[Show abstract][Hide abstract] ABSTRACT: We established Safeguard the Family (STF) to support Ministry of Health (MoH) scale-up of universal antiretroviral therapy (ART) for HIV-infected pregnant and breastfeeding women (Option B+) and to strengthen the prevention of mother-to-child transmission (PMTCT) cascade from HIV testing and counseling (HTC) through maternal ART provision and post-delivery early infant HIV diagnosis (EID). To these ends, we implemented the following interventions in 5 districts: 1) health worker training and mentorship; 2) couples' HTC and male partner involvement; 3) women's psychosocial support groups; and 4) health and laboratory system strengthening for EID.
We conducted a serial cross-sectional study using facility-level quarterly (Q) program data and individual-level infant HIV-1 DNA PCR data to evaluate STF performance on PMTCT indicators for project years (Y) 1 (April-December 2011) through 3 (January-December 2013), and compared these results to national averages.
Facility-level uptake of HTC, ART, infant nevirapine prophylaxis, and infant DNA PCR testing increased significantly from quarterly baselines of 66 % (n/N = 32,433/48,804), 23 % (n/N = 442/1,958), 1 % (n/N = 10/1,958), and 52 % (n/N = 1,385/2,644) to 87 % (n/N = 39,458/45,324), 96 % (n/N = 2,046/2,121), 100 % (n/N = 2,121/2,121), and 62 % (n/N = 1,462/2,340), respectively, by project end (all p < 0.001). Quarterly HTC, ART, and infant nevirapine prophylaxis uptake outperformed national averages over years 2-3. While transitioning EID laboratory services to MoH, STF provided first-time HIV-1 DNA PCR testing for 2,226 of 11,261 HIV-exposed infants (20 %) tested in the MoH EID program in STF districts from program inception (Y2) through Y3. Of these, 78 (3.5 %) tested HIV-positive. Among infants with complete documentation (n = 608), median age at first testing decreased from 112 days (interquartile range, IQR: 57-198) in Y2 to 76 days (IQR: 46-152) in Y3 (p < 0.001). During Y3 (only year with national data for comparison), non-significantly fewer exposed infants tested HIV-positive (3.6 %) at first testing in STF districts than nationally (4.1 %) (p = 0.4).
STF interventions, integrated within the MoH Option B+ program, achieved favorable HTC, maternal ART, infant prophylaxis, and EID services uptake, and a low proportion of infants found HIV-infected at first DNA PCR testing. Continued investments are needed to strengthen the PMTCT cascade, particularly around EID.
[Show abstract][Hide abstract] ABSTRACT: Background: Combination antiretroviral therapy (ART) for HIV-1–infected individuals prevents sexual transmission if viral load is suppressed. Methods: Participants were HIV-1–infected partners randomized to early ART (CD4 350–550) in HPTN052 (n = 886, median follow-up = 2.1 years), a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries. Adherence was assessed through pill count (dichotomized at <95%) and through self-report items. Predictors of adherence were mental health and general health perceptions, substance use, binge drinking, social support, sexual behaviors, and demographics. Viral suppression was defined as HIV plasma viral load <400 copies per milliliter. Adherence counseling and couples' counseling about safer sex were provided. Logistic and linear regression models using generalized estimating equation for repeated measurements were used. Findings: Through pill count, 82% of participants were adherent at 1 month and 83.3% at 1 year. Mental health was the only psychosocial variable associated with adherence [pill count, odds ratios (OR) = 1.05, 95% confidence intervals (CIs): 1.00 to 1.11; self-report parameter estimate, OR = 0.02, 95% CI: 0.01 to 0.04], although regional differences emerged. Pill count (OR = 1.19, 95% CI: 1.10 to 1.30) and self-report (OR = 1.42, 95% CI: 1.14 to 1.77) adherence were associated with viral suppression. Interpretation: Although adherence was high among individuals in stable relationships taking ART for prevention, mental health and adherence covaried. Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored. Adherence and couples' counseling, feedback about viral suppression, and/or altruism may also help explain the magnitude of adherence observed.
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE: We pilot tested a Motivational Interviewing (MI) -based counseling intervention for individuals with Acute HIV Infection (AHI) to reduce risky sexual behavior in Lilongwe, Malawi. METHODS: Twenty-eight individuals diagnosed with AHI were randomized to receive either brief education alone, or the brief education plus the MI-based intervention, called Uphungu Wanga. Participants in Uphungu Wanga received four sessions delivered on the day of diagnosis, three days later and at weeks 1 and 2 with a booster session at week 8; participants were followed for 24 weeks from diagnosis. An interviewer administered quantitative questionnaire was conducted at baseline and at weeks 2, 4, 8, 12, 16, 20 and 24. Semi-structured qualitative interviews (SSI) were conducted at weeks 2, 8, 12, and 24. RESULTS: The majority of participants in both arms reported rapid and sustained behavior change following diagnosis with AHI. Very few participants reported having sex without a condom after diagnosis. Participants reported a trend towards fewer sex partners and abstaining from sex during study follow-up. Participants in the MI-based arm provided concrete examples of risk reduction strategies in the SSIs while those in the brief education arm primarily described reducing risk behavior, suggesting that the MI-based group may have acquired more risk reduction skills. CONCLUSIONS: Individuals in both study arms reduced risky sexual behaviors after diagnosis with AHI. We found few major differences between study arms during the 6-month follow up period in self-reported sexual behaviors therefore a MI-based intervention may not be needed to trigger behavior change following AHI. However, comparing the MI-based intervention to repeated brief education sessions made it difficult to assess the potential benefit of an MI-based intervention in a setting where standard counseling often consists of one post-test session. Nevertheless, provision of counseling immediately following diagnosis with HIV to support behavior change should remain a priority. TRIAL REGISTRATION: ClinicalTrials.gov NCT01197027.
PLoS ONE 05/2015; 10(5-5):e0124452. DOI:10.1371/journal.pone.0124452 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Summary
Background The effi cacy and safety of the RTS,S/AS01 candidate malaria vaccine during 18 months of follow-up have
been published previously. Herein, we report the fi nal results from the same trial, including the effi cacy of a booster dose.
Methods From March 27, 2009, until Jan 31, 2011, children (age 5–17 months) and young infants (age 6–12 weeks) were
enrolled at 11 centres in seven countries in sub-Saharan Africa. Participants were randomly assigned (1:1:1) at fi rst
vaccination by block randomisation with minimisation by centre to receive three doses of RTS,S/AS01 at months 0, 1,
and 2 and a booster dose at month 20 (R3R group); three doses of RTS,S/AS01 and a dose of comparator vaccine at
month 20 (R3C group); or a comparator vaccine at months 0, 1, 2, and 20 (C3C [control group]). Participants were
followed up until Jan 31, 2014. Cases of clinical and severe malaria were captured through passive case detection.
Serious adverse events (SAEs) were recorded. Analyses were by modifi ed intention to treat and per protocol. The
coprimary endpoints were the occurrence of malaria over 12 months after dose 3 in each age category. In this fi nal
analysis, we present data for the effi cacy of the booster on the occurrence of malaria. Vaccine effi cacy (VE) against
clinical malaria was analysed by negative binomial regression and against severe malaria by relative risk reduction.
This trial is registered with ClinicalTrials.gov, number NCT00866619.
Findings 8922 children and 6537 young infants were included in the modifi ed intention-to-treat analyses. Children
were followed up for a median of 48 months (IQR 39–50) and young infants for 38 months (34–41) after dose 1. From
month 0 until study end, compared with 9585 episodes of clinical malaria that met the primary case defi nition in
children in the C3C group, 6616 episodes occurred in the R3R group (VE 36·3%, 95% CI 31·8–40·5) and 7396 occurred
in the R3C group (28·3%, 23·3–32·9); compared with 171 children who experienced at least one episode of severe
malaria in the C3C group, 116 children experienced at least one episode of severe malaria in the R3R group (32·2%,
13·7 to 46·9) and 169 in the R3C group (1·1%, –23·0 to 20·5). In young infants, compared with 6170 episodes of
clinical malaria that met the primary case defi nition in the C3C group, 4993 episodes occurred in the R3R group (VE
25·9%, 95% CI 19·9–31·5) and 5444 occurred in the R3C group (18·3%, 11·7–24·4); and compared with 116 infants
who experienced at least one episode of severe malaria in the C3C group, 96 infants experienced at least one episode
of severe malaria in the R3R group (17·3%, 95% CI –9·4 to 37·5) and 104 in the R3C group (10·3%, –17·9 to 31·8).
In children, 1774 cases of clinical malaria were averted per 1000 children (95% CI 1387–2186) in the R3R group and
1363 per 1000 children (995–1797) in the R3C group. The numbers of cases averted per 1000 young infants were
983 (95% CI 592–1337) in the R3R group and 558 (158–926) in the R3C group. The frequency of SAEs overall was
balanced between groups. However, meningitis was reported as a SAE in 22 children: 11 in the R3R group, ten in the
R3C group, and one in the C3C group. The incidence of generalised convulsive seizures within 7 days of RTS,S/AS01
booster was 2·2 per 1000 doses in young infants and 2·5 per 1000 doses in children.
Interpretation RTS,S/AS01 prevented a substantial number of cases of clinical malaria over a 3–4 year period in young
infants and children when administered with or without a booster dose. Effi cacy was enhanced by the administration of
a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria
control when used in combination with other eff ective control measures, especially in areas of high transmission.
The Lancet 04/2015; 385:1581. · 45.22 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The optimal approach of provider-initiated HIV testing and counseling (PITC) for inpatients in high-burden settings is unknown. We prospectively evaluated the implementation of task-shifting from clinician-referral to counselor-initiated PITC on the medical wards of Kamuzu Central Hospital, Malawi. The majority of patients (1905/3154, 60.4%) had an unknown admission HIV status. Counselors offered testing to 66.6% (1268/1905). HIV prevalence was 39.3%. Counselor-initiated PITC significantly increased HIV testing by 85% (643/2957 vs. 1268/3154), resulting in an almost 2-fold increase in patients with known HIV status (2447/3154 vs. 1249/3154) (both p<.0001), with 17.9% of those tested receiving a new diagnosis of HIV.
[Show abstract][Hide abstract] ABSTRACT: Objective
The pipeline of vaginal microbicides for HIV prevention has expanded to include products for multipurpose prevention, but the interests of potential users and those advising on use have not been sufficiently investigated. Rather, assumptions about interest in multipurpose prevention technologies (MPTs) are inferred from what is known about acceptability and use of microbicides or contraceptives. Design and settingThis paper presents data on concerns and preferences for multipurpose prevention of HIV and pregnancy. Data were collected in two microbicide gel studies in Malawi and Zimbabwe. Participants were women using candidate vaginal products, their male partners, health professionals and community stakeholders. Methods
An individual interview was conducted with participants. Interviews were audio-recorded, transcribed, coded for content and analysed for key themes. ResultsParticipants indicated strong interest in a vaginal HIV prevention product that could also prevent pregnancy. Reasons for this interest were convenience, problems with adverse effects with current contraceptive methods, concerns about long-term effects of contraceptives, and concerns about the health burdens of HIV infection during pregnancy. The main disadvantage of an MPT was recognition that while interest in preventing HIV is constant, contraceptive needs change over time. Conclusion
The study population indicated support for an MPT to prevent HIV and pregnancy. This support may be further strengthened if the product is also available for prevention of only HIV. Women and men will be more willing to use an MPT if they can be reassured that its use will have no long-term effect on fertility.
BJOG An International Journal of Obstetrics & Gynaecology 10/2014; 121 Suppl 5(s5):45-52. DOI:10.1111/1471-0528.12875 · 3.86 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Problem Traditional random sampling at community level requires a list of every individual household that can be randomly selected in the study community. The longitudinal demographic surveillance systems often used as sampling frames are difficult to create in many resource-poor settings. Approach We used Google Earth imagery and geographical analysis software to develop a sampling frame. Every household structure within the catchment area was digitized and assigned coordinates. A random sample was then generated from the list of households. Local setting The sampling took place in Lilongwe, Malawi and formed a pin of an investigation of the intensity of Plasmodium falciparum transmission in a multi-site Phase III trial of a candidate malaria vaccine. Relevant changes Creation of a complete list of household coordinates within the catchment area allowed us to generate a random sample representative of the population. Once the coordinates of the households in that sample had been entered into the hand-held receivers of a global positioning system device, the households could be accurately identified on the ground and approached. Lessons learnt In the development of a geographical sampling frame, the Use of Google Earth satellite imagery and geographical software appeared to be an efficient alternative to the use of a demographic surveillance system. The use of a complete list of household coordinates reduced the time needed to locate households in the random sample. Our approach to generate a sampling frame is accurate, has utility beyond morbidity studies and appears to be a cost-effective option in resource-poor settings.
Bulletin of the World Health Organisation 09/2014; 92(9):690-4. DOI:10.2471/BLT.14.140756 · 5.11 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective
To determine medical eligibility for contraceptive use, contraceptive preference, and acceptance of a copper intrauterine device (IUD) among a cohort of HIV-infected women receiving antiretroviral therapy (ART).
All HIV-infected women who received ART and sought contraceptive services at the Lighthouse clinic, an integrated HIV/ART clinic in Lilongwe, Malawi, between August and December 2010 were invited to participate in a structured interview. Eligibility and preference for the following contraceptive methods were assessed: combined hormonal contraceptives, progestogen-only pills, copper IUD, injectable depot medroxyprogesterone acetate (DMPA), and contraceptive implants.
The final sample included 281 women; five were pregnant. The remaining 276 women were eligible for at least three contraceptive methods, with 242 (87.7%) eligible for all five methods evaluated. After counseling, 163 (58.0%) selected DMPA and 98 (34.9%) selected an IUD as their preferred contraceptive method. Regardless of their method of choice, 222 (79.0%) women agreed to have an IUD placed on the same day.
Most methods of contraception are safe for use by HIV-infected women. Approximately 80% of the women were willing to receive an IUD. Efforts must be made to increase education about, and access to, long-acting reversible methods that may be acceptable and appropriate contraceptive options for HIV-infected women.
International Journal of Gynecology & Obstetrics 09/2014; 126(3). DOI:10.1016/j.ijgo.2014.03.026 · 1.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Kaposi's sarcoma (KS), caused by KS-associated herpesvirus (KSHV), is the most common cancer among HIV-infected patients in Malawi and in the United States today. In Malawi, KSHV is endemic. We conducted a cross-sectional study of patients with HIV infection and KS with no history of chemo- or antiretroviral therapy (ART). Seventy patients were enrolled. Eighty-one percent had T1 (advanced) KS. Median CD4 and HIV RNA levels were 181 cells/mm(3) and 138,641 copies/ml, respectively. We had complete information and suitable plasma and biopsy samples for 66 patients. For 59/66 (89%) patients, a detectable KSHV load was found in plasma (median, 2,291 copies/ml; interquartile range [IQR], 741 to 5,623). We utilized a novel KSHV real-time quantitative PCR (qPCR) array with multiple primers per open reading frame to examine KSHV transcription. Seventeen samples exhibited only minimal levels of KSHV mRNAs, presumably due to the limited number of infected cells. For all other biopsy samples, the viral latency locus (LANA, vCyc, vFLIP, kaposin, and microRNAs [miRNAs]) was transcribed abundantly, as was K15 mRNA. We could identify two subtypes of treatment-naive KS: lesions that transcribed viral RNAs across the length of the viral genome and lesions that displayed only limited transcription restricted to the latency locus. This finding demonstrates for the first time the existence of multiple subtypes of KS lesions in HIV- and KS-treatment naive patients.
[Show abstract][Hide abstract] ABSTRACT: Abstract
Background:A malaria vaccine could be an important addition to current control strategies. We report the safety and
vaccine efficacy (VE) of the RTS,S/AS01 vaccine during 18 mo following vaccination at 11 African sites with varying malaria
Methods and Findings:6,537 infants aged 6–12 wk and 8,923 children aged 5–17 mo were randomized to receive three
doses of RTS,S/AS01 or comparator vaccine. VE against clinical malaria in children during the 18 mo after vaccine dose 3
(per protocol) was 46% (95% CI 42% to 50%) (range 40% to 77%; VE, p,0.01 across all sites). VE during the 20 mo after
vaccine dose 1 (intention to treat [ITT]) was 45% (95% CI 41% to 49%). VE against severe malaria, malaria hospitalization, and
all-cause hospitalization was 34% (95% CI 15% to 48%), 41% (95% CI 30% to 50%), and 19% (95% CI 11% to 27%),
respectively (ITT). VE against clinical malaria in infants was 27% (95% CI 20% to 32%, per protocol; 27% [95% CI 21% to 33%],
ITT), with no significant protection against severe malaria, malaria hospitalization, or all-cause hospitalization. Postvaccination anti-circumsporozoite antibody geometric mean titer varied from 348 to 787 EU/ml across sites in children and
from 117 to 335 EU/ml in infants (per protocol). VE waned over time in both age categories (Schoenfeld residualsp,0.001).
The number of clinical and severe malaria cases averted per 1,000 children vaccinated ranged across sites from 37 to 2,365
and from21 to 49, respectively; corresponding ranges among infants were210 to 1,402 and213 to 37, respectively (ITT).
Meningitis was reported as a serious adverse event in 16/5,949 and 1/2,974 children and in 9/4,358 and 3/2,179 infants in
the RTS,S/AS01 and control groups, respectively.
Conclusions:RTS,S/AS01 prevented many cases of clinical and severe malaria over the 18 mo after vaccine dose 3, with the
highest impact in areas with the greatest malaria incidence. VE was higher in children than in infants, but even at modest
levels of VE, the number of malaria cases averted was substantial. RTS,S/AS01 could be an important addition to current
malaria control in Africa.
Trial registration:http://www.ClinicalTrials.gov NCT00866619
Please see later in the article for the Editors’ Summary
PLoS Medicine 07/2014; 11(7). DOI:10.1371/journal.pmed.1001685 · 14.00 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: In sub-Saharan Africa, although male involvement in antenatal care is associated with positive outcomes for HIV-infected women and their infants, men rarely accompany female partners. We implemented a project to increase the number of male partners attending an antenatal clinic at Bwaila Hospital in Lilongwe, Malawi. We evaluated changes in the proportion of women who came with a partner over three periods. During period 1 (January 2007 - June 2008) there was didactic peer education. During period 2 (July 2008 - September 2009) a peer-led male-involvement drama was introduced into patient waiting areas. During period 3 (October 2009 - December 2009) changes to clinical infrastructure were introduced to make the clinic more male-friendly. The proportion of women attending ANC with a male partner increased from 0.7% to 5.7%, to 10.7% over the three periods. Peer education through drama and male-friendly hospital infrastructure coincided with substantially greater male participation, although further gains are necessary.
African Journal of Reproductive Health 06/2014; 18(2):97-104.
[Show abstract][Hide abstract] ABSTRACT: To determine, for the WHO algorithm for point-of-care diagnosis of HIV infection, the agreement levels between paediatricians and non-physician clinicians, and to compare sensitivity and specificity profiles of the WHO algorithm and different CD4 thresholds against HIV PCR testing in hospitalised Malawian infants.
In 2011, hospitalised HIV-exposed infants <12 months in Lilongwe, Malawi, were evaluated independently with the WHO algorithm by both a paediatrician and clinical officer. Blood was collected for CD4 and molecular HIV testing (DNA or RNA PCR). Using molecular testing as the reference, sensitivity, specificity and positive predictive value (PPV) were determined for the WHO algorithm and CD4 count thresholds of 1500 and 2000 cells/mm(3) by paediatricians and clinical officers.
We enrolled 166 infants (50% female, 34% <2 months, 37% HIV infected). Sensitivity was higher using CD4 thresholds (<1500, 80%; <2000, 95%) than with the algorithm (physicians, 57%; clinical officers, 71%). Specificity was comparable for CD4 thresholds (<1500, 68%, <2000, 50%) and the algorithm (paediatricians, 55%, clinical officers, 50%). The positive predictive values were slightly better using CD4 thresholds (<1500, 59%, <2000, 52%) than the algorithm (paediatricians, 43%, clinical officers 45%) at this prevalence.
Performance by the WHO algorithm and CD4 thresholds resulted in many misclassifications. Point-of-care CD4 thresholds of <1500 cells/mm(3) or <2000 cells/mm(3) could identify more HIV-infected infants with fewer false positives than the algorithm. However, a point-of-care option with better performance characteristics is needed for accurate, timely HIV diagnosis.
Tropical Medicine & International Health 04/2014; DOI:10.1111/tmi.12326 · 2.30 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Patients with newly diagnosed HIV may be part of social networks with elevated prevalence of undiagnosed HIV infection. Social network recruitment by persons with newly diagnosed HIV may efficiently identify undiagnosed cases of HIV infection. We assessed social network recruitment as a strategy for identifying undiagnosed cases of HIV infection.
In a sexually transmitted infection (STI) clinic in Lilongwe, Malawi, 3 groups of 45 "seeds" were enrolled: STI patients with newly diagnosed HIV, STI patients who were HIV-uninfected, and community controls. Seeds were asked to recruit up to 5 social "contacts" (sexual or nonsexual). Mean number of contacts recruited per group was calculated. HIV prevalence ratios (PRs) and number of contacts needed to test to identify 1 new case of HIV were compared between groups using generalized estimating equations with exchangeable correlation matrices.
Mean number of contacts recruited was 1.3 for HIV-infected clinic seeds, 1.8 for HIV-uninfected clinic seeds, and 2.3 for community seeds. Contacts of HIV-infected clinic seeds had a higher HIV prevalence (PR: 3.2, 95% confidence interval: 1.3 to 7.8) than contacts of community seeds, but contacts of HIV-uninfected clinic seeds did not (PR: 1.1, 95% confidence interval: 0.4 to 3.3). Results were similar when restricted to nonsexual contacts. To identify 1 new case of HIV, it was necessary to test 8 contacts of HIV-infected clinic seeds, 10 contacts of HIV-uninfected clinic seeds, and 18 contacts of community seeds.
Social contact recruitment by newly diagnosed STI patients efficiently led to new HIV diagnoses. Research to replicate findings and guide implementation is needed.
[Show abstract][Hide abstract] ABSTRACT: Use of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1. However, the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown. We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96%. We aimed to compare the effects of early and delayed initiation of antiretroviral treatment on clinical outcomes.
The HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries. We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation, stratified by site. Random assignment was unblinded. The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study (early treatment group) or after a decline in CD4 count or with onset of an AIDS-related illness (delayed treatment group). Primary events were AIDS clinical events (WHO stage 4 HIV-1 disease, tuberculosis, and severe bacterial infections) and the following serious medical conditions unrelated to AIDS: serious cardiovascular or vascular disease, serious liver disease, end-stage renal disease, new-onset diabetes mellitus, and non-AIDS malignant disease. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00074581.
1763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group (two individuals were excluded from this group after randomisation). Median CD4 counts at randomisation were 442 (IQR 373-522) cells per μL in patients assigned to the early treatment group and 428 (357-522) cells per μL in those allocated delayed antiretroviral treatment. In the delayed group, antiretroviral treatment was initiated at a median CD4 count of 230 (IQR 197-249) cells per μL. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment (hazard ratio 0·73, 95% CI 0·52-1·03; p=0·074). New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation (0·64, 0·43-0·96; p=0·031), tuberculosis developed in 17 versus 34 patients, respectively (0·49, 0·28-0·89, p=0·018), and primary non-AIDS events were rare (12 in the early group vs nine with delayed treatment). In total, 498 primary and secondary outcomes occurred in the early treatment group (incidence 24·9 per 100 person-years, 95% CI 22·5-27·5) versus 585 in the delayed treatment group (29·2 per 100 person-years, 26·5-32·1; p=0·025). 26 people died, 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group.
Early initiation of antiretroviral treatment delayed the time to AIDS events and decreased the incidence of primary and secondary outcomes. The clinical benefits recorded, combined with the striking reduction in HIV-1 transmission risk previously reported, provides strong support for earlier initiation of antiretroviral treatment.
US National Institute of Allergy and Infectious Diseases.