National Institute for Health Research.

SummaryOffering human papillomavirus (HPV) vaccination to men who have sex with men up to age 40 years via genitourinary clinics will have a large impact on HPV-related diseases and is likely to be cost-effective.

Clinical effectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV acquisition in men who have sex with men (MSM) at high HIV risk is established. A static decision analytical model was constructed to inform policy prioritisation in England around cost-effectiveness and budgetary impact of a PrEP programme covering 5,000 MSM during an initial high-risk period. National genitourinary medicine clinic surveillance data informed key HIV risk assumptions. Pragmatic large-scale implementation scenarios were explored. At 86% effectiveness, PrEP given to 5,000 MSM at 3.3 per 100 person-years annual HIV incidence, assuming risk compensation (20% HIV incidence increase), averted 118 HIV infections over remaining lifetimes and was cost saving. Lower effectiveness (64%) gave an incremental cost-effectiveness ratio of + GBP 23,500 (EUR 32,000) per quality-adjusted life year (QALY) gained. Investment of GBP 26.9 million (EUR 36.6 million) in year-1 breaks even anywhere from year-23 (86% effectiveness) to year-33 (64% effectiveness). PrEP cost-effectiveness was highly sensitive to year-1 HIV incidence, PrEP adherence/effectiveness, and antiretroviral drug costs. There is much uncertainty around HIV incidence in those given PrEP and adherence/effectiveness, especially under programme scale-up. Substantially reduced PrEP drug costs are needed to give the necessary assurance of cost-effectiveness, and for an affordable public health programme of sufficient size.

Background The effi cacy and eff ectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV infection acquisition by high-risk men who have sex with men (MSM) is established. We estimated the cost and cost-eff ectiveness of a proposed daily oral PrEP programme covering 10 000 high-risk MSM attending genitourinary medicine clinics in England. Methods From the perspective of public providers, a static decision analytical model was used to investigate lifetime HIV infections, treatment costs, and quality-adjusted-life-year (QALY) losses associated with daily PrEP given for 1 year, beginning in 2016, compared with no intervention. A cohort of MSM who were not known to be HIV positive at their fi rst attendance in 2012 and had tested HIV negative between 42 and 365 days previously was identifi ed. These men were followed up from the date of their earliest negative HIV test in 2012 for up to 1 year either until they seroconverted or until their last attendance. HIV incidence was calculated as the number of seroconversions (new HIV diagnoses) per 100 person-years. Data sources including genitourinary medicine clinic activity data were used to estimate HIV incidence in year 1 and thereafter. Costs were updated to 2013-14 values and both future costs and QALYs were discounted at 3•5%. Budgetary impact was undiscounted. Findings At 86% eff ectiveness, delivery of PrEP to 10 000 high-risk MSM in the fi rst year (target population with an HIV incidence of 2•4 per 100 person-years in year 1) resulted in 178 fewer lifetime HIV infections, 28 delayed infections, and an incremental cost-eff ectiveness ratio (ICER) of £26 300, compared with no PrEP. More conservative assumptions of 64% PrEP eff ectiveness gave an ICER of £54 500, compared with no PrEP. ICER was highly sensitive to year 1 HIV incidence (eg, with HIV incidence of 3•3 per 100 person-years and at 86% PrEP eff ectiveness, ICER was £4170), PrEP eff ectiveness, PrEP drug costs, and potential changes in antiretroviral treatment cost upon patent expiry. An investment of £54 million in year 1 breaks even anywhere from year 42 (86% PrEP eff ectiveness) to beyond year 61 (64% PrEP eff ectiveness). Interpretation The model shows that the estimated cost-eff ectiveness of PrEP is very sensitive to key variables (eg, year 1 HIV incidence and patient adherence), about which there is much uncertainty, especially if programme scale-up occurs. A substantial reduction in the price of antiretroviral drugs, when used for PrEP, is needed to give the necessary assurance of cost-eff ectiveness, and for an aff ordable public health programme of suffi cient size. Funding None. Contributors KJO, AJvH, and ONG designed the analysis and developed the methodology. SD performed analysis of genitourinary medicine clinic activity data and provided HIV incidence estimates. KJO performed the cost-eff ectiveness analysis, which was appraised by AJvH. KJO and ONG drafted the abstract. SD, MD, AN, and AJvH commented on the abstract.

Many studies have shown an association between human leucocyte antigens (HLA) and systemic lupus erythematosus (SLE) in the various study populations. Although SLE is not an uncommon disease in the Malaysian Archipelago, and appears to affect all three major racial groups equally (i.e. Southern Chinese, Malays and Southern Indians), very little information is available on the HLA profiles in the two latter groups. In phase I of our study of the HLA profiles in Malaysian SLE patients, the HLA phenotypes (class I: A, B, C; Class II: DR, DQ) of Malay patients with confirmed SLE and 91 normal Malay controls were determined using the microcytotoxicity assay. The strong association between DR (RR 3.28, P = 0.008) concurs with that reported among Chinese and Japanese populations. Moderate to strong associations with HLA-B 7 (RR 4.99, P = 0.02) and Cw 7 (RR 2.94, P = 0.003) were also found. We believe this is the first report of the association of HLA and SLE in the Malay population.