HIV Management

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FDA Alerts

Treatment

FDA Approves First 2-Drug Regimen for HIV-1

04/09/2019

After 2 randomized clinical trials found it as safe and effective as the standard 3-drug regimen, the FDA approved the first 2-drug regimen for adults with HIV-1 who have never been treated with ART.

04/09/2019

HIV Management Snapshot

Reviewed by Daniel Erias, MD & Jeffrey Kwong, DNP, MPH

For more infectious diseases content, visit the Disease State Hub

HIV is an infection caused by an enveloped retrovirus that weakens the immune system by reducing WBCs' ability to fight infections, bacterial infections, and certain cancers. Left untreated, HIV advances to acquired immunodeficiency syndrome.

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Primary care providers, infectious disease specialists, OB/GYN, pharmacists, dietitians, nutritionists, dentists, emergency, family, and internal medicine specialists.

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Those with HIV may experience flu-like symptoms, including: Fever, sore throat, swollen lymph nodes, rash, muscle aches, night sweats, mouth ulcers, chills, and fatigue. However, some with an acute infection may not experience symptoms.

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Despite high accuracy of diagnostic tests, there are no available options for detection immediately following infection. The type of test determines how quickly HIV is detected. Available tests: antibody, antigen/antibody, nucleic acid.

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75% of infectious disease specialists act as primary care for patients with HIV.

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New HIV Diagnoses By Age, 2020

Age 13-24: 20%
Age 25-34: 37%
Age 35-44: 20%
Age 45-54: 13%
Age 55 & older: 10%

Research Summaries

FDA Alert

FDA Alert

FDA approves Tivicay PD for Newborns with HIV in the United States

09/11/2026

Ashton L. Stahl

The FDA expands dolutegravir treatment to newborns from birth to 4 weeks who weigh at least 2 kg.

09/11/2026

FDA Approval Timeline

Notable FDA Approvals in August

09/01/2026

August 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a...

09/01/2026

RESEARCH SUMMARY

RESEARCH SUMMARY

Ibrutinib Plus R-da-EPOCH Shows Manageable Toxicity in HIV-Related DLBCL

07/31/2026

Anthony Calabro, MA

In a multicenter dose de-escalation and expansion study of adults with HIV-related DLBCL, ibrutinib plus R-da-EPOCH showed manageable toxicity and clinical activity, with 3-year event-free and overall...

07/31/2026

Research Summary

Research Summary

Bictegravir–Lenacapavir Switch Maintains Viral Suppression in HIV-1, Phase 3 Trial Finds

06/09/2026

Ashton L. Stahl

A phase 3 trial found that switching from bictegravir–emtricitabine–tenofovir alafenamide to once-daily bictegravir–lenacapavir maintained viral suppression in adults with HIV-1.

06/09/2026

FDA Approval

FDA Approval

Doravirine/Islatravir (IDVYNSO) FDA Approval for Virologically Suppressed HIV-1 In Adults

05/13/2026

Anthony Calabro, MA

The FDA approved a once-daily, 2-drug oral regimen for adults with virologically suppressed HIV-1 to replace existing antiretroviral therapy.

05/13/2026

September 2026

Current Issue

September 2026

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