HIV: Evidence-Based Clinical Summary

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RxDrug of choiceDolutegravir (50 mg) + Tenofovir + Lamivudine (TLD)

AltAlternativesBictegravir-based regimens; Efavirenz (600 mg) if INSTIs are unavailable

⊘AvoidMonotherapy; delaying ART for baseline labs (except in CNS infections like Cryptococcus/TB)

DxTest of choice4th Generation HIV-1/2 Ag/Ab Immunoassay

ScKey scoreCD4+ T-cell count (Threshold <200 cells/µL for AIDS/Prophylaxis)

→When to referTreatment failure (VL >1000), suspected IRIS, pregnancy, or immunological non-response (CD4 <500 despite suppression)

Start ART on the day of diagnosis for all patients to achieve rapid viral suppression and prevent transmission (U=U).

Human Immunodeficiency Virus (HIV) is a chronic, progressive [[retrovirus]] infection that targets [[CD4+ T lymphocytes]], leading to profound immunosuppression and, if untreated, Acquired Immune Deficiency Syndrome (AIDS). The clinical landscape has shifted from managing a terminal illness to coordinating a chronic condition, where the primary goal is rapid and sustained viral suppression. Modern management centers on the "test and treat" strategy, emphasizing Same-Day Initiation (SDI) of [[antiretroviral therapy]] (ART) to improve long-term retention and prevent onward transmission.

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

Epidemiology and Risk Factors

▸HIV epidemiology differs substantially across sexual, geographic, behavioral, maternal, and clinical populations [255][257][258][262].
▸Key acquisition and prevention-risk contexts include sex between men, transgender populations, chemsex, PrEP interruption or poor adherence, and disrupted HIV testing services [257][259][262].
▸Among HIV-exposed uninfected neonates in Uganda, adverse birth-outcome thresholds were preterm delivery at <37 weeks and low birth weight at <2,500 g; congenital infections were evaluated as potential risk factors [253].
▸Important HIV-associated comorbidity domains include AIDS-defining cancers, tuberculosis, cardiovascular disease, hypertension, steatotic liver disease, and age-related multimorbidity [256][261][263][264][265][266][267][269].
▸Treatment interruption, poor retention, virological failure, and drug resistance are clinically important modifiers of HIV outcomes [178][254][268].
▸Stigma and regional social context may affect HIV prevention, testing, treatment engagement, and social inclusion [270].

HY High Yield: Risk assessment should integrate HIV exposure context, PrEP and testing continuity, sexualized substance use, pregnancy and congenital infection risks, tuberculosis and other comorbidities, treatment interruption, stigma, and access to person-centered care [253][254][257][259][262][265][266][268][270].

Global distribution and population heterogeneity

The supplied evidence describes HIV epidemiology across diverse populations and settings rather than providing a single contemporary global prevalence estimate. HIV-related risk and outcomes vary by geography, age, sex, sexual network, comorbidity profile, prevention access, and continuity of care ^[255]^[257]^[258]^[259]^[262]. Southern African women were the population assessed in the HVTN 705/HPX2008 vaccine trial, in which a heterologous Ad26.Mos4.HIV plus clade C gp140 regimen did not demonstrate statistically significant overall efficacy against HIV-1 acquisition; the estimated efficacy was 14.1% (95% CI, −22.0% to 39.5%) during 7–24 months after the first dose ^[255]. Vaccine efficacy was additionally investigated according to HIV-1 envelope sequence characteristics, indicating that viral genetic diversity may be relevant to prevention performance ^[255].

In Lima, Peru, comparative incidence analyses focused on men who have sex with men and transgender people enrolled in AMP, Sabes, and ImPrEP seroincidence studies between 2013 and the study period, reflecting populations with substantial vulnerability to HIV acquisition and the methodological importance of estimating counterfactual incidence when placebo-controlled PrEP trials are not feasible ^[257]. In Zhejiang Province, China, routine data from voluntary counseling and testing clinics were used to examine HIV, syphilis, and anti-hepatitis C virus seropositivity and associated factors from 2022–2024, including coinfection patterns among clinic attendees ^[258].

Sexual, behavioral, and substance-related risk

Men who have sex with men and transgender people remain important populations for HIV prevention research because of elevated vulnerability to acquisition and the need for effective PrEP strategies ^[257]. Among gay, bisexual, and other men who have sex with men in Switzerland, longitudinal data from the Swiss HIV Cohort Study and SwissPrEPared study examined use of methamphetamine, new psychoactive stimulants, and GHB/GBL (“chems”) between April 2019 and December 2024; the study evaluated determinants of chemsex and its clinical implications among people living with HIV and people using PrEP ^[262]. These data support considering sexualized substance use as a potentially relevant behavioral and service-delivery factor when assessing HIV and sexually transmitted infection risk, while the supplied abstract does not provide effect estimates ^[262].

PrEP use, adherence, and continuity of prevention services influence observed HIV incidence. A retrospective cohort of commercially insured adult men aged 18–49 years compared PrEP adherence, HIV incidence, and sexually transmitted infection rates before versus during the COVID-19 pandemic among new users of tenofovir disoproxil fumarate/emtricitabine or tenofovir alafenamide/emtricitabine ^[259]. Pandemic-related disruption of HIV prevention services, including reduced PrEP prescribing and testing, was identified as an epidemiologically relevant concern ^[259].

Maternal, neonatal, and congenital factors

Pregnancy-related outcomes are an important component of HIV epidemiology. In Uganda, a 1:2 nested case-control study within the IMPAACT PROMISE 1077BF trial evaluated mother–infant pairs in which women living with HIV were receiving antiretroviral therapy. Cases were HIV-exposed uninfected neonates with preterm delivery, defined as <37 weeks, or low birth weight, defined as <2,500 g; the study assessed selected congenital infections as possible risk factors for these adverse outcomes ^[253]. The study was motivated by high rates of adverse pregnancy outcomes observed among women randomized to triple antiretroviral treatment compared with zidovudine alone in the parent trial ^[253].

Comorbidities and disease-associated risk

HIV substantially modifies the epidemiology of several serious comorbidities. A 2022 global modeling study estimated HIV-attributable and all-cause AIDS-defining cancers—cervical cancer, non-Hodgkin lymphoma, and Kaposi sarcoma—using updated risk ratios, population-attributable fractions, country-specific HIV prevalence, and cancer incidence data ^[256]. Tuberculosis remains a major overlapping epidemic in settings with substantial HIV burdens. Nigerian investigators assessed tuberculosis-treatment uptake and outcomes among 213 people living with HIV receiving antiretroviral therapy at a tertiary facility, using records from 2015–2019 ^[265]. In Liangshan, Southwest China, surveillance data included 3,367 HIV–tuberculosis coinfected cases from 2019–2024, with analyses of trends, transmission routes, treatment outcomes, and drug resistance ^[266]. A nationwide Israeli registry study followed 3,018 men who have sex with men living with HIV for 30,617 person-years; tuberculosis occurred in 16 (0.5%), corresponding to 5 cases per 10,000 person-years, compared with 244 cases among non-MSM people living with HIV (6.6%; 70 per 10,000 person-years) ^[267].

Ageing and chronic disease increasingly shape the HIV burden. Studies examined diet and body composition among virologically suppressed adults with HIV in two Italian centers ^[260], healthcare utilization and comorbidity incidence before and for up to 5 years after HIV diagnosis in insured adults ^[261], steatotic liver disease and associated mortality, cardiovascular disease, and cirrhosis in 4,597 Korean people living with HIV ^[269], and hypertension-care progression among people with and without HIV in South African primary-care clinics ^[264]. People living with HIV on antiretroviral therapy also have increased risk of heart failure with preserved ejection fraction; a South African study enrolled 1,508 adults aged ≥40 years, including 1,008 people with HIV and 500 without HIV, to develop a prediction score ^[263].

Health-system and treatment-related factors

Retention in HIV care is an epidemiologic determinant of treatment continuity and reengagement. In Zambia, a stepped-wedge cluster-randomized trial involving 24 clinics from August 2019 to November 2021 evaluated person-centered care and its effects on return after treatment interruptions and sustained retention after return ^[254]. Among people receiving dolutegravir-based therapy with viral rebound of ≥400 copies/mL, South African investigators evaluated plasma dolutegravir exposure to identify those at greatest risk of resistance and to target resistance testing where resources are limited ^[268]. In Rwanda, national surveillance from 2019–2025 was used to study virological failure and mortality after transition to second- or third-line therapy ^[178]. Treatment adherence and care engagement are therefore relevant risk modifiers, although the supplied abstracts do not provide complete effect estimates for these studies ^[178]^[254]^[268].

In children and adolescents, a national Indonesian cohort of 509,290 tuberculosis patients aged 0–19 years examined unsuccessful treatment outcomes, defined as death, loss to follow-up, or treatment failure, with non-adherence identified as an important concern ^[177]. Digital stigma may also vary geographically and influence social inclusion and intervention uptake; a Chinese ecological study assessed spatial patterns of HIV/AIDS stigma in responses to people living with HIV on Douyin and their relationships with regional sociodemographic and epidemiological contexts ^[270].

Selected epidemiologic populations and thresholds

Domain	Population or threshold	Evidence
Sexual and prevention risk	Men who have sex with men, transgender people, and PrEP users	^[257]^[259]
Chemsex	Methamphetamine, new psychoactive stimulants, and GHB/GBL among gay, bisexual, and other men who have sex with men	^[262]
Neonatal outcomes	Preterm delivery <37 weeks; low birth weight <2,500 g	^[253]
Tuberculosis coinfection	3,367 HIV–TB cases in Liangshan, 2019–2024	^[266]
Ageing and chronic disease	Adults aged ≥40 years assessed for HIV-associated HFpEF risk in South Africa	^[263]
Treatment continuity	Viral rebound threshold ≥400 copies/mL for dolutegravir exposure-guided resistance testing	^[268]

Supportive Care and Complication Management

▸Screening, OI prophylaxis and treatment, rapid ART initiation, and adherence support are core components of advanced HIV disease management; AHD includes WHO stage III/IV disease, CD4 **<200 cells/mm³**, or age **<5 years**. [191]
▸Palliative care needs are common and frequently under-recognized; 43.3% of assessed patients in an Indian HIV clinic met criteria for palliative-care need. [204]
▸The supplied SaDAPT abstract describes, but does not report results from, a trial comparing same-day with diagnostic-result-deferred ART in people with HIV and TB symptoms. [74]
▸Integrase inhibitor-based ART was not associated with higher TB-IRIS risk than non-integrase regimens in a 133-person cohort. [193]
▸Asymptomatic CrAg-positive people remain at risk of meningitis or death; the cited trial tested single-dose liposomal amphotericin B plus fluconazole, but its result is not provided in the supplied evidence. [75]
▸IRIS may involve TB, nontuberculous mycobacteria, fungi, toxoplasmosis, Kaposi sarcoma, ocular disease, or the CNS and may require drainage, corticosteroids, oncologic intervention, or individualized immunotherapy. [78, 92, 198, 200-203]

Dx Diagnostic Essentials: In advanced HIV disease, actively screen for major opportunistic infections and cryptococcal antigenemia, particularly when CD4 count is **<200 cells/mm³**; neurologic symptoms or meningitis features require urgent CNS evaluation. [191, 74, 75]

! Warning: Do not assume every deterioration after ART is microbiologic treatment failure. IRIS can produce paradoxical TB or NTM disease, fungal or toxoplasmosis-associated inflammation, Kaposi sarcoma progression, retinal necrosis, or CNS inflammation; reassess for untreated infection, drug resistance, obstruction, abscess, and CSF viral escape. [92, 199-203]

CP Clinical Pearl: Palliative care should be presented as concurrent supportive care, not only end-of-life care; misconceptions, stigma, and service barriers commonly limit access. [195, 196, 204]

Advanced HIV disease and routine supportive care

Advanced HIV disease (AHD) is defined in the cited programmatic study as WHO stage III/IV disease, a CD4 count <200 cells/mm³, or age <5 years. Its management should combine screening for major opportunistic infections (OIs), treatment and prophylaxis, rapid ART initiation, and adherence support. In 17 ART centres in Mumbai, India, implementation of this WHO-aligned advanced disease management package was assessed among treatment-naive and treatment-experienced adults and children; the study supports integration of these components into routine HIV services, although the available abstract does not provide complete outcome estimates. ^[191]^C

Palliative and supportive care should be integrated across the disease course rather than reserved exclusively for the terminal phase. In a UK survey of 90 people living with HIV, only 58.9% reported that they knew what palliative care was well enough to explain it, and respondents commonly viewed palliative care as synonymous with end-of-life care. HIV-related stigma also affected care experiences: 27.8% reported that their HIV status sometimes negatively affected their experiences of care. ^[195] Among women living with HIV in 12 Nigerian health-care facilities, knowledge gaps and health-system barriers were identified as obstacles to integrating palliative care into routine services. ^[196] In an Indian tertiary HIV clinic, 97 of 118 eligible patients participated in a symptom and needs assessment; 43.3% met the study definition for palliative-care need, demonstrating substantial unmet physical, psychological, and social-care requirements. ^[204]

Tuberculosis, ART timing, and IRIS

The timing of ART in people with HIV who have tuberculosis symptoms remains clinically important. The SaDAPT randomised, non-inferiority trial in Lesotho and Malawi enrolled people aged ≥12 years who were initiating or restarting ART and had at least one TB symptom, while excluding those with symptoms or signs of meningitis. It compared same-day ART with ART deferred until TB diagnostic results were available, using viral suppression at 6 months as the primary outcome. The supplied abstract does not report the trial result; therefore, the evidence provided here should not be interpreted as establishing equivalence or superiority of either strategy. ^[74]

TB-IRIS risk is associated with profound immunosuppression. In the PredART-linked analysis, lower pre-ART CD4 counts were confirmed to be associated with TB-IRIS, and several class I and II HLA alleles showed population-specific protective or risk associations; HLA-DQB105:01 was strongly protective (OR 0.07, 95% CI 0.02–0.28), whereas HLA-DRB101:02 was associated with increased risk (OR 5.92, 95% CI 1.3–27.0). These genetic findings are not currently a routine basis for individual clinical prediction. ^[78]

In a Hong Kong cohort of 133 people with HIV and TB, paradoxical TB-IRIS occurred in 16/70 (22.9%) receiving an integrase inhibitor-based regimen and 14/63 (22.2%) receiving a non-integrase inhibitor regimen. The reported findings did not indicate an increased TB-IRIS risk with integrase inhibitor-based ART in people with profound immunosuppression. ^[193] Case reports illustrate that IRIS may produce enlarging lymph nodes, abscesses, or unusual multi-pathogen inflammatory syndromes. Disseminated Mycobacterium simiae infection caused progressive lymph-node swelling and abscess formation requiring drainage after ART initiation; corticosteroids were used for IRIS. ^[200]^C TB-IRIS has also been reported with large bilateral psoas abscesses requiring surgical drainage and prednisone. ^[202]^C Concomitant disseminated histoplasmosis and presumptive CNS toxoplasmosis-associated IRIS has likewise been described. ^[201]^C

Cryptococcal disease and adjunctive strategies

Cryptococcal antigen (CrAg) screening identifies people at risk of cryptococcal meningitis. Historically, 25%–30% of asymptomatic CrAg-positive people developed breakthrough meningitis or died despite standard fluconazole in the population described by the study. A Ugandan randomised trial evaluated a single 10 mg/kg dose of liposomal amphotericin B added to fluconazole versus fluconazole alone in people with HIV-associated asymptomatic cryptococcal antigenemia and low plasma CrAg titres, with 24-week meningitis-free survival as the outcome. The supplied abstract does not provide the final comparative result, so the efficacy of this adjunctive strategy cannot be concluded from the information available. ^[75]

Glutathione (GSH) and its precursors are being investigated as adjuncts in HIV–TB co-infection involving the CNS. A systematic review identified preclinical and clinical research examining effects on microbial control, antibiotic efficacy, inflammation, and immune dysfunction. The review suggests therapeutic potential, but the available evidence summary does not establish a standard dose, regimen, or clinical recommendation. ^[76]

Other infectious and inflammatory complications

Immunosuppression may worsen the clinical consequences of mpox. A meta-analysis of 34 studies from the 2022 outbreak found no significant difference in hospitalization risk between HIV-positive and HIV-negative individuals overall (OR 1.03; P=0.85; seven studies); the analysis specifically assessed hospitalization for severity rather than isolation, and included heterogeneous immunocompromised populations. ^[77]

IRIS can unmask or exacerbate malignancy and viral or mycobacterial disease. Laryngeal Kaposi sarcoma shortly after ART initiation caused severe supraglottic obstruction requiring tracheostomy; preoperative arterial embolization followed by transoral resection was successful in the reported case. ^[198]^C A case of varicella-zoster virus-associated acute retinal necrosis after bictegravir-based ART was followed by progressive neurocognitive decline and symptomatic CSF HIV escape, with CSF HIV RNA 7,100 copies/mL versus plasma 583 copies/mL and subsequent second-generation integrase-inhibitor resistance. ^[199]^C Recurrent steroid-dependent cortical encephalitis after cryptococcal meningitis and ART showed sequential migratory MRI lesions despite negative infectious and autoimmune investigations, prompting individualized immunotherapy. ^[92]^C

Prevention, vaccination, and additional complications

HIV-associated immune activation can impair vaccine quality. In pregnant women living with HIV, Tdap vaccination produced attenuated polyfunctional IgG and memory B-cell responses compared with HIV-uninfected pregnant women; the study also assessed Fc-dependent activity, memory B cells, placental IgG transfer, and cord-blood avidity. ^[194] Ocular syphilis may present with painful visual loss, rash, and a vascularized iris mass; in the reported patient, ocular disease resolved after intravenous ceftriaxone and penicillin, emphasizing the importance of early recognition. ^[197]^C

Complex co-infection requires coordinated antimicrobial, hepatic, neurologic, and ART management. A reported patient with AIDS had MDR pulmonary TB, HBV-related liver failure, and disseminated cryptococcosis, illustrating the substantial treatment complexity and mortality risk when severe infections and liver disease coexist. ^[203]^C

Complication-focused supportive care evidence

Clinical issue	Evidence-informed management implication	Evidence
Advanced HIV disease	Combine OI screening, prophylaxis/treatment, rapid ART, and adherence support	^[191]^C
TB symptoms at ART initiation	Same-day versus diagnostic-result-deferred ART is being evaluated; supplied abstract reports no outcome	^[74]
TB-IRIS	Assess risk in profound immunosuppression; evaluate enlarging nodes, abscesses, or new inflammatory lesions; drainage and corticosteroids may be required in selected cases	^[78]^[193]^[200]^C^[202]^C
Cryptococcal antigenemia	Use CrAg-directed pre-emptive therapy; adjunctive single-dose liposomal amphotericin was evaluated with fluconazole	^[75]
Palliative needs	Incorporate symptom, psychosocial, communication, and advance-care assessment early	^[195]^[196]^[204]
Mpox and immunosuppression	Monitor severity and complications; hospitalization risk estimates are heterogeneous and not significantly different overall in the cited meta-analysis	^[77]

Prognosis and Long-term Outcomes

▸Sustained viral suppression and durable ART remain the core determinants of favourable long-term outcomes. [205,221]
▸Virological failure can increase the risk of resistance and mortality, particularly after transition to second- or third-line therapy. [178,218,220]
▸Advanced immunosuppression, anaemia, elevated C-reactive protein, and multiple cytopenias are adverse prognostic markers. [211,217]
▸Frailty and sarcopenia are modifiable components of functional ageing with HIV; supervised aerobic and resistance exercise has been formally evaluated in people aged ≥50 years. [208]
▸TB, HBV, hypertension, mpox, intimate-partner violence, and mental-health barriers can materially influence long-term outcomes. [177,182,206,207,210,212,216]
▸Newer two-drug, long-acting, and single-tablet strategies are being evaluated for suppression, immune recovery, resistance, and treatment durability. [207,209,214,219]

HY High Yield: A favourable HIV prognosis requires more than an undetectable viral load: monitor immune recovery, treatment durability, resistance, frailty, cardiovascular risk, cytopenias, TB/HBV, and other comorbidities over time. [177,178,182,207,208,210,212,217,218]

! Warning: Evidence for adjunctive therapies, newer dual regimens, and predictive models should be interpreted according to study design, population, follow-up duration, and external validity; observational or small studies do not establish universal treatment superiority. [207,211,215,219,220]

Overall prognosis

The long-term prognosis of people with HIV is increasingly determined by sustained viral suppression, immune recovery, treatment durability, comorbidity management, and prevention of treatment failure rather than by HIV infection alone. Contemporary evidence spans randomized trials, systematic reviews, observational cohorts, programme analyses, and prediction modelling; therefore, estimates are not directly interchangeable across populations or settings. [205–221]

Sustained antiretroviral therapy (ART) remains the central determinant of favourable long-term outcomes. Digital health interventions are being evaluated across multiple modalities to improve ART adherence, retention, viral suppression, and clinical outcomes; the most recent meta-analysis incorporated prediction intervals and trial-sequential analysis to assess the robustness and generalisability of these effects. ^[205] A patient-centred, data-driven care programme in Trinidad and Tobago reported longitudinal treatment outcomes using routine electronic records and specifically addressed sustained viral suppression and structural or health-system barriers within differentiated service delivery. ^[221] In women living with HIV who experienced intimate-partner violence in South Africa, a randomized trial assessed whether a lay-health-worker-delivered Common Elements Treatment Approach could improve HIV treatment outcomes in the context of violence and mental-health barriers to retention and suppression. ^[206]

Virological failure and regimen durability

Virological failure has important prognostic implications because it may lead to drug resistance, treatment intensification, and increased risk of adverse clinical outcomes. In Rwanda, national surveillance was used to estimate virological failure and mortality after transition to second- or third-line ART, with competing-risks methods applied to distinguish these outcomes. ^[178] A South African district-level study described the clinical and demographic profile of adults experiencing virological failure despite broad ART access, highlighting persistent challenges in maintaining suppression in resource-limited settings. ^[218] For people with multidrug-resistant HIV-1, a prediction model based on data from 6,844 participants in 18 clinical trials was developed to capture nonlinear interactions among viral, host-immunity, and treatment variables during salvage therapy; its clinical utility requires external validation before routine adoption. ^[220]^C

Among virologically suppressed people with HIV who were hepatitis B core-antibody positive but HBsAg negative, a target-trial emulation compared tenofovir-based triple therapy with tenofovir-sparing dual therapy after suppression. The dual-therapy strategies included several combinations, including lamivudine plus a boosted protease inhibitor or dolutegravir, dolutegravir plus rilpivirine, doravirine plus dolutegravir, and long-acting cabotegravir plus rilpivirine; the primary concern was subsequent virological failure after switching. ^[207] These findings are relevant to long-term regimen selection, although the observational design and eligibility restrictions limit causal generalisation. ^[207]

Randomized evidence has also evaluated newer simplified regimens. A GRADE-assessed systematic review and meta-analysis examined doravirine/islatravir across treatment-experience categories, using week 48 viral suppression and CD4-cell change as primary outcomes while specifically comparing islatravir doses of 0.25 mg and 0.75 mg. ^[209] In virologically suppressed participants receiving complex regimens, week-96 resistance analyses evaluated once-daily bictegravir/lenacapavir after transition to a single-tablet regimen; participants without known integrase resistance were randomized to bictegravir/lenacapavir doses or continuation of the background regimen. ^[214] In treatment-naive adults with HIV RNA of ≥500,000 copies/mL and CD4 counts of ≥200 cells/mm³, a retrospective cohort compared dolutegravir/lamivudine with bictegravir/emtricitabine/tenofovir alafenamide at week 48, including immune, metabolic, and renal outcomes. ^[219]

Immune recovery, frailty, and functional ageing

Virological suppression does not guarantee complete immune restoration. In treatment-naive patients with advanced HIV and baseline CD4 counts of <200 cells/μL, a propensity-score-matched cohort assessed whether adjunctive albuvirtide added to bictegravir/emtricitabine/tenofovir alafenamide improved a composite of CD4 increase of >150 cells/μL plus HIV RNA below 50 copies/mL at week 24. ^[211] A small randomized study examined adjunctive spleen- and kidney-invigorating Chinese herbal therapy with HAART using CD4/CD8 and Th17-cell measures, inflammatory cytokines, haematological and nutritional indices, adverse reactions, and health-related quality-of-life scores; the limited sample size and specific intervention constrain interpretation. ^[215]

Ageing with HIV is associated with clinically important risks of frailty, sarcopenia, and functional decline. The HEALTH randomized trial enrolled sedentary people with HIV aged ≥50 years and compared 16 weeks of supervised high-intensity interval training or continuous moderate exercise, both combined with progressive resistance training; outcomes included transitions in Fried frailty phenotype, sarcopenia-related measures, functional performance, withdrawal, and intervention response. ^[208]

Comorbid disease and advanced presentation

Prognosis is also shaped by non-HIV disease. A Tanzanian pilot integrated community-health-worker education, monthly blood-pressure monitoring, care coordination, subsidised antihypertensive medicines, a standardised treatment algorithm, and provider training into HIV clinics to address uncontrolled hypertension. ^[212]^C In newly diagnosed patients, anaemia was the most frequent haematological abnormality and was associated with lower CD4 counts, higher viral load, and reduced survival; elevated C-reactive protein and multiple cytopenias were also associated with poorer outcomes during 12 months of ART follow-up. ^[217]

Tuberculosis (TB) remains a major prognostic threat. A nationwide Korean cohort compared TB treatment outcomes in people with HIV and the general population and used Cox models to identify predictors of death during TB treatment; approximately 90% of the HIV-TB group received ART. ^[182] In Indonesia, a registry cohort of 509,290 children and adolescents with TB classified death, loss to follow-up, or treatment failure as unsuccessful outcomes and evaluated associated factors. ^[177] Hepatitis B treatment outcomes may also be influenced by nucleos(t)ide analogue exposure: a systematic review examined relationships between tenofovir or entecavir concentrations and virological treatment outcomes, including studies involving HIV/HBV coinfection. ^[210] Finally, a multicentre retrospective study in South Kivu, Democratic Republic of the Congo, explored whether HIV infection and selected comorbidities were associated with mpox severity, mortality, and hospitalisation duration among adults admitted between 2024 and 2025. ^[216]

Practical prognostic assessment

Long-term assessment should therefore combine HIV RNA, CD4 trajectory, adherence and retention, resistance history, ART tolerability, cytopenias and inflammatory markers, frailty and functional status, blood pressure, TB and HBV status, and other comorbidities. ^[177]^[178]^[182]^[207]^[208]^[210]^[212]^C^[217]^[218] Prognosis is most favourable when viral suppression is sustained and treatment remains effective, while advanced immunosuppression, anaemia or multiple cytopenias, virological failure, serious coinfection, uncontrolled hypertension, frailty, and barriers related to violence or mental health identify patients needing intensified, multidisciplinary follow-up. ^[177]^[178]^[182]^[206]^[208]^[212]^C^[217]^[218]

Prognostic domains and evidence

Domain	Relevant evidence	Prognostic relevance
Viral suppression and retention	Digital health, patient-centred care, and IPV-focused interventions	Targets adherence, retention, and sustained suppression. ^[205]^[206]^[221]
Virological failure and resistance	National cohorts, district studies, salvage-therapy modelling, regimen-switch studies	Signals risk of resistance, treatment failure, and mortality. ^[178]^[207]^[218]^[220]^C
Immune recovery	Advanced HIV cohorts and adjunctive-treatment studies	CD4 recovery may remain incomplete despite virological control. ^[211]^[215]
Ageing and function	Supervised exercise trial in people with HIV aged ≥50 years	Frailty, sarcopenia, and functional decline are important long-term outcomes. ^[208]
Comorbidity and coinfection	TB, HBV, hypertension, mpox, and haematological cohorts	Non-HIV disease and systemic complications substantially modify prognosis. ^[177]^[182]^[210]^[212]^C^[216]^[217]

Landmark Trials and Key Evidence

▸START established the clinical benefit of immediate ART in asymptomatic people with high CD4 counts and continues to provide evidence on renal, hepatic, cardiovascular, immunologic, virologic, and inflammatory outcomes. [116][124][125][225][226]
▸Low CD4 recovery despite viral suppression occurred in 39.7% of immediate-ART participants and was defined as a CD4 increase of <50 cells/mm³ after 8 months with viral load ≤200 copies/mL. [128]
▸ECHO found no substantial difference in HIV acquisition among DMPA-IM, copper-IUD, and levonorgestrel-implant groups. [117][121]
▸Integrating oral PrEP into trial prevention services enabled evaluation of PrEP access, tenofovir exposure, and HIV-incidence trends in African women. [118][122][123]
▸PARTNER tested adapted motivational interviewing to address substance use, sexual risk, and PrEP uptake among partnered sexual-minority men. [114]

HY High Yield: Immediate ART is supported even at high CD4 counts; delaying treatment exposes patients to preventable clinical risk and is not justified by concerns about prolonged ART exposure alone. [116][125][226]

CP Clinical Pearl: ECHO’s contraceptive comparison should be interpreted alongside comprehensive HIV prevention, including PrEP when indicated; the trial also demonstrated the feasibility and importance of integrating PrEP into endpoint-driven prevention research. [117][122][123]

! Warning: Mechanistic findings, mathematical models, and ethical critiques provide context but should not be conflated with the primary randomized estimate of HIV acquisition in ECHO. [119][120][126][222]

START: immediate antiretroviral therapy and end-organ outcomes

The Strategic Timing of Antiretroviral Treatment (START) trial randomized 4,684 ART-naive adults with CD4 counts below 500 cells/mm³ to immediate or deferred ART; subsequent analyses have informed treatment timing, renal health, liver fibrosis, hypertension, immune recovery, virologic control, host genetics, and trial conduct. ^[116] In the principal high-CD4 population, immediate ART was established as beneficial for reducing serious AIDS- and non-AIDS-related morbidity and mortality compared with deferral until CD4 decline. ^[125]^[226] A post-hoc analysis examined which asymptomatic adults with CD4 counts >500 cells/µL derived the greatest benefit from immediate treatment, although subgroup findings should not replace the overall evidence supporting immediate ART. ^[226]

Renal follow-up found a small but statistically significant greater decline in estimated glomerular filtration rate among participants assigned to deferred ART during the first median 2.1 years; the newer analysis assessed longer-term chronic kidney disease events, eGFR, and urine albumin/creatinine ratio. ^[116] Immediate ART was also associated with evaluation of liver-fibrosis progression using APRI and FIB-4 indices in participants with CD4 counts >500 cells/µL, randomized across 222 sites in 35 countries. ^[225] START analyses further assessed inflammatory biomarkers, including IL-6 and high-sensitivity C-reactive protein, in relation to prevalent and incident hypertension among ART-naive people with CD4 counts >500 cells/mm³. ^[124]

Among immediate-ART participants who achieved viral suppression, low CD4 recovery—defined as an increase of <50 cells/mm³ after 8 months despite viral load ≤200 copies/mL—occurred in 39.7%; male sex and lower baseline CD4 count were associated with this outcome. ^[128] A subgroup with pretreatment viremia below 3,000 copies/mL, including participants with viremia ≤50 copies/mL, was analyzed for clinical outcomes, hospitalization, death, virologic control, CD4 counts, biomarkers, and adverse events. ^[125] Genome-wide analyses in 2,440 ART-naive START participants identified significant associations between major-histocompatibility-complex class I-region variants and viral load, with reported effect sizes of 0.14–0.39 log10 copies/mL. ^[127]

A randomized substudy evaluated annual on-site monitoring versus no annual on-site monitoring, with central monitoring for all sites and local monitoring twice yearly; the composite outcome included eligibility errors, consent violations, protocol-inconsistent ART, and delayed endpoint reporting. ^[223] Separately, valaciclovir 500 mg twice daily did not serve as a substitute for ART; a blinded randomized trial in treatment-naive adults with CD4 counts 400–900 cells/mm³ assessed CD4 decline, CD4 percentage, viral load, herpes simplex virus recurrences, and adverse events until predefined treatment-progression criteria were met. ^[224]

REPRIEVE: statins in people with HIV

REPRIEVE was a completed randomized, placebo-controlled trial conducted from 2015–2023 at 145 sites in 12 countries, evaluating pitavastatin 4 mg daily for cardiovascular prevention in people with HIV. ^[115] A prespecified secondary analysis assessed major non-cardiovascular events, including AIDS-defining events, non-AIDS-defining cancers, renal disease, and liver disease, thereby extending the trial’s relevance beyond cardiovascular outcomes. ^[115]

ECHO: contraception, HIV acquisition, and prevention integration

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial randomized 7,829–7,830 HIV-negative women aged 16–35 years to intramuscular depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device, or levonorgestrel implant. ^[121]^[123] The primary trial found no substantial or clear difference in HIV acquisition among the three contraceptive groups. ^[117]^[121] An ancillary behavioral study evaluated menstrual symptoms, sexual behavior, and their relationship to HIV acquisition. ^[121]

A substudy of 458 participants used prostate-specific antigen detection in vaginal swabs as an objective marker of condomless vaginal sex and compared findings across contraceptive arms. ^[117] Oral PrEP was incorporated into the prevention package at South African sites and was offered on-site during the trial’s later period. ^[118]^[122]^[123] A nested interrupted-time-series analysis evaluated whether introducing on-site PrEP access changed HIV incidence among women followed at 12 sites in four countries. ^[122] Among South African women reporting ongoing PrEP use, plasma tenofovir was measured at the final visit, with analyses of demographic and sexual-risk correlates of quantifiable drug exposure. ^[118]

Biological ECHO substudies examined whether contraceptive initiation altered genital HIV susceptibility. In 58 women, cervical cytobrushes collected at baseline and 1 month were used to phenotype cervical T cells; the analysis focused on Th17-like CD4+ target cells. ^[119] In 251 women from South Africa and Kenya, 27 cervicovaginal cytokines were measured at baseline and 1 and 6 months, with additional comparison of preseroconversion profiles in 25 HIV cases and controls. ^[120] These mechanistic studies do not overturn the primary ECHO finding of no substantial difference in HIV acquisition between methods. ^[117]^[121]

Modeling studies estimated the potential population effect of DMPA if it increased HIV susceptibility by 1.20-fold (95% CI 1.06–1.36) compared with a no-effect scenario; such simulations are not equivalent to direct randomized clinical evidence. ^[222] Ethical critiques of ECHO raised concerns about incentives, coercive language, and disclosure of study risks; these arguments concern trial ethics rather than the randomized estimate of HIV incidence. ^[126]

PARTNER: behavioral prevention for sexual-minority men

The PARTNER study randomized or evaluated a four-session adapted motivational-interviewing intervention among 196 HIV-negative cisgender sexual-minority men aged 18–34 years in primary relationships. ^[114] Participants reported recent cannabis or illicit-drug use and condomless anal sex with a casual partner or with a serodiscordant or nonmonogamous main partner. ^[114] The intervention was designed to reduce cannabis and illicit-drug use, increase PrEP uptake, and reduce HIV infection risk; procedures were conducted in New York City from January 2018 through February 2024. ^[114]

Selected landmark trials and evidence domains

Trial or study	Population/intervention	Principal evidence domain
START	ART-naive adults; immediate versus deferred ART	Morbidity, mortality, kidney health, liver fibrosis, hypertension, immune recovery, virology, genetics ^[116]^[124]^[125]^[127]^[128]^[225]^[226]
REPRIEVE	People with HIV; pitavastatin 4 mg versus placebo	Cardiovascular prevention and major non-cardiovascular events ^[115]
ECHO	Women aged 16–35 years; DMPA-IM, copper-IUD, or LNG implant	HIV acquisition, sexual behavior, genital immunology, cytokines, and PrEP integration ^[117]^[118]^[119]^[120]^[121]^[122]^[123]
PARTNER	HIV-negative partnered sexual-minority men aged 18–34 years	Motivational interviewing, substance use, sexual risk, and PrEP uptake ^[114]

Prevention and Screening

▸Integrate HIV testing, PrEP, STI care, contraception, vaccination, and treatment within stigma-responsive sexual and reproductive health services. [173,231]
▸Offer prevention choices that include oral PrEP, CAB-LA, and emerging twice-yearly lenacapavir, while recognizing that the supplied abstracts do not provide complete outcome data for the lenacapavir pregnancy substudy or Ugandan F/TAF trial. [227,228]
▸Use objective drug-level monitoring and persistence measures to identify adherence problems and target support. [227,230,233]
▸Address insurance, logistics, cost, missed injections, and limited patient demand when implementing injectable PrEP. [238]
▸Include STI screening, vaccination assessment, counseling, and consideration of DoxyPEP for appropriate populations. [234,236,243]
▸Improve PEP and PrEP knowledge among healthcare trainees and providers. [237,239,242]
▸Combine biomedical prevention with human-rights, anti-stigma, and structural interventions. [232,241,244]

CP Clinical Pearl: PrEP programs should monitor both biological exposure and engagement in care: dried-blood-spot or urine drug levels, refill history, persistence, HIV testing, STI testing, vaccination, and follow-up can identify different prevention gaps. [227,230,233,234]

! Warning: The supplied abstracts do not contain complete numerical outcomes for the Ugandan F/TAF randomized trial, the lenacapavir pregnancy and lactation substudy, the Amsterdam diagnosis analysis, or the New York City STI trend analysis; these findings should not be inferred from study design alone. [227,228,243,245]

Combination prevention and service delivery

HIV prevention should combine biomedical methods with accessible, stigma-responsive sexual and reproductive health services. A co-created model for female sex workers (FSWs) in Buenos Aires integrated HIV testing, sexual and reproductive health care, sexually transmitted infection (STI) services, pre-exposure prophylaxis (PrEP), and HIV treatment while addressing occupational stigma and concerns about disclosure. ^[173] Integration of oral PrEP into family-planning clinics in Kenya was similarly designed to reach women at increased risk within an existing care platform; provider training, service organization, and delivery under one roof were identified as important implementation considerations. ^[231] Qualitative evidence from Thailand linked criminalization of sex work with stigma, discrimination, gender-based violence, incarceration, and restricted access to HIV services, indicating that structural and human-rights barriers must be addressed alongside biomedical prevention. ^[241]

Implementation strategies should be tailored to local populations and settings. In South Africa, qualitative work with FSWs identified multilevel contextual factors relevant to introducing long-acting injectable PrEP, including the need to adapt delivery to decentralized services and the realities of sex-work settings. ^[244]^C In the United States, clinicians reported that long-acting injectable cabotegravir (CAB-LA) was available at 71% (51/72) of surveyed sites, but only 44% (20/45) had prescribed it; prominent barriers included insurance coverage (84%, 38/45), logistical complexity (78%, 35/45), lack of patient requests (71%, 32/45), concern about missed injections (68%, 17/25), and cost (64%, 16/25). ^[238] A simplified algorithm combining PrEP, post-exposure prophylaxis (PEP), and HIV treatment initiation was developed for resource-limited and nonspecialist US settings, although the study was exploratory and based on published clinical guidance rather than a clinical outcomes trial. ^[239]^C

PrEP options and adherence

Long-acting prevention is expanding beyond daily oral PrEP. In the PURPOSE 1 trial substudy, twice-yearly subcutaneous lenacapavir was compared with daily oral emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) among cisgender adolescent girls and young women initially enrolled while not pregnant; the substudy evaluated HIV acquisition, safety, and pharmacokinetics during pregnancy and lactation. ^[228] The available report describes this population and evaluation but does not provide the complete numerical outcome data in the supplied abstract. ^[228]

A randomized trial in Uganda evaluated same-day initiation of F/TAF PrEP among 200 HIV-negative transgender women, with quarterly follow-up for 12 months from November 2021 to July 2023. Participants were assigned to drug-level feedback with tailored adherence counseling or standard care; adherence was assessed using tenofovir concentrations in dried blood spots for longer-term exposure and urine for recent exposure. ^[227] The supplied abstract does not include the trial’s complete comparative adherence, acceptability, safety, or HIV-acquisition results. ^[227]

Objective adherence monitoring can identify gaps that indirect measures may miss. The ImPrEP implementation study enrolled 9509 participants in Brazil, Mexico, and Peru between 2018 and 2021; the reported analysis focused on young men who have sex with men and transgender women and compared tenofovir-diphosphate levels in dried blood spots with indirect adherence measures. ^[230] In a real-world Buenos Aires cohort, persistence on daily or event-driven oral PrEP was examined among transgender women, men who have sex with men, and cisgender women engaged in sex work, with discontinuation analyzed by survival methods. ^[233] These studies support monitoring persistence and adherence as part of PrEP delivery, while their observational designs limit causal interpretation. ^[230]^[233]

Behavioral monitoring remains appropriate, but available evidence does not establish that PrEP causes risk compensation. In the ASPIRE trial and its HOPE open-label extension, longitudinal comparisons examined sex with nonprimary partners and condom use among HIV-negative women in Malawi, South Africa, Uganda, and Zimbabwe. ^[229] In New York City, serial surveillance from 2014–2023 assessed bacterial STI trends by PrEP use among cisgender men who have sex with men and explicitly addressed potential bias in associations between PrEP and STI diagnoses. ^[243]

STI prevention, vaccination, and PEP

PrEP services should include assessment for bacterial and vaccine-preventable STIs. A São Paulo cohort evaluated coverage for hepatitis A, hepatitis B, human papillomavirus, and mpox vaccination among PrEP users, together with STI-prevention counseling and related clinical factors. ^[234] Doxycycline post-exposure prophylaxis (DoxyPEP) is an emerging intervention for bacterial STI prevention among men who have sex with men and transgender women; an early implementation study in a US infectious-diseases clinic evaluated prescribing and follow-up among patients receiving HIV PrEP or care. ^[236]

PEP is time-sensitive and requires recognition of exposure indications and prompt initiation, but knowledge may be a barrier. A multicentre survey of 1382 medical students at three Chinese medical schools assessed PEP knowledge, attitudes, and HIV-related stigma during March–August 2025, highlighting the importance of education for future clinicians and trainees who may experience occupational exposure. ^[237] Health-science students in South Africa were also surveyed regarding PrEP knowledge, attitudes, and intention to use it; the cross-sectional design measured correlates but cannot establish whether education changes prevention uptake. ^[242]

Screening and prevention impact

HIV testing remains central to prevention because PrEP and PEP require attention to HIV status, while integrated services can reduce access barriers. ^[173]^[231] A time-series analysis from Amsterdam compared 647 people diagnosed with HIV between 2015 and June 2024 before and during the national PrEP-programme era, examining changes in demographic, sexual, and PrEP-related characteristics at diagnosis. ^[245] The study was designed to assess whether the population diagnosed with HIV changed after PrEP implementation; the supplied abstract does not provide the complete numerical findings. ^[245]

New long-acting technologies should complement—not displace—social, structural, and rights-based prevention. Critical analysis of lenacapavir cautioned that claims of a “game-changing” effect, cost-efficiency, or capacity to end AIDS can encourage biomedical triumphalism and divert attention from structural responses, particularly amid reduced donor funding. ^[232]

Evidence-informed prevention components

Component	Evidence and implementation implication
PrEP access	Same-day F/TAF initiation was evaluated in 200 transgender women in Uganda; adherence feedback used dried-blood-spot and urine tenofovir levels. ^[227]
Long-acting PrEP	Lenacapavir was evaluated during pregnancy and lactation in a PURPOSE 1 substudy; CAB-LA implementation is limited by coverage, logistics, cost, and missed-injection concerns. ^[228]^[238]
Adherence and persistence	Objective tenofovir-diphosphate measurement and survival analysis can characterize non-adherence and discontinuation. ^[230]^[233]
STI prevention	Include STI testing, vaccination assessment, counseling, and emerging DoxyPEP services. ^[234]^[236]^[243]
Structural prevention	Integrate services and address stigma, criminalization, violence, and disclosure barriers. ^[173]^[231]^[241]^[244]^C
PEP education	Improve recognition and knowledge of PEP among trainees and nonspecialist providers. ^[237]^[239]^C^[242]

Guidelines and Resources

▸EACS 2025 lists TDF or TAF plus lamivudine or emtricitabine with DTG, BIC, or DOR, and XTC plus DTG dual therapy, among adult HIV-1 first-line options. [154]
▸nPEP should begin as soon as possible, ideally within **24 hours** and no later than **72 hours** after a substantial-risk exposure. [158]
▸Injectable lenacapavir PrEP is administered every **6 months** and was approved in the United States in **June 2025**. [155]
▸Australian anal-cancer screening guidance recommends offering screening to GBM and transgender women with HIV from **age 35 years**. [153]
▸Breastfeeding counseling should follow current national guidance and shared decision-making because recommendations differ across jurisdictions. [246,156]

! Warning: Do not delay the first nPEP dose while awaiting laboratory results; initiate immediately when clinically indicated, provided the exposure occurred no later than **72 hours** previously. [158]

CP Clinical Pearl: Breastfeeding decisions for people with HIV are jurisdiction-sensitive and should incorporate current national guidance, sustained viral suppression, adherence, infant-management protocols, and shared decision-making. [246,156,251]

Core HIV treatment and prevention guidance

The 2025 European AIDS Clinical Society (EACS) guideline revision reorganizes recommendations 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 (DTG), bictegravir (BIC), or doravirine (DOR); dual therapy with lamivudine or emtricitabine plus DTG is also included. Version 13.0 adds a dedicated HIV-2 section. ^[154]

The International Antiviral Society–USA 2024 recommendations address antiretroviral treatment, prevention, and clinical management in adults, incorporating literature and conference evidence through October 2024 and newer antiretroviral drugs and formulations. ^[161] The recommendations should be used with current regional guidance, drug-label information, resistance results, comorbidity assessment, pregnancy considerations, and patient preferences. ^[161]

PrEP and PEP

The 2025 Canadian guideline updates national indications, risk assessment, and drug regimens for HIV preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP), using systematic reviews and community-informed, formal evidence-to-decision methods. ^[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; its statement evaluates both prevention benefits and harms and the accuracy of risk-assessment tools. ^[163]

In the United States, injectable lenacapavir was approved in June 2025 for PrEP administered every 6 months, based on the PURPOSE 1 and PURPOSE 2 randomized trials. CDC guidance identifies it as an additional injectable option alongside established oral tenofovir-based regimens and cabotegravir, while emphasizing assessment of efficacy, safety, adherence, persistence, and implementation. ^[155]

For nonoccupational exposure involving mucous membranes or nonintact skin, nPEP is recommended when the source has HIV without sustained viral suppression or when suppression status is unknown and the exposure presents substantial transmission risk. 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—without waiting for pending laboratory results. ^[158]

Sexual, reproductive, pregnancy, and infant-feeding resources

The 2026 British Association for Sexual Health and HIV/British HIV Association guideline updates UK recommendations for sexual and reproductive health in people with HIV using GRADE methodology and substantially revises recommendations from the 2008 guideline. ^[271] The 2026 Belgian guidance addresses pregnancy, antiretroviral selection, breastfeeding, and infant management; it classifies drugs for people considering pregnancy or who are pregnant as recommended, not recommended, or supported by insufficient data. ^[251]

U.S. obstetric guidance was updated in 2026 to reflect revised Department of Health and Human Services and American Academy of Pediatrics recommendations on infant feeding for patients with HIV. ^[246] European practice remains heterogeneous: a WAVE survey summarized guidance from 23 countries, focusing on breastfeeding decisions in settings with continuous ART access and viral-load suppression. ^[156] Counseling should therefore be individualized and aligned with the applicable national guideline, documented viral suppression, adherence, infant prophylaxis and monitoring protocols, and shared decision-making. ^[246]^[156]

Screening and prevention of associated infections and cancers

Australian 2025 guidelines recommend primary high-risk human papillomavirus testing with cytology triage and referral for high-resolution anoscopy in people living with HIV. Screening should be offered to gay, bisexual, and other men who have sex with men and to transgender women living with HIV from age 35 years; the guideline also addresses cisgender women, transgender men, and cisgender men who are not gay, bisexual, or other men who have sex with men. ^[153]

The 2026 BASHH viral-hepatitis guideline provides recommendations for prevention, diagnosis, and initial management of hepatitis A, B, C, and D in UK practice. ^[252] The 2024 European genital-herpes guideline covers diagnosis, treatment, follow-up, transmission reduction, pregnancy, and management of genital herpes coinfection with HIV. ^[160] The 2025 BASHH doxycycline postexposure prophylaxis guideline concerns syphilis prevention and places doxycycline postexposure prophylaxis within a broader package that includes condoms, HIV prevention, vaccination, STI testing and treatment, risk-reduction counseling, and psychological support when indicated. ^[164]

Comorbidities, ageing, and integrated care

U.S. Department of Health and Human Services HIV guidelines, developed with ACC, AHA, and HIVMA representatives, recommend statin-based primary prevention strategies for people with HIV in response to REPRIEVE findings showing cardiovascular benefit with pitavastatin; these recommendations supplement general cholesterol guidelines and identify remaining evidence gaps. ^[157]

A multidisciplinary strategy for healthy cognitive ageing in people with HIV emphasizes brain health, age-related comorbidities, epigenetic ageing, frailty, and collaboration among clinicians, researchers, and the HIV community. ^[162] The 2026 HIV+D cluster-randomized trial evaluated collaborative stepped-care depression management integrated into adult HIV services in Uganda, addressing the limited availability of mental-health interventions in African HIV care. ^[249]

Specialty guidance should also be consulted when HIV coexists with other conditions. North American hidradenitis suppurativa guidance provides consensus recommendations for seven special populations, including people with HIV, pregnancy, breastfeeding, and tuberculosis or viral hepatitis. ^[159] A pilot randomized trial in Rwanda examined whether newly diagnosed patients could enter differentiated service delivery at 6 months after ART initiation after one versus two suppressed viral loads, providing preliminary implementation evidence rather than a universal eligibility rule. ^[250]^C

Additional prevention evidence

A 2025 systematic review and meta-analysis examined HIV risk compensation after male circumcision among men who have sex with men, specifically changes in condomless sex and number of sexual partners. ^[247] These findings support counseling that no single prevention intervention replaces combination prevention, including PrEP or PEP when indicated, condoms, testing, vaccination, STI management, and sustained viral suppression. ^[247]^[152]^[158]^[164]

Practical resource use

Clinicians should select the governing national guideline, verify publication updates and regulatory status, assess HIV status and viral suppression, review renal, hepatic, pregnancy, drug-interaction, resistance, and comorbidity considerations, and involve the patient in decisions about prevention, treatment, breastfeeding, and reproductive health. ^[154]^[161]^[152]^[246]^[251]^[271]

Selected updated HIV-related guidance

Topic	Current resource and principal update
ART	EACS 2025: TDF/TAF plus XTC with DTG, BIC, or DOR; XTC plus DTG dual therapy; new HIV-2 section. ^[154]
PrEP	Canadian 2025 update; USPSTF recommendation for adolescents and adults at increased risk; U.S. lenacapavir every 6 months. ^[152]^[163]^[155]
nPEP	CDC 2025: initiate ideally within 24 hours, no later than 72 hours. ^[158]
Pregnancy and infant feeding	U.S. 2026 update, European WAVE comparison, and Belgian 2026 guidance. ^[246]^[156]^[251]
Anal cancer	Australian 2025: primary high-risk HPV testing with cytology triage; selected groups from 35 years. ^[153]
Comorbidity care	Statin primary prevention, cognitive ageing, depression-integrated care, viral hepatitis, herpes, and hidradenitis suppurativa resources. ^[157]^[162]^[249]^[252]^[160]^[159]

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