scholarly journals Southern African HIV Clinicians Society adult antiretroviral therapy guidelines: Update on when to initiate antiretroviral therapy

2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Graeme Meintjes ◽  
John Black ◽  
Francesca Conradie ◽  
Sipho Dlamini ◽  
Gary Maartens ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
New England ◽  
Hiv Transmission ◽  
Clinical Indication ◽  
Optimal Timing ◽  
Cd4 Counts ◽  
The Public ◽  
Art Initiation ◽  
Randomised Controlled ◽  
Early Antiretroviral Treatment

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.

scholarly journals Antiretroviral therapy for prevention of HIV transmission: implications for Europe

2013 ◽  
Vol 18 (48) ◽  
Author(s):  
V Cambiano ◽  
J O’Connor ◽  
A N Phillips ◽  
A Rodger ◽  
R Lodwick ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
People Who Inject Drugs ◽  
Hiv Transmission ◽  
Controlled Trial ◽  
Population Level ◽  
Hiv Infections ◽  
Cd4 Count ◽  
Art Initiation ◽  
Sex With Men ◽  
Randomised Controlled

The aim of this review is to summarise the evidence on the population-level effect of antiretroviral therapy (ART) in preventing HIV infections, and to discuss potential implications in the European context of recommending starting ART when the CD4 count is above 350 cells/mm3. The ability of ART to reduce the risk of HIV transmission has been reported in observational studies and in a randomised controlled trial (HPTN 052), in which ART initiation reduced HIV transmission by 96% within serodiscordant couples. As yet, there is no direct evidence for such an effect among men having sex with men or people who inject drugs. HPTN 052 led international organisations to develop recommendations with a higher CD4 threshold for ART initiation. However, there remains a lack of strong evidence of clinical benefit for HIV-positive individuals starting ART with CD4 count above 350 cells/mm3. The main goal of ART provision should be to increase ART coverage for all those in need, based on the current guidelines, and the offer of ART to those who wish to reduce infectivity; increased HIV testing is therefore a key requirement. Other proven prevention means such as condom use and harm reduction for people who inject drugs remain critical.

scholarly journals Retesting for verification of HIV diagnosis before antiretroviral therapy initiation in Harare, Zimbabwe: Is there a gap between policy and practice?

2019 ◽  
Vol 113 (10) ◽  
pp. 610-616
Author(s):  
Beatrice Dupwa ◽  
Ajay M V Kumar ◽  
Jaya Prasad Tripathy ◽  
Owen Mugurungi ◽  
Kudakwashe C Takarinda ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Secondary Data ◽  
Future Research ◽  
Hiv Positive ◽  
National Guidelines ◽  
Hiv Diagnosis ◽  
Policy And Practice ◽  
The Public ◽  
Art Initiation ◽  
Study Participants

Abstract Background WHO recommends retesting of HIV-positive patients before starting antiretroviral therapy (ART). There is no evidence on implementation of retesting guidelines from programmatic settings. We aimed to assess implementation of HIV retesting among clients diagnosed HIV-positive in the public health facilities of Harare, Zimbabwe, in June 2017. Methods This cohort study involved analysis of secondary data collected routinely by the programme. Results Of 1729 study participants, 639 (37%) were retested. Misdiagnosis of HIV was found in six (1%) of the patients retested—all were infants retested with DNA-PCR. There was no HIV misdiagnosis among adults. Among those retested, 95% were retested on the same day and two-thirds were tested by a different provider as per national guidelines. Among those retested and found positive, 95% were started on ART, while none of those with negative retest results were started on ART. Of those not retested, about half (51%) were started on ART. The median (IQR) time to ART initiation from diagnosis was 0 (0–1) d. Conclusion The implementation of HIV-retesting policy in Harare was poor. While most HIV retest positives were started on ART, only half non-retested received ART. Future research is needed to understand the reasons for non-retesting and non-initiation of ART among those not retested.

scholarly journals Durability of different initial regimens in HIV-infected patients starting antiretroviral therapy with CD4+ counts 5 log10 copies/mL

2019 ◽  
Vol 74 (9) ◽  
pp. 2732-2741 ◽  
Author(s):  
Nicola Gianotti ◽  
Patrizia Lorenzini ◽  
Alessandro Cozzi-Lepri ◽  
Andrea De Luca ◽  
Giordano Madeddu ◽  
...  
Keyword(s):  
Hiv Transmission ◽  
Composite Endpoint ◽  
Strand Transfer ◽  
Cd4 Counts ◽  
Opportunistic Disease ◽  
Hiv Rna ◽  
Art Initiation ◽  
Adjusted Incidence Rate ◽  
Pre Treatment ◽  
Adjusted Incidence

Abstract Objectives Our aim was to investigate the durability of different initial regimens in patients starting ART with CD4+ counts <200 cells/mm3 and HIV-RNA >5 log10 copies/mL. Methods This was a retrospective study of HIV-infected patients prospectively followed in the ICONA cohort. Those who started ART with boosted protease inhibitors (bPIs), NNRTIs or integrase strand transfer inhibitors (InSTIs), with CD4+ <200 cells/mm3 and HIV-RNA >5 log10 copies/mL, were included. The primary endpoint was treatment failure (TF), a composite endpoint defined as virological failure (VF, first of two consecutive HIV-RNA >50 copies/mL after 6 months of treatment), discontinuation of class of the anchor drug or death. Independent associations were investigated by Poisson regression analysis in a model including age, gender, mode of HIV transmission, CDC stage, HCV and HBV co-infection, pre-treatment HIV-RNA, CD4+ count and CD4+/CD8+ ratio, ongoing opportunistic disease, fibrosis FIB-4 index, estimated glomerular filtration rate, haemoglobin, platelets, neutrophils, calendar year of ART initiation, anchor drug class (treatment group) and nucleos(t)ide backbone. Results A total of 1195 patients fulfilled the inclusion criteria: 696 started ART with a bPI, 315 with an InSTI and 184 with an NNRTI. During 2759 person-years of follow up, 642 patients experienced TF. Starting ART with bPIs [adjusted incidence rate ratio (aIRR) (95% CI) 1.62 (1.29–2.03) versus starting with NNRTIs; P < 0.001] and starting ART with InSTIs [aIRR (95% CI) 0.68 (0.48–0.96) versus starting with NNRTIs; P = 0.03] were independently associated with TF. Conclusions In patients starting ART with <200 CD4+ cells/mm3 and >5 log10 HIV-RNA copies/mL, the durability of regimens based on InSTIs was longer than that of NNRTI- and bPI-based regimens.

scholarly journals Timing of Antiretroviral Therapy for HIV-Infected Patients with Cytomegalovirus Retinitis: Study Protocol of a Multi-Center Prospective Randomized Controlled Trial

2020 ◽  
Author(s):  
Xiao-Qing He ◽  
Yin-Qiu Huang ◽  
Yan-Ming Zeng ◽  
Yuan-Yuan Qin ◽  
Sheng-Quan Tang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Controlled Trial ◽  
Cytomegalovirus Retinitis ◽  
Optimal Timing ◽  
Randomized Controlled ◽  
Art Initiation ◽  
Cell Counts ◽  
Prospective Randomized Controlled Trial

Abstract Background: Cytomegalovirus retinitis (CMVR) is an important opportunistic infection (OI) occurring mainly in patients with acquired immunodeficiency syndrome (AIDS), and has the potential to cause severe visual impairment and blindness among AIDS patients. Subsequent to the adoption and implementation of widespread antiretroviral therapy (ART), the prognosis of AIDS-associated CMVR has been substantially improved. Nevertheless, there remains some controversy with regards to the optimal timing for ART initiation in patients with an established CMVR diagnosis. We therefore designed the present study in order to investigate the optimal timing for ART initiation in AIDS/CMVR patients.Methods: This will be a prospective, randomized controlled trial to be performed at 17 hospitals in mainland China. A total of 300 participants with CMVR will be randomly assigned to an early ART initiation group (ART initiation within 2 weeks after anti-CMV therapy), or a deferred ART initiation group (initiation of ART more than 2 weeks after anti-CMV therapy) at a 1:1 ratio. All participants will receive 48-weeks of follow-up after anti-CMV therapy initiation. Our primary outcome will be the incidence of visual loss (to a visual acuity worse than 20/40 or 20/200) in the two groups during the 48-week follow-up period. Secondary outcomes will include changes in HIV virological suppression and serum CD4+ T-cell counts, the incidence of mortality, retinitis progression (movement of the peripheral border of a CMV lesion ≥ ½ disc diameter, or occurrence of a new CMV lesion), retinal detachment, immune recovery uveitis (IRU), and other OIs and adverse events between the two study groups during the 48 weeks of follow-up. Discussion:The study aims to investigate the optimal timing for ART initiation in AIDS/CMVR patients. We hope to be able to extract robust clinical evidence for use in optimal AIDS/CMVR management should our trial be successful.Trial registration: This research was registered as one of the twelve clinical trials under the name of a general project “A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections”, ChiCTR1900021195. Registered 1 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35362.

scholarly journals Associations between HIV Antiretroviral Therapy and the Prevalence and Incidence of Pregnancy in Rakai, Uganda

2011 ◽  
Vol 2011 ◽  
pp. 1-10 ◽  
Author(s):  
Fredrick. E. Makumbi ◽  
Gertrude Nakigozi ◽  
Steven. J. Reynolds ◽  
Anthony Ndyanabo ◽  
Tom Lutalo ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Pregnancy Rates ◽  
Response To Therapy ◽  
Reproductive Age ◽  
Immunologic Response ◽  
Reproductive Health Services ◽  
Cd4 Counts ◽  
Art Initiation ◽  
Hiv Antiretroviral Therapy ◽  
Rate Ratios

Background. Use of antiretroviral therapy (ART) may be associated with higher pregnancy rates.Methods. The prevalence and incidence of pregnancy was assessed in 712 HIV+ pre-ART women of reproductive age (WRA) (15–45) and 244 HIV+ WRA initiating ART. Prevalence rate ratios (PRR), incidence rate ratios (IRR), and 95% confidence interval (CI) were assessed.Results. The incidence of pregnancy was 13.1/100 py among women in pre-ART care compared to 24.6/100 py among women on ART (IRR = 0.54; 95% CI 0.37, 0.81,p<0.0017). The prevalence of pregnancy at ART initiation was 12.0% with CD4 counts 100–250 compared with 3.2% with CD4 <100 (PRR = 3.24, CI 1.51–6.93), and the incidence of pregnancy while on ART was highest in women with a good immunologic response. Desire for more children was a very important factor in fertility.Conclusion. ART was associated with increased pregnancy rates in HIV+ women, particularly those with higher CD4 counts and good immunologic response to therapy, suggesting a need to strengthen reproductive health services for both women and their partners that could address their fertility decisions/intentions particularly after ART initiation.

scholarly journals Timing of antiretroviral therapy for HIV-infected patients with cytomegalovirus retinitis: study protocol of a multi-center prospective randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiao-Qing He ◽  
Yin-Qiu Huang ◽  
Yan-Ming Zeng ◽  
Yuan-Yuan Qin ◽  
Sheng-Quan Tang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Clinical Evidence ◽  
Controlled Trial ◽  
Cytomegalovirus Retinitis ◽  
Optimal Timing ◽  
Randomized Controlled ◽  
Art Initiation ◽  
Prospective Randomized Controlled Trial

Abstract Background Cytomegalovirus retinitis (CMVR) is an important opportunistic infection (OI) occurring mainly in patients with acquired immunodeficiency syndrome (AIDS) and has the potential to cause severe visual impairment and blindness among AIDS patients. Subsequent to the adoption and implementation of widespread antiretroviral therapy (ART), the prognosis of AIDS-associated CMVR has been substantially improved. Nevertheless, the equivocal clinical evidence as regards the optimal timing for ART initiation in patients with an established CMVR diagnosis is required. We therefore designed the present study in order to investigate the optimal timing for ART initiation in AIDS/CMVR patients. Methods This will be a prospective, randomized controlled trial to be performed at 17 hospitals in mainland China. A total of 300 participants with CMVR will be randomly assigned to an early ART initiation group (ART initiation within 2 weeks after anti-CMV therapy), or a deferred ART initiation group (initiation of ART more than 2 weeks after anti-CMV therapy) at a 1:1 ratio. All participants will receive 48 weeks of follow-up after anti-CMV therapy initiation. Our primary outcome will be the incidence of visual loss (to a visual acuity worse than 20/40 or 20/200) in the two groups during the 48-week follow-up period. Secondary outcomes will include changes in HIV virological suppression and serum CD4+ T-cell counts, the incidence of mortality, retinitis progression (movement of the peripheral border of a CMV lesion ≥ ½ disc diameter, or occurrence of a new CMV lesion), retinal detachment, immune recovery uveitis (IRU), and other OIs and adverse events between the two study groups during the 48 weeks of follow-up. Discussion The study aims to investigate the optimal timing for ART initiation in AIDS/CMVR patients. We hope to be able to extract robust clinical evidence for use in optimal AIDS/CMVR management should our trial be successful. Trial registration This research was registered as one of the twelve clinical trials under the name of a general project “A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections”, ChiCTR1900021195. Registered on 1 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35362.

scholarly journals Timing of antiretroviral therapy for HIV-infected patients with moderate-to-severe Pneumocystis pneumonia: study protocol for a multi-center prospective randomized controlled trial

2020 ◽  
Author(s):  
Yuanyuan Qin ◽  
Yanqiu Lu ◽  
Yihong Zhou ◽  
Vijay Harypursat ◽  
Feng Sun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Opportunistic Infections ◽  
Controlled Trial ◽  
Pneumocystis Pneumonia ◽  
Optimal Timing ◽  
Randomized Controlled ◽  
Art Initiation ◽  
Prospective Randomized Controlled Trial ◽  
Registration Number

Abstract Background: Pneumocystis pneumonia (PCP) is a common AIDS-related opportunistic infection. Recent reports estimate that more than 400,000 HIV patients develop PCP each year globally. However, the timing of antiretroviral therapy (ART) initiation for HIV infected patients with PCP is still controversial, and the benefits and risks of early initiation of ART are not completely clear. We thus designed this study in order to determine the optimal timing for ART initiation for HIV-positive patients with moderate to severe PCP.Methods: This study will be an open-labelled, multi-center, prospective, randomized controlled trial. A total of 200 subjects will be randomized to an early ART initiation group (≤14 days after PCP diagnosis), and a deferred ART initiation group (>14 days after PCP diagnosis) at a 1:1 ratio. All subjects will be followed up for 48 weeks after starting ART. The primary outcome is incidence of disease progression (including new opportunistic infections and all-cause mortality) at week 48. The secondary endpoints are the changes in CD4 counts from baseline at week 12, week 24 and week 48, the degree of virological suppression (HIV-RNA<50 copies/mL) at week 24 and week 48, the rate of development of PCP-associated immune reconstitution inflammatory syndrome (IRIS), and adverse events(AEs) at each visit.Discussion: We hope that the results of this study will reveal the optimal timing for initiation of ART in HIV-infected patients with moderate to severe PCP.Trial registration: This trial was registered as one of the twelve trials under the name of a general project at chictr.org.cn on February 1, 2019, and the registration number of the general project is ChiCTR1900021195.

scholarly journals The Effect of Early vs. Deferred Antiretroviral Therapy Initiation in HIV-Infected Patients With Cryptococcal Meningitis: A Multicenter Prospective Randomized Controlled Analysis in China

2021 ◽  
Vol 8 ◽  
Author(s):  
Ting Zhao ◽  
Xiao-lei Xu ◽  
Yan-qiu Lu ◽  
Min Liu ◽  
Jing Yuan ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Adverse Events ◽  
Antifungal Therapy ◽  
Cryptococcal Meningitis ◽  
Antifungal Treatment ◽  
Optimal Timing ◽  
Probability Of Survival ◽  
Intention To Treat ◽  
Art Initiation ◽  
Therapy Initiation

Background: The optimal timing for initiation of antiretroviral therapy (ART) in HIV-positive patients with cryptococcal meningitis (CM) has not, as yet, been compellingly elucidated, as research data concerning mortality risk and the occurrence of immune reconstitution inflammatory syndrome (IRIS) in this population remains inconsistent and controversial.Method: The present multicenter randomized clinical trial was conducted in China in patients who presented with confirmed HIV/CM, and who were ART-naïve. Subjects were randomized and stratified into either an early-ART group (ART initiated 2–5 weeks after initiation of antifungal therapy), or a deferred-ART group (ART initiated 5 weeks after initiation of antifungal therapy). Intention-to-treat, and per-protocol analyses of data for these groups were conducted for this study.Result: The probability of survival was found to not be statistically different between patients who started ART between 2–5 weeks of CM therapy initiation (14/47, 29.8%) vs. those initiating ART until 5 weeks after CM therapy initiation (10/55, 18.2%) (p = 0.144). However, initiating ART within 4 weeks after the diagnosis and antifungal treatment of CM resulted in a higher mortality compared with deferring ART initiation until 6 weeks (p = 0.042). The incidence of IRIS did not differ significantly between the early-ART group and the deferred-ART group (6.4 and 7.3%, respectively; p = 0.872). The percentage of patients with severe (grade 3 or 4) adverse events was high in both treatment arms (55.3% in the early-ART group and 41.8% in the deferred-ART group; p=0.183), and there were significantly more grade 4 adverse events in the early-ART group (20 vs. 13; p = 0.042).Conclusion: Although ART initiation from 2 to 5 weeks after initiation of antifungal therapy was not significantly associated with high cumulative mortality or IRIS event rates in HIV/CM patients compared with ART initiation 5 weeks after initiation of antifungal therapy, we found that initiating ART within 4 weeks after CM antifungal treatment resulted in a higher mortality compared with deferring ART initiation until 6 weeks. In addition, we observed that there were significantly more grade 4 adverse events in the early-ART group. Our results support the deferred initiation of ART in HIV-associated CM.Clinical Trials Registration:www.ClinicalTrials.gov, identifier: ChiCTR1900021195.

scholarly journals No association between early antiretroviral therapy during pregnancy and plasma levels of angiogenic factors: a cohort study

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Ameyo Djeha ◽  
Sylvie Girard ◽  
Helen Trottier ◽  
Fatima Kakkar ◽  
Hugo Soudeyns ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Hiv Transmission ◽  
Smoking Status ◽  
Biological Data ◽  
Angiogenic Factors ◽  
Angiogenic Factor ◽  
Premature Delivery ◽  
Second Trimester ◽  
Art Initiation ◽  
Perinatal Hiv

Abstract Background Early antiretroviral therapy (ART) during pregnancy has dramatically reduced the risk of perinatal HIV transmission. However, studies have shown an association between premature delivery and the use of ART during pregnancy (particularly protease inhibitor (PI)-based therapies), which could be explained by placental dysfunction. The objective of this study was to evaluate the association of ART (class, duration of exposure and time of initiation) with placental function by using angiogenic factors placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) as biomarkers. Methods Clinical and biological data from 159 pregnant women living with HIV were analyzed. Levels of each biomarker were measured in the first and second trimester of pregnancy. After logarithmic transformation, we compared these using generalized estimating equations according to (a) the type of ART; (b) the duration of exposure to ART; and (c) the time of initiation of ART. Results After adjusting for variables such as ethnicity, maternal age, gestational age, body mass index, parity, smoking status, and sex of the fetus, we found no significant association between the class of ART (PI-based or not) and serum concentrations of PlGF or sFlt-1. Furthermore, no significant association was found between biomarker levels and the duration of ART exposure or the timing of ART initiation (pre- or post-conception). Conclusions This study suggests that first and second trimester angiogenic factor levels are not significantly associated with ART, regardless of the duration or type (with or without PI). These observations seem reassuring when considering the use of ART during early pregnancy.

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