In the current era of universal antiretroviral treatment (ART), health systems have the dual challenge of a growing number of people living with HIV and on ART who are also receiving chronic, life-long treatment for non-communicable diseases. Current evidence suggests that 6-month multi-month dispensing (6MMD) can maintain at least equivalent clinical outcomes to conventional care and reduce costs, but little is known when integrating 6MMD for multiple conditions. We examined the cost-effectiveness of integrated multi-month drug dispensing for people living with HIV and hypertension.
Using an age- and sex-specific hybrid decision tree and Markov state-transition model, we constructed a 100,000-person simulated population cohort who may develop HIV and hypertension and initiate treatment at clinics in South Africa over a 10-year time horizon. We assessed the incremental costs and effectiveness of 6MMD versus conventional care from a health system perspective under different conditions of care-seeking, eligibility and uptake of 6MMD for clinically stable patients. Model inputs were sourced from previously published literature. 6MMD was defined as reducing the frequency of clinic visits by increasing the number of medications dispensed to stable patients at each visit from 3 to 6 months. For the integrated 6MMD, we assumed that comorbid patients receive both HIV and hypertension drugs at the same facility on the same day.
Our study demonstrates that integrated 6MMD for HIV and hypertension in South Africa can avert between 0.8 and 1 DALYs and increase health systems costs between $24 and $49 per patient per year, compared to the status quo. One-way sensitivity analysis showed that HTN drug cost and prevalence of HIVHTN and HIV were key drivers in the cost per DALYs averted. Overall, integrated 6MMD with a greater proportion of well-controlled patients and lower mortality rates led to greater cost savings or better cost-effectiveness (less than $50 per DALY averted) across a wide range of loss-to-follow-up (LTFU) factor variation.
By better controlling disease among patients already in care, integrated 6MMD can be more beneficial than the status quo treatment by resulting in fewer cases of LTFU and fewer deaths through high-quality care.
Hepatitis C virus (HCV) prevalence and adverse outcomes are higher among people with human immunodeficiency virus (HIV) than people without HIV. Yet, HCV prevalence among people with HIV in Cameroon remains unknown, with HCV diagnosis and treatment largely inaccessible due to care centralization by specialists with high out-of-pocket costs. Integration of HCV services into routine HIV care by general practitioners could improve diagnosis and treatment coverage. We aimed to examine HCV prevalence and treatment cure rate among people with HIV attending 11 HIV clinics in the Centre Region of Cameroon.
We offered HCV rapid antibody testing, and, if positive, RNA testing to all persons ≥21 years, on HIV ART for ≥6 months and with suppressed HIV RNA (<1000 copies) who attended HIV counselling and treatment appointments between 20 April 2021 and 31 May 2022. Participants with an HCV RNA positive test received 12 weeks of pangenotypic sofosbuvir/velpatasvir. We calculated the cure rate as the proportion of participants with a sustained virological response 12 weeks after treatment completion (SVR12) among all starting and completing treatment.
We tested 8266 persons for HCV antibodies, 316 (3.8%, 95% CI = 3.4−4.3%) of whom were anti-HCV positive. Of these, 286 (90.5%) were sampled for HCV RNA, 20 (6.3%) ineligible, 5 (1.6%) declined, 4 (1.3%) left before sampling and 1 (0.3%) had an unknown reason. Among 286 sampled, 251 (87.8%) had detectable HCV RNA. Of these, 173 (68.9%) enrolled for treatment, 55 (21.9%) were eligible but not enrolled (49 lost-to-follow-up, 6 denied) and 23 (9.2%) were ineligible. Of 173 enrolled, 165 completed treatment, 6 were lost-to-follow-up and 2 were excluded due to treatment interruption. SVR12 was achieved in 93.6% (n = 162; 95% CI: 88.9–96.8%) of those enrolled and 98.2% (95% CI: 94.8–99.6%) of treatment completers. All three initially not achieving SVR12 were cured with second-line treatment (sofosbuvir/velpatasvir/voxilaprevir).
Our study demonstrates the viability of integrating HCV testing and treatment into routine HIV care in Cameroon, yielding new HCV diagnoses and high cure rates. Cameroon can use this strategy to achieve HCV elimination goals, although improvements in testing uptake, diagnosis and treatment access, and laboratory capacity are needed.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) was efficacious and well tolerated in children/adolescents with HIV (aged ≥6 years, weighing ≥25 kg) in a Phase 2/3 study. Here, we report data from children aged ≥2 years and weighing ≥14–<25 kg.
This is an analysis of data from the youngest cohort in an open-label, multicentre, multi-cohort, single-group, international study of children/adolescents with HIV. Participants in this cohort were children aged ≥2 years, weighing ≥14–<25 kg at screening and able to swallow tablets, on stable antiretroviral therapy with virologic suppression (HIV-1 RNA <50 copies/ml for ≥6 consecutive months) and a CD4 count ≥400 cells/µl. Eligible participants received low-dose E/C/F/TAF (90/90/120/6 mg) once daily through Week 48. The study included pharmacokinetic evaluation of the low-dose E/C/F/TAF tablet at Week 2. Safety, efficacy, palatability and acceptability were also evaluated.
Between 16 January and 25 November 2019, 27 participants were enrolled with a median (quartile [Q]1, Q3) age of 6 (4, 8) years, body weight of 19.3 (17.0, 20.5) kg, CD4 count of 1061 (895, 1315) cells/µl and CD4 cell percentage of 37.4 (30.6, 40.3). Most (92.6%) participants acquired HIV through vertical transmission. On 6 October 2020 (data-cut), median (Q1, Q3) exposure to E/C/F/TAF was 48.3 (48.0, 60.1) weeks. Pharmacokinetic parameters were within the safe and efficacious range of previous data in adult and paediatric populations. Drug-related treatment-emergent adverse events occurred in 4/27 (15%) participants. There were no Grade 3/4 adverse events, or adverse events leading to E/C/F/TAF discontinuation. One participant experienced a serious treatment-emergent adverse event (Grade 2 pneumonia not considered E/C/F/TAF related). Virologic suppression (US FDA Snapshot algorithm) was maintained by 26/27 (96%) participants at Weeks 24 and 48. At Week 48, most children reported positive palatability (84.6%) and acceptability (96.2%).
These data support the use of single-tablet E/C/F/TAF (90/90/120/6 mg) regimen for the treatment of HIV in children aged ≥2 years and weighing ≥14–<25 kg.
NCT01854775
Globally, children living with HIV continue to lag behind UNAIDS targets for viral suppression (VS). Because studies with linked mother-child data are limited, we describe VS and associated factors among young children in a setting with early infant HIV testing (at birth, age 10 weeks and 6 months) and early protease inhibitor-based first-line antiretroviral therapy (ART).
We analysed routinely collected mother-child data for children living with HIV born 2018–2022 in Western Cape province, South Africa (followed through mid-2023). We assessed associations between child and maternal viral load (VL) results at 12 and 24 months after child ART start using logistic regression, adjusted for child sex, birthyear, severity of child immunodeficiency at ART start, maternal age and timing of maternal HIV diagnosis.
Among 2219 children living with HIV; 30% were diagnosed at birth (≤7 days), 41% before age 1 year (8−365 days) and 29% at age >1 year. Overall, 5% (n = 112/2219) of children died, a third of whom had not started ART; 90% of children (n = 1990) started ART, at median age 5 months (IQR 1–16). Median follow-up from ART start was 26 months (IQR 14–40). Among children with available VL at 12 months (n = 853/1582), 24 months (n = 614/1129) and 36 months (n = 350/658) after ART start, 36%, 43% and 48% were virally suppressed, respectively (VL<100 copies/ml). VS among children at 12 and 24 months was more likely if maternal VL was <100 versus ≥100 copies/ml at 12 months (adjusted odds ratio [aOR] = 3.5; 95% CI 1.9−6.5) and 24 months (aOR = 6.1; 95% CI 2.8−13.1) after child ART start. Children with no/mild versus advanced/severe immunodeficiency at ART start were more likely to achieve VS at 12 months (aOR = 2.3; 95% CI 1.3−4.2) but not at 24 months. Eligible children with missing VL at 24 months (39%) were more likely to have gaps in care of >6 months than those with VL≥100 or VL<100 copies/ml (84% vs. 28% vs. 14%, respectively; p<0.001).
Less than half of children on ART achieved VS, and children were more likely to achieve VS if their mothers were also virally suppressed. Significant efforts are needed to support mother-child dyads to achieve optimal VS.
Molecular surveillance is an important tool for detecting chains of transmission and controlling the HIV epidemic. This can also improve our knowledge of molecular and epidemiological factors for the optimization of prevention. Our objective was to illustrate this by studying the molecular and epidemiological evolution of the cluster including the new circulating recombinant form (CRF) 94_cpx of HIV-1, detected in 2017 and targeted by preventive actions in 2018.
In June 2022, 32 HIV-1 sequence databases from French laboratories were screened to identify all individuals who had acquired CRF94_cpx or a similar strain, whatever the date of diagnosis. Phylogenetic analyses were performed with the sequences identified, and biological parameters were collected at the time of diagnosis and after the start of treatment to analyse the evolution of the cluster. Full genomes were sequenced to characterize the new strains.
We analysed 98 HIV-1 isolates: 63 were CRF94, three were unclassifiable, and the other 32 formed a new cluster containing a new recombinant, CRF132_94B, derived from CRF94 and a subtype B strain. At least 95% of the individuals in both the CRF94 and CRF132 clusters were men who have sex with men (MSM), most of whom had acquired HIV less than 12 months before diagnosis. The number of CRF94 diagnoses declined drastically after 2018, but CRF132 strains spread widely between 2020 and 2022, into a different area of Ile-de-France region and within a younger population nevertheless aware of pre-exposure prophylaxis. Higher viraemia, lower CD4 cell counts and delayed treatment efficacy suggested that CRF94 was more virulent than CRF132, possibly due to the F subtype fragment of the vif gene.
These findings highlight the role of the MSM transmission cluster in spreading HIV and new variants. They show also the benefits of cluster surveillance for improving the targeting of preventive interventions, detecting the emergence of new strains and enriching our knowledge on virulence mechanisms. However, these investigations require support with sufficient resources dedicated to a regional or national programme to be responsive and effective.
Sexually transmitted infections (STIs) in pregnancy are associated with an increased risk of vertical HIV transmission and adverse pregnancy and birth outcomes. In South Africa, syndromic management is the standard of care for STI management. We assessed the potential impact of point-of-care (POC) screening for curable STIs (Chlamydia trachomatis [CT], Trichomonas vaginalis [TV] and Neisseria gonorrhoeae [NG]) during pregnancy on vertical HIV transmission and adverse pregnancy and birth outcomes.
We developed a static mathematical model to estimate the impact of syndromic management compared to POC screening of STIs in pregnant women attending antenatal clinics in South Africa over one calendar year (2022). Our model assumptions regarding the effect of CT, NG and TV on adverse pregnancy/birth outcomes and vertical HIV transmission were informed by two separate meta-analyses that we conducted. Local studies informed estimates of STI prevalence, POC screening uptake and treatment, and sensitivity of syndromic management.
In the absence of POC screening for curable STIs, 25.5% of pregnant women without HIV and 34.6% of pregnant women living with HIV were estimated to have undiagnosed and untreated STIs. In the POC scenario, 92% (95% CI: 85−100%) of STIs were diagnosed and treated during pregnancy, reducing antenatal maternal HIV incidence by 10.0% (95% CI: 1.0−20.1%). Overall, vertical HIV transmission was anticipated to reduce by 8.6% (5.2−13.8%), with reductions of 20.9% (15.2−27.0%) at birth and 2.5% (−0.9% to 9.0%) postnatally, in the POC screening scenario compared to current syndromic management. POC screening of curable STIs is further estimated to reduce the incidence of stillbirth by 10.1% (1.3–18.7%), preterm delivery by 6.3% (3.4–9.7%), infants born small for gestational age by 2.7% (0.7–4.9%) and low birth weight by 9.1% (0.9–18%).
POC STI screening and treatment may modestly reduce maternal HIV incidence, vertical HIV transmission, and the risk of adverse pregnancy and birth outcomes, and would substantially reduce the burden of curable STIs in pregnancy. The study provides evidence to move beyond the syndromic management of STIs in South Africa, particularly in antenatal care.
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