Name of the Procedure:

Infectious agent genotype analysis by nucleic acid (DNA or RNA); HIV-1, other region (e.g., integrase, fusion)

• Common Names: HIV-1 Genotyping, HIV-1 Genetic Resistance Testing

Summary

Infectious agent genotype analysis involves examining the genetic material (DNA or RNA) of the HIV-1 virus to identify mutations in specific regions, such as integrase or fusion, which could affect how the virus responds to antiretroviral treatments.

Purpose

This procedure addresses the need to tailor HIV treatment plans based on the specific genetic makeup of the virus in an individual. The goal is to identify mutations that confer drug resistance, allowing for personalized and effective treatment strategies.

Indications

• Patients with newly diagnosed HIV-1 infection
• Those experiencing treatment failure or virologic rebound
• Individuals suspected of harboring drug-resistant strains of HIV-1
• Patients who are considering a change in their antiretroviral therapy regimen

Preparation

• No specific fasting or medication adjustments are typically required.
• Blood sample collection is the primary diagnostic test needed.
• The healthcare provider may review the patient's medical history and current medications.

Procedure Description

1. A blood sample is drawn from the patient.
2. The sample is sent to a specialized laboratory.
3. The lab isolates the HIV-1 genetic material (DNA or RNA) from the sample.
4. Genetic sequencing technologies are used to analyze specific regions of the virus's genome (such as integrase or fusion).
5. Results are interpreted by experts to identify any genetic mutations linked to drug resistance.

Duration

• Blood sample collection: Approximately 10-15 minutes.
• Laboratory analysis: Typically 1-2 weeks.

Setting

• Blood sample collection can be performed in a hospital, outpatient clinic, or laboratory.
• Laboratory analysis is conducted in a specialized molecular diagnostic laboratory.

Personnel

• Phlebotomist or nurse for blood sample collection.
• Laboratory technicians and molecular biologists for genomic analysis.
• Infectious disease specialists or primary care physicians for result interpretation and treatment planning.

Risks and Complications

• Minor discomfort or bruising from blood draw.
• Rare risk of infection at the puncture site.
• Possibility of inconclusive or indeterminate results requiring repeat testing.

Benefits

• Personalized HIV treatment plan based on genetic resistance profile.
• Increased likelihood of achieving viral suppression.
• Reduced risk of developing drug resistance.

Recovery

• No significant recovery needed from the blood draw.
• Patients can resume normal activities immediately.
• Follow-up appointments to discuss results and update treatment plans as needed.

Alternatives

• Phenotypic resistance testing, which measures the ability of the virus to grow in the presence of antiretroviral drugs.
• Standard clinical management based on guidelines without genotyping.
• Each alternative has its pros and cons; genotyping provides more specific information for personalized treatment.

Patient Experience

• Mild discomfort during blood draw.
• Waiting period of 1-2 weeks for results.
• Little to no pain or discomfort post-procedure.
• Emotional relief and better-informed treatment decisions after receiving tailored treatment guidance.