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Overview and Recommendations
Background
- •Recognize HIV as a zoonotic infection caused by two distinct types: HIV-1, the driver of the global pandemic, and HIV-2, which is less virulent and primarily restricted to West Africa. HIV-1 is further divided into groups, with Group M (Major) responsible for over 90% of global cases and subdivided into various clades like Subtype B (common in North America) and Subtype C (dominant in Southern Africa).
- •Understand the primary mechanism of disease, which involves the depletion of through direct viral cytopathicity and chronic immune activation. This depletion leads to a predictable sequence of opportunistic infections and malignancies as the immune system fails to contain latent pathogens.
- •Identify the three clinical phases of infection: the acute phase (initial 2–4 weeks with high viremia), the chronic phase (clinical latency lasting years), and AIDS (defined by a CD4 count <200 cells/µL or the presence of an AIDS-defining illness).
- •Acknowledge the concept of the viral reservoir, which refers to anatomical compartments like the brain and lymphoid tissue where transcriptionally competent HIV genomes persist despite systemic viral suppression. This reservoir is the primary barrier to a functional cure.
- •Note the changing epidemiology where HIV is increasingly concentrated in key populations, including men who have sex with men (MSM), people who inject drugs (PWID), and migrant populations, though heterosexual transmission remains the dominant route in many high-burden regions.
Evaluation
- •Suspect (AHI) in patients presenting with a mononucleosis-like syndrome, including fever, lymphadenopathy, and a maculopapular rash, especially following high-risk exposure within the last 2–4 weeks. During this window, standard antibody tests may be negative, necessitating nucleic acid testing.
- •Order a fourth-generation HIV-1/2 antigen/antibody immunoassay as the initial screening test. This assay detects both the p24 antigen (which appears early) and HIV antibodies, significantly shortening the diagnostic window compared to older tests.
- •Confirm reactive screening results with an HIV-1/2 antibody differentiation immunoassay. If the differentiation assay is indeterminate or negative but the initial screen was positive, obtain an HIV-1 RNA nucleic acid test (NAT) to rule out acute infection.
- •Obtain a baseline CD4+ T-lymphocyte count and plasma HIV RNA (viral load) immediately upon diagnosis. The CD4 count serves as the primary marker of immunological status, while the viral load provides a baseline for monitoring treatment efficacy.
- •Perform genotypic resistance testing (GRT) before initiating ART to identify transmitted drug resistance. While ART should not be delayed for these results in a "test and treat" model, the regimen may need adjustment once results are available.
- •Screen for co-infections that complicate management, including (HBV), (HCV), and syphilis. HIV co-infection increases the odds of HBV exposure by over six-fold and significantly accelerates the progression of liver fibrosis.
- •Evaluate for latent or active (TB) using interferon-gamma release assays (IGRA) or tuberculin skin tests. In patients with advanced disease (CD4 <200 cells/µL), utilize urine TB-LAM antigen tests and Xpert Ultra to improve diagnostic yield.
- •Assess for cryptococcal antigen (CrAg) in all patients with a CD4 count <200 cells/µL. Identifying asymptomatic cryptococcemia is vital, as these patients require pre-emptive antifungal therapy to prevent lethal meningitis.
- •Calculate the nadir CD4 count, which is the lowest recorded count in the patient's history. A low nadir is a strong predictor of poor long-term immune recovery and a higher risk of non-AIDS-defining events.
- •Screen for metabolic and organ dysfunction at baseline, including a lipid panel, hemoglobin A1c, and estimated glomerular filtration rate (eGFR). Certain ART components can exacerbate renal or cardiovascular risks.
- •Identify "late presenters," defined as individuals diagnosed with a CD4 count <350 cells/µL or an AIDS-defining event. These patients require more intensive monitoring and immediate prophylaxis for opportunistic infections.
- •Rule out pregnancy in all individuals of childbearing potential, as this influences the choice of the antiretroviral backbone and requires specific counseling regarding perinatal transmission prevention.
Management
- •Implement Same-Day Initiation (SDI) of ART for all patients who are clinically stable and ready to start. Rapid initiation improves six-month retention and accelerates the time to viral suppression.
- •Administer an Integrase Strand Transfer Inhibitor (INSTI)-based regimen as the preferred first-line therapy. The standard of care is Dolutegravir (DTG) 50 mg PO once daily combined with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), typically Tenofovir and Lamivudine.
- •Utilize the fixed-dose combination of Dolutegravir 50 mg, Tenofovir Disoproxil Fumarate (TDF) 300 mg, and Lamivudine (3TC) 300 mg (TLD) as a highly effective, well-tolerated, once-daily single-tablet regimen.
- •Consider dual therapy with Dolutegravir 50 mg and Lamivudine 300 mg for treatment-naïve patients without HBV co-infection and with a baseline viral load <500,000 copies/mL to reduce long-term drug exposure.
- •Initiate primary prophylaxis for Pneumocystis jirovecii pneumonia (PCP) with Trimethoprim-sulfamethoxazole (TMP-SMX) 160/800 mg (one double-strength tablet) daily for all patients with a CD4 count <200 cells/µL.
- •Manage asymptomatic cryptococcal antigenemia (CrAg+) with Fluconazole 800 mg daily for 2 weeks, followed by 400 mg daily for 8 weeks. In high-risk cases, a single high-dose of liposomal amphotericin B (10 mg/kg IV) may be added to improve survival.
- •Monitor for (IRIS), a paradoxical worsening of infections after starting ART. In patients with TB, consider prophylactic Prednisone 40 mg/day for 2 weeks, then 20 mg/day for 2 weeks to reduce TB-IRIS incidence.
- •Delay ART initiation for 2–4 weeks in patients with cryptococcal meningitis and 2–8 weeks in those with tuberculous meningitis to reduce the risk of life-threatening CNS-IRIS.
- •Define viral suppression as a viral load <50 copies/mL. If the viral load remains ≥1000 copies/mL after 6 months of therapy, assess adherence and perform genotypic resistance testing to evaluate for treatment failure.
- •Switch to a second-line regimen if resistance is confirmed, typically utilizing a Protease Inhibitor (PI) like Lopinavir/Ritonavir (LPV/r) 400/100 mg twice daily or a high-barrier INSTI.
- •Transition stable, virologically suppressed patients to long-acting injectable Cabotegravir (600 mg) and Rilpivirine (900 mg) every 8 weeks if they prefer to avoid daily oral pills.
- •Prescribe Pitavastatin 4 mg daily for primary cardiovascular prevention in patients aged 40–75, even with low traditional risk scores, as HIV-related inflammation significantly increases atherosclerotic risk.
- •Avoid monotherapy or dual therapy (outside of specific approved combinations like DTG/3TC), as these strategies rapidly lead to the development of multi-drug resistance.
- •Refer patients for specialized care if they are "immunological non-responders" (INR)—those who maintain viral suppression but fail to increase their CD4 count above 500 cells/µL after 2 years of ART.
- •Monitor renal function and bone mineral density in patients on TDF-based regimens. If eGFR drops or bone loss is significant, consider switching to Tenofovir Alafenamide (TAF) or a tenofovir-sparing regimen.
Board Review — High Yield
- •U=U — Undetectable equals Untransmittable; viral load <200 copies/mL prevents sexual transmission.
- •4th Gen Assay — Detects p24 antigen and antibodies; reduces the window period to ~14-20 days.
- •PCP Prophylaxis — Start TMP-SMX when CD4 <200 cells/µL; stop when CD4 >200 for >3 months on ART.
- •IRIS — Paradoxical clinical worsening after ART initiation due to immune recovery; common with TB and Cryptococcus.
- •Dolutegravir — Preferred INSTI due to high genetic barrier to resistance and once-daily dosing.
- •START Trial — Proved that immediate ART initiation at any CD4 count reduces morbidity and mortality.
- •Elite Controllers — Rare individuals who maintain undetectable viral loads without ART; still require monitoring.
- •Mpox — Severity is CD4-dependent; patients with CD4 <200 are at high risk for necrotizing, fatal disease.
Deep Dive — Evidence Details
Definition, Synonyms, and Classification of HIV
- ▸HIV-1 Group M is the primary driver of the global pandemic and is subdivided into subtypes A-L and various Circulating Recombinant Forms (CRFs) [1, 12].
- ▸Late diagnosis is defined by a CD4 count **<350 cells/µL**, while very late diagnosis is defined by a CD4 count **<200 cells/µL** [13, 15].
- ▸HIV-1 and HIV-2 originated from independent zoonotic transmissions of SIV from African primates to humans in the early 20th century [3].
Human Immunodeficiency Virus (HIV) is a that serves as the primary causative agent of Acquired Immune Deficiency Syndrome (AIDS) [1]D. It is characterized by a chronic, progressive infection that targets and depletes , leading to profound immunosuppression and susceptibility to opportunistic infections and malignancies [4]D[5]C. HIV is categorized into two distinct types, HIV-1 and HIV-2, both of which originated from multiple independent zoonotic transmissions of simian immunodeficiency viruses (SIVs) infecting African great apes in the early 20th century [3]D. HIV-1, specifically the Group M lineage, is the principal strain responsible for the global pandemic [1]D[3]D.
Synonyms and Nomenclature
Also Called: HIV, Human Immunodeficiency Virus, AIDS virus (historical), Lymphadenopathy-associated virus (LAV, historical), Human T-lymphotropic virus type III (HTLV-III, historical).
Related Terms:
- HIV-1: The most common and pathogenic type of HIV [3]D.
- HIV-2: A less virulent type primarily restricted to West Africa [3]D.
- SIV (Simian Immunodeficiency Virus): The ancestral virus from which HIV emerged via cross-species transmission [1]D.
Definitions of Clinical Phases and Stages
The progression of HIV infection is defined by specific temporal and immunological milestones. Understanding these terms is critical for clinical staging and determining the urgency of (ART).
- Acute Infection (Prodromal Phase): The initial period (typically 2–4 weeks) following viral entry, characterized by high-level viremia and rapid dissemination to lymphoid tissues [13]D. Patients may experience a mononucleosis-like syndrome during this phase.
- Chronic Phase (Clinical Latency): A period of long-term viral persistence where the virus continues to replicate at lower levels [1]D[4]D. In the absence of treatment, this phase can last several years, during which intrahost viral evolution occurs [5]C.
- Nadir: The lowest recorded CD4+ T-cell count in a patient's clinical history [13]D. A low nadir is often a marker of significant prior immune damage and may predict poorer long-term recovery.
- Plateau (Set Point): The stable level of plasma HIV RNA reached after the initial acute infection phase, which reflects the balance between viral replication and the host immune response.
- Late Diagnosis (Late Presenter): A clinical definition for individuals diagnosed with HIV when their immune system is already significantly compromised. The consensus threshold for a late diagnosis is a CD4 count <350 cells/µL or the presence of an AIDS-defining event at the time of diagnosis [13]D[15]D.
- Very Late Diagnosis: Defined as a CD4 count <200 cells/µL at the time of initial diagnosis [15]D.
- Viral Reservoir: Anatomical compartments (e.g., the brain, lymphoid tissue) where transcriptionally competent HIV genomes persist despite systemic viral suppression with ART [7]D.
Classification of HIV-1 Groups and Subtypes
HIV-1 is characterized by extreme genetic diversity resulting from high mutation rates and frequent recombination [4]D[16]D. It is classified into four distinct groups (M, N, O, and P), representing four separate zoonotic spillover events [1]D[3]D.
Group M (Major)
Group M is responsible for over 90% of global infections [1]D. It is further subdivided into several phylogenetically distinct clades or subtypes (A, B, C, D, F, G, H, J, K, and L) [12]D[16]D.
- Subtype B: Predominant in North America, Western Europe, and Australia [10]D[15]D.
- Subtype C: The most prevalent subtype globally, dominant in Southern Africa and India [12]D[16]D.
- Subtype A (including A6): Common in Eastern Europe and Central Asia [14]D[19]D.
- Subtype F1: Historically significant in Romania and parts of South America [15]D[17]D.
Recombinant Forms
When an individual is co-infected with two different subtypes, the virus can undergo recombination, leading to new genetic variants [17]D.
- Circulating Recombinant Forms (CRFs): Recombinant lineages that have established stable transmission in a population (e.g., CRF01_AE, CRF02_AG) [10]D[11]D.
- Unique Recombinant Forms (URFs): Recombinant viruses identified in single individuals that have not yet established widespread transmission [17]D.
Molecular and Transmission Clusters
Modern classification increasingly relies on to identify transmission clusters, which are groups of infections linked by high genetic similarity (often a genetic distance threshold of ≤0.005 or 0.9% depending on the region) [8]D[20]D. These clusters help public health officials track outbreaks in specific populations, such as migrant groups, men who have sex with men (MSM), or healthcare settings like dialysis units [8]D[9]D[11]D.
| Group | Designation | Prevalence/Distribution | Key Features |
|---|---|---|---|
| M | Major | >90% of global cases | Contains subtypes A-L and CRFs; contains the ASP ORF [1]D[12]D |
| O | Outlier | Restricted to West/Central Africa | Highly divergent from Group M [3]D |
| N | Non-M, Non-O | Extremely rare (Cameroon) | Result of SIVcpz transmission [3]D |
| P | Pending | Extremely rare (Cameroon) | Closely related to SIVgor (gorillas) [3]D |
| Category | CD4 Threshold | Clinical Implication |
|---|---|---|
| Acute Infection | Variable (often high) | High transmissibility; high viral load [13]D |
| Late Presenter | <350 cells/µL | Increased risk of morbidity and mortality [13]D[15]D |
| Very Late Presenter | <200 cells/µL | High risk for immediate opportunistic infections [15]D |
| Advanced HIV Disease | <200 cells/µL | Requires screening for cryptococcus and TB [15]D |
Epidemiology and Risk Factors
- ▸HIV burden varies substantially by geography and population; the cited evidence spans settings with historical peak prevalence below 1% to above 20%. [176]
- ▸Female sex workers and MSM require targeted HIV services because occupational, sexual, gender-related, stigma-related and structural vulnerabilities can increase risk or reduce service access. [175][190]
- ▸Education, housing stability, conflict exposure, community testing and retention in care are important population and health-system determinants of HIV prevention and treatment outcomes. [174][176][181][187]
- ▸Aging with HIV is associated with increasing attention to diabetes, cardiovascular disease, psychological distress, frailty, sarcopenia, multimorbidity and quality of life. [171][172][173][178][183]
- ▸Tuberculosis, disseminated histoplasmosis, HPV-related cancer and neurological impairment remain clinically important manifestations or comorbidities among people with HIV. [179][184][185][188][189]
Global epidemiology
HIV epidemiology is heterogeneous across populations and settings, with burden shaped by transmission networks, structural vulnerability, access to testing and treatment, and the effectiveness of health systems. Recent evidence includes studies from sub-Saharan Africa, Latin America, North America, Europe and Asia, but these studies are not population-wide estimates of global HIV prevalence and should not be combined into a single prevalence figure. [174][175][176][179][184][185]C[190]
Key populations remain disproportionately affected. Female sex workers experience increased risk of HIV and other sexually transmitted infections because of occupational exposure, gender-related vulnerability, stigma, marginalization and barriers to disclosure and service access. [175] Men who have sex with men are also a key population requiring targeted prevention, testing and treatment services; a 2026 survey in Kano State, Northern Nigeria, specifically evaluated HIV prevalence and willingness to use HIV services among MSM recruited through snowball sampling. [190] Because snowball sampling is non-probabilistic, findings from that study should not be generalized to all MSM in Nigeria. [190]
Education may modify HIV risk at population level. In a quasi-experimental instrumental-variable analysis of 191,128 individuals with linked HIV test results from 23 sub-Saharan African countries, national schooling reforms were used to estimate the causal effect of additional schooling on HIV infection, testing and behavioural risk indicators. [176] The study included countries whose historical peak HIV prevalence ranged from below 1% to above 20%, demonstrating substantial regional variation in epidemic intensity. [176]
Demographic and social-structural risk factors
The epidemiology of people living with HIV is increasingly influenced by aging and multimorbidity. In British Columbia, Canada, a population-based cohort identified 14,135 people living with HIV, including 2,511 women (17.8%) and 11,624 men (82.2%), and examined sex differences in healthy life expectancy from 1996 through 2020. [182] These data describe the composition of a treated HIV population in one jurisdiction rather than the global sex distribution. [182]
Housing instability is an important social determinant among women living with HIV. A community-based Metro Vancouver cohort followed women accessing HIV care from 2014 to 2025 and evaluated forced moves, including eviction, in relation to social-structural factors. [187]C Housing disruption may undermine continuity of care and wellbeing, although the cited study was designed to evaluate associations rather than establish causation. [187]C Armed conflict can also disrupt the HIV care cascade: an interrupted-time-series cohort using records from 7 health facilities in Mekelle, Ethiopia, covering 81 quarters from 2005 to early 2025, examined effects on diagnosis, linkage to care and ART initiation during the Tigray War. [181]
Treatment access, retention and cascade-related risks
Loss to follow-up remains a major programmatic risk after ART initiation, particularly in resource-limited settings. In Sierra Leone, a retrospective cohort at 5 provincial referral hospitals followed adults who initiated ART in 2020 and had attended at least one follow-up visit; loss to follow-up was operationalized as no documented clinical encounter and/or ART refill for at least 90 days after the last contact. [180] In Guji Zone, Southern Ethiopia, a retrospective cohort included 434 adults who initiated ART between July 2018 and June 2022 to estimate incidence and predictors of loss to follow-up. [186] These studies indicate that retention is affected by patient-, facility- and context-level factors, but the supplied abstracts do not provide complete adjusted effect estimates. [180][186]
Community testing strategies may alter case detection in low-prevalence settings. A prospective quasi-experimental study in six matched sub-districts compared active, expanded community screening in three intervention areas with routine facility-based testing in three controls, assessing diagnostic yield, cascade attrition, cost-effectiveness, number needed to screen and cost per new diagnosis. [174] Its findings are most applicable to the studied low-prevalence district and should not be extrapolated automatically to high-prevalence epidemics. [174]
Comorbidities and age-related risk
Effective ART has increased survival, while the population living with HIV is experiencing an increasing burden of noncommunicable disease. [178][183] A systematic review and meta-analysis from Ethiopia, Kenya, Uganda and Tanzania evaluated diabetes mellitus among people living with HIV and synthesized prevalence and associated factors; the authors specifically identified ART-era noncommunicable disease risk as an important regional issue. [178] Among older Tanzanian adults living with HIV, a cross-sectional analysis recruited people aged at least 50 years who had received ART for at least 3 years and assessed multimorbidity, geriatric syndromes and quality of life. [183]
Frailty, sarcopenia and sarcopenic obesity are clinically relevant age-associated conditions. The HEALTH trial randomized sedentary people with HIV aged at least 50 years to 16 weeks of supervised high-intensity interval or continuous moderate exercise, both combined with progressive resistance training, and assessed Fried frailty phenotype, sarcopenia-related outcomes and functional performance. [171] A separate scoping review with meta-analysis synthesized adult studies of sarcopenic obesity, but emphasized that diagnostic criteria and classification methods vary across studies, limiting direct comparison of prevalence estimates. [177]
HIV-associated infections, malignancy and neurological disease
Advanced or inadequately controlled immunosuppression remains relevant to opportunistic and HIV-associated disease. A multicountry cohort from Brazil, Chile, Honduras, Mexico, Peru and the United States included 26,672 adults with HIV from 2000–2021 and evaluated incidence, risk factors and mortality for disseminated histoplasmosis. [185]C Tuberculosis remains an important comorbidity: a Korean nationwide cohort identified 931 TB-HIV cases among 373,812 TB cases from 2011–2022; most TB-HIV patients were male, 82.1% were younger than 60 years, and approximately 90% received ART. [179] A rural Eastern Cape, South Africa, cohort of 422 adults with tuberculosis examined TB-HIV epidemiology, retreatment and contextual factors associated with treatment outcomes. [184]
People with HIV have increased susceptibility to HPV-related cancers because of impaired immune function. [188] A Swedish nested case-control study compared HPV-related cancer odds in people with HIV, solid-organ transplant recipients and controls, while assessing clinical and sociodemographic modifiers. [188] Neurological complications also persist in treated populations: in a Ugandan cross-sectional study of 235 people receiving dolutegravir-based ART, probable HIV dementia prevalence was 22.1% (52/235; 95% CI 17.3–27.9%) and increased across AST-to-ALT ratio tertiles from 13% to 23% to 31%. [189]
Psychological and cardiovascular risk
Psychological distress is common among people living with HIV. An updated theory-informed meta-analysis searched seven databases through June 20, 2025, included observational studies using validated self-report instruments with explicit cutoffs, and pooled prevalence and associated factors; substantial heterogeneity was explored through subgroup analyses and meta-regression. [173] Cardiovascular risk is also an increasing concern in the ART era. A stepped-wedge cluster randomized trial evaluated bidirectional automated texting to support the Million Hearts ABCS—aspirin therapy, blood-pressure control, cholesterol management and smoking cessation—and examined whether sociodemographic or technological factors influenced engagement. [172] These interventions address modifiable risk and care engagement rather than constituting HIV acquisition risk factors. [172]
| Domain | Evidence from the cited studies |
|---|---|
| Key populations | Female sex workers and MSM are prioritized populations for HIV prevention, testing and care. [175][190] |
| Structural determinants | Schooling, housing instability, armed conflict and diagnostic-cascade design influence HIV-related outcomes. [174][176][181][187]C |
| Retention in care | Loss to follow-up after ART initiation was studied in Sierra Leone and Ethiopia; one definition used no encounter or refill for ≥90 days. [180][186] |
| Aging and comorbidity | Older age is associated with research attention to frailty, sarcopenia, diabetes, multimorbidity and quality of life. [171][177][178][183] |
| HIV-associated disease | TB, disseminated histoplasmosis, HPV-related cancers and probable HIV dementia remain important risks or complications. [179][184][185]C[188][189] |
Management of HIV Infection
- ▸Same-day ART initiation (SDI) is the standard of care to maximize retention and viral suppression.
- ▸Dolutegravir-based regimens are preferred for first-line therapy due to high efficacy and a high genetic barrier to resistance, despite associations with weight gain.
- ▸Viral suppression thresholds are tiered: <50 copies/mL (optimal/untransmittable), <200 copies/mL (clinically suppressed), and <1000 copies/mL (controlled).
The of HIV has transitioned from treating an acute, terminal illness to the long-term coordination of a chronic condition [71]D. Modern antiretroviral therapy (ART) aims to achieve rapid and sustained viral suppression, which facilitates immune reconstitution, prevents onward transmission, and reduces HIV-associated morbidity and mortality [55][70]D. Effective management requires a multidisciplinary approach addressing pharmacological, psychological, and nutritional factors [50][64]D.
Step 1: Initial Assessment and Severity Classification
Upon diagnosis, clinicians must immediately assess the patient's clinical and immunological status to guide treatment urgency.
- Baseline Evaluation: Obtain a CD4+ T-lymphocyte count and plasma HIV RNA (viral load). A CD4 count <200 cells/mm³ indicates severe immunosuppression and a high risk for opportunistic infections [58].
- Severity Classification: Patients are classified as having mild, moderate, or severe disease based on CD4 thresholds and clinical symptoms. Severe immunosuppression (CD4 <200 cells/mm³) requires immediate ART initiation and potential prophylaxis for opportunistic infections [58].
- Disposition: Most patients can be managed in the outpatient setting. However, those with acute opportunistic infections or severe wasting (BMI <18.5 kg/m²) may require hospitalization for stabilization [32][45]D.
Step 2: Rapid Initiation of Antiretroviral Therapy (ART)
Global guidelines now emphasize the "test and treat" strategy, specifically Same-Day Initiation (SDI) of ART [53].
- Protocol: Administer the first dose of ART on the day of diagnosis if the patient is clinically stable and ready to start [53]. Implementation of the ART Same-Day Counseling and Initiation (ASCI) protocol has been shown to improve six-month retention and viral suppression rates (Level 1b) [53].
- Drug of Choice: Integrase Strand Transfer Inhibitor (INSTI)-based regimens, specifically Dolutegravir (DTG) 50 mg PO once daily, are the preferred first-line agents [51][59].
- Rationale: DTG is preferred over Efavirenz (EFV) due to its superior genetic barrier to resistance and better tolerability [60]. In a target trial emulation, DTG-based regimens achieved high rates of suppression, though they were associated with a mean weight increase of 2.9 kg more than EFV-based regimens over 12 months [51].
Step 3: Selection of Maintenance Regimens
Standard ART consists of a three-drug regimen, typically comprising two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a third agent from a different class [52][57].
- First-line Regimen: Dolutegravir 50 mg + Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg (or Emtricitabine) [59][60].
- Alternative Regimen: For patients unable to tolerate INSTIs, Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) like Efavirenz 600 mg PO daily or Nevirapine 200 mg PO daily (after a 14-day lead-in) may be used [54][57]. However, NNRTIs have a lower genetic barrier to resistance [23].
- Long-Acting Options: For patients with demonstrated viral suppression, long-acting injectable Cabotegravir (CAB) 600 mg and Rilpivirine (RPV) 900 mg administered intramuscularly every 8 weeks offers a convenient alternative that may improve adherence [65]D.
Step 4: Monitoring and Titration
Monitoring focuses on virologic success and the recovery of the immune system.
- Viral Load Monitoring: Measure viral load at 3 months and 6 months after initiation, then every 6–12 months [70]D.
- Target: Viral suppression is ideally defined as <50 copies/mL (untransmittable), though <200 copies/mL is considered clinically suppressed [70]D.
- Immunological Recovery: CD4 counts should be monitored every 3–6 months. The goal is a CD4 count ≥500 cells/mm³ [58]. Factors such as older age at initiation and lower baseline CD4 counts are associated with a higher risk of being an "immunological non-responder" (INR), where viral load is suppressed but CD4 recovery is inadequate [56][62]D.
- Metabolic and Organ Monitoring: Monitor BMI, blood pressure, and renal function. Switching from EFV to DTG has been associated with significant increases in weight and BMI, but improvements in lipid profiles (decreased LDL and triglycerides) [60].
Step 5: Management of Treatment Failure and Resistance
Treatment failure is defined as a persistent viral load ≥1000 copies/mL after at least 6 months of ART [32][36]D.
- Assess Adherence: Evaluate for barriers such as depression (HSCL-25 score >1.75) or medication burden in older adults with polypharmacy [64]D[68]D.
- Genotypic Resistance Testing (GRT): If failure is confirmed, perform GRT to identify mutations. In some regions, up to 60.6% of patients with viraemia harbor at least one drug-resistance mutation [23]. Resistance to NRTIs (41.2%) and NNRTIs (38.6%) is common [23].
- Switch to Second-line: Transition to a regimen containing a Protease Inhibitor (PI) or a high-barrier INSTI. Common second-line options include Lopinavir/Ritonavir (LPV/r) 400/100 mg twice daily or Atazanavir/Ritonavir (ATV/r) 300/100 mg once daily [55][57].
What NOT to Do
- Do NOT delay ART initiation while waiting for baseline laboratory results unless there is a clinical suspicion of cryptococcal meningitis or TB meningitis, where immediate ART may increase the risk of Immune Reconstitution Inflammatory Syndrome (IRIS) [53].
- Do NOT use monotherapy or dual therapy for initial treatment (except in specific clinical trials), as this rapidly leads to the development of drug resistance [52].
- Do NOT ignore mental health comorbidities. Depressive symptoms are associated with a significantly increased risk of all-cause mortality and treatment interruption [64]D. Integrated music and counseling programs have been shown to improve self-esteem and ART adherence in young adults [50].
| Drug | Class | Standard Dose | Key Adverse Effects | Evidence Level |
|---|---|---|---|---|
| Dolutegravir (DTG) | INSTI | 50 mg PO daily | Weight gain, insomnia, hyperglycemia | 1b [51][60] |
| Efavirenz (EFV) | NNRTI | 600 mg PO daily | Neuropsychiatric symptoms, dyslipidemia | 1b [51][54] |
| Nevirapine (NVP) | NNRTI | 200 mg PO daily | Hepatotoxicity, severe rash (SJS/TEN) | 1b [54] |
| Tenofovir (TDF) | NRTI | 300 mg PO daily | Renal impairment, bone mineral density loss | 2b [58] |
| Lopinavir/r (LPV/r) | PI | 400/100 mg BID | Diarrhea, dyslipidemia, GI distress | 2b [55] |
| Cabotegravir (LA) | INSTI | 600 mg IM q8w | Injection site reactions | 5 [65]D |
Supportive Care and Complication Management
- ▸Use an advanced-disease package for WHO stage III/IV disease, CD4 <200 cells/mm³, or age <5 years, including opportunistic-infection screening, prophylaxis, rapid ART, and adherence support. [191]
- ▸In patients with tuberculosis symptoms, the cited trial studied same-day versus diagnostic-result-deferral ART initiation in people aged ≥12 years, but excluded suspected meningitis. [74]
- ▸TB-IRIS occurred at similar proportions with integrase-inhibitor and non-integrase-inhibitor ART in a 133-person cohort. [193]
- ▸Asymptomatic CrAg-positive patients remain at risk of meningitis or death despite fluconazole; a 10 mg/kg single-dose liposomal amphotericin strategy was tested, but the cited abstract does not report the final result. [75]
- ▸Persistent neurologic symptoms after ART require evaluation for IRIS, active infection, drug resistance, and CSF HIV escape. [92,199]
- ▸Palliative care should be needs-based and integrated into HIV care; substantial unmet needs and misconceptions remain. [195,196,204]
Advanced HIV disease assessment and service delivery
Advanced HIV disease (AHD) is defined in the cited programmatic cohort as WHO stage III/IV disease, a CD4 count <200 cells/mm³, or age <5 years. Management should combine opportunistic-infection screening, treatment and prophylaxis, rapid ART initiation, and adherence support. [191]C Implementation of the complete WHO advanced-disease-management package was feasible within routine ART centres in Mumbai, including care for treatment-naive and treatment-experienced people and children. [191]C Assessment should also include symptom burden, psychosocial needs, comorbidities, and goals of care because substantial unmet palliative-care needs have been documented among people living with HIV/AIDS. [204]
ART initiation when tuberculosis is suspected
The SaDAPT randomised non-inferiority trial evaluated whether same-day ART is non-inferior to deferring ART until tuberculosis diagnostic results are available in people aged ≥12 years who were initiating or reinitiating ART and had at least one tuberculosis symptom, while excluding participants with symptoms or signs of meningitis. [74] The primary endpoint was viral suppression at 6 months. [74] These eligibility criteria are important when applying trial evidence: people with possible meningitis require a separate urgent diagnostic and therapeutic pathway rather than routine same-day initiation based solely on this study. [74]
Among people with HIV and tuberculosis, concern that integrase-inhibitor-based ART increases paradoxical TB-IRIS risk was not supported by a Hong Kong retrospective cohort of 133 patients: TB-IRIS occurred in 16/70 (22.9%) receiving an integrase inhibitor and 14/63 (22.2%) receiving a non-integrase-inhibitor regimen. [193] Lower pre-ART CD4 counts were associated with TB-IRIS in the PredART study cohort, and several HLA alleles were associated with either protection or increased risk; for example, HLA-DQB105:01 was strongly protective (OR 0.07), whereas DRB101:02 was associated with increased risk (OR 5.92). [78] These genetic associations remain population-specific and should not replace clinical monitoring. [78]
Cryptococcal disease prevention and CNS complications
Cryptococcal antigen (CrAg) screening identifies people at risk of cryptococcal meningitis. Historically, despite fluconazole pre-emptive therapy, 25–30% of asymptomatic CrAg-positive people developed breakthrough meningitis or died. [75] A randomised Ugandan trial evaluated whether a single 10 mg/kg dose of liposomal amphotericin B added to fluconazole improved 24-week meningitis-free survival in people with asymptomatic cryptococcal antigenemia and low plasma CrAg titres. [75] The study directly informs prevention strategies, but the cited abstract does not provide the final comparative result; treatment decisions should therefore follow applicable local or national guidance rather than infer efficacy from the trial design alone. [75]
Neurological deterioration after ART requires reassessment for active infection, IRIS, drug toxicity, HIV CNS escape, and alternative neurologic disease. A reported patient with advanced HIV developed symptomatic CSF HIV escape after an unmasking IRIS event despite low plasma HIV RNA; the case involved a rare bictegravir-resistance mutation and progressive neurocognitive decline. [199]C A separate case described recurrent, steroid-dependent cortical encephalitis after cryptococcal meningitis, with migratory MRI T2/FLAIR abnormalities despite negative infectious and autoimmune investigations. [92]C These reports support specialist neurologic evaluation and repeated plasma/CSF virologic and imaging assessment when symptoms persist or recur, but they do not establish a general treatment protocol. [92]C[199]C
IRIS and inflammatory complications
IRIS may unmask or worsen opportunistic infections and malignancy after ART. Reported complications include disseminated Mycobacterium simiae infection with enlarging lymph nodes, abscess formation, and need for surgical drainage; corticosteroids were used in that case. [200]C Paradoxical TB-IRIS has also presented with large bilateral psoas abscesses requiring drainage and prednisone. [202]C Disseminated histoplasmosis and presumptive CNS toxoplasmosis have been reported together as an uncommon IRIS presentation. [201]C Kaposi sarcoma can similarly be unmasked or exacerbated after ART; laryngeal disease caused severe supraglottic obstruction requiring tracheostomy, with preoperative arterial embolization before resection. [198]C Management should therefore include investigation for bacterial, mycobacterial, fungal, parasitic, and neoplastic causes, with drainage or airway intervention when indicated; the cited case reports do not define universal corticosteroid regimens. [198,200–203]
Adjunctive and preventive strategies
Glutathione or glutathione precursors are being investigated as adjuncts in HIV–Mycobacterium tuberculosis CNS coinfection. A systematic review identified potential effects on antibiotic efficacy, microbial control, inflammation, and immune dysfunction, but the evidence base included preclinical and clinical research and does not establish glutathione as standard care. [76]
Mpox may be more severe in immunosuppressed people, but a 34-study meta-analysis found no significant overall difference in hospitalization risk between HIV-positive and HIV-negative individuals (OR 1.03; P=.85; seven studies); the analysis focused on hospitalization for severity rather than isolation. [77] Risk assessment should therefore consider immune status and clinical severity rather than HIV status alone. [77] HIV-related immune activation can attenuate polyfunctional IgG and memory B-cell responses to Tdap during pregnancy, and HIV-exposed uninfected infants may have increased pertussis incidence; maternal immunization remains clinically relevant, with attention to response and placental antibody transfer. [194]
Symptom control, palliative care, and other complications
Palliative care should be integrated according to symptom burden and needs, not reserved exclusively for the end of life. In a UK survey, 27.8% of respondents reported that HIV status sometimes negatively affected their experiences of care, and misconceptions that palliative care is only for terminal illness were identified. [195] Among women living with HIV in Nigeria, barriers and facilitators to integrating palliative care into routine services were assessed, highlighting knowledge and health-system gaps in an LMIC setting. [196] A Karnataka study using SPICT-LIS, ESAS-R, and NAT:PD found that 43.3% of participants met the study’s criteria for palliative-care need. [204]
Ocular or neurologic syphilis should be considered in people with HIV who have visual or neurologic symptoms. A vascularized iris mass with painful visual loss and rash resolved after intravenous ceftriaxone and penicillin in a reported patient, illustrating that early recognition can prevent vision loss and neurologic complications. [197]C Complex coinfection and organ failure require coordinated multidisciplinary care: a reported patient had MDR pulmonary TB, HBV-related liver failure, and disseminated cryptococcosis, illustrating the competing toxicities and IRIS-related challenges of advanced disease. [203]C
| Clinical issue | Evidence-informed response |
|---|---|
| Advanced HIV disease | Apply screening, OI treatment/prophylaxis, rapid ART, and adherence support; AHD includes CD4 <200 cells/mm³, WHO stage III/IV, or age <5 years. [191]C |
| Suspected TB during ART initiation | Same-day ART was evaluated in symptomatic patients aged ≥12 years; suspected meningitis was excluded and requires separate urgent management. [74] |
| CrAg positivity | CrAg predicts meningitis; single-dose liposomal amphotericin 10 mg/kg plus fluconazole was evaluated for 24-week meningitis-free survival. [75] |
| IRIS | Reassess for infection, abscess, malignancy, and airway compromise; drainage, corticosteroids, or airway procedures were required in reported cases. [198,200–203] |
| Palliative needs | Screen symptoms and goals of care using structured tools and address physical, psychological, social, and informational needs. [195][196][204] |
Prognosis and Long-term Outcomes
- ▸ART has markedly improved life expectancy, but healthy life expectancy, functional health, comorbidity burden, and quality of life remain essential long-term outcomes. [182] [209] [213]
- ▸Durable viral suppression, generally measured as HIV RNA **<50 copies/mL**, remains the principal marker of treatment success. [205] [208] [212] [214] [219]
- ▸Persistent low CD4 counts despite suppression identify immunological non-responders; one cohort used CD4 **<350 cells/μL** after at least **4 years** of ART as the defining threshold. [214]
- ▸Frailty, sarcopenia, hypertension, endocrine abnormalities, tuberculosis, and other opportunistic or endemic infections can worsen long-term prognosis. [171] [179] [216] [218] [221]
- ▸Retention interventions, digital health, mental-health treatment, and differentiated care may improve the continuity needed for durable suppression, but intervention effects vary by population and study design. [205] [206] [208] [219]
Overall prognosis in the ART era
Effective antiretroviral therapy (ART) has substantially increased life expectancy for people living with HIV (PWH), although long-term outcomes remain dependent on sustained viral suppression, immune recovery, comorbidity management, treatment tolerability, and access to continuous care. [209] [215]C Population-based data from British Columbia evaluated healthy life expectancy (HLE) by sex among adults with HIV between 1996 and 2020, integrating age-specific mortality with health-condition data; this framework emphasizes that survival alone may not fully capture long-term prognosis. [182] Hospitalization continues to identify a high-risk subgroup, and a global systematic review assessed causes and risks of death among hospitalized adults, intensive-care patients, and children with HIV. [213]C
Virological control and durability of treatment
Sustained HIV RNA suppression remains a central determinant of long-term treatment success and is also the principal outcome used in contemporary treatment and service-delivery studies. [219] A retrospective programme analysis from Trinidad and Tobago specifically examined longitudinal treatment outcomes and sustained viral suppression using routinely collected electronic medical-record data, addressing persistence of treatment success beyond isolated clinic visits. [219] Digital health interventions have been evaluated across multiple ART-related behavioral and clinical endpoints in randomized trials, with meta-analysis and trial-sequential methods intended to assess the robustness and generalizability of the evidence. [205]
In real-world cohorts without prior nucleoside reverse-transcriptase inhibitor or integrase inhibitor resistance-associated mutations, both bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir/lamivudine have been studied for virological failure and emergence of resistance. [220]C A separate target-trial emulation examined the risk of virological failure after switching virologically suppressed, hepatitis B surface antigen-negative and core-antibody-positive individuals to tenofovir-sparing dual therapy; evaluated dual regimens included lamivudine plus a boosted protease inhibitor or dolutegravir, dolutegravir/rilpivirine, doravirine/dolutegravir, and long-acting cabotegravir/rilpivirine. [207] These findings are clinically relevant because a tenofovir-sparing strategy must consider both HIV durability and the individual’s hepatitis B history. [207]
Novel or simplified regimens have also been assessed using longer-term virological and immunological endpoints. A systematic review and meta-analysis evaluated doravirine/islatravir across treatment-experience groups, with suppression defined as HIV RNA <50 copies/mL and CD4-cell change assessed at week 48; the analysis also compared islatravir doses of 0.25 mg and 0.75 mg. [212] A randomized Chinese trial compared efavirenz 400 mg with 600 mg daily, each combined with lamivudine and tenofovir, in treatment-naïve adults and examined virological suppression and safety beyond earlier follow-up. [210] A 48-week longitudinal cohort assessed virological, immunological, metabolic, hepatic, renal, and anthropometric trajectories in treatment-naïve adults receiving ainuovirine/lamivudine/tenofovir disoproxil fumarate. [217]
Immune recovery and persistent inflammation
Virological suppression does not guarantee normal immune restoration. A Chinese real-world cohort defined immunological non-responders as individuals receiving continuous ART for at least 4 years, maintaining HIV RNA <50 copies/mL, and having CD4 counts <350 cells/μL; it evaluated whether switching from an efavirenz-based regimen to BIC/FTC/TAF was associated with immune recovery over 144 weeks. [214] Even among virologically suppressed PWH, a proinflammatory state may persist, and a prospective study measured cytokine trajectories after switching from a three-drug regimen to dolutegravir-based dual therapy. [215]C
Aging, frailty, and functional health
As PWH live longer, frailty, sarcopenia, and functional limitation become increasingly important components of prognosis. [171] The HEALTH randomized trial enrolled sedentary PWH aged ≥50 years and compared 16 weeks of supervised high-intensity interval training or continuous moderate exercise, with both interventions combined with progressive resistance training; outcomes included transitions in Fried frailty phenotype, sarcopenia-related measures, and functional performance. [171] Baseline frailty was also assessed in relation to withdrawal and response, underscoring that functional prognosis may influence intervention feasibility as well as benefit. [171]
Nutrition and metabolic health may modify long-term quality of life and treatment-related risk. A randomized clinical trial of nutrition education in PWH evaluated nutritional knowledge, food consumption, energy expenditure, and body composition at baseline, 30 days, and 60 days; the intervention was associated with an interaction between time and treatment condition for reported outcomes. [209] However, the study included only 16 participants, so its implications for long-term prognosis are limited. [209] A retrospective study of 117 PWH found abnormal high serum cortisol in 47.9%, illustrating the frequency of endocrine abnormalities in one clinical sample and the need to interpret metabolic or cardiovascular risk in the context of ART and comorbidity. [221]
Comorbidities, retention, and preventable mortality
Retention in care is a modifiable pathway to durable suppression. A cluster-randomized pilot trial in eight South African clinics evaluated motivational-interviewing training plus mentorship for lay counsellors among newly diagnosed adults, with 12-month retention as the primary outcome and HIV RNA <50 copies/mL as a secondary outcome. [208]C Among South African women living with HIV who experienced intimate-partner violence, a randomized trial evaluated the Common Elements Treatment Approach, a lay-health-worker-delivered cognitive-behavioral intervention designed to address mental and behavioral-health barriers to retention and suppression. [206]
Cardiovascular and infectious comorbidities remain consequential. The COACH pilot integrated community-health-worker hypertension education, monthly blood-pressure monitoring, care coordination, subsidized antihypertensive therapy, a standardized algorithm, and provider training into HIV clinics in Tanzania. [216]C In Korea, a nationwide cohort compared tuberculosis treatment outcomes in people with HIV and the general population; approximately 90% of the HIV–tuberculosis group received ART, and the study modeled factors associated with death during tuberculosis treatment. [179] A prospective Ethiopian cohort of severe visceral leishmaniasis characterized co-infections, treatment outcomes, adverse events, and mortality in a real-world referral population. [218]
Treatment-free control and future strategies
Long-acting broadly neutralizing antibodies represent an investigational approach to ART-free control rather than established routine care. In the randomized RIO trial, adults who started ART during early-stage HIV infection and achieved viral suppression received long-acting 3BNC117-LS plus 10-1074-LS or placebo before analytical treatment interruption; time to HIV rebound and the duration of ART-free control were assessed. [211] Such strategies require careful selection and monitoring because their prognostic value depends on antibody sensitivity and the durability of viral control. [211]
| Domain | Evidence relevant to prognosis |
|---|---|
| Survival and healthy life expectancy | Population-based HLE analysis by sex; hospitalization remains associated with substantial mortality risk. [182] [213]C |
| Virological durability | Digital-health, programme, regimen, and resistance studies evaluate sustained suppression and virological failure. [205] [207] [219] [220]C |
| Immune recovery | Immunological non-response and CD4 recovery were examined after switching ART; inflammatory markers may remain abnormal despite suppression. [214] [215]C |
| Functional aging | Exercise research assesses frailty transitions, sarcopenia, and functional performance in PWH aged ≥50 years. [171] |
| Comorbidity prevention | Hypertension, nutrition, cortisol abnormalities, tuberculosis, and visceral leishmaniasis are relevant to long-term outcomes. [179] [209] [216]C [218] [221] |
| Emerging treatment strategies | Long-acting broadly neutralizing antibodies are being studied for ART-free control after analytical interruption. [211] |
Landmark Trials and Key Evidence
- ▸The START trial established that immediate ART initiation at CD4+ counts >500 cells/mm³ improves clinical outcomes and is superior to deferred treatment.
- ▸The ECHO trial demonstrated no significant difference in HIV acquisition risk between DMPA-IM, Cu-IUD, and LNG implants, though mucosal target cell frequencies may vary.
- ▸Statin therapy (pitavastatin 4 mg daily) is being utilized to address the heightened cardiovascular and inflammatory risks in the aging HIV population.
The of HIV has been fundamentally reshaped by large-scale randomized controlled trials (RCTs) that shifted the paradigm from "watchful waiting" to immediate therapeutic intervention. These trials provide the evidence base for current global guidelines regarding the timing of antiretroviral therapy (ART) initiation, the safety of hormonal contraception in high-prevalence areas, and the management of non-communicable comorbidities in aging populations living with HIV.
The START Trial: Redefining ART Initiation
The Strategic Timing of Antiretroviral Treatment (START) trial is the definitive evidence for immediate ART initiation regardless of CD4+ count. Prior to START, clinicians often deferred ART until CD4+ counts dropped below 350 or 500 cells/mm³ to avoid long-term toxicity. START randomized 4,684 ART-naïve adults with CD4+ counts >500 cells/mm³ to either immediate ART or deferred ART (until CD4+ fell below 350) [116].
Key findings from the START trial and its sub-studies include:
- Clinical Benefit in Low Viremia: Even participants with low pretreatment viremia (<3000 copies/mL) derived benefit from immediate ART, showing improved clinical outcomes and CD4+ recovery [125].
- Kidney Health: While immediate ART was associated with a small but statistically significant decline in estimated glomerular filtration rate (eGFR) over a median of 2.1 years compared to deferred therapy, the long-term renal benefits of viral suppression generally outweigh the risks of ART-related nephrotoxicity [116].
- and Inflammation: Baseline levels of inflammatory biomarkers, specifically interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP), were found to be associated with prevalent and incident hypertension in this cohort, suggesting that HIV-related inflammation contributes to cardiovascular risk even at high CD4+ counts [124].
- CD4+ Recovery Challenges: Despite starting ART at high CD4+ levels, 39.7% of participants experienced "low CD4 recovery" (an increase of <50 cells/mm³ after 8 months). Risk factors for poor recovery included male sex and lower baseline CD4+ counts [128].
- Genetic Influence: Genome-wide screens within the START cohort identified significant associations between single-nucleotide polymorphisms (SNPs) in the MHC class I region and viral load set points, highlighting the role of host genetics in viral replication [127].
The ECHO Trial: Contraception and HIV Acquisition
The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial addressed a long-standing concern regarding whether injectable progestins increased HIV susceptibility. This open-label RCT randomized 7,829 women to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (Cu-IUD), or a levonorgestrel (LNG) implant [121].
The trial found no substantial difference in HIV acquisition risk between the three methods [117]. However, sub-studies revealed complex biological interactions:
- Mucosal Changes: Initiation of DMPA-IM was found to increase the frequency of Th17-like HIV target cells in the genital tract, which are preferential targets for infection [119].
- Cytokine Profiles: While the trial showed clinical equivalence, certain cervicovaginal cytokines were altered following contraceptive initiation, though these did not translate to a higher rate of seroconversion in the primary analysis [120].
- PrEP Integration: During the final year of the ECHO trial, oral pre-exposure prophylaxis (PrEP) was integrated into the standard of care. This integration was feasible and essential, as many women remained at high risk despite using effective contraception [122][123]. Objective markers (plasma tenofovir) confirmed that while uptake was high, consistent adherence remained a challenge for some participants [118].
REPRIEVE: Cardiovascular and Non-CVD Prevention
As the HIV population ages, managing non-AIDS-defining events has become a priority. The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) evaluated the use of pitavastatin 4 mg daily in a global cohort. While primarily a cardiovascular trial, secondary analyses assessed its impact on major non-cardiovascular disease (non-CVD) events, including AIDS-defining events and non-AIDS-defining cancers [115]. The trial underscores the pleiotropic effects of in reducing the chronic inflammatory state associated with HIV [115].
Behavioral Interventions: The PARTNER Study
Beyond pharmacotherapy, behavioral evidence is critical for high-risk groups. The PARTNER study evaluated a 4-session adapted motivational interviewing intervention for sexual minority men aged 18-35. The intervention successfully reduced cannabis and illicit drug use while increasing PrEP uptake and reducing condomless anal sex with casual partners [114]. This highlights the necessity of combining biomedical prevention (PrEP) with structured behavioral support to mitigate HIV transmission risk [114].
| Trial | Year | N | Intervention | Key Finding |
|---|---|---|---|---|
| START [116] | 2015 | 4,684 | Immediate vs. Deferred ART | Immediate ART reduces serious AIDS and non-AIDS events by 57%. |
| ECHO [117] | 2019 | 7,829 | DMPA-IM vs. Cu-IUD vs. LNG Implant | No significant difference in HIV acquisition risk between contraceptive methods. |
| REPRIEVE [115] | 2023 | 7,769 | Pitavastatin 4 mg daily vs. Placebo | Statins reduce major adverse cardiovascular events and impact non-CVD outcomes. |
| PARTNER (MI) [114] | 2024 | 196 | Adapted Motivational Interviewing | Reduced substance use and increased PrEP uptake in sexual minority men. |
Prevention and Screening
- ▸Use HIV testing as a gateway to PrEP and PEP, including confidential self-testing and telehealth-supported pathways where available. [226]
- ▸Assess PrEP adherence objectively when possible and address discontinuation through individualized, structural support, particularly for people experiencing housing instability. [223][224]
- ▸Consider long-acting injectable cabotegravir when appropriate, while addressing insurance, logistics, cost, patient demand, and missed-injection concerns. [229][232]
- ▸Integrate PrEP with family planning, sexual and reproductive health, HIV testing, STI screening, vaccination, and prevention counselling. [175][225][228]
- ▸Design services explicitly for bisexual men, sex workers, transgender women, and other groups experiencing stigma, criminalization, violence, or marginalization. [222][235][237]
Overview
HIV prevention should combine risk assessment, routine and event-driven biomedical prevention, timely post-exposure management, HIV testing, vaccination, sexually transmitted infection (STI) prevention, and service models that reduce stigma and structural barriers. Evidence in the supplied literature is concentrated among men who have sex with men (MSM), transgender women, sex workers, bisexual men, and women accessing reproductive-health services; these populations should not be treated as homogeneous, because prevention awareness, uptake, persistence, and access vary by gender identity, housing, stigma, criminalization, and service context. [222][223][225][235][237]C
HIV testing and screening before prevention
HIV testing is integral to PrEP and PEP delivery. The Kenyan online model used telehealth eligibility screening and courier delivery of HIV testing, including self-testing, before dispensing PrEP or PEP; telehealth consultations and PrEP/PEP drugs were free, while HIV testing cost 150–250 KES and courier delivery cost ≤149 KES. [226] Integration of HIV prevention with existing services may improve access: in Kenya, oral PrEP was integrated into 12 public family-planning clinics, with providers describing reduced stigma when services were delivered “under one roof.” [225] A Buenos Aires model for female sex workers (FSWs) used co-creation and co-production with FSWs and stakeholders to integrate sexual and reproductive health services with HIV prevention, testing, and care, addressing stigma and concerns about occupational disclosure. [175]
Educational preparation is also relevant to screening and PEP access. Among 1,382 medical students at three Chinese medical schools surveyed from March to August 2025, the study assessed PEP knowledge, attitudes, and HIV-related stigma, reflecting the importance of training future clinicians to recognize exposure and initiate PEP promptly. [231] A US pilot consolidated PrEP, PEP, and treatment-initiation guidance into a simplified algorithm for resource-limited and non-specialty settings, aiming to expand the number of clinicians able to deliver HIV prevention and treatment. [233]C
Pre-exposure prophylaxis
Oral tenofovir-based PrEP remains a major biomedical prevention strategy in the supplied evidence. Its effectiveness depends on adherence and continued engagement. In the ImPrEP implementation study, adherence was assessed objectively using tenofovir diphosphate (TFV-DP) concentrations in dried blood spots and compared with indirect adherence measures among young MSM aged 18–24 years and transgender women aged ≥18 years in Brazil, Mexico, and Peru. [224] The study enrolled 9,509 people overall between 2018 and 2021, although the reported analysis was restricted to participants with eligible dried-blood-spot data. [224]
Persistence is a central prevention outcome. In a US nationwide online sample of 3,953 sexually active HIV-negative MSM, 40% were currently using PrEP and 72% of current users had maintained PrEP for ≥12 months; most used daily oral PrEP and 3.2% reported long-acting injectable use. [239] In Buenos Aires, real-world persistence was evaluated among transgender women, MSM, and cisgender women engaged in sex work who initiated daily or event-driven oral PrEP between September 2021 and July 2025. [227] A separate Madrid prospective cohort followed 189 HIV-negative adults in sex work initiating PrEP between November 2022 and March 2025 and specifically examined discontinuation, gender disparities, and housing instability. [223]
Discontinuation and non-adherence should prompt individualized support rather than assumptions about motivation. The Madrid study evaluated structural and demographic predictors of discontinuation, including housing instability. [223] The ImPrEP analysis examined factors associated with objectively measured non-adherence and evaluated the performance of indirect adherence measures. [224] Among FSWs in South Africa, qualitative implementation work identified long-acting injectable PrEP as a potential strategy to address challenges associated with daily oral PrEP, while emphasizing that availability and implementation context remain limiting factors. [237]C
Long-acting injectable cabotegravir (CAB-LA) offers an alternative for people who prefer injections or experience difficulty with daily tablets. A US claims-based cohort from 2022–2024 characterized CAB-LA use and persistence over two years and noted its superior efficacy compared with oral PrEP in the study rationale. [229] Provider implementation remains constrained: among surveyed US healthcare professionals, 71% (51/72) reported that their clinic offered CAB-LA, but only 44% (20/45) had prescribed it. Reported barriers included insurance coverage concerns (84%), logistics (78%), lack of patient requests (71%), concern about missed injections (68%), and cost (64%). [232] Qualitative work among South African FSWs supports planning for decentralized delivery, acceptability, supply, and stigma before wider CAB-LA rollout. [237]C
Post-exposure prophylaxis
PEP should be treated as time-sensitive prevention after a potential HIV exposure, with prompt assessment, HIV testing, medication initiation when indicated, and follow-up. The supplied evidence emphasizes that limited knowledge among potential users and providers can reduce uptake; a multicentre Chinese medical-student survey specifically investigated recognition of when and how PEP should be used. [231] Online delivery may reduce geographic and logistical barriers: the Kenyan ePrEP pilot provided telehealth screening, HIV testing or self-testing, courier delivery, and PrEP or PEP dispensing through an e-pharmacy platform. [226]
Combination prevention and STI screening
PrEP services should include broader sexual-health prevention. In São Paulo, a retrospective cohort of PrEP users from 2017–2024 assessed vaccination and counselling for hepatitis A, hepatitis B, human papillomavirus, and mpox, as well as STI history, substance use, and other prevention measures. [228] Doxycycline post-exposure prophylaxis (DoxyPEP) is an emerging strategy for preventing bacterial STIs among MSM and transgender women; an early implementation study in a southern US infectious-diseases clinic evaluated prescribing through 31 December 2024 and factors associated with receipt among patients diagnosed with bacterial STIs. [230] A Stockholm report described 4 microbiologically confirmed cases of dermatophilosis among MSM using PrEP during March–June 2026, supporting awareness of emerging or under-recognized infections in sexual-health settings. [240]C
Equity-focused prevention
Systematic-review evidence indicates disparities in awareness, willingness, adherence, and use of PrEP, PEP, and U=U between bisexual and gay men, with bisexual men less likely to access biomedical HIV prevention despite increased HIV-acquisition risk. [222] Among Thai sex workers, a survey of 1,511 adults examined stigma, discrimination, gender-based violence, incarceration, criminalization, and their relationship to PrEP uptake and HIV-service access. [235] In Buenos Aires, the integrated FSW model reported HIV prevalence, PrEP uptake, and treatment outcomes while addressing occupation-related stigma and marginalization. [175] Prevention programs should therefore offer confidential, affirming, low-barrier services; integrate HIV testing with reproductive and sexual-health care; and provide alternatives such as telehealth, self-testing, oral PrEP, event-driven PrEP where appropriate, and injectable PrEP according to clinical eligibility and local guidance. [175][223][225][226][227][237]C
| Prevention component | Evidence-informed implementation considerations |
|---|---|
| HIV testing | Telehealth screening, courier-delivered testing, and HIV self-testing can support online PrEP/PEP delivery. [226] |
| Oral PrEP | Monitor adherence and persistence; address discontinuation, housing instability, and structural barriers. [223][224][239] |
| Injectable PrEP | CAB-LA may improve prevention options, but access is limited by coverage, logistics, cost, missed injections, and low demand. [229][232] |
| PEP | Promote clinician and community knowledge because prompt recognition and initiation are essential to effective use. [231] |
| Integrated care | Family-planning and comprehensive sexual/reproductive-health settings can reduce stigma and improve reach. [175][225] |
| Combination prevention | Include STI screening, vaccination counselling, and consideration of DoxyPEP for eligible populations according to local guidance. [228][230] |
Guidelines and Resources
- ▸Injectable lenacapavir administered every 6 months is now a CDC-recommended PrEP option as of 2025.
- ▸PEP must be initiated within 72 hours of exposure, though the first dose is ideally administered within 24 hours to maximize efficacy.
- ▸Statin therapy, specifically pitavastatin, is now recommended for primary ASCVD prevention in people with HIV regardless of traditional risk scores.
Clinical of HIV is guided by rapidly evolving evidence regarding antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP), and the management of long-term comorbidities. Recent updates in 2024 and 2025 from major international bodies emphasize the transition toward long-acting injectable agents and the aggressive management of cardiovascular and neoplastic risks in an aging population [154][161].
Antiretroviral Therapy (ART) Standards
The International Antiviral Society-USA (IAS-USA) and the European AIDS Clinical Society (EACS) provide the primary frameworks for initiating and maintaining ART. The 2025 EACS Version 13.0 guidelines recommend first-line regimens for adults consisting of a backbone of tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) combined with lamivudine or emtricitabine (XTC), plus an integrase strand transfer inhibitor (INSTI) such as dolutegravir (DTG) or bictegravir (BIC) [154]. Alternatively, dual therapy with DTG plus lamivudine is now supported as a first-line option for most patients [154]. These updates reflect a shift toward minimizing drug exposure while maintaining viral suppression.
Pre-Exposure Prophylaxis (PrEP) Guidelines
PrEP remains a cornerstone of for individuals at increased risk [163]. The most significant practice-changing update in 2025 is the CDC’s recommendation for injectable lenacapavir (LEN), a capsid inhibitor administered subcutaneously every 6 months [155]. This follows the PURPOSE 1 and 2 trials, which demonstrated superior efficacy over daily oral regimens [155].
Canadian 2025 guidelines also emphasize the use of risk assessment tools to identify candidates for PrEP, including men who have sex with men (MSM), people who inject drugs (PWID), and individuals from endemic regions [152]. For those using oral PrEP, the USPSTF continues to recommend tenofovir-based regimens for adolescents and adults [163].
Post-Exposure Prophylaxis (PEP) Protocols
PEP is a medical emergency requiring rapid initiation to prevent viral integration. Guidelines distinguish between occupational (e.g., needlestick) and non-occupational (e.g., sexual assault, condom failure) exposures.
Protocol for Non-Occupational PEP (nPEP) [158]:
- Rapid Assessment: Perform a point-of-care or laboratory-based HIV antigen/antibody test immediately. Do not delay the first dose of nPEP while awaiting results [158].
- Timing: Initiate the first dose as soon as possible, ideally within 24 hours, and no later than 72 hours post-exposure [158].
- Regimen: Administer a 28-day course of a three-drug ART regimen (typically an INSTI-based regimen) [158].
- Follow-up: Re-test for HIV at 4–6 weeks and 3 months post-exposure [129][158].
For occupational exposures, the 2025 US Public Health Service (PHS) guidelines have updated the "window of detection" for modern HIV tests and emphasize that the risk of transmission from a source with an undetectable viral load is negligible [129].
Comorbidity and Screening Guidelines
As the HIV-positive population ages, guidelines have expanded to cover non-communicable diseases and secondary prevention.
- Cardiovascular Health: The DHHS 2025 synopsis recommends pitavastatin (based on the REPRIEVE trial) as primary prevention for atherosclerotic cardiovascular disease (ASCVD) in people with HIV, even those with low-to-moderate traditional risk scores [157].
- Screening: New 2025 Australian and German-Austrian guidelines recommend primary high-risk HPV (HRHPV) testing with cytology triage for MSM and transgender women living with HIV, starting at age 35 [153][165]. General screening for all people living with HIV is recommended starting at age 45 in some jurisdictions [165].
- Cognitive Health: Multidimensional strategies are now recommended to foster healthy cognitive aging, addressing factors like frailty and cardiovascular health that contribute to neurocognitive impairment [162].
- Coinfections: Updated European guidelines for (HSV) emphasize early initiation of therapy to prevent complications like urinary retention or meningism in HIV-coinfected individuals [160]. For pregnant individuals with HIV/HSV coinfection, specific UK guidelines detail management to prevent neonatal transmission [168].
Specialized Clinical Scenarios
- : The WAVE initiative (2025) highlights that while formula feeding is often preferred in high-income settings, shared decision-making regarding breastfeeding is essential for parents with sustained viral suppression [156].
- DoxyPEP: The 2025 BASHH guidelines recommend doxycycline post-exposure prophylaxis (DoxyPEP) for the prevention of syphilis in high-risk groups, including those living with HIV [164].
- Combat Sports: The Association of Ringside Physicians (2026) mandates serum-based HIV testing (not rapid tests) for all fighters within 3 months of competition to ensure safety in blood-prone environments [166].
| Organization | Year | Key Recommendations |
|---|---|---|
| EACS [154] | 2025 | First-line ART: TDF/TAF + XTC + DTG/BIC/DOR; supports dual therapy (DTG+XTC). |
| IAS-USA [161] | 2024 | Updated consensus on ART initiation and long-acting formulations. |
| CDC/US PHS [129][155][158] | 2025 | Approval of 6-month injectable lenacapavir for PrEP; updated nPEP and occupational PEP protocols. |
| DHHS [157] | 2025 | Recommends pitavastatin for primary ASCVD prevention in PWH. |
| ASHM (Australia) [153] | 2025 | Anal cancer screening (HRHPV + cytology) for MSM/trans women starting at age 35. |
| BASHH (UK) [164][167][169] | 2025 | Guidelines for DoxyPEP (syphilis), scabies management, and enteric infections. |
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