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Background: Especially in high HIV prevalence contexts, such as Zambia, effective biomedical prevention tools are needed for priority populations (PPs), including key populations (KPs), who are at higher risk. HIV pre-exposure prophylaxis (PrEP) has been scaled up nationally in Zambia, but little is known about barriers to PrEP use among specific PPs to date., Methods: To understand barriers and facilitators to PrEP use in Zambia, we conducted a qualitative case study of PrEP services to PPs including sero-discordant couples (SDCs), female sex workers (FSWs), and men who have sex with men (MSM) in Livingstone. The study conducted in 2021 included in-depth interviews (n = 43) guided by the socio-ecological model, and focus group discussions (n = 4) with clinic and community-based providers and PrEP-eligible clients including users and non-users across PP groups. We used thematic analysis to analyze data using codes derived both deductively and inductively., Results: We found multilevel barriers and facilitators to PrEP use. Cross-cutting barriers shared across PP groups included amplifying effects of PrEP being mistaken for antiretroviral drugs used to treat HIV, including anticipated stigma, and concerns about side-effects based on both misinformation and experience. In addition, stigmatized identities, particularly that of MSM, served as a barrier to PrEP use. The fear of being mislabeled as having HIV was of greatest concern for FSWs. Facilitators to PrEP use primarily included the importance of confidential, KP-sensitive services, and the role of informed, supportive family, friends, and peers. Participants across all PP groups urged expanded education efforts to increase awareness of PrEP within the general population toward mitigating concerns of being mislabeled as living with HIV., Conclusion: To our knowledge, this is the first qualitative study of the PrEP cascade among multiple PPs in Zambia. This study provides important explanation for the low rates of PrEP continuation found in earlier demonstration trials among KPs in Zambia. The study also offers recommendations for programming efforts going forward such as inclusive PrEP awareness campaigns, expanded KP sensitivity training, and related efforts to thwart PrEP stigma while expanding access., (© 2024. The Author(s).)

Objective: We completed a cross-sectional survey study to determine headache prevalence and its association with HIV characteristics among people living with HIV (PLHIV) in Lusaka, Zambia., Background: Headaches are common but their association with HIV status is unknown., Methods: The HARDSHIP survey, a headache epidemiology questionnaire previously validated in Zambia, was distributed during a 3-month period to 3666 consecutive adult PLHIV attending routine clinic appointments at the Adult Infectious Diseases Centre at the University Teaching Hospital in Lusaka, Zambia. HIV disease characteristics were abstracted from their charts., Results: 1015 (27.7%) participants responded to the survey. Adjusted for age, 64% reported having a headache within the last year unrelated to another illness. Among participants, 201 met criteria for migraine (20%), 259 for tension-type headache (26%), 18 for probable medication-overuse headache (2%), and 121 for undetermined headache (12%). Prevalence for tension-type headache was significantly higher than that of migraine (P < 0.001). After adjusting for age and sex, higher CD4 counts were associated with migraine. No other associations were observed between overall headache or headache type with HIV disease characteristics including CD4 count, viral load, antiretroviral regimen, and time since HIV diagnosis., Conclusions: Headaches are highly prevalent among this cohort of PLHIV in Zambia. Optimizing headache treatment and integrating it into routine HIV care may improve quality of life for a substantial proportion of PLHIV in Zambia., Competing Interests: Declaration of competing interest All authors report no conflicts of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Novel community-based approaches are needed to achieve and sustain HIV epidemic control in Zambia. Under the Stop Mother and Child HIV Transmission (SMACHT) project, the Community HIV Epidemic Control (CHEC) differentiated service delivery model used community health workers to support HIV testing, ART linkage, viral suppression, and prevention of mother-to-child transmission (MTCT). A multi-methods assessment included programmatic data analysis from April 2015 to September 2020, and qualitative interviews from February to March 2020. CHEC provided HIV testing services to 1,379,387 clients; 46,138 were newly identified as HIV-positive (3.3% yield), with 41,366 (90%) linked to ART. By 2020, 91% (60,694/66,841) of clients on ART were virally suppressed. Qualitatively, healthcare workers and clients benefitted from CHEC, with provision of confidential services, health facility decongestion, and increased HIV care uptake and retention. Community-based models can increase uptake of HIV testing and linkage to care, and help achieve epidemic control and elimination of MTCT., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Adolescent girls and young women (AGYW) in sub-Saharan Africa remain at high risk for HIV, yet limited data exist on implementation of HIV pre-exposure prophylaxis (PrEP) for this group. We examined PrEP uptake among AGYW using a retrospective cohort enrolled in the Determined Resilient Empowered AIDS-free Mentored Safe (DREAMS) initiative in Zambia between October 2020 and March 2022. Consent was obtained from eligible AGYW at substantial risk for HIV, and they voluntarily participated in PrEP. Multivariable logistic regression was used to examine factors associated with PrEP refills following initiation. Of 4,162 HIV-negative AGYW, 3,233 (77%) were at substantial risk and initiated on PrEP. Overall, 68% of AGYW had at least one refill, but this differed significantly by age group and district. DREAMS was successful at reaching AGYW with PrEP services. More evidence is needed to assess reasons for discontinuation and to improve persistence for those with sustained HIV risk.

Background: The HIV care continuum comprises well-defined steps and indicators. In contrast, indicators along the preexposure prophylaxis (PrEP) cascade are still in the early stages of implementation. Monitoring and evaluation (M&E) of PrEP services is critical to optimizing PrEP uptake and adherence during periods of HIV risk. We provide an overview of global indicators for PrEP, describe the development process and outcomes of Zambia's 2022 National Pre-Exposure Prophylaxis (PrEP) Program Monitoring & Evaluation Implementation Guide , and discuss the guide's implications for other countries in sub-Saharan Africa., National M&e Guide Development Process: During the scale-up of PrEP, the Zambia Ministry of Health (MOH) and the National HIV/AIDS/STI/TB Council recognized the need for a national unified monitoring system to guide the effective implementation of PrEP services. Stakeholders from the MOH, civil society, professional organizations, funding agencies, and implementing partners developed the National Pre-Exposure Prophylaxis (PrEP) Program Monitoring & Evaluation Implementation Guide . This guide is aligned with the existing global indicators from the World Health Organization and the U.S. President's Emergency Plan for AIDS Relief and adapted to the country's needs, context, and health information systems. Zambia's experience in developing the guide has highlighted the importance of strengthening client-level monitoring systems for HIV prevention, ensuring flexibility of the PrEP monitoring system to accommodate PrEP delivery modalities and differentiated service delivery models, and training health workers to enhance PrEP services and deliver care PrEP services along the continuum to prevent HIV acquisition effectively., Conclusions: Using a collaborative and consensus-based approach, Zambia developed its first national PrEP M&E implementation guide to provide standardized guidelines for optimizing the delivery, monitoring, and evaluation of PrEP service delivery. Zambia's experience can inform other countries in sub-Saharan Africa as they develop national M&E implementation approaches for PrEP., (© Lavoie et al.)

Background: There are over 23 000 incarcerated people in Zambia, a population which has higher HIV prevalence than the general population yet has no access to HIV prevention. To evaluate the feasibility of HIV pre-exposure prophylaxis (PrEP) implementation in Zambian criminal justice facilities, we offered PrEP services to incarcerated people and aimed to describe early implementation outcomes., Methods: In this cross-sectional observational study, we implemented a PrEP programme between Oct 1, 2020, and March 31, 2021, supporting 16 criminal justice facilities in four Zambian provinces. Before implementation, we held stakeholder engagement meetings with Zambia Correctional Service officials to discuss PrEP benefits, and trained Zambia Correctional Service health-care workers in PrEP management using the national PrEP training package. People who were incarcerated and screened positive for substantial HIV risk by use of a standardised HIV risk assessment tool were offered voluntary HIV testing and counselling. Those who tested positive were linked to antiretroviral therapy, and those who tested negative and met national HIV prevention eligibility criteria were offered PrEP. We assessed PrEP uptake and used descriptive statistics to characterise programme beneficiaries and the cascade of PrEP services., Findings: During the study period, we reached 12 367 people older than 15 years with HIV risk assessment and counselling, including 11 794 (95·4%) men and 573 (4·6%) women. Of these, 2610 people received HIV testing, with 357 (13·7%) testing HIV positive; positivity was significantly higher in women (20·6%) than men (13·2%, p=0·011). 1276 people were identified as HIV negative and PrEP eligible. Of these, 1190 (93·3%) initiated PrEP. The age group with the highest proportion reached and initiated on PrEP was those aged 25-29 years, representing 19·2% (2377 of 12 367) of all people reached and 24·1% (287 of 1190) of those who initiated PrEP., Interpretation: Delivery of PrEP to people who are incarcerated is feasible with adequate resourcing and support to the criminal justice health system, and can result in high uptake among eligible individuals. Further assessment is needed of PrEP persistence and adherence, and the perceptions of people who are incarcerated regarding their HIV risk and preferences for combination HIV prevention services., Funding: US President's Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Introduction: Zambia has made tremendous progress towards HIV epidemic control; however, gaps remain among key populations (KPs), such as female sex workers (FSWs), men who have sex with men (MSM), people who inject drugs (PWID) and people in prisons and enclosed settings due to cultural, social and legal barriers. The University of Maryland, Baltimore Zambia Community HIV Epidemic Control for Key Populations (Z-CHECK) project aimed to improve HIV case-finding, linkage and treatment adherence at the community level for KPs in Zambia. We describe Z-CHECK strategies and examine HIV positivity yield and antiretroviral therapy (ART) linkage among KPs to inform ongoing programme improvement., Methods: Z-CHECK recruited, trained and deployed peer community health workers (CHWs) for KP groups, with ongoing mentorship in community engagement. CHWs offered HIV testing in safe spaces and escorted newly HIV-diagnosed clients for same-day ART initiation. Z-CHECK also reached out to KP community leaders and gatekeepers for KP mobilization and trained healthcare workers (HCWs) on KP services and sensitivity. We conducted a retrospective observational review of routinely collected aggregate data for KPs aged ≥15 years at high risk for HIV transmission across five districts in Zambia from January 2019 to December 2020., Results: Z-CHECK provided HIV testing for 9211 KPs, of whom 2227 were HIV positive (positivity yield, 24%). Among these, 1901 (85%) were linked to ART; linkage for MSM, FSW, PWID and people in prisons and enclosed settings was 95%, 89%, 86% and 65%, respectively. Programme strategies that contributed to high positivity yield and linkage included the use of peer KP CHWs, social network testing strategies and opportunities for same-day ART initiation. Challenges to programme implementation included stigma and discrimination among HCWs, as well as KP CHW attrition, which may be explained by high mobility., Conclusions: Peer CHWs were highly effective at reaching KP communities, identifying persons living with HIV and linking them to care. Engaging KP community gatekeepers resulted in high diffusion of health messages and increased access to health resources. The mobility of CHWs and HCWs is a challenge for programme implementation. Innovative interventions are needed to support PWID and people in prisons and enclosed settings., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: Transgender and gender-diverse communities in Zambia are highly vulnerable and experience healthcare differently than cisgender persons. The University of Maryland, Baltimore (UMB) supports projects in Zambia to improve HIV case-finding, linkage and antiretroviral treatment (ART) for Zambia's transgender community. We describe programme strategies and outcomes for HIV prevention, testing and ART linkage among transgender communities., Methods: UMB utilizes a differentiated service delivery model whereby community health workers (CHWs) recruited from key populations (KPs) reach community members through a peer-to-peer approach, with the support of local transgender civil society organizations (CSOs) and community gatekeepers. Peer CHWs are trained and certified as HIV testers and psychosocial counsellors to offer counselling with HIV testing and prevention services in identified safe spaces. HIV-negative people at risk of HIV infection are offered pre-exposure prophylaxis (PrEP), while those who test positive for HIV are linked to ART services. CHWs collect data using the standardized facility and community tools and a dedicated DHIS2 database system. We conducted a descriptive analysis examining HIV testing and prevention outcomes using proportions and comparisons by time period and geographic strata., Results: From October 2020 to June 2021, across Eastern, Lusaka, Western and Southern Provinces, 1860 transgender persons were reached with HIV prevention messages and services. Of these, 424 (23%) were tested for HIV and 78 (18%) tested positive. Of the 346 HIV-negative persons, 268 (78%) eligible transgender individuals were initiated on PrEP. ART linkage was 97%, with 76 out of the 78 transgender individuals living with HIV initiating treatment. Programme strategies that supported testing and linkage included peer CHWs, social network strategy testing, same-day ART initiation and local KP CSO support. Challenges included non-transgender-friendly environments, stigma and discrimination, the high transiency of the transgender community and the non-availability of transgender-specific health services, such as hormonal therapy., Conclusions: Peer KP CHWs were able to reach many members of the transgender community, providing safe HIV testing, PrEP services and linkage to care. Focusing on community gatekeepers and CSOs to disburse health messages and employ welcoming strategies supported high linkage to both PrEP and ART for transgender people in Zambia., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: Malawi is rapidly closing the gap in achieving the UNAIDS 95-95-95 targets, with 90% of people living with HIV in Malawi aware of their status. As we approach epidemic control, interventions to improve coverage will become more costly. There is, therefore, an urgent need to identify innovative and low-cost strategies to maintain and increase testing coverage without diverting resources from other HIV services. The objective of this study is to model different combinations of facility-based HIV testing modalities and determine the most cost-effective strategy to increase the proportion of men and youth testing for HIV., Methods: A data-driven individual-based model was parameterized with data from a community-representative survey (socio-demographic, health service utilization and HIV testing history) of men and youth in Malawi (data collected August 2019). In total, 79 different strategies for the implementation of HIV self-testing (HIVST) and provider-initiated-testing-and-counselling at the outpatient department (OPD) were evaluated. Outcomes included percent of men/youth tested for HIV in a 12-month period, cost-effectiveness and human resource requirements. The testing yield was assumed to be constant across the scenarios., Results: Facility-based HIVST offered year-round resulted in the greatest increase in the proportion of men and youth tested in the OPD (from 45% to 72%-83%), was considered cost-saving for HIVST kit priced at $1.00, and generally reduced required personnel as compared to the status quo. At higher HIVST kit prices, and more relaxed eligibility criteria, all scenarios that considered year-round HIVST in the OPD remained on the cost-effectiveness frontier., Conclusions: Facility-based HIVST is a cost-effective strategy to increase the proportion of men/youth tested for HIV in Malawi and decreases the human resource requirements for HIV testing in the OPD-providing additional healthcare worker time for other priority healthcare activities., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Zambia recently achieved UNAIDS 90-90-90 treatment targets for HIV epidemic control; however, inpatient facilities continue to face a large burden of patients with advanced HIV disease and HIV-related mortality. Management of advanced HIV disease, following guidelines from outpatient settings, may be more difficult within complex inpatient settings. We evaluated adherence to HIV guidelines during hospitalization, including opportunistic infection (OI) screening, treatment, and prophylaxis., Methods: We reviewed inpatient medical records of people living with HIV (PLHIV) admitted to the University Teaching Hospital in Lusaka, Zambia between December 1, 2018 and April 30, 2019. We collected data on patient demographics, antiretroviral therapy (ART), HIV biomarkers, and OI screening and treatment-including tuberculosis (TB), Cryptococcus, and OI prophylaxis with co-trimoxazole (CTX). Screening and treatment cascades were constructed based on the 2017 WHO Advanced HIV Guidelines., Results: We reviewed files from 200 charts of patients with advanced HIV disease; of these 92% (184/200) had been on ART previously; 58.1% (107/184) for more than 12 months. HIV viral load (VL) testing was uncommon but half of VL results were high. 39% (77/200) of patients had a documented CD4 count result. Of the 172 patients not on anti-TB treatment (ATT) on admission, TB diagnostic tests (either sputum Xpert MTB/RIF MTB/RIF or urine TB-LAM) were requested for 105 (61%) and resulted for 60 of the 105 (57%). Nine of the 14 patients (64%) with a positive lab result for TB died before results were available. Testing for Cryptococcosis was performed predominantly in patients with symptoms of meningitis. Urine TB-LAM testing was rarely performed., Conclusions: At a referral hospital in Zambia, CD4 testing was inconsistent due to laboratory challenges and this reduced recognition of AHD and implementation of AHD guidelines. HIV programs can potentially reduce mortality and identify PLHIV with retention and adherence issues through strengthening inpatient activities, including reflex VL testing, TB-LAM and serum CrAg during hospitalization., (© 2022. The Author(s).)

Introduction: Daily pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but not yet widely deployed in sub-Saharan Africa. We describe how Zambia developed PrEP health policy and then successfully implemented national PrEP service delivery., Policy Development: Zambia introduced PrEP as a key strategy for HIV prevention in 2016, and established a National PrEP Task Force to lead policy advocacy and development. The Task Force was composed of government representatives, regulatory agencies, international donors, implementation partners and civil society organisations. Following an implementation pilot, PrEP was rolled out nationally using risk-based criteria alongside a national HIV prevention campaign., National Scale-Up: In the first year of implementation, ending September 2018, 3626 persons initiated PrEP. By September 2019, the number of people starting PrEP increased by over sixfold to 23 327 persons at 728 sites across all ten Zambian provinces. In the first 2 years, 26 953 clients initiated PrEP in Zambia, of whom 31% were from key and priority populations. Continuation remains low at 25% and 11% at 6 and 12 months, respectively., Lessons Learnt: Risk-based criteria for PrEP ensures access to those most in need of HIV prevention. Healthcare worker training in PrEP service delivery and health needs of key and priority populations is crucial. PrEP expansion into primary healthcare clinics and community education is required to reach full potential. Additional work is needed to understand and address low PrEP continuation. Finally, a task force of key stakeholders can rapidly develop and implement health policy, which may serve as a model for countries seeking to implement PrEP., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Established antiretroviral therapy (ART) programs in sub-Saharan Africa have well-defined first-and second-line therapies but no standard third-line ART regimen. The impact of third-line ART on patients with multiclass-resistant HIV in resource-limited settings has not been well characterized. We conducted a retrospective review of patients on third-line ART at the University Teaching Hospital in Lusaka, Zambia. We assessed virologic and immunologic outcomes following 6 months of third-line therapy and found among those with a documented viral load, viral suppression (≤1000 copies/ml) at 24 weeks was 95% (63/66) with a mean increase in CD4 count of 116 cells/mm 3 and viral suppression of 63% (63/100) by imputation of missing data. This study suggests that third-line therapy is clinically and virologically effective among patients with multiclass-resistance in a resource-limited setting in sub-Saharan Africa.

Introduction: Current healthcare systems fail to provide adequate HIV services to men. In Zambia, 25% of adult men living with HIV were unaware of their HIV status in 2018, and 12% of those who were unaware of their HIV statu were not receiving antiretroviral therapy (ART) due to pervasive barriers to HIV testing services (HTS) and linkage to ART. To identify men and key and priority populations living with HIV in Zambia, and link them to care and treatment, we implemented the Community Impact to Reach Key and Underserved Individuals for Treatment and Support (CIRKUITS) project. We present HTS and ART linkage results from the first year of CIRKUITS., Methods: CIRKUITS aimed to reach beneficiaries by training, mentoring, and deploying community health workers to provide index testing services and targeted community HTS. Community leaders and workplace supervisors were engaged to enable workplace HTS for men. To evaluate the effects of these interventions, we collected age- and sex-disaggregated routinely collected programme data for the first 12 months of the project (October 2018 to September 2019) across 37 CIRKUITS-supported facilities in three provinces. We performed descriptive statistics and estimated index cascades for indicators of interest, and used Chi square tests to compare indicators by age, sex, and district strata., Results: Over 12 months, CIRKUITS tested 38,255 persons for HIV, identifying 10,974 (29%) new people living with HIV, of whom 10,239 (93%) were linked to ART. Among men, CIRKUITS tested 18,336 clients and identified 4458 (24%) as HIV positive, linked 4132 (93%) to ART. Men who tested HIV negative were referred to preventative services. Of the men found HIV positive, and 13.0% were aged 15 to 24 years, 60.3% were aged 25 to 39, 20.9% were aged 40 to 49 and 5.8% were ≥50 years old. Index testing services identified 2186 (49%) of HIV-positive men, with a positivity yield of 40% and linkage of 88%. Targeted community testing modalities accounted for 2272 (51%) of HIV-positive men identified, with positivity yield of 17% and linkage of 97%., Conclusions: Index testing and targeted community-based HTS are effective strategies to identify men living with HIV in Zambia. Index testing results in higher yield, but lower linkage and fewer absolute men identified compared to targeted community-based HTS., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Although large-scale provision of HIV pre-exposure prophylaxis (PrEP) is gaining momentum, no systematic method to evaluate or compare the effectiveness of different scale-up strategies in real-world settings exists. To date, estimating the effectiveness of PrEP has relied on clinical trials or mathematical models. We propose a novel and pragmatic metric to evaluate and compare programme effectiveness using routine implementation data. Using South African and Zambian PrEP guidelines, we provide two examples of how to consistently measure PrEP-programme effectiveness with routinely collected data. PrEP effectiveness should account for HIV seroconversion, the variable risk of HIV infection (seasons of risk) estimated with routine risk assessment at each clinic visit (when available), and the persistence of PrEP use. Three criteria should be met in order to be considered a successful outcome: first, a person who initiates PrEP must not seroconvert; second, there should be no more than one period at high risk of HIV infection during the follow-up period when not taking PrEP; and finally, an individual must continue to attend health-care visits or discontinue prophylaxis in consultation with a health-care provider within a specified follow-up period. The number of PrEP successes could then be compared with the total number of people initiating PrEP to establish a success ratio. This outcome is a useful and easily interpretable metric to monitor effectiveness of PrEP programmes with routinely collected clinical data and can be used in cost-effectiveness analyses. These measurements allow for comparisons of scale-up strategies for PrEP programmes and, if widely adopted, will allow comparative studies of different approaches for PrEP service delivery., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Patient's gender may impact pharmacokinetics and play a role in viral suppression. Existing literature has focused on treatment-naïve patients and produced inconclusive results, often implicating differences in adherence as the driver of gender-based outcome differences. The present analysis assessed whether viral suppression on third-line HIV treatment among a closely followed population differs by gender. A retrospective cohort study of patients on third-line HIV treatment was initiated at the HIV Advanced Treatment Centre in Lusaka, Zambia between January 2012 and December 2015. The association between gender and viral suppression was assessed using log binomial regression adjusted for core drug, number of drug mutations, and baseline viral load. Of the 80 included patients (56% female; median age: 40 years), 50 (62%) were virally suppressed at six months. After adjustment, females were less likely to be virologically suppressed at six months on third-line treatment compared to male HIV patients (relative risk 0.82, 95% confidence interval: 0.56, 1.20). Our data suggest that women were less likely to be suppressed following six months of third-line therapy compared to men; however, the difference was not statistically significant. Larger studies are needed to determine whether women are at increased risk of viral failure on third-line therapy compared to men.

Background: Characterizing viral response to lopinavir/ritonavir (LPV/r) monotherapy as second-line treatment may guide recommendations for resource-limited settings (RLS)., Methods: We conducted a 48-week prospective, single-arm study of LPV/r monotherapy in patients failing first-line therapy in Nigeria. The primary outcome was sustained HIV-1 viral load (VL) <400 copies/mL at 48 weeks., Results: Of 30 enrolled patients, 28 (93%) achieved viral suppression on LPV/r, while 29 (96%) experienced low-level viremia. At 48 weeks, 9 (30%) met the primary outcome of sustained viral suppression; 14 (47%) patients were suppressed on LPV/r in a snapshot analysis. Detectable VLs at 12 and 24 weeks were strongly associated with treatment failure at 48 weeks. New resistance mutations were not detected. The trial was stopped early due to treatment failure., Conclusion: In this study, the rate of virologic failure among patients on a second-line lopinavir monotherapy regimen was relatively high and predicted by early detectable viremia. However, no LPV/r-associated resistance mutations were detected despite fluctuating low-level viremia, demonstrating the high genetic barrier to resistance of the protease inhibitor class which could be useful in RLS.

Background: Cirrhosis of the liver can induce splenic sequestration of peripheral blood cells, recently suggested to reduce the number but not percentage of circulating CD4(+) T cells in persons uninfected with human immunodeficiency virus (HIV). We investigated whether earlier stages of liver fibrosis prior to cirrhosis were associated with discordance between CD4 count (CD4N) and CD4 percentage (CD4%) in HIV-infected patients., Methods: In cross-sectional analysis of 287 HIV-infected participants of the AIDS Linked to the Intravenous Experience cohort, we evaluated CD4N, CD4%, and transient elastography staging of liver fibrosis. High CD4(+) lymphocyte discordance was defined as higher CD4% relative to CD4N based on accepted clinical cutoffs; multivariable logistic regression was used to determine covariates associated with discordance., Results: Of 287 participants, 99 (34.4%) had high CD4(+) discordance, which increased to 76% of 114 participants with marked lymphopenia (total lymphocyte count [TLC] ≤1200 cells/μL). In multivariable analysis, the odds of having high CD4(+) discordance was increased in persons with significant liver fibrosis compared to those without fibrosis (odds ratio, 1.69; 95% confidence interval [CI], .95-2.96); the odds ratio of discordance increased to 2.66 (95% CI, 1.11-6.40) among the subset of participants with TLC ≤1200 cells/μL. The odds for discordance associated with cirrhosis were of similar magnitude as those observed with significant fibrosis., Conclusions: In HIV-infected persons, liver fibrosis is associated with discordant peripheral CD4(+) lymphocyte results, especially in the setting of marked lymphopenia. Clinicians should also consider CD4% when interpreting absolute CD4(+) counts of HIV-infected persons with known or suspected liver disease, particularly if TLC is <1200 cells/μL.

Background: The HIV Network for Prevention Trials (HIVNET) 012 trial showed that NVP resistance (NVPR) emerged in some women and children after the administration of single-dose nevirapine (SD-NVP). We tested whether K103N-containing human immunodeficiency virus (HIV)-1 variants persisted in women and infants 1 year or more after the administration of SD-NVP., Methods: We analyzed samples from 9 women and 5 infants in HIVNET 012 who had NVPR 6-8 weeks after the administration of SD-NVP. Samples were analyzed with the ViroSeq system and with 2 sensitive resistance assays, LigAmp and TyHRT., Results: ViroSeq detected the K103N mutation in 8 of 9 women and in 2 of 5 infants. LigAmp detected the K103N mutation at low levels in 8 of 9 women and in 4 of 5 infants. K103N was not detected by ViroSeq 12-24 months after the administration of SD-NVP but was detected by LigAmp in 3 of 9 women and in 1 of 5 infants. K103N was also detected in those samples by use of the TyHRT assay., Conclusions: K103N-containing variants persist in some women and infants for 1 year or more after the administration of SD-NVP. Sensitive resistance assays may provide new insight into the impact of antiretroviral drug exposure on HIV-1 evolution.