As a Black cis-woman and mother, my intersectionality informs how I center people living with HIV, queer people, Black trans women, and folks in the Black communities who are marginalized because of who they are,” says Copeland.

Lambda Legal victory over Michigan prisons

The Michigan Department of Corrections (MDOC) settled a lawsuit filed by Lambda Legal and Michigan Protection & Advocacy Services over excessive punishment of an inmate based solely on his positive HIV status. After John Dorn and another incarcerated man were accused of engaging in consensual sex, Dorn was immediately taken from the lowest-level security facility to the highest and placed in solitary confinement. He was kept there for 21 months, in contrast, the other inmate (who is HIV negative) lost 30 days of privileges. MDOC’s settlement includes substantial changes to its policy allowing disproportionate punishment of inmates with HIV, and a monetary settlement of $150,000.

“I lost over 21 months of my life to solitary confinement for no good reason because of the prior MDOC policy directive,” Dorn said in a Lambda press release. “No human being should have to endure that type of punishment. In my case, the directive that led to nearly two years of isolation was based on old science. It was also based on a presumption that did not consider the actual risk of transmission.  I am proud that I survived to tell my story. I am also satisfied that I was able to fight for changes in the system that will help other incarcerated people living with HIV in Michigan not experience what I, and others, have.”

Discriminatory policies hurt LGBT healthcare, says statement

Three health associations teamed up to issue an anti-discrimination policy statement on behalf of the LGBTQ community. The statement, released in October, reads:

“The Infectious Diseases Society of America (IDSA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS) oppose laws and policies that discriminate against Lesbian, Gay, Bisexual and Transgender (LGBT) individuals. Such laws and policies harm individual and public health and impede the response to the HIV and STD epidemics. We affirm the rights of all individuals, regardless of their gender orientation or sexual identity, to access quality competent health care services free from stigma and discrimination. We emphasize that all health care providers have an ethical and professional obligation to provide all patients with humane and competent medical care and treatment.”

In addition to their statement, the three organizations discuss research findings on the effects of discrimination on LGBTQ health and provide references. Read the findings at idsociety.org, hivma.org, or pids.org.

Fentanyl and tramadol interactions with Genvoya and Stribild

The FDA added fentanyl and tramadol to the narcotic analgesics (pain medication) section of the drug labels for Genvoya and Stribild late last year. “Careful monitory of therapeutic and adverse effects of fentanyl (including potentially fatal respiratory depression) is recommended with coadministration. A dose decrease may be needed for tramadol with concomitant use.”

Police Charged in AIDS Activist’s Death

Four Athens police officers were charged in the beating death of Greek AIDS activist Zak Kostopoulos, 33, in September, as reported in POSITIVELY AWARE’s November + December 2018 issue. Also charged was the owner of a store where Kostopoulos had broken in, seeking shelter from a street brawl, his friends say. Hundreds of people attended a memorial rally following his death. The charges filed were of inflicting “fatal bodily harm,” which his family has asked be upgraded to murder. The beating was caught on camera.

PrEP Data Online

AIDSvu.org—the website that provides interactive maps and data visualization of HIV statistics in the U.S. by county—now offers similar state-level information about PrEP usage. Local HIV testing and services and PrEP providers can also be located by ZIP Code.

Using data from the Centers for Disease Control and Prevention and state and local health departments, AIDSVu’s interactive maps illustrate the prevalence of HIV based on race/ethnicity, gender, age, education, and income. The site is optimized for Chrome, Edge, and Firebox web browsers. AIDSVu also operates a similar interactive site for hepatitis C information, HepVu.org.

‘Sex Ed Is Lit’

Claudia Dibbs and Zakk Marquez in South Africa during MTV’s Staying Alive Foundation grantee workshop. (Photo courtesy of Zakk Marquez)

Claudia Dibbs and Zakk Marquez became 2018 grantees of the MTV Staying Alive Foundation, tasking themselves to build a multimedia platform which harnesses the power of technology, peer support, honesty, and humor to communicate truths about sexual health and allied topics.

 Literally Sex Ed is poised to be a new tool to foster awareness and educate young audiences around key components and the intersectional forces of sexual health like STI risk, HIV, and consent through short videos, memes, gifs, and graphics while leveraging the hyper-connectivity among folks via social media. “The idea is,” Marquez says, “if we talk about sexual health in a light-hearted and humorous way, we can have deep, sustained conversations. We have to be able to talk about things like gender, sexuality, and race in order to talk about HIV.”

 The mission of Literally Sex Ed is to help people, especially youth, on their journeys to self-love though sex education, because, says Marquez, “it is this kind of love that can change the world.”

Echoes of Rage From the Early Years of AIDS

Head (circa 1984); acyrilic on plaster, 10 x 8 1/2 x 9 1/2 inches. One of a series of 23  heads created by Wojnarowicz, equating to the 23 pairs of human chromosomes. Each eye contains four pupils, symbolizing splintered consciousness.

AIDS activist David Wojnarowicz was a prominent artist out of the New York East Village arts scene in the 1980s who wrote and painted and sculpted and photographed and collaged and created video and music, until his death due to AIDS in 1992 at the age of 37. The Whitney Museum of American Art presented a retrospective of his work last year, with concurrent exhibits in New York City.

David Wojnarowicz: Flesh of My Flesh comes from last summer’s exhibit of the same title at Iceberg Projects in Chicago, and is the title of the second book from HIV specialist and art curator and collector Daniel S. Berger, MD. It follows his first book, “Militant Eroticism: The Art+ Positive Archives,” also the title of the exhibit at Berger’s Iceberg Projects gallery, which included Wojnarowicz’s work, as he was part of the ACT UP affinity group.

In his afterword, Dr. Berger writes, “The rage Wojnarowicz expressed echoed my own rage during the early years of the AIDS crisis, when challenges were all-consuming.”

The book includes historic photographs, essays by P.P.O.W co-founder Wendy Olsoff and artist Elijah Burgher, and a transcript of a conversation between Dr. Berger and gallery director Barry Blinderman.

“By the late 1980s David happened to be without a gallery, and P.P.O.W was in the right place at the right time,” writes Olsoff. “By this period David’s work had become razor focused on the AIDS crisis, driven by the death of his mentor Peter Hujar and many other friends, by his own HIV-positive diagnosis, and by the censorship wars and Christian right-wing politics, which refused to acknowledge the epidemic’s existence.”

Flesh of our flesh indeed.

International Congress on Drug Therapy in HIV Infection

Glasgow, Scotland October 28–31, 2018

Following are brief items from the conference. The community-based NAM (formerly the National AIDS Manual) from the United Kingdom is the official reporter of the conference. Read their reports at aidsmap.com. For more information, including research abstracts, go to hivglasgow.org.

  • No increased risk of serious side effects was seen with Truvada for PrEP, according to a meta-analysis of PrEP studies (looking at a combination of trials). Of note, there were no adverse events in kidney or bone outcomes (side effects associated with Truvada) for either the PrEP takers or the individuals given a placebo. After their analysis of 13 randomized studies with 15,678 individuals, the researchers concluded that, “The safety profile of [Truvada] would support more widespread use of PrEP in populations with a lower risk of HIV infection.”
  • Using two drugs instead of a triple-drug combination is part of the wave of the future. Another meta-analysis, this time looking at seven randomized trials of dual-drug HIV therapy, concluded that “dual therapy was non-inferior to triple therapy by U.S. FDA criteria, with significantly fewer discontinuations for adverse events.” More importantly, perhaps, was the fact that results were good in both people with HIV treatment experience as well as those taking HIV therapy for the first time, who usually do the best with HIV medication. Results are from 1,624 patients, at one year out in their study, looking at the dual combos of a ritonavir-boosted protease inhibitor plus 3TC or tenofovir DF (TDF). Drop the extra drug, drop the extra cost and the extra side effects.
  • Researchers in Warsaw confirmed previous reports that a chronic infection with hepatitis C virus (HCV) is a risk factor for preterm births. In one analysis, the following were associated with preterm birth in the women who were also living with HIV: the use of a nucleoside reverse transcriptase inhibitor (NRTI medication), dolutegravir, drug use, and the previously mentioned hep C infection. The research team stressed that the risk with dolutegravir be viewed with caution due to limited number of individuals in the analysis.
  • New findings suggest the need for greater awareness of the risk for type 2 diabetes and poorly controlled blood sugar levels among people living with HIV. Nearly one-third of people living with HIV receiving care at three large HIV clinics in south London had diabetes or pre-diabetes. Type 2 diabetes is one of the most common chronic health conditions in older adults. Doctors at King’s College Hospital and Guy’s and St. Thomas’s Hospitals reviewed the prevalence of elevated glucose levels and type 2 diabetes in 338 individuals with HIV receiving care at their clinics. The sample reflected the demographics of those receiving care at the clinics: 49% were Caucasian, 31% Black African, and 17% Black Caribbean. Median age was 49 years; 74% were male. Among patients tested, 15% had diabetes (fasting glucose >7.0 mmol/L), and 17% had pre-diabetes (6.0–6.9 mmol/L). While 14% of patients ages 40–49 had diabetes, 17% had pre-diabetes; those who were ages 60–69 and 70–79 saw rates of 33% for diabetes and 25% for pre-diabetes.