For years the POSITIVELY AWARE HIV Drug Guide has reported that, “There aren’t sufficient data to support the initiation of Biktarvy during pregnancy.” We went on quickly to explain that, “People who become pregnant while on Biktarvy do not necessarily have to switch to another regimen, but may undergo closer monitoring of viral load.”
Now it’s official: Biktarvy can be used in pregnancy. This is important because Biktarvy is a recommended regimen for most people living with HIV and one of the most commonly prescribed HIV medications in the U.S. It is a single-tablet regimen, taken as one daily pill for complete HIV treatment.
In January, the Department of Health of Human Services (HHS) perinatal HIV treatment guidelines upgraded its Biktarvy recommendation from “insufficient data to recommend” to an “alternative drug” for use in pregnancy or around the time of conception.
Then in April, the U.S. Food and Drug Administration (FDA) approved a change to the Biktarvy package insert (PI, also known as the drug label), adding new pregnancy data.
Still, pregnancy does have the effect of lowering blood levels of Biktarvy—something that’s already known—and closer monitoring of viral load is recommended.
HHS
“Based on new data about pharmacokinetics [basically, how drugs are processed in the body] in pregnancy and updated information in the Antiretroviral Pregnancy Registry, bictegravir (BIC) is now recommended as an Alternative ARV [antiretroviral] for use in pregnancy and for people who are trying to conceive; it was previously categorized as Insufficient Data to Recommend use in pregnancy. Data are still limited, but no safety concerns have been observed,” the HHS perinatal guidelines panel of experts reported in January.
Lower blood levels of Biktarvy in pregnancy were “not considered clinically significant in virologically suppressed pregnant individuals,” HHS guidelines said. The upgraded recommendation thus applies to people with undetectable viral loads—less than 50 copies per mL. That’s the number one goal of HIV treatment—getting to undetectable.
Having an undetectable viral load, however, nearly always requires HIV medication. Therefore, the upgraded rating for Biktarvy implies that anyone with HIV who hopes to become pregnant should consider being on HIV treatment first, whether on Biktarvy or on another medication. HHS perinatal guidelines strongly recommend HIV therapy for positive pregnant individuals.
At any rate, the upgrade is a reassuring advance in evidence-based HIV treatment.
Gilead Sciences
The maker of Biktarvy presented the FDA with data from Study 5310, which reviewed the safety, efficacy and pharmacokinetics of Biktarvy in pregnancy.
“This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant PWH [people with HIV], an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, vice president of HIV Clinical Development at Gilead Sciences, in a press release. “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant.”
The Biktarvy label was also updated in February to include the breastfeeding/chestfeeding guidance from the U.S. Centers for Disease Control and Prevention, which urges doctors to work with positive pregnant people in deciding whether they want to breastfeed or chestfeed.
In Study 5310, the 32 participants who completed the study remained undetectable throughout pregnancy and through 18 weeks after giving birth. The 29 infants born during the study remained HIV-negative out to eight weeks following birth.
“This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant,” Gilead reported.
As stated by HHS guidelines, the label says that pregnant individuals must have undetectable viral load before going on Biktarvy, on a stable HIV regimen, and have no drug resistance to any of the three medications found in Biktarvy.
GO TO clinicalinfo.hiv.gov.
Preferred HIV medications for pregnancy
“All pregnant people with HIV should initiate antiretroviral therapy (ART) as early in pregnancy as possible, regardless of their HIV RNA [viral load] level or CD4 T lymphocyte cell count, to maximize their health and prevent perinatal HIV transmission and sexual transmission,” according to the perinatal HIV treatment guidelines from the U.S. Department of Health and Human Services (HHS).
The HIV medications listed here are recommended by the expert panel behind the perinatal guidelines for use during pregnancy or conception by people taking HIV treatment for the first time (called treatment-naïve). SEE Table 6 of the guidelines. Table 6 also includes a list of what not to take. SEE Table 7 of the guidelines for recommendations for people who are already taking HIV therapy. Both tables list advantages and disadvantages of the medications, as well as special considerations. See other sections of this POSITIVELY AWARE HIV drug guide issue for information on these medications and their drug classes.
Note that according to the guidelines, “In general, the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission (the Panel) recommends that people who are already on fully suppressive [undetectable viral load] ARV regimens when pregnancy occurs should continue with those regimens, unless they are receiving an ARV drug or ARV regimen that is not recommended for use in nonpregnant adults or concerns exist about safety and inferior efficacy during pregnancy (SEE Table 7.).”
To see the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States, GO TO clinicalinfo.hiv.gov.
PREFERRED DRUG
Preferred INSTI regimens
Triumeq or Tivicay plus a preferred dual-NRTI backbone
Preferred PI regimens
If pregnant person has used Apretude, Prezista boosted by ritonavir plus a preferred dual-NRTI backbone
Preferred dual-NRTI backbone medications
Epzicom
Descovy or Vemlidy plus Epivir
Truvada or Viread plus Epivir
ALTERNATIVE DRUGS
Alternative INSTI regimens
Biktarvy raltegravir 400 mg twice daily
(SEE Isentress on page 41) plus a preferred dual-NRTI backbone
Alternative PI regimens
Prezista twice daily boosted by Norvir plus a preferred dual-NRTI backbone
Reyataz boosted by Norvir plus a preferred dual-NRTI backbone
Alternative NNRTI regimens
Atripla or Symfi or Sustiva plus a preferred dual-NRTI backbone
Complera or Odefsey or Edurant plus a preferred dual-NRTI backbone
Alternative dual-NRTI backbone medications
Combivir (considered a legacy drug in this drug guide issue and no longer appears in the drug pages; an FDC - fixed-dose combination of AZT and Epivir)
NOTE: Two-drug regimens are not recommended for initiation of ART in pregnancy due to a lack of data.
FDA approves HPV self-collection kit
Roche Pharmaceuticals announced the approval of its new self-collection kit for human papilloma virus (HPV) by the U.S. Food and Drug Administration (FDA). It is one of the first approved by the FDA.
“Screening for HPV can help identify women who are at risk of developing cervical cancer so that the disease can be found and treated early before cervical cancer has a chance to develop,” Roche announced in a May 15 press release.
A positive result for HPV requires follow up with a provider.
Cervical cancer occurs more often in women living with HIV than among other women. It is an AIDS-defining condition. Most people in the U.S. who have had sex will acquire HPV, of which there are more than 100 strains.
“More than half the patients diagnosed with cervical cancer in the U.S. have never been screened or have only been screened infrequently, and they do not participate in routine screening,” Roche reported. “Many factors can contribute to individuals not participating in cervical cancer screening programs, such as access to healthcare, social and economic barriers, history of traumatic experience, cultural concerns and embarrassment. Roche’s self-collection solution can help reduce these barriers by offering an alternative to clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions.”
Roche is working with the Cervical Cancer ‘Last Mile’ Initiative of the U.S. National Cancer Institute.
GO TO prevention.cancer.gov/major-programs/nci-cervical-cancer-last-mile-initiative.
“With vaccinations, innovative diagnostic tools and screening programs, achieving the [World Health Organization’s] goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, CEO of Roche Diagnostics. “Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing.”
Center for Black Equity names interim CEO
The DC Center for AIDS Research (DFAR) announced that Kenya Hutton, a member of its Community Partnership Council, has been named interim CEO and president of the Center for Black Equity. The mission of CBE is to “promote a multinational LGBTQ+ network dedicated to improving health and wellness opportunities, economic empowerment and equal rights while promoting individual and collective work, responsibility and self-determination.” CBE focuses on three areas: economic equity, social equity and health equity. Within the health arena, CBE focuses on “allowing Black LGBT people to thrive physically, behaviorally, environmentally and spiritually.”
Hutton has served as CBE’s deputy director for four years, and in other capacities for a decade before that. He succeeds founding CEO and president Earl Fowlkes, Jr. Although retiring after 25 years, Fowlkes will continue to serve the global organization in an advisory capacity as CEO/president emeritus.
In a separate announcement, CBE described Hutton as “a seasoned leader with a proven track record in advancing racial justice initiatives.” GO TO centerforblackequity.org.
New HHS recommendations on anal cancer screening in HIV
U.S. HIV treatment guidelines added new recommendations for anal cancer screening and prevention thanks to the ANCHOR study. “These recommendations include a screening program that uses high resolution anoscopy (HRA) to help detect and treat precancer and prevent anal cancer for people with HIV,” the Department of Health and Human Services reported. “The guidelines recommend that all adults with HIV be assessed at least once per year for anal abnormalities (such as pain, burning or masses) and undergo digital anorectal examination (DARE).
“People under the age of 35 who are symptomatic or show signs of anal cancer (visual or palpable abnormalities) during DARE should undergo standard anoscopy.
“Older people should undergo additional lab-based screening with subsequent HRA, rather than standard anoscopy, if they are among the following populations:
- Men who have sex with men and transgender women ages 35 and older
- All other people with HIV ages 45 and older
“This lab-based screening should include collection of anorectal specimens for diagnosis,” wrote HHS in July. “If there are any abnormalities on those specimens, or symptoms or signs of anal cancer in the initial assessment and DARE, clinicians should make a referral for HRA.” GO TO clinicalinfo.hiv.gov.
Sluts: new book takes on PrEP shaming
London-based writer Beth Ashley, editor-in-chief of Paperfox literary magazine, has written Sluts: The Truth about Slutshaming and What We Can Do to Fight It. In an excerpt at Gay Times, a global online news and lifestyle magazine based in Great Britain, she writes, “The slutshaming around PrEP has the potential to overshadow its scientific accomplishment and even ‘cloud the judgment of medical providers, policymakers, insurers and potential PrEP users,’ according to the ‘PrEP Whores’ research. Essentially, the availability of PrEP could be affected by the slutshaming that surrounds it, as lawmakers and governing bodies could deem it a ‘dirty’ device for promiscuity and see it as less of a priority.”
Or, as the Gay Times subhead says, PrEP slutshaming is still alive and well—and it's harming us all.
Ashley goes on to quote people on PrEP and HIV prevention and treatment advocates, including individuals working on behalf of the LGBTQ+ community. She also covers research findings around HIV PrEP. The book launch was held in May.
To read the excerpt, GO TO gaytimes.com/life/prep-slutshaming.
CDC reports new HIV statistics
In May, the U.S. Centers for Disease Control and Prevention (CDC) issued its latest statistics on HIV incidence and prevalence.
According to the HIV + Hepatitis Policy Institute, “CDC data released today [May 20] show that the number of new HIV diagnoses in the United States remained stubbornly stable at 31,800 in 2022. While new HIV diagnoses have fallen by 12 percent over the past five years, driven by a 30 percent decrease in new cases among young people, the number remains high and is not decreasing at the rate needed to end HIV by 2030.”
For transgender women, diagnoses increased by 25 percent. Latino gay men now account for 39 percent of all HIV diagnoses among men who have sex with men. GO TO hivhep.org.
Estimated HIV Incidence and Prevalence in the United States, 2018–2022 is a supplemental report of the CDC’s HIV Surveillance Report. CDC explained that incidence refers to “the number of infections during a specified time” and prevalence refers to the number of people living with HIV at a given time, regardless of when they acquired the virus or were diagnosed.
GO TO cdc.gov. Download the supplemental report at stacks.cdc.gov/view/cdc/156513/cdc_156513_DS1.pdf.
Updated OI guidelines
The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV were updated in May regarding the treatment of mycobacterium tuberculosis.
According to the update, the guidelines:
- Recommended a 4-month regimen of daily rifapentine, isoniazid, pyrazinamide and moxifloxacin as an alternative treatment for active pulmonary tuberculosis (TB) in people receiving efavirenz-based antiretroviral therapy.
- Recommended a regimen consisting of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) as the preferred treatment for rifampin-resistant TB.
As with the adult and adolescent treatment guidelines and the perinatal guidelines, the OI guidelines are produced by the Department of Health and Human Services. Note: efavirenz-based treatments are rarely prescribed in the U.S. today.
GO TO bit.ly/3KDRq6L.
CDC issues guidelines for using doxy-PEP against STIs
It’s official. The U.S. Centers for Disease Control and Prevention (CDC) has issued guidelines for preventing STIs through the use of doxy-PEP. “In three large randomized controlled trials, 200 mg of doxycycline taken within 72 hours after sex has been shown to reduce syphilis and chlamydia infections by greater than 70% and gonococcal infections by approximately 50%,” the CDC reported. The recommendation is to take 200 mg doxy within 72 hours after a sexual exposure, real or potential, and no more than 200 mg every 24 hours. Specifically, providers should offer the option of a doxy prescription to men who have sex with men and transgender women who have had a bacterial STI (specifically syphilis, chlamydia or gonorrhea) diagnosis within the previous 12 months, because they are the groups most affected by the growing rate of STI cases. A doxy prescription should be enough to cover the number of anticipated sexual encounters before the next clinic visit. The need for doxy-PEP (post-exposure prophylaxis) should then be assessed every 3 to 6 months, along with STI testing. “We will continue to adjust our recommendations as additional data are available,” the CDC stated.
GO TO bit.ly/3VWEYFC.
NIAID updates HIV language guide
The National Institute of Allergy and Infectious Diseases in April updated its HIV language guide. NIAID said it strove to eliminate language and terminology considered “offensive and stigmatizing.” NIAID also announced a campaign to “educate and strongly advocate for person-first, non-stigmatizing language in all of our communications, including but not limited to grant applications, contracts, publications, presentations, abstracts and press materials.” SEE “A call to end stigmatizing language in HIV research” in the FEB+MAR issue; GO TO bit.ly/4eA7K6z. SEE below.
From the NIAID HIV Language Guide
Emphasizing use of Non-stigmatizing, Person-First Language
Do not describe people by their disease, infection or condition; use instead:
- People with HIV rather than HIV-infected people
- People who inject drugs rather than injection drug users
Do not use subjects or patients to describe people enrolled in research studies or clinical trials; use instead:
- Participant
- Volunteer
Do not use ‘sex’ and ‘gender’ interchangeably:
- Sex (refers to sex assigned at birth)
- Gender (refers to psychosocial or cultural identity)
- Use cisgender for people whose gender matches their sex assigned at birth and transgender for people whose gender does not match their sex assigned at birth
Do not use at risk or high-risk to characterize a person, use instead:
- Person/population with greater likelihood of HIV exposure
- Population experiencing a disproportionate impact of HIV
- High-incidence population
- Affected community
Do not use sterilizing when referring to HIV cure; use instead:
- Elimination
- Eradication
- Clearance