Consensus Statement on Human Immunodeficiency Virus Pre-Exposure Prophylaxis in China

Introduction

The global HIV epidemic has been curbed through sustained efforts, but challenges persist in preventing new infections among high-risk populations. In China, sexual contact remains the dominant transmission route, accounting for over 90% of new cases. Pre-exposure prophylaxis (PrEP), an innovative strategy utilizing antiretroviral drugs to prevent HIV acquisition, has gained international recognition. Despite its proven efficacy, China lacked standardized guidelines for PrEP implementation until recent years. This consensus statement, developed by multidisciplinary experts, addresses critical aspects of PrEP deployment in China, including medical eligibility, drug regimens, safety protocols, and monitoring frameworks.

Efficacy of HIV PrEP

Extensive global clinical trials and real-world studies have validated PrEP’s effectiveness. For men who have sex with men (MSM), the iPERGAY trial demonstrated an 86% reduction in HIV incidence with on-demand tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) compared to placebo. Similarly, the Partners PrEP study among serodiscordant couples in Africa reported 66%–84% efficacy for daily TDF/FTC, depending on adherence. In Thailand’s Bangkok Tenofovir Study, TDF monotherapy reduced HIV incidence by 48.9% overall, rising to 73.5% in highly adherent participants.

In China, epidemiological data underscore the urgency of PrEP adoption. Among MSM, HIV incidence reaches 5.6/100 person-years (PY), far exceeding the World Health Organization (WHO) threshold of 3/100 PY for PrEP recommendation. Conversely, incidence rates are lower among female sex workers (1.4/100 PY) and people who inject drugs (1.6/100 PY). These disparities highlight the need for targeted PrEP strategies prioritizing MSM and other key populations.

Safety and Adverse Effects

TDF/FTC, the cornerstone of PrEP regimens, exhibits favorable safety profiles. Common side effects, such as nausea, headache, and diarrhea, typically resolve within four weeks. However, clinicians must monitor renal function, as TDF may cause proximal renal tubular dysfunction. Guidelines recommend against PrEP initiation in individuals with an estimated creatinine clearance rate <60 mL/min and mandate biannual renal function assessments during therapy. Bone mineral density reductions, though transient and non-progressive, necessitate vigilance in populations at risk for osteoporosis.

Drug resistance remains rare but requires attention. Resistance mutations primarily arise in individuals unknowingly initiating PrEP during acute HIV infection (the “window period”). Robust pre-PrEP HIV testing, including nucleic acid amplification tests (NAATs) to detect acute infection, mitigates this risk. Meta-analyses confirm that PrEP does not promote de novo resistance when administered correctly.

PrEP Eligibility and Medical Evaluation

Risk Assessment

PrEP candidates undergo a structured risk assessment evaluating behaviors within the preceding six months:

• Unprotected anal or vaginal sex.
• Sharing injection equipment.
• Engagement with HIV-positive partners not on suppressive antiretroviral therapy (ART).
• Recent diagnosis of bacterial sexually transmitted infections (STIs) like syphilis or gonorrhea.
• Prior use of post-exposure prophylaxis (PEP) or expressed interest in PrEP.

Individuals affirming any criterion qualify for PrEP unless in a monogamous relationship with a virally suppressed HIV-positive partner.

Medical Screening

Mandatory pre-PrEP evaluations include:

• HIV Testing: Dual antigen/antibody assays to exclude acute infection (Figure 1). Self-test results are insufficient for eligibility determination.
• Renal Function: Baseline creatinine clearance ≥60 mL/min.
• Hepatitis Screening: HBV surface antigen testing, as TDF/FTC affects HBV replication. Chronic HBV carriers require hepatology consultation before PrEP discontinuation.
• Pregnancy Testing: PrEP is safe during pregnancy but warrants contraception counseling.

Recommended PrEP Regimens

Daily Oral Regimen

One TDF/FTC (300 mg TDF + 200 mg FTC) tablet taken daily. This regimen suits all high-risk populations, including heterosexuals and people who inject drugs.

On-Demand Regimen (2+1+1 Dosing)

Exclusively recommended for MSM with infrequent or predictable sexual activity:

• Two tablets taken 2–24 hours pre-exposure.
• One tablet 24 hours post-first dose.
• One tablet 48 hours post-first dose.

This strategy, validated in the iPERGAY trial, capitalizes on rapid rectal tissue drug penetration. It is contraindicated for vaginal exposure due to slower genital tract pharmacokinetics.

Alternative Agents

• TAF/FTC: Tenofovir alafenamide/emtricitabine shows non-inferior efficacy to TDF/FTC with improved renal and bone safety. Faster intracellular tenofovir-diphosphate accumulation (1–2 hours vs. 3 days for TDF) enhances on-demand utility.
• Long-Acting Cabotegravir (CAB-LA): Bi-monthly intramuscular injections reduced HIV incidence by 69% vs. daily TDF/FTC in the HPTN 083 trial. Pending regulatory approval in China.

Adherence and Monitoring

PrEP efficacy correlates tightly with adherence. Strategies to optimize adherence include:

• Pill Counts and Drug-Level Monitoring: Plasma or dried blood spot tenofovir concentrations verify recent adherence.
• Mobile Health Tools: SMS reminders and adherence apps improve regimen consistency.
• Quarterly Follow-Up: Mandatory HIV/STI testing, renal function monitoring, and behavioral counseling (Table 2).

Suboptimal adherence (<40% adherence rate) nullifies PrEP benefits and increases breakthrough infection risks. Discontinuation is advised for individuals unable to sustain adherence or no longer at high risk.

Special Considerations

Acute HIV Infection During PrEP

Seroconversion despite PrEP necessitates immediate ART initiation and resistance genotyping. Most failures result from undiagnosed pre-existing infection or poor adherence rather than drug resistance.

COVID-19 Adaptations

Telemedicine services and home-based testing (HIV self-tests, dried blood spot collection) ensure PrEP continuity during public health emergencies.

Conclusion

China’s endorsement of TDF/FTC for PrEP in August 2020 marked a pivotal advancement in HIV prevention. Tailored regimens, rigorous monitoring, and community engagement are critical to curbing HIV transmission among key populations. Ongoing research into novel agents like CAB-LA and TAF/FTC will further refine PrEP accessibility and acceptability.

doi:10.1097/CM9.0000000000001181

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