Update - Monkeypox in People with HIV, Children and Adolescents, and People who are Pregnant or Breastfeeding
Update for Clinicians: People with HIV, individuals who are immunocompromised, children, adolescents, and people who are pregnant or breastfeeding may be at risk
KEY FINDINGS: As of July 29, 2022, the Centers for Disease Control and Prevention (CDC) and state and local public health partners are reporting 5,189 cases of Monkeypox virus infections in the United States across 47 states, Washington, D.C., and Puerto Rico. CDC is also reporting multiple outbreaks of monkeypox that have been reported globally in 71 countries that do not normally report monkeypox activity. On Friday, July 22, CDC reported the first two cases of monkeypox in children in the United States during the current outbreak. This Health Alert Network (HAN) Health Update serves to alert clinicians to clinical considerations for preventing, diagnosing, and managing monkeypox in people with HIV, children, adolescents, and people who are pregnant or breastfeeding.
BACKGROUND: Since May 2022, CDC has been urging healthcare providers in the United States to be on alert for patients who have rash illnesses consistent with monkeypox. People with HIV, individuals who are immunocompromised, children, adolescents, and people who are pregnant or breastfeeding may be at risk for increased disease severity and adverse health outcomes associated with monkeypox infection. Clinicians should be familiar with unique clinical considerations for monkeypox in these patient populations. A broad diagnostic approach is encouraged to distinguish Monkeypox virus infection from other causes of fever and rash illness. Testing should be performed on persons for whom monkeypox is suspected based on clinical presentation or epidemiologic criteria. Clinicians should consult their state or territorial health department (State Contacts) or CDC through the CDC Emergency Operations Center (770-488-7100) as soon as monkeypox is suspected.
DETAILS: CDC has issued clinical considerations for monkeypox infection in multiple populations including: people with HIV, children and adolescents, and people who are pregnant or breastfeeding. These newly released clinical considerations complement existing clinical guidance for managing monkeypox and provide information on signs and symptoms of Monkeypox virus infection; pre- and post-exposure prophylaxis; treatment; and infection control in these populations.
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Recommendations and Information for Healthcare Providers on Monkeypox in People with HIV
In the current outbreak, available international summary surveillance data in the CDC-issued clinical considerations for people with HIV indicate 30-51% HIV prevalence among persons with monkeypox for whom HIV status was known. It is currently unknown whether HIV infection affects a person's risk of acquiring Monkeypox virus infection and developing disease after exposure.
Persons with advanced and uncontrolled HIV might be at higher risk for severe or prolonged monkeypox disease. Therefore, prophylaxis (e.g., vaccination), medical treatment and close monitoring are a priority for this population. Compared with other persons with monkeypox, case reports among persons with inadequately treated HIV who have CD4 counts <=350 per mm3 reported higher rates of secondary bacterial infection, more prolonged illness (and thereby also longer period of infectiousness), as well as a higher likelihood of a confluent or partially confluent rash, rather than discrete lesions. In contrast, recent reports of patients with HIV infection and monkeypox who are on effective antiretroviral therapy (ART) have noted no deaths or evident excess hospitalizations to date. Providers should consider both viral suppression and CD4 count in weighing the risk of severe outcomes from monkeypox for any patient with HIV.
The rash of monkeypox can be confused with other rash illnesses that are considered in people with HIV, including herpes zoster (shingles), scabies, molluscum contagiosum, herpes, syphilis, chancroid, lymphogranuloma venereum, allergic skin rashes, and drug eruptions. Immunocompromised persons, including persons with advanced, untreated or inadequately suppressed HIV, may present with an atypical rash, including a disseminated rash that may make diagnosis more challenging.
Prevention of monkeypox and infection control practices in the home or healthcare setting are the same regardless of peoples' HIV status. Post-exposure prophylaxis (PEP) and antiviral treatments, including tecovirimat, are available for persons exposed to monkeypox or with Monkeypox virus infection. The safety and immunogenicity of JYNNEOS, a live, non-replicating viral vaccine, has been specifically established in people with HIV; however, immunogenicity among persons with HIV who have CD4 counts below 100 cells/mm3 or who are not virologically suppressed remains unknown. ACAM2000, a replicating viral vaccine, should not be given to people with HIV (regardless of immune status). Antiviral treatments for monkeypox have few interactions with antiretroviral therapy. ART and opportunistic infection prophylaxis should be continued in all people with HIV who develop monkeypox.
Recommendations and Information for Healthcare Providers on Monkeypox in Children and Adolescents
Limited pediatric data on infection with the Congo Basin clade of Monkeypox virus suggest increased risk of severe disease in children younger than 8 years of age. Rare complications of monkeypox include abscess, airway obstruction due to severe lymphadenopathy, cellulitis, corneal scarring, encephalitis, keratitis, pneumonia, and sepsis. The West African clade of Monkeypox virus involved in the current outbreak typically causes less severe disease than the Congo Basin clade.
Monkeypox virus can spread to children through contact with infectious body fluids (e.g., lesion exudates and respiratory secretions) of people or animals or through contact with fomites, as may occur in households and other close contact settings. The number of monkeypox cases among children in the United States is currently low; however, CDC acknowledges that the expanding U.S. outbreak and the possible risk for transmission in households and other settings may result in additional pediatric cases. Pediatric providers should be familiar with prevention, recognition, and testing considerations for monkeypox in children and adolescents.
Families should be counseled about preventing the spread of Monkeypox virus between children, caregivers, and household members in the home, including avoidance of contact with persons who have monkeypox, the body fluids of an infected person, and fomites (e.g., clothing, towels, bedding); wearing a well-fitting mask or respirator by the person with monkeypox and the contact (for children over 2 years of age) when interaction is unavoidable; and minimizing the number of caregivers for children with monkeypox. Particular attention should be made to keep children with monkeypox from scratching lesions or touching their eyes to prevent auto-inoculation and more severe illness. Caregivers should cover areas of broken skin with bandages to the extent possible and avoid direct skin-to-skin contact with the rash.
Children and adolescents who are close contacts of a person with monkeypox (e.g., household contact, other family member, caregiver, or friend) should be evaluated for illness and offered post-exposure prophylaxis with JYNNEOS or ACAM2000 (for children older than 12 months) or treatment when indicated. Monkeypox should be considered when children or adolescents present with signs or symptoms that could be consistent with the disease, especially if epidemiologic criteria are present. The rash of monkeypox can be confused with other rash illnesses that are commonly considered in children including varicella (chickenpox); hand, foot, and mouth disease; measles; scabies; molluscum contagiosum; herpes; allergic skin rashes and syphilis (including congenital syphilis); and drug eruptions.
Data are limited on the effectiveness of PEP for children who have been exposed to monkeypox or treatment for children with illness, and no vaccines or other products are currently licensed for monkeypox prevention or treatment in children or adolescents. However, PEP should not be withheld from children or adolescents who are otherwise eligible. Decisions about whether to offer PEP should take into account the patient's degree of exposure and the patient's individual risk of severe disease.
Prophylactic therapeutics that can be administered include vaccination, Vaccinia immune globulin, and antiviral medication. For almost all children and adolescents, vaccination is the preventive treatment that should be administered. Immune globulin or antivirals may also be considered for infants under 6 months of age, given their immature immune systems and possible decreased responses to vaccination.
Tecovirimat is currently being used as the first-line treatment for infection with Monkeypox virus, including for children and adolescents with severe disease or underlying medical conditions that may increase risk for severe disease and those with complications from monkeypox. Individual risks and benefits must be considered prior to initiating tecovirimat. Other treatments such as Vaccinia immune globulin may be considered in unusual circumstances.
In pediatric inpatient care settings, infection control procedures for children with monkeypox infection should also consider the child's age and caregiving needs; family and caregiver preferences; the extent, severity, and course of the child's illness; and risks for severe monkeypox disease in exposed caregivers (e.g., pregnancy or immunocompromising conditions).
Recommendations and Information for Healthcare Providers on Monkeypox in People who are Pregnant or Breastfeeding
Data regarding Monkeypox virus infection during pregnancy are limited. It is unknown if pregnant people are more susceptible to acquiring Monkeypox virus infection or if illness is more severe during pregnancy. Other poxviruses cause more severe infection during pregnancy. Monkeypox virus can be transmitted to the fetus during pregnancy and to the newborn by close contact during and after birth. There are few case reports of spontaneous pregnancy loss and stillbirth, preterm delivery, and neonatal monkeypox infection; the frequency and circumstances for these outcomes are unknown. Whether Monkeypox virus is present in breast milk is unknown; however, it may be transmitted through close contact during breastfeeding.
Prevention measures for monkeypox infection are similar for pregnant and non-pregnant people. Pre- or post-exposure prophylaxis should be offered to people who are pregnant or breastfeeding. When pre- or post-exposure prophylaxis by vaccination is chosen, JYNNEOS, a live, non-replicating viral vaccine, can be used. ACAM2000, a replicating viral vaccine, should not be used in people who are pregnant or breastfeeding.
During pregnancy, the cause of fever may be difficult to differentiate from other infections, such as intraamniotic infection (chorioamnionitis), until the monkeypox rash appears. Pregnant patients with rashes initially considered characteristic of dermatoses of pregnancy (e.g., polymorphic eruption of pregnancy) or of more common infections (e.g., varicella zoster or sexually transmitted infections) should be carefully evaluated for a monkeypox rash, and submission of specimens of lesions for monkeypox diagnosis should be considered, especially if the person has any epidemiologic risk factors for monkeypox infection.
While most adults with Monkeypox virus infection experience self-limiting infection and recover within 2-4 weeks, pregnant and breastfeeding people should be prioritized for medical treatment, if needed, due to the probable increased risk of severe disease during pregnancy, risk of transmission to the fetus during pregnancy or to the newborn by close contact during and after birth, and risk of severe infection in newborns. Treatment for Monkeypox virus infection should be offered to people who are pregnant or breastfeeding. The risks and benefits of treatment options should be discussed with the patient.
Recommendations for infection prevention and control of monkeypox in healthcare settings are the same for pregnant and non-pregnant patients. Newborns born to people with monkeypox should be placed in isolation, and healthcare personnel should follow infection prevention and control recommendations. Patients with monkeypox should be counseled about measures to prevent risk of transmission of Monkeypox virus to their newborn from close contact and breastfeeding.
Source: Centers for Disease Control and Prevention (U.S.) (2022). Update for Clinicians on Monkeypox in People with HIV, Children and Adolescents, and People who are Pregnant or Breastfeeding. Centers for Disease Control and Prevention. Published: July 30, 2022. DOI: CDCHAN-00472.
Accounting for Long-Term Consequences of Tuberculosis Strengthens the Case for Preventive Screening in New Immigrants
A Canadian modeling study found that including long-term illness and mortality after tuberculosis more than doubled the estimated health benefits of postarrival TB screening and preventive treatment among new immigrants. Incorporating these consequences reduced the projected cost from $235,088 to $100,742 CAD per QALY gained. The findings highlight the importance of considering the long-term burden of TB when evaluating prevention strategies.
KEY FINDINGS: The analysis suggests that excluding long-term illness, mortality, and healthcare costs after TB treatment can substantially underestimate the health value of TB prevention. In the modeled Canadian immigrant population, incorporating these consequences more than doubled the estimated QALY benefit of postarrival TB infection screening and preventive treatment and reduced the estimated cost per QALY by more than half. However, the findings depend on assumptions about the long-term effects of TB, and the investigators noted that some underlying associations may include residual confounding and that post-TB illness estimates are less certain.
BACKGROUND: Tuberculosis prevention strategies are commonly evaluated by considering acute TB disease and death, while longer-term consequences after successful treatment may be overlooked. These consequences can include persistent illness, increased mortality, and additional healthcare utilization. This study assessed how incorporating these longer-term effects would change estimates of the health benefits and cost-effectiveness of postarrival TB infection screening and preventive treatment among people newly immigrating to Canada.
DETAILS: The investigators developed a Markov microsimulation model representing a hypothetical cohort of 400,000 people immigrating permanently to Canada in 2025. The analysis compared the existing postarrival TB infection screening level of 0.5% with a modeled screening strategy reaching 68% of eligible new immigrants. The intervention targeted new permanent residents from countries with annual TB incidence >50/100,000 persons; individuals testing positive for TB infection were assumed to receive 4 months of daily rifampin as preventive treatment. Outcomes were projected over 25 years and included TB episodes, TB deaths, quality-adjusted life-years (QALYs), and TB-related healthcare costs. The model incorporated three post-TB consequences: increased mortality after TB treatment, persistent illness or disability, and excess healthcare costs. A total of 2,000 probabilistic simulations were performed to account for uncertainty in model parameters.
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When only acute TB consequences were considered under the current screening scenario, the model projected 927 (95% UR 764-1,123) TB cases, 30 (95% UR 24-36) TB deaths, and 312 (95% UR 241-386) QALYs lost over 25 years. Adding post-TB death increased estimated QALYs lost by 1.6-fold, while including post-TB illness increased them by 1.5-fold. When all three long-term consequences were incorporated, TB was projected to account for 657 (95% UR 479-876) QALYs lost, a 2.1-fold increase compared with considering acute consequences alone.
The expanded screening and preventive-treatment strategy produced 2.4-fold greater estimated QALY gains (95% UR 1.6-4.4-fold) and 2.2-fold more TB deaths averted (95% UR 1.6-3.0-fold) when all post-TB consequences were included. The estimated incremental cost-effectiveness ratio decreased from $235,088 to $100,742 CAD per QALY gained. In the model incorporating all post-TB consequences, 53% of simulations fell below a willingness-to-pay threshold of $100,000 per QALY, compared with 8% when only acute TB consequences were considered.
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Source: Ainiwaer, A., Uppal, A., Schwartzman, K., et al. Posttuberculosis Consequences on Tuberculosis Prevention Effectiveness and Cost-effectiveness among New Immigrants, Canada. Emerging Infectious Diseases. 2026; 32(9): 1421-1429. Published: September, 2026. DOI: 10.3201/eid3209.260473.
Broad-Spectrum Antibiotic Use Is Lower Among Hospice Patients With Cancer at the End of Life
In this nationwide Korean cohort, hospice utilization was associated with lower broad-spectrum antibiotic use as death approached, particularly during the final week and final 3 days of life. The findings suggest that hospice involvement may be associated with a transition toward more selective antimicrobial use and less intensive treatment near the end of life. However, the study was observational, and causality cannot be established. Important clinical variables, including infection severity, microbiological findings, functional status, symptom burden, cancer stage, and treatment intent, were unavailable in the claims data.
KEY FINDINGS: Among adults with cancer approaching death, hospice utilization was associated with less frequent and lower-intensity broad-spectrum antibiotic exposure, particularly during the final days of life. The findings are consistent with a transition toward comfort-focused care, although they do not establish that hospice care itself caused the reduction. Hospice initiation occurred relatively close to death, with a mean interval of 39.9 days and a median of 22.0 days, and some antibiotic treatment may have preceded hospice enrollment. In addition, cancer stage, treatment status, infection severity, microbiological findings, functional status, symptom burden, and treatment intent were unavailable in the claims data.
BACKGROUND: Antibiotic treatment remains common during end-of-life care for patients with cancer, despite uncertain benefits for survival and potential burdens including drug toxicity, intravenous administration, adverse effects, and antimicrobial resistance. This retrospective cohort study evaluated whether hospice involvement was associated with differences in broad-spectrum antibiotic use among adults with cancer during the final 3 months of life.
DETAILS: Investigators analyzed Korean National Health Insurance Service claims data for adults aged ≥18 years who died between January 1, 2018, and December 31, 2021, with one of the 10 leading cancer-related causes of death. Hospice users had received inpatient, home-based, or consultation-based hospice care before death. Broad-spectrum antibiotic exposure included anti-pseudomonal penicillins, anti-pseudomonal cephalosporins, carbapenems, and glycopeptides. The final 90 days of life were divided into four intervals: 1–3 months before death, 1 week to 1 month before death, the final week, and the final 3 days. Antibiotic exposure was assessed by the proportion of patients receiving antibiotics and by days of therapy (DOT) per 1,000 patient-days. Propensity score matching was performed at a 1:2 ratio.
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After matching, 38,102 hospice users and 75,736 non-hospice users were analyzed. During the final 3 months of life, 74.6% of hospice users and 79.0% of non-hospice users received at least one broad-spectrum antibiotic (P0.001). Antibiotic use was initially slightly higher among hospice users during the period 1–3 months before death, at 34.0% versus 32.2% (P0.001), but became consistently lower among hospice users thereafter. From 1 week to 1 month before death, use was 31.1% versus 32.8%; during the final week, 11.3% versus 18.5%; and during the final 3 days, 4.8% versus 10.3% among hospice and non-hospice users, respectively (all P0.001).
Days of therapy per 1,000 patient-days were also consistently lower among hospice users, with the greatest differences occurring during the final week and final 3 days of life. Carbapenems and glycopeptides demonstrated particularly pronounced differences between the groups. In cancer-specific analyses, patients with hematologic malignancies had the highest overall antibiotic exposure, followed by those with pancreatobiliary and gastric cancers, while exposure was comparatively lower among patients with breast and liver cancers.
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Source: Jeung, Y. S., Kim, H. J., Yu, J., et al. Comparison of Broad-Spectrum Antibiotic Use According to Hospice Utilization Among Patients with Cancer at the End of Life in South Korea: A Nationwide Analysis. Journal of Hospice and Palliative Care. 2026; 29(2): 41-50. Published: June 1, 2026. DOI: 10.14475/jhpc.2026.29.2.41.
US Measles Cases Rise in 2026 as Outbreaks Continue Amid Declining MMR Coverage
US measles activity has increased substantially in 2026, with 2,465 confirmed cases and 38 new outbreaks reported as of August 6. Declining MMR coverage may increase community vulnerability to transmission. Maintaining high vaccination coverage remains central to preventing measles outbreaks and sustaining elimination.
KEY FINDINGS: As of August 6, 2026, the US had reported 2,465 confirmed measles cases and 38 new outbreaks, with 94% of cases outbreak-associated. The increase occurs alongside a decline in kindergarten MMR coverage to 92.5% in 2024-2025 from 95.2% in 2019-2020. CDC emphasizes that measles can spread rapidly in communities with lower vaccination coverage, while 2 doses of MMR vaccine provide 97% protection against measles.
BACKGROUND: Measles was officially eliminated in the United States in 2000 following widespread use of the measles, mumps, and rubella (MMR) vaccine. However, declining vaccination coverage and increasing global measles activity have increased opportunities for measles transmission following importation into the United States.
DETAILS: As of August 6, 2026, the Centers for Disease Control and Prevention (CDC) reported 2,465 confirmed measles cases in the United States in 2026. Of these, 2,449 cases were reported by 47 jurisdictions, while 16 cases occurred among international visitors to the United States. Thirty-eight new outbreaks had been reported during 2026.
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Overall, 94% of confirmed cases in 2026 (2,309 of 2,465) were associated with outbreaks, including 936 cases from outbreaks beginning in 2026 and 1,373 from outbreaks that began in 2025. For comparison, 2,289 confirmed cases and 48 outbreaks were reported during the full year of 2025; 90% of cases (2,066 of 2,289) were outbreak-associated.
CDC reports confirmed measles cases notified by jurisdictions as of noon on Thursdays. An outbreak is defined as 3 or more related cases. State and CDC counts may differ because jurisdictions update and publicly report their data on different schedules.
MMR vaccination coverage among US kindergartners declined from 95.2% during the 2019-2020 school year to 92.5% during the 2024-2025 school year, leaving approximately 286,000 kindergartners at risk during the 2024-2025 school year. CDC notes that communities with vaccination coverage below the 95% level are more vulnerable to measles outbreaks. The 2026 measles case count reported by CDC as of August 6, 2026, had already exceeded the total number of confirmed cases reported during all of 2025 (2,465 vs 2,289). The high proportion of outbreak-associated cases indicates sustained transmission within affected communities.
The burden of measles remains closely associated with vaccination status. CDC reports that 2 doses of MMR vaccine are 97% effective at preventing measles, while 1 dose is 93% effective. Breakthrough infections can occur, particularly during outbreaks with high levels of circulating measles virus, and account for approximately 10% of all measles infections.
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Source: CDC: Measles Cases and Outbreaks. Centers for Disease Control and Prevention (CDC). 2026; Published: August 7, 2026.
Global Forecasts Reveal Rising Antimicrobial Resistance Threats in Children
Global pediatric antimicrobial resistance increased from 2004 to 2022 across all regions. Resistance was highest among Gram-negative pathogens, children in intensive care, those with sepsis, and resource-limited settings. By 2035, carbapenem resistance is projected to reach 35% in Klebsiella species and 82% in Acinetobacter baumannii.
KEY FINDINGS: This global pediatric surveillance study demonstrates a sustained increase in antimicrobial resistance among children, with the greatest concern involving Gram-negative pathogens, intensive care settings, sepsis cases, and resource-limited regions. Increasing resistance to Watch and Reserve antibiotics may compromise treatment options for severe childhood infections. Forecasted growth in carbapenem resistance among Klebsiella species and Acinetobacter baumannii highlights the need for strengthened antimicrobial stewardship, surveillance systems, and development of effective pediatric treatment strategies.
BACKGROUND: Antimicrobial resistance (AMR) threatens the effectiveness of antibiotic therapy for severe childhood infections, yet comprehensive pediatric AMR surveillance data across multiple regions remain limited. This study evaluated global and temporal patterns of antimicrobial resistance among children using the World Health Organization (WHO) Access, Watch, and Reserve (AWaRe) antibiotic classification framework and projected future resistance trends
DETAILS: This cross-sectional surveillance study analyzed pediatric bacterial isolates from the Antimicrobial Testing Leadership and Surveillance (ATLAS) database collected between January 2004 and December 2022. The study included 106 581 isolates from 106 581 children aged 0 to 18 years across 82 countries. Data were analyzed from February 2024 to April 2026. Resistance trends were assessed by geographic region, age group, clinical setting, infection syndrome, and pathogen type, with spatiotemporal models used to forecast resistance patterns through 2035.
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The analysis categorized antibiotics according to the WHO AWaRe framework: Access antibiotics used for first-line treatment, Watch antibiotics with higher resistance potential, and Reserve antibiotics intended for difficult-to-treat infections. The study evaluated WHO priority pathogens and examined resistance patterns among different pediatric populations, including children with sepsis and respiratory infections.
From 2004 to 2022, pediatric AMR increased across all regions, with higher resistance levels and faster increases observed in resource-limited settings. Resistance to Access-group antibiotics was highest overall, with a mean resistance of 36% (range, 2%-66%), compared with Watch-group antibiotics at a mean of 22% (range, 1%-47%) and Reserve-group antibiotics at a mean of 13% (range, 0%-30%).
Resistance to higher-tier antibiotics increased substantially in vulnerable clinical groups. In intensive care units, Watch-group resistance increased from 15% (517/3564) to 33% (2910/8748) (P < .001), particularly among children aged 0 to 2 years, where resistance increased from 12% (325/2649) to 32% (1257/3959) (P < .001). Among children with sepsis, Watch-group resistance increased from 15% (298/2030) to 30% (1409/4705) (P < .001), while Reserve-group resistance increased from 3% (16/474) to 26% (746/2824) (P < .001).
Among critical pathogens, Acinetobacter baumannii demonstrated the highest overall resistance, exceeding 55% in every AWaRe antibiotic category in 2022. Klebsiella species showed the fastest increases in resistance, particularly to third- or fourth-generation cephalosporins and carbapenems. Forecasts estimated that by 2035, carbapenem resistance would reach 35% (95% uncertainty interval [UI], 29%-40%) in Klebsiella species and 82% (95% UI, 77%-85%) in A baumannii.
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Source: Hu, Y. J., Qiu, H., Harwell, J. I., et al. Childhood Antimicrobial Resistance With Global Forecasts. JAMA Pediatrics. 2026; Published: July 20, 2026. DOI: 10.1001/jamapediatrics.2026.2808.
Once-Weekly Oral Islatravir-Lenacapavir Maintains HIV-1 Viral Suppression at 48 Weeks
In 607 adults with virologically suppressed HIV-1, once-weekly oral ISL/LEN was noninferior to once-daily B/F/TAF at week 48. HIV-1 RNA levels of 50 copies/mL or higher occurred in 0% versus 0.3% of participants, respectively. Virologic suppression, CD4+ T-cell changes, and safety outcomes were comparable between the groups.
KEY FINDINGS: Once-weekly oral ISL/LEN was noninferior to once-daily B/F/TAF for maintaining virologic suppression through week 48 in adults with previously suppressed HIV-1. No participants receiving ISL/LEN had HIV-1 RNA levels of 50 copies/mL or higher, and virologic suppression rates remained high in both treatment groups. CD4+ T-cell changes and safety outcomes were broadly comparable. The once-weekly oral regimen may provide a less frequent treatment option for patients who prefer oral therapy but may benefit from reduced dosing frequency.
BACKGROUND: Daily single-tablet antiretroviral regimens have substantially improved HIV-1 management; however, maintaining long-term adherence remains challenging for some patients. Less frequent oral treatment schedules may provide an alternative to daily therapy while avoiding the need for injectable regimens. This phase 3 trial evaluated the efficacy and safety of once-weekly oral islatravir-lenacapavir (ISL/LEN) in adults with virologically suppressed HIV-1.
DETAILS: This phase 3, double-blind, randomized, active-controlled, noninferiority trial was conducted in 12 countries. Adults with HIV-1 viral suppression for at least 6 months while receiving once-daily bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF) were randomly assigned in a 1:1 ratio to switch to once-weekly oral ISL/LEN (2 mg/300 mg) or continue once-daily B/F/TAF for 96 weeks. The primary endpoint was the proportion of participants with HIV-1 RNA levels of 50 copies/mL or higher at week 48, assessed using the FDA-defined snapshot algorithm. The prespecified noninferiority margin was 4 percentage points. A total of 607 participants underwent randomization, including 304 assigned to ISL/LEN and 303 assigned to B/F/TAF. At week 48, no participants in the ISL/LEN group and 1 participant (0.3%) in the B/F/TAF group had HIV-1 RNA levels of 50 copies/mL or higher (difference, -0.3 percentage points; 95.002% CI, -1.4 to 0.8), meeting the criterion for noninferiority. HIV-1 RNA levels below 50 copies/mL were observed in 284 participants (93.4%) receiving ISL/LEN and 280 participants (92.4%) receiving B/F/TAF (difference, 1.0 percentage point; 95% CI, -3.2 to 5.2). The mean change in CD4+ T-cell count was -10 cells/µL with ISL/LEN and -18 cells/µL with B/F/TAF, with a least-squares mean difference of 12 cells/µL (95% CI, -16 to 39). Treatment discontinuation due to adverse events occurred in 6 participants (2.0%) receiving ISL/LEN and 5 participants (1.7%) receiving B/F/TAF; serious adverse events occurred in 16 participants (5.3%) and 14 participants (4.6%), respectively.
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