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Background: Protease inhibitors (PIs) have been recommended as World Health Organization second-line antiretroviral therapy (ART) for low- to middle-income countries for two decades. As dolutegravir-based regimens have become widely available, the future role of PIs is uncertain. Objectives: To describe the characteristics of patients on PI-based ART (in first-line and second-line regimens), double-boosted protease inhibitors (DBPI) and patients who received recycled nucleoside reverse transcriptase inhibitors (NRTI) in second-line regimens at a tertiary level ART clinic. Method: We conducted a descriptive retrospective record review of adult patients on PI-based ART who attended Nthabiseng Adult Infectious Diseases Clinic at Chris Hani Baragwanath Academic Hospital in Soweto, South Africa, between January 2021 and April 2022. Results: Of the 900 patients sampled, 543 (60.3%) were female, the median age was 45 and 703 (79.1%) had viral loads (VL) below 1000 copies/mL. In contrast, 21 (58.3%) of 36 vertically infected patients had VLs below 1000 copies/mL. Thirty-seven (4.1%) patients were on DBPIs. The commonest reason for DBPI use in 24 (64.9%) patients was drug resistance test (DRT)-guided switch after virological failure. Forty-nine (5.4%) patients were on recycled NRTIs with no DRT, and 24 (2.6%) patients were on NRTIs to which there was documented resistance. Outcomes for these patients were similar to the total sample. Conclusion: PIs have long been a cornerstone of second-line ART. This study demonstrates the real-world utility of PIs, as well as their disadvantages. There was no difference in the outcomes of patients who received recycled NRTIs in second-line regimens.

Background: Dolutegravir, a component of the preferred first-line antiretroviral therapy regimen, has been associated with increased weight gain. South Africa has a high prevalence of obesity, especially among women. Understanding dolutegravir exposure in patients with obesity is important for dose optimisation. Objectives: We compared the pharmacokinetic parameters of dolutegravir in Southern African adults living with HIV with and without obesity. Method: Blood samples were collected at various time points over a 24 h-period for dolutegravir assays. Non-compartmental analysis was conducted and geometric mean ratios (GMRs), with 90% confidence intervals (CIs), were generated to compare dolutegravir pharmacokinetic parameters between the groups. Regression analyses to assess predictors of dolutegravir exposure were done. Results: Forty participants were enrolled, 26 were women and 10 had obesity. Dolutegravir area under the concentration-time curve to 24-h and the maximum concentrations were not statistically significantly lower in participants with obesity: GMR 0.91 (90% CI: 0.71–1.16) and GMR 0.86 (90% CI: 0.68–1.07), respectively. In a multivariate linear regression analysis adjusting for age, gender, body mass index, creatinine clearance and randomisation arm (tenofovir alafenamide or tenofovir disoproxil fumarate), a unit increase in body mass index was associated with 1.2% lower dolutegravir area under the concentration-time curve to 24-h (P = 0.035). Conclusion: Dolutegravir exposure was marginally lower in participants with obesity, but this is not clinically significant. Our findings suggest that there is no need to dose adjust dolutegravir in people with obesity.

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The gap in HIV testing remains significant and new modalities such as HIV self-testing (HIVST) have been recommended to reach key and under-tested populations. In December 2016, the World Health Organization (WHO) released the Guidelines on HIV Self-Testing and Partner Notification: A Supplement to the Consolidated Guidelines on HIV Testing Services (HTS) and urged member countries to develop HIVST policy and regulatory frameworks. In South Africa, HIVST was included as a supplementary strategy in the National HIV Testing Services Policy in 2016, and recently, guidelines for HIVST were included in the South African National Strategic Plan for HIV, sexually transmitted infections and tuberculosis 2017–2022. This document serves as an additional guidance for the National HIV Testing Services Policy 2016, with specific focus on HIVST. It is intended for policy advocates, clinical and non-clinical HTS providers, health facility managers and healthcare providers in private and public health facilities, non-governmental, community-based and faith-based organisations involved in HTS and outreach, device manufacturers, workplace programmes and institutes of higher education.

These guidelines are intended as an update to those published in the Southern African Journal of HIV Medicine in 2014 and the update on when to initiate antiretroviral therapy in 2015. Since the release of the previous guidelines, the scale-up of antiretroviral therapy (ART) in southern Africa has continued. New antiretroviral drugs have become available with improved efficacy, safety and robustness. The guidelines are intended for countries in the southern African region, which vary between lower and middle income.

The Southern African HIV Clinicians Society published its first set of oral pre-exposure prophylaxis (PrEP) guidelines in June 2012 for men who have sex with men (MSM) who are at risk of HIV infection. With the flurry of data that has been generated in PrEP clinical research since the first guideline, it became evident that there was a need to revise and expand the PrEP guidelines with new evidence of safety and efficacy of PrEP in several populations, including MSM, transgender persons, heterosexual men and women, HIV-serodiscordant couples and people who inject drugs. This need is particularly relevant following the World Health Organization (WHO) Consolidated Treatment Guidelines released in September 2015. These guidelines advise that PrEP is a highly effective, safe, biomedical option for HIV prevention that can be incorporated with other combination prevention strategies in Southern Africa, given the high prevalence of HIV in the region. PrEP should be tailored to populations at highest risk of HIV acquisition, whilst further data from studies in the region accrue to guide optimal deployment to realise the greatest impact regionally. PrEP may be used intermittently during periods of perceived HIV acquisition risk, rather than continually and lifelong, as is the case with antiretroviral treatment. Recognition and accurate measurement of potential risk in individuals and populations also warrants discussion, but are not extensively covered in these guidelines.

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The most recent version of the Southern African HIV Clinicians Society’s adult antiretroviral therapy (ART) guidelines was published in December 2014. In the 27 August 2015 edition of the New England Journal of Medicine, two seminal randomised controlled trials that addressed the optimal timing of ART in HIV-infected patients with high CD4 counts were published: Strategic timing of antiretroviral therapy (START) and TEMPRANO ANRS 12136 (Early antiretroviral treatment and/or early isoniazid prophylaxis against tuberculosis in HIV-infected adults). The findings of these two trials were consistent: there was significant individual clinical benefit from starting ART immediately in patients with CD4 counts higher than 500 cells/μL rather than deferring until a certain lower CD4 threshold or clinical indication was met. The findings add to prior evidence showing that ART reduces the risk of onward HIV transmission. Therefore, early ART initiation has the public health benefits of potentially reducing both HIV incidence and morbidity. Given this new and important evidence, the Society took the decision to provide a specific update on the section of the adult ART guidelines relating to when ART should be initiated.

This guideline is an update of the post-exposure prophylaxis (PEP) guideline published by the Southern African HIV Clinicians Society in 2008. It updates the recommendations on the use of antiretroviral medications to prevent individuals who have been exposed to a potential HIV source, via either occupational or non-occupational exposure, from becoming infected with HIV. No distinction is made between occupational or non-occupational exposure, and the guideline promotes the provision of PEP with three antiretroviral drugs if the exposure confers a significant transmission risk. The present guideline aligns with the principles of the World Health Organization PEP guidelines (2014), promoting simplification and adherence support to individuals receiving PEP.

Editor’s note: In this section of the Journal, we present complex, real-world HIV medicine cases to two experienced clinicians working in very different environments, and ask them to describe the approach that they would take if they saw the case in their local hospital setting. In our first edition, a patient with deteriorating liver function is presented by Prof. Francois Venter and Dr Ntsakisi Masingi, and then discussed by Dr Sarah Stacey in Johannesburg and Dr Sarah Fidler in London.

Current recommendations advise that stavudine be phased out of use. The logistics and cost of switching are significant, and the World Health Organization has forecast that 1.55 million people will still be on stavudine-based antiretroviral therapy by the end of 2012. Stavudine is co-formulated in many countries, is very cheap and effective, and is well tolerated in initial therapy. However, the 40 mg BD dose was associated with considerable long-term toxicity. Several studies suggest that half the original recommended dose has excellent antiviral efficacy with significantly reduced metabolic side-effects. Despite generic tenofovir now being cheaper than zidovudine, tenofovir consumes the majority of adult antiretroviral programme medication budgets in programmes in Africa, where it is used in first-line therapy. Abacavir is far more expensive than zidovudine or tenofovir, and is a major cost driver in paediatric programmes with access to abacavir-based first-line treatment. Low-dose stavudine may offer the only cheaper (and possibly as effective and safe) alternative to programmes grappling with limited financial resources.

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The article discusses a study on low-dose stavudine in developing countries. The study aims to optimise the dosage of stavudine to minimise toxicity, while maintaining virological efficacy. It also looks into the safety and toxicity monitoring of the drug, the cost of tenofovir, and the drug availability.

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The debate around relooking at stavudine dosing, both in terms of the adult low-dose stavudine study and more broadly, is welcome. The study being proposed to evaluate low-dose stavudine v. tenofovir is a fairly standard placebo-controlled non-inferiority study. The study design is not controversial; however, the choice of study drug has attracted critical attention.