Heterogeneities of the impact of public health policies on HIV/AIDS indicators in Brazil according to sociodemographic factors: A real-life study.

INTRODUCTION: The impact of specific policies on HIV care has been scarcely investigated. In this study we aimed to analyze the impact of the Treatment For All policy (TFA-2013) and the adoption of integrase strand transfer inhibitors (INSTIs-2017) as first-line therapy on clinical indicators of people living with HIV (PLHIV) in Brazil. METHODS: We assessed the public database of Brazil's Ministry of Health and extracted data from 2009 to 2019. We investigated the impact of TFA and INSTIs with a time-series analysis of four health indicators in PLHIV: antiretroviral treatment (ART) initiation with a CD4+ count >500/mm3 ; ART initiation <1 month after the first CD4+ measurement; viral load suppression (VLS); and treatment adherence. We explored trends over time by gender, age, macroregion of residency and municipal-level social vulnerability index. RESULTS: We included 753 316 PLHIV in 2019. Most were males (64.81%) in the 30-49 years age category (50.86%). We observed an overall improvement in all HIV clinical indicators, with notable impact of TFA on timely ART initiation and VLS, and mild impact of INSTIs on treatment adherence. Such improvements were heterogeneous, with remarkable gaps in gender, age and socioeconomic groups that have persisted over time. Indicators point to inferior outcomes among children, older adults, women and people living in socially vulnerable locations. CONCLUSIONS: Recent Brazilian public policies have had positive impacts on key HIV clinical indicators. However, our results highlight the need for specific policies to improve HIV care for children, older adults, women and socially vulnerable groups.

Impact of coronavirus disease (COVID-19) on HIV testing and care provision across four continents.

OBJECTIVES: The coronavirus disease (COVID-19) pandemic has been associated with severe disruptions in health care services, and nonpharmacological measures such as social distancing also have an impact on access to screening tests and on the long-term care of patients with chronic conditions globally. We aimed to describe the impact of the COVID-19 pandemic on HIV testing and treatment and to describe strategies employed to mitigate the impact of COVID-19 on HIV care. METHODS: In this retrospective cohort study, we used secondary data from the AIDS Healthcare Foundation (AHF) Global Quality Program from 44 countries in four continents (Asia, Latin America and the Caribbean, Europe and Africa), and compared information on HIV testing, percentage of positive results, number of in-person appointments, and number of new enrolments in HIV care from 1 January 2020 to 31 August 2020 with the equivalent period in 2019. RESULTS: Despite marked inter-country heterogeneities, we found that COVID-19 was associated with a significant reduction in HIV testing, an increase in the percentage of positive tests, a reduction in the number of in-person consultations and a reduction in the number of new enrolments in care, despite the implementation of several mitigation strategies. The impact of COVID-19 differed across continents and key populations. CONCLUSIONS: Our findings suggest that, in the years to come, health care services must be prepared to respond to the impact of COVID-19 on HIV testing and care. Providers and facilities should build on the lessons learned so far to further improve mitigation strategies and establish care priorities for both the pandemic and the post-pandemic periods.

Impact of COVID-19 on income, prevention attitudes, and access to healthcare among male clients in a Sexually Transmitted Infections clinic.

BACKGROUND: Mobility restrictions and overloaded health services during the COVID-19 pandemic compromised services dedicated to the prevention and care of HIV and other sexually transmitted infections (STI). In this study, we present client's responses to standardized questionnaires applied during the COVID-19 pandemic period as part of the strategy to measure impacts on social and sexual vulnerability, access to STI prevention services, and access to STI care. METHODS: The questionnaires included variables on sociodemographics, behavior, risk perception, prevention attitudes, barriers to service-based HIV rapid test, reasons for taking an HIV self-test, and access to health services for STI diagnosis and treatment. We explored demographic variables associated with income reduction, reduced access to HIV/STI testing/treatment and increased vulnerability to HIV/STI. RESULTS: 847 participants responded to the study questionnaire between May 2020 and January 2021. Most were young, cisgender male, and 63% self-reported as men who have sex with men. Income reductions were reported by 50%, with 30% reporting a decline over 50% of total income. An increase in heavy episodic drinking (>5 doses) was reported by 18%; 7% reported more sexual partners and 6% reported using condoms less often. Difficulties in obtaining HIV tests, tests for other STI and treatment for STI were reported by 5%, 6% and 6%, respectively. Lower schooling was significantly associated with income reduction (p = 0.004) and with reduced access to HIV/STI testing or STI treatment (p = 0.024); employment status was associated with income reduction (p < 0.001) and increased vulnerability to HIV/STI (p = 0.027). Having access to an expedite test result, avoiding physical attendance in health units during the pandemic, and undertaking the test with privacy with a trusted person were reported as motivators for HIV self-test. CONCLUSIONS: Our findings are relevant to promote service improvements tailored to subgroups more likely to struggle with detrimental effects during and after the COVID-19 pandemic.

Dolutegravir and pregnancy outcomes in women on antiretroviral therapy in Brazil: a retrospective national cohort study.

BACKGROUND: Dolutegravir has been widely available in Brazil since 2017. Following the signal that infants born to women with dolutegravir exposure at conception in Botswana had a higher risk of neural tube defects (NTDs), public health leaders initiated a national investigation to evaluate periconception dolutegravir exposure among all pregnant Brazilian women with HIV and its potential association with risk of NTDs, stillbirth, or miscarriage before 22 weeks (also called spontaneous abortion). METHODS: In this retrospective, observational, national, cohort study, we identified all women with pregnancies and possible dolutegravir exposure within 8 weeks of estimated date of conception between Jan 1, 2017, and May 31, 2018, and approximately 3:1 matched pregnant women exposed to efavirenz between Jan 1, 2015, and May 31, 2018, using the Brazilian antiretroviral therapy database. We did detailed chart reviews for identified women. The primary outcomes were NTD and a composite measure of NTD, stillbirth, or miscarriage. NTD incidences were calculated with 95% CI. The composite outcome was examined with logistic regression using propensity score matching weights to balance confounders. FINDINGS: Of 1427 included women, 382 were exposed to dolutegravir within 8 weeks of estimated date of conception. During pregnancy, 183 (48%) of 382 dolutegravir-exposed and 465 (44%) of 1045 efavirenz-exposed women received folic acid supplementation. There were 1452 birth outcomes. There were no NTDs in either dolutegravir-exposed (0, 95% CI 0-0·0010) or efavirenz-exposed groups (0, 95% CI 0-0·0036). There were 23 (6%) stillbirths or miscarriages in 384 dolutegravir-exposed fetuses and 28 (3%) in the 1068 efavirenz-exposed fetuses (p=0·0037). Logistic regression models did not consistently indicate an association between dolutegravir exposure and risk of stillbirths or miscarriages. After study closure, two confirmed NTD outcomes in fetuses with periconception dolutegravir exposure were reported to public health officials. An updated estimate of NTD incidence incorporating these cases and the estimated number of additional dolutegravir-exposed pregnancies between Jan 1, 2015 and Feb 28, 2019, is 0·0018 (95% CI 0·0005-0·0067). INTERPRETATION: Neither dolutegravir nor efavirenz exposure was associated with NTDs in our national cohort; incidence of NTDs is probably well under 1% in dolutegravir-exposed HIV-positive women but still slightly above HIV-uninfected women (0·06%) in Brazil. FUNDING: The Brazilian Ministry of Health and the United States' National Institutes of Health.

Impact of COVID-19 on income, prevention attitudes, and access to healthcare among male clients in a Sexually Transmitted Infections clinic

ABSTRACT Background Mobility restrictions and overloaded health services during the COVID-19 pandemic compromised services dedicated to the prevention and care of HIV and other sexually transmitted infections (STI). In this study, we present client's responses to standardized questionnaires applied during the COVID-19 pandemic period as part of the strategy to measure impacts on social and sexual vulnerability, access to STI prevention services, and access to STI care. Methods: The questionnaires included variables on sociodemographics, behavior, risk perception, prevention attitudes, barriers to service-based HIV rapid test, reasons for taking an HIV self-test, and access to health services for STI diagnosis and treatment. We explored demographic variables associated with income reduction, reduced access to HIV/STI testing/treatment and increased vulnerability to HIV/STI. Results: 847 participants responded to the study questionnaire between May 2020 and January 2021. Most were young, cisgender male, and 63% self-reported as men who have sex with men. Income reductions were reported by 50%, with 30% reporting a decline over 50% of total income. An increase in heavy episodic drinking (>5 doses) was reported by 18%; 7% reported more sexual partners and 6% reported using condoms less often. Difficulties in obtaining HIV tests, tests for other STI and treatment for STI were reported by 5%, 6% and 6%, respectively. Lower schooling was significantly associated with income reduction (p = 0.004) and with reduced access to HIV/STI testing or STI treatment (p = 0.024); employment status was associated with income reduction (p < 0.001) and increased vulnerability to HIV/STI (p = 0.027). Having access to an expedite test result, avoiding physical attendance in health units during the pandemic, and undertaking the test with privacy with a trusted person were reported as motivators for HIV self-test. Conclusions: Our findings are relevant to promote service improvements tailored to subgroups more likely to struggle with detrimental effects during and after the COVID-19 pandemic.

Comparison of cumulative viraemia following treatment initiation with different antiretroviral regimens: a real-life study in Brazil.

INTRODUCTION: The relative efficacy of different antiretroviral (ART) regimens has been extensively evaluated in the context of clinical trials, using HIV viral load (VL) measurements at pre-specified timepoints after ART onset. However, data from real-life studies using combined longitudinal measurements of cumulative viraemia are scarce. This study aimed to address the independent effect of different ART regimens on HIV cumulative viraemia over the first 12 months after treatment initiation, using programmatic data from the Ministry of Health of Brazil. METHODS: Retrospective cohort study analysing cumulative viraemia under the most frequently used ART regimens in Brazil (tenofovir, lamivudine and dolutegravir (regimen 1); tenofovir, lamivudine and efavirenz (regimen 2); tenofovir, lamivudine and ritonavir-boosted atazanavir (regimen 3)). RESULTS AND DISCUSSION: We included 112,243 patients >12 years old who received their first ART prescription between January 2014 and August 2017. Univariate analysis indicated that cumulative viraemia was significantly lower in patients receiving regimen 1 as compared with those receiving regimens 2 or 3 (p<0.0001 for both pairwise comparisons). In a multivariable analysis adjusted for age, sex, baseline T CD4+ counts and baseline HIV VL, ART regimen persisted with statistically significant effect on 12-month cumulative viraemia. The model predicted a 45-unit increase in log10 copy-days/mL cumulative viraemia for regimen 2 as compared with regimen 1, and a 70-unit increase in log10 copy-days/mL cumulative viraemia for regimen 3 as compared with regimen 1 (95%CI 41 to 49 and 61 to 79 respectively; p<0.001 for both comparisons). In models restricted to youths (13 to 24 years old) and female patients, ART regimen had similar effects. ART regimen with dolutegravir in association with a tenofovir-lamivudine backbone was superior to regimens containing efavirenz or boosted atazanavir in reducing HIV VL, as shown by cumulative viraemia over the first 12 months after treatment initiation. The superiority persisted even after adjusting the analysis for potential confounders. CONCLUSIONS: Our findings could bring direct benefits to patients as suggested by lower viral replication during treatment, lower risk of HIV transmission, and a potential reduction in resistance mutations in the initial 12 months under ART.

High rates of hypertension, diabetes, elevated low-density lipoprotein cholesterol, and cardiovascular disease risk factors in HIV-infected patients in Malawi.

OBJECTIVES: Data on cardiovascular disease risks among HIV-infected patients taking antiretroviral therapy (ART) over long periods of time are lacking in Sub-Saharan Africa. METHODS: A cross-sectional study was conducted in Chiradzulu, Malawi from December 2015 to June 2016. HIV-infected persons on ART for more than 10 years (patients) and HIV-negative individuals (controls) from selected clinics participated. Following informed consent, a standardized questionnaire, clinical and laboratory examinations were performed. The prevalence of cardiovascular disease risk factors was calculated and stratified by age group. RESULTS: Overall, 379 HIV-infected patients and 356 controls participated. Median time on ART among patients was 11.6 years (interquartile range 10.6-12.4).Within the 30-44, 45-59, and at least 60-year age groups, respectively, the prevalence of hypertension was 10.8, 20.4, and 44.7% among patients and 6.1, 25.8, and 42.9% among controls. Hypertension was previously undiagnosed in 60.3% patients and 37.0% controls with elevated blood pressure. The prevalence of diabetes within the respective age groups was 5.0, 6.4, and 13.2% among patients, and 3.4, 4.2, and 1.7% among controls. HIV-infected patients were more likely to have an glycated hemoglobin at least 6.0% (adjusted odds ratio 1.9; 95% confidence interval 1.1-3.2, P = 0.02). Prevalence of low-density lipoprotein cholesterol more than 130 mg/dl within the respective age groups was 8.0, 15.4, and 23.7% among patients and 1.8, 12.5, and 11.8% among controls. CONCLUSION: Noncommunicable diseases were a significant burden in Malawi, with high prevalence of hypercholesterolemia in all survey participants and an especially acute diabetes burden among older HIV infected. Hypertension screening and treatment services are needed among identified high-risk groups to cover unmet needs.

Cryptococcal antigen screening by lay cadres using a rapid test at the point of care: A feasibility study in rural Lesotho.

INTRODUCTION: Cryptococcal meningitis is one of the leading causes of death among people with HIV in Africa, primarily due to delayed presentation, poor availability and high cost of treatment. Routine cryptococcal antigen (CrAg) screening of patients with a CD4 count less than 100 cells/mm3, followed by pre-emptive therapy if positive, might reduce mortality in high prevalence settings. Using the cryptococcal antigen (CrAg) lateral flow assay (LFA), screening is possible at the point of care (POC). However, critical shortages of health staff may limit adoption. This study investigates the feasibility of lay counsellors conducting CrAg LFA screening in rural primary care clinics in Lesotho. METHODS: From May 2014 to June 2015, individuals who tested positive for HIV were tested for CD4 count and those with CD4 <100 cells/mm3 were screened with CrAg LFA. All tests were performed by lay counsellors. CrAg-positive asymptomatic patients received fluconazole, while symptomatic patients were referred to hospital. Lay counsellors were trained and supervised by a laboratory technician and counsellor activity supervisor. Additionally, nurses and doctors were trained on CrAg screening and appropriate treatment. RESULTS: During the study period, 1,388 people were newly diagnosed with HIV, of whom 129 (9%) presented with a CD4 count <100 cells/mm3. Of these, 128 (99%) were screened with CrAg LFA and 14/128 (11%) tested positive. Twelve of the 14 (86%) were asymptomatic, and received outpatient fluconazole. All commenced ART with a median time to initiation of 15.5 days [IQR: 14-22]. Of the asymptomatic patients, nine (75%) remained asymptomatic after a median time of 5 months [IQR; 3-6] of follow up. One (8%) became co-infected with tuberculosis and died and two were transferred out. The two patients with symptomatic cryptococcal meningitis (CM) were referred to hospital, where they later died. CONCLUSIONS: CrAg LFA screening by lay counsellors followed by pre-emptive fluconazole treatment for asymptomatic cases, or referral to hospital for symptomatic cases, proved feasible. However, regular follow-up to ensure proper management of cryptococcal disease was needed. These early results support the wider use of CrAg LFA screening in remote primary care settings where upper cadres of healthcare staff may be in short supply.

Triple combination therapy for hepatitis C with telaprevir exhibits greater early antiviral activity than with boceprevir.

BACKGROUND: Achievement of early viral suppression is important in patients with chronic HCV infection treated with telaprevir (TLV) or boceprevir (BOC) to avoid selection of drug resistance and attain cure. No head-to-head studies comparing TLV and BOC have been performed so far. METHODS: All consecutive individuals who initiated triple HCV therapy with TLV or BOC outside clinical trials at three European clinics were evaluated. Rapid virological response (RVR) was defined as unquantifiable HCV RNA (<25 IU/ml) at week 4 for TLV and at week 8 for BOC (4 weeks after lead-in). RESULTS: A total of 106 patients were evaluated, 33 treated with BOC and 73 with TLV. Median age, gender, body mass index, baseline HCV RNA, HCV subtype 1a (45% versus 42%) and IL28B-CC alleles (29% versus 23%) did not differ significantly in BOC and TLV groups, respectively. HIV coinfection was more prevalent in patients on TLV than BOC (24% versus 44%). Conversely, more patients on BOC than TLV had previously failed pegylated interferon plus ribavirin (82% versus 64%). RVR was achieved by 82% of patients on TLV versus 59% on BOC (P=0.001). Multivariate logistic regression analysis confirmed that TLV use was the strongest predictor of RVR (OR 3.54 [95% CI 1.23, 10.24]; P=0.02), others being HCV subtype 1b versus 1a (OR 3.26 [95% CI 1.17, 9.09]; P=0.02) and low baseline HCV RNA (OR 0.41 [95% CI 0.16, 1.03]; P=0.06). Prior interferon exposure, HIV coinfection or absence of advanced liver fibrosis did not influence the likelihood of RVR. CONCLUSIONS: Compared to BOC, triple therapy with TLV produces greater RVR rates. TLV might be a better option in more difficult-to-cure patients, such as those with high baseline HCV RNA and/or HCV 1a subtype. HIV coinfection does not influence early HCV RNA responses.