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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
- ▸Sustained viral suppression remains the principal determinant of favorable long-term outcomes, but residual inflammation and incomplete immune recovery may persist, particularly in children and people with advanced HIV. [252][255]
- ▸Long-acting injectable and less frequent oral regimens are being evaluated to improve treatment durability and reduce adherence burden in selected virologically suppressed patients. [247][249][253][257]
- ▸TB preventive treatment is evaluated for reducing both TB incidence and all-cause mortality among people initiating ART in high-burden settings. [246]
- ▸TB, HCV, metabolic liver disease, treatment resistance, psychosocial barriers, pregnancy complications, and emerging infections remain important threats to long-term prognosis. [248][251][256][259][260][261][262][263]
Overall prognosis
Long-term outcomes for people living with HIV are increasingly determined by sustained viral suppression, immune recovery, prevention and treatment of comorbid infections, medication tolerability, and continuity of care rather than by HIV infection alone. The supplied evidence emphasizes that prognosis remains heterogeneous, particularly among people with advanced disease, adolescents, individuals requiring second- or third-line ART, and those affected by tuberculosis (TB), hepatitis C virus (HCV), metabolic liver disease, or psychosocial barriers to treatment. [246][247][252][255][262]
Virological suppression and treatment durability
Long-term virological control can be maintained with simplified oral or injectable regimens in appropriately selected, already suppressed patients. In the 96-week LATA trial, adolescents aged 12 to <20 years in sub-Saharan Africa with HIV-1 RNA <50 copies/mL for >12 months were randomized to every-8-week injectable cabotegravir–rilpivirine or daily oral ART, directly addressing whether long-acting treatment can improve durability in an age group with poorer treatment outcomes. [247] Weekly oral islatravir–lenacapavir was evaluated in a phase 3 non-inferiority trial among adults suppressed for at least 6 months on bictegravir–emtricitabine–tenofovir alafenamide, reflecting the potential for less frequent dosing to reduce adherence-related loss of control. [249]
Other switch studies similarly address long-term maintenance rather than initial treatment. Doravirine plus raltegravir was studied in virologically suppressed adults without raltegravir resistance, with virological failure defined as confirmed HIV-1 RNA ≥50 copies/mL at week 48. [250] Week-96 ARTISTRY-1 data evaluated bictegravir–lenacapavir after transition from complex ART in participants without known integrase-strand-transfer-inhibitor resistance. [257] A small pilot examined switching from etravirine to doravirine in 13 suppressed, treatment-experienced people with historical NNRTI resistance-associated mutations, so its prognostic implications remain exploratory. [254]C After discontinuation of long-acting cabotegravir–rilpivirine, observational data from 75 of 682 monitored people who discontinued injections found no new or worsening adverse events after oral ART initiation, although discontinuations were frequently related to adverse events and the evidence is not comparative. [253]
Immune recovery and residual inflammation
Virological suppression does not guarantee complete immune normalization. A pediatric longitudinal study assessed systemic immune-inflammation index, CD4 percentage, HIV RNA, and double-negative T-cell percentage before and 12 months after ART in 30 children, specifically highlighting persistent inflammation as a potential component of long-term risk despite virological response. [252] In treatment-naive adults with advanced HIV and baseline CD4 counts <200 cells/μL, a propensity-score-matched cohort evaluated adjunctive albuvirtide with bictegravir–emtricitabine–tenofovir alafenamide using a composite of CD4 increase >150 cells/μL and HIV RNA <50 copies/mL at week 24; this addresses early immune recovery, but does not establish long-term mortality benefit. [255] A small randomized study of Chinese herbal therapy added to HAART assessed CD4/CD8 cells, Th17 cells, inflammatory cytokines, nutritional markers, adverse reactions, and health-related quality of life; the limited sample and short-term design make its prognostic value uncertain. [258]
Opportunistic and co-infection outcomes
TB prevention remains central to prognosis. PROTECT emulated six randomized trials using electronic health-record data from Haiti, Kenya, Nigeria, Uganda, Ukraine, and Zimbabwe among people initiating ART between 2018 and 2021, estimating the programmatic effect of TB preventive treatment on TB incidence and all-cause mortality in the contemporary universal-ART era. [246] Complementary Nigerian and Indonesian observational studies show that TB treatment outcomes remain clinically important: one reviewed 213 people with HIV treated for TB at a tertiary facility, while another analyzed 509,290 children and adolescents with TB aged 0–19 years, defining unsuccessful treatment as death, loss to follow-up, or treatment failure. [260][261]
HCV elimination may improve long-term health and transmission outcomes. A large Chinese cohort of 143,959 people with HIV assessed an eight-stage HCV care cascade from antibody testing through sustained virological response, demonstrating the importance of linkage and treatment completion rather than diagnosis alone. [259] A systematic review evaluated interferon-free dual direct-acting antiviral regimens for acute or recently acquired HCV, including people with HIV and short-course strategies, with SVR12 as the principal outcome. [251]
Mortality, comorbidity, and quality of life
People transitioning to second- or third-line ART remain at risk of virological failure and mortality despite strong national treatment-program performance. Rwanda’s national surveillance study followed adults aged ≥15 years transitioned between 2019 and 2025 using competing-risks methods, underscoring the need for resistance assessment, adherence support, and close monitoring. [262] Metabolic disease is also increasingly relevant: the SLIM LIVER phase 2b study evaluated 24 weeks of semaglutide in people with HIV and MASLD/MASH, including metabolomic monitoring among participants with >2.27 kg weight loss. [256]
Pregnancy and childhood outcomes influence long-term prognosis across generations. In Uganda, a nested case-control analysis investigated congenital infections in relation to preterm delivery <37 weeks and low birth weight <2500 g among HIV-exposed uninfected neonates born to women receiving ART. [248] Psychosocial and behavioral determinants remain modifiable prognostic factors: a South African randomized trial tested a lay-health-worker-delivered cognitive-behavioral intervention for women living with HIV experiencing intimate-partner violence, targeting mental-health barriers to retention and viral suppression. [206] Digital-health interventions have also been synthesized across randomized trials for adherence, behavioral, and clinical ART outcomes, although the review’s emphasis on prediction intervals and trial-sequential analysis indicates that generalizability and evidential certainty remain important considerations. [205]
Mpox adds another potential acute risk in settings with overlapping infections and comorbidity. A multicentre retrospective study in South Kivu evaluated whether HIV, malaria, and hyperglycaemia were associated with disease severity, mortality, and hospital-stay duration among hospitalized adults. [263] Overall, the evidence supports a prognosis based on sustained suppression plus proactive management of TB, HCV, metabolic disease, mental-health and violence-related barriers, treatment resistance, pregnancy risks, and emerging infections. [205][206][246][248][251][256][259][262][263]
| Prognostic domain | Population or intervention | Outcomes addressed |
|---|---|---|
| TB prevention | People with HIV initiating ART in six high-TB-burden countries | TB incidence and all-cause mortality [246] |
| Treatment durability | Suppressed adolescents and adults receiving injectable or less frequent oral ART | Virological suppression, safety, and adherence-related durability [247][249][250][253][257] |
| Immune recovery | Children and adults with advanced HIV | CD4 recovery, inflammatory indices, and composite virological-immunological response [252][255] |
| Co-infection and comorbidity | People with HIV and TB, HCV, MASLD/MASH, or mpox | Treatment success, SVR12, liver outcomes, severity, mortality, and hospitalization [251][256][259][260][263] |
| Social and developmental outcomes | Women experiencing IPV, HIV-exposed neonates, and people using digital health interventions | Retention, viral suppression, prematurity, low birth weight, and ART outcomes [205][206][248] |
Landmark Trials and Key Evidence
- ▸START established immediate ART for people with **CD4 >500 cells/mm³** as the safer treatment strategy than deferral. [241]
- ▸Immediate ART was evaluated for long-term kidney, liver, inflammatory, immunologic, virologic, and clinical outcomes. [116,124,125,128,245]
- ▸Incomplete CD4 recovery can occur despite viral suppression; **39.7%** had a CD4 increase of fewer than **50 cells/mm³** after 8 months in one START analysis. [128]
- ▸REPRIEVE evaluated pitavastatin **4 mg daily** and prespecified major non-cardiovascular outcomes in a global randomized trial. [115]
- ▸ECHO found no substantial difference in HIV acquisition among DMPA-IM, copper-IUD, and levonorgestrel-implant groups, while integrated PrEP delivery strengthened the prevention standard. [117,118,121-123]
- ▸DMPA-related HIV susceptibility remains biologically, epidemiologically, and ethically debated; modeling estimated a possible **1.20-fold** effect, whereas ECHO itself found no substantial contraceptive-group difference in HIV acquisition. [117,121,242]
- ▸Recent evidence continues to evaluate behavioral prevention, including motivational interviewing, substance use, PrEP uptake, and sexual risk reduction. [114]
Strategic Timing of Antiretroviral Treatment (START)
START established the clinical benefit of initiating antiretroviral therapy (ART) at high CD4 counts. ART-naive adults with CD4 >500 cells/mm³ were randomized to immediate ART or deferred ART until the CD4 count fell below 350 cells/mm³ or AIDS developed; immediate treatment reduced serious AIDS-related and non-AIDS-related morbidity and mortality and became the standard of care. [241] The trial enrolled 4,684 ART-naive adults, and subsequent analyses have examined the long-term effects of treatment timing across renal, hepatic, cardiovascular, immunologic, virologic, and inflammatory outcomes. [116][124][125][127][128][245]
A long-term START kidney analysis found that immediate ART did not produce a clinically important excess of chronic kidney disease despite greater cumulative ART exposure. Earlier follow-up had shown a small, statistically significant difference in estimated glomerular filtration rate, with greater decline in the deferred-treatment group; the later analysis assessed chronic kidney disease events, estimated glomerular filtration rate, and urine albumin/creatinine ratio. [116] In participants with high baseline CD4 counts, early ART was also evaluated for liver fibrosis using the AST-to-platelet ratio index and Fibrosis-4 index, including thresholds of APRI >0.5, APRI >1.5, FIB-4 >1.45, and FIB-4 >3.2. [245]
Among START participants with pretreatment viremia below 3,000 copies/mL, including a subgroup with viremia ≤50 copies/mL, immediate ART was assessed for clinical outcomes, hospitalizations, grade 4 adverse events, death, viral suppression, CD4 recovery, and biomarker changes. [125] These data addressed whether the benefit of early ART extended to people with low-level viremia or apparent virologic suppression. [125] A related analysis found that incomplete immune recovery remained common despite virologic suppression: 39.7% of participants initiating ART with CD4 counts above 500 cells/mm³ had a CD4 increase of fewer than 50 cells/mm³ after 8 months while viral load was ≤200 copies/mL. [128]
START analyses also explored mechanisms and comorbidity. In ART-naive participants, HLA-region single-nucleotide polymorphisms were associated with viral load, with reported effect sizes of approximately 0.14–0.39 log10 copies/mL, supporting a role for host genetics in HIV-1 replication. [127] Baseline inflammatory biomarkers, including interleukin-6 and high-sensitivity C-reactive protein, were evaluated in relation to prevalent and incident hypertension among people with CD4 counts above 500 cells/mm³. [124] A 2026 analysis measured anti-CD4 autoantibodies at baseline and month 24 in START participants randomized to immediate or deferred ART, extending earlier observations of these antibodies in ART-naive people with CD4 counts below 100 cells/mm³ and evaluating their relationship with CD4 recovery. [241]
REPRIEVE and non-AIDS comorbidity prevention
The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) was a global, randomized, placebo-controlled trial conducted from 2015 to 2023 at 145 sites in 12 countries. It evaluated pitavastatin 4 mg daily for cardiovascular disease prevention in people with HIV. A prespecified secondary analysis assessed major non-cardiovascular disease events, including AIDS-defining events, non-AIDS-defining cancers, renal disease, and liver disease. [115] These analyses broadened evaluation of statins beyond lipid lowering and cardiovascular outcomes. [115]
ECHO: contraception, HIV acquisition, and prevention implementation
The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial randomized 7,829–7,830 women aged 16–35 years in four African countries to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device, or a levonorgestrel implant. The primary trial found no substantial difference in HIV acquisition between the three contraceptive methods. [117][121][123] An ancillary behavioral study found no clear HIV-incidence difference attributable to menstrual symptoms or sexual behavior across randomized methods. [121] Objective testing with prostate-specific antigen in a substudy evaluated condomless vaginal sex and its concordance with self-report. [117]
The ECHO prevention package incorporated onsite oral pre-exposure prophylaxis (PrEP), reflecting the ethical obligation to provide effective HIV prevention in endpoint-driven trials. [123] A nested interrupted time-series analysis assessed whether PrEP availability changed HIV incidence, while a South African substudy measured quantifiable plasma tenofovir among women reporting PrEP use. [118][122] In a mucosal substudy, initiation of DMPA-IM was associated with assessment of cervical Th17-like CD4+ T cells, which are preferential HIV target cells, compared with the copper IUD and levonorgestrel implant. [119] Another substudy compared 27 cervicovaginal cytokines at baseline and after contraceptive initiation and examined preseroconversion profiles among women who acquired HIV. [120]
The interpretation of DMPA evidence remains contested. A modeling study estimated the potential population effect of a 1.20-fold increase in HIV susceptibility, with a 95% confidence interval of 1.06–1.36, in South Africa, while explicitly comparing scenarios with and without such an effect. [242] A separate critique raised concerns about consent, incentives, coercive language, and disclosure of trial information in the ECHO trial. [126]
Other randomized and methodological evidence
In an international randomized trial of ART-naive adults with CD4 counts 400–900 cells/mm³ who did not meet contemporaneous ART criteria, valaciclovir 500 mg twice daily was compared with placebo until sustained CD4 decline to ≤350 cells/mm³ or ART initiation; the primary outcome was the rate of CD4 decline. [244] A cluster-randomized study nested within START evaluated annual onsite monitoring versus no onsite monitoring, with central monitoring for all sites and local monitoring twice yearly, to assess participant-level trial-quality outcomes. [243]
For prevention among partnered sexual-minority men, the 2026 PARTNER study randomized or evaluated a four-session adapted motivational-interviewing intervention in 196 HIV-negative cisgender men aged 18–34 years with recent drug use and condomless anal sex involving casual, serodiscordant, or nonmonogamous partners. Outcomes included cannabis and illicit drug use, PrEP uptake, and sexual HIV risk. [114]
| Trial or analysis | Population/intervention | Principal contribution |
|---|---|---|
| START | ART-naive adults with CD4 >500 cells/mm³; immediate versus deferred ART | Established the benefit of early ART and generated long-term renal, hepatic, inflammatory, genetic, virologic, and immune-recovery analyses. [116][124][125][127][128][241][245] |
| REPRIEVE | People with HIV; pitavastatin 4 mg daily versus placebo | Cardiovascular prevention trial with prespecified analysis of major non-cardiovascular disease events. [115] |
| ECHO | 7,829–7,830 women; DMPA-IM, copper-IUD, or levonorgestrel implant | No substantial difference in HIV acquisition; provided evidence on behavior, mucosal biology, cytokines, PrEP integration, and trial ethics. [117-123,126] |
| PARTNER | 196 HIV-negative partnered sexual-minority men aged 18–34 years | Tested adapted motivational interviewing for substance use, PrEP uptake, and sexual HIV-risk reduction. [114] |
| Valaciclovir trial | ART-naive adults with CD4 400–900 cells/mm³ | Tested whether valaciclovir altered CD4 decline before ART. [244] |
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
- ▸EACS 2025 version 13.0 lists TDF or TAF plus lamivudine or emtricitabine with dolutegravir, bictegravir, or doravirine, and includes a dual lamivudine or emtricitabine plus dolutegravir option. [154]
- ▸Nonoccupational PEP should begin ideally within **24 hours** and no later than **72 hours** after a substantial-risk exposure, without waiting for laboratory results. [158]
- ▸Injectable lenacapavir PrEP is administered every **6 months** under 2025 CDC guidance. [155]
- ▸Australian anal-cancer guidance recommends screening from **age 35 years** for gay, bisexual, and other men who have sex with men and transgender women living with HIV. [153]
- ▸Breastfeeding and infant-feeding decisions should follow current national guidance, including updated U.S. recommendations and jurisdiction-specific European policies. [156][264][269]
Core HIV treatment guidance
The 2025 European AIDS Clinical Society (EACS) guideline revision, version 13.0, reorganizes guidance into Part I, covering HIV management and prevention, and Part II, covering comorbidities and related topics. For adults with HIV-1, listed first-line options include tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) with lamivudine or emtricitabine, combined with dolutegravir, bictegravir, or doravirine; a dual-therapy option of lamivudine or emtricitabine plus dolutegravir is also listed. Version 13.0 adds a dedicated HIV-2 section. [154]
The 2024 International Antiviral Society–USA recommendations address adult HIV treatment, prevention, and clinical management. The panel incorporated literature searches, ongoing evidence surveillance, manufacturer-submitted data, and conference findings through October 2024. [161]
HIV prevention: PrEP, PEP, and sexual health
The 2025 Canadian guideline updates national recommendations for HIV preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP), using evidence from systematic reviews and consultation with community organizations and a 19-member expert panel. [152] The U.S. Preventive Services Task Force recommends offering effective antiretroviral PrEP to adolescents and adults without HIV who are at increased risk of acquisition, based on evidence of benefit and assessment of risk-identification tools. [163]
CDC 2025 recommendations cover nonoccupational PEP after sexual, injection-drug-use, or other exposures involving nonintact skin or mucous membranes when the source has HIV without sustained viral suppression or suppression status is unknown. Rapid or laboratory antigen/antibody HIV testing should be obtained before initiation, but the first dose should be given as soon as possible, ideally within 24 hours and no later than 72 hours after exposure; treatment should not be delayed while awaiting laboratory results. [158]
In 2025, the CDC issued guidance for injectable lenacapavir PrEP after U.S. Food and Drug Administration approval of a 6-monthly regimen based on the PURPOSE 1 and PURPOSE 2 randomized trials. The recommendation addresses efficacy, safety, and implementation in the context of suboptimal acceptance, adherence, and persistence with existing oral and injectable PrEP options. [155]
BASHH’s 2025 doxycycline postexposure prophylaxis guideline recommends that doxyPEP for syphilis prevention be integrated with condoms, HIV-prevention interventions, vaccination, STI testing and treatment, risk-reduction counseling, and psychological support when indicated. [164] The 2026 British sexual and reproductive health guideline updates UK guidance for people living with HIV using GRADE methodology and reports substantial revisions to recommendations. [268]
Pregnancy, infant feeding, and breastfeeding
The 2026 American College of Obstetricians and Gynecologists Clinical Practice Update revises guidance on infant feeding for patients with HIV in response to updated U.S. Department of Health and Human Services and American Academy of Pediatrics recommendations, superseding content from the 2018 committee opinion on breastfeeding support. [264] European guidance remains heterogeneous: a WAVE survey summarized HIV-and-breastfeeding policies from 23 countries, highlighting the evidence gap in high-income settings where continuous ART access and sustained viral suppression are common. [156]
Belgian 2026 guidance addresses pregnancy, breastfeeding, and infant management through expert consensus from the BREACH network. Antiretroviral drugs for people considering pregnancy or who are pregnant are categorized as recommended, not recommended, or supported by insufficient data, with recommendations updated annually. [269]
Screening and management of comorbid conditions
Australian 2025 anal-cancer screening guidance for people living with HIV recommends primary high-risk human papillomavirus testing with cytology triage for high-resolution anoscopy. Screening should be offered from age 35 years to gay, bisexual, and other men who have sex with men and transgender women living with HIV; the guideline also addresses cisgender women, transgender men, and cisgender men who are not men who have sex with men. [153]
U.S. HIV guidelines developed with ACC, AHA, and HIVMA representatives recommend statin-based primary cardiovascular prevention informed by REPRIEVE, which demonstrated benefit from pitavastatin in people with HIV. These recommendations supplement general AHA/ACC/multisociety cholesterol guidance. [157]
North American hidradenitis suppurativa guidance provides 118 consensus statements for special populations, including people with HIV, pregnancy, breastfeeding, pediatrics, malignancy, tuberculosis, and hepatitis B or C; recommendations were developed using GRADE and a modified Delphi process. [159] The 2024 European genital-herpes guideline covers diagnosis, treatment, follow-up, transmission reduction, pregnancy, and HIV coinfection. [160]
BASHH’s 2026 viral-hepatitis guideline provides recommendations for prevention, diagnosis, and initial management of hepatitis A, B, C, and D in the UK. [270]
Ageing, mental health, and service delivery
A multidimensional strategy for healthy cognitive ageing in people living with HIV emphasizes brain health across clinical, public-health, research, and community settings, reflecting the increasing burden of ageing-related conditions, cardiovascular disease, frailty, and other factors that may occur earlier or more frequently in HIV. [162]
The HIV+D cluster-randomized trial in Uganda evaluated collaborative stepped-care depression management integrated into adult HIV services across 40 primary-care facilities, comparing the intervention plus enhanced usual care with enhanced usual care alone. [266] A pilot randomized trial in Kigali evaluated entry into differentiated service delivery for newly diagnosed people at 6 months after ART initiation, comparing eligibility after one versus two suppressed viral loads with usual care. [267]C
Practical resource use
Use the EACS and IAS–USA documents for treatment selection, CDC and Canadian guidance for PEP and PrEP decisions, and national pregnancy, infant-feeding, sexual-health, anal-screening, hepatitis, and comorbidity guidelines when jurisdiction-specific recommendations apply. [152][154][155][158][161][264][268][269][270]
| Clinical area | Current resource and principal focus |
|---|---|
| HIV treatment | EACS 2025 version 13.0; IAS–USA 2024 recommendations. [154][161] |
| PrEP and PEP | Canadian 2025 guideline; USPSTF PrEP statement; CDC 2025 nPEP guidance; CDC lenacapavir PrEP guidance. [152][155][158][163] |
| Pregnancy and infant feeding | ACOG 2026 update, WAVE European survey, and Belgian 2026 guidance. [156][264][269] |
| Sexual health and STI prevention | BASHH 2026 sexual/reproductive-health guideline and 2025 doxyPEP guideline. [164][268] |
| Screening and comorbidities | Australian anal-cancer screening, statin prevention, genital herpes, hidradenitis suppurativa, and viral-hepatitis guidance. [153][157][159][160][270] |
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