No differences in clinical outcomes with the addition of viral load testing to CD4 cell count monitoring among HIV infected participants receiving ART in rural Uganda: Long-term results from the Home Based AIDS Care Project

Okoboi, Stephen; Ekwaru, Paul; Campbell, James D.; Egessa, Aggrey; King, Racheal; Bakanda, Celestin; Muramuzi, Emmy; Kaharuza, Frank; Malamba, Samuel; Moore, David

doi:10.1186/s12889-016-2781-y

Cited by 4 publications

(9 citation statements)

References 26 publications

(29 reference statements)

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“…Our findings are consistent with data previously reported in Uganda and Thailand . The Ugandan study compared clinical outcomes among patients with one of three monitoring strategies, including a clinical arm (weekly home visits), CD4 arm (quarterly CD4 cell counts and weekly home visits) and VL arm (quarterly CD4 cell count and VL testing and weekly home visits), over a median follow‐up of three years.…”

Section: Discussionmentioning

confidence: 99%

“…The study found no significant difference between the CD4 arm and the VL arm in the rate of new AIDS‐defining events or death (adjusted HR = 1.23, 95% CI = 0.82 to 1.84) . Following the initial analysis, individuals in the clinical arm were re‐randomized to the other two arms and all participants were followed up for a median follow‐up of 5.2 years . Once again, no association was found between the monitoring arms and new AIDS defining events or death (adjusted HR = 1.19 for CD4‐only vs. CD4‐VL; 95% CI 0.82 to 1.73).…”

Section: Discussionmentioning

confidence: 99%

“…It is possible that a longer follow‐up period may be needed to demonstrate the benefits of RVL monitoring. However, Okoboi followed their patents a median of 5.2 years and had similar findings to our study . Fourth, genotype resistance testing was not performed for all patients with virological failure.…”

Section: Discussionmentioning

confidence: 99%

“…Some observational and modelling studies have suggested that VL monitoring may reduce opportunistic infections (OIs) and improve survival . However, three randomized clinical trials, conducted in Uganda, Zambia and Thailand, have failed to demonstrate a difference in clinical outcomes with the addition of VL monitoring to immunological and/or clinical monitoring . A 2012 systematic review commissioned by WHO concluded that there was no difference in mortality or new AIDS‐defining illnesses between clinical plus immunological plus virological monitoring and clinical plus immunological monitoring.…”

Section: Introductionmentioning

confidence: 99%

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Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

et al. 2019

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Introduction HIV viral load (VL) testing is recommended by the WHO as the preferred method for monitoring patients on antiretroviral therapy (ART). However, evidence that routine VL (RVL) monitoring improves clinical outcomes is lacking. Methods We conducted a prospective, randomized controlled trial of RVL monitoring every six months versus a targeted VL (TVL) strategy (routine CD4 plus VL testing if clinical or immunological failure) in patients starting ART between April 2011 and April 2014 at Bach Mai Hospital in Hanoi. Six hundred and forty‐seven subjects were randomized to RVL (n = 305) or TVL monitoring (n = 342) and followed up for three years. Primary endpoints were death or WHO clinical Stage 4 events between six and thirty‐six months of ART and rate of virological suppression at three years. Results Overall, 37.1% of subjects were female, median age was 33.4 years (IQR: 29.5 to 38.6), and 47% had a CD4 count ≤100 cells/mm3 at time of ART initiation. Approximately 44% of study events (death, LTFU, withdrawal, or Stage 4 event) and 68% of deaths occurred within the first six months of ART. Among patients on ART at six months, death or Stage 4 event occurred in 3.6% of RVL and 3.9% of TVL (p = 0.823). Survival analysis showed no significant difference between the groups (p = 0.825). Viral suppression at 36 months of ART was 97.2% in RVL and 98.9% in TVL (p = 0.206) at a threshold of 400 copies/mL and was 98.0% in RVL and 98.9% in TVL (p = 0.488) at 1000 copies/mL. In ITT analysis, 20.7% in RVL and 21.9% in TVL (p = 0.693) were unsuppressed at 1000 copies/mL. Conclusions We found no significant difference in rates of death or Stage 4 events and virological failure in patients with RVL monitoring compared to those monitored with a TVL strategy after three years of follow‐up. Viral suppression rates were high overall and there were few study events among patients alive and on ART after six months, limiting the study's power to detect a difference among study arms. Nonetheless, these data suggest that the choice of VL monitoring strategy may have less impact on patient outcomes compared to efforts to reduce early mortality and improve ART retention.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

et al. 2019

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“…[ 4 ] Furthermore, initial WHO guidelines did not recommend the use of viral load (VL) testing for routine clinical monitoring, [ 4 ] given the high cost and lack of evidence regarding improved clinical outcomes associated with VL testing. [ 5 – 7 ]…”

Section: Introductionmentioning

confidence: 99%

Durability of non-nucleotide reverse transcriptase inhibitor-based first-line ART regimens after 7 years of treatment in rural Uganda

et al. 2021

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Most antiretroviral therapy (ART) programs in resource-limited settings have historically used non-nucleotide reverse transcriptase inhibitor (NNRTI)-based regimens with limited access to routine viral load (VL) testing. We examined the long-term success of these regimens in rural Uganda among participants with 1 measured suppressed VL. We conducted a prospective cohort study of participants who had been on NNRTI-based first-line regimens for ≥4 years and had a VL <1000 copies/mL at enrollment in Jinja, Uganda. We collected clinical and behavioral data every 6 months and measured VL again after 3 years. We quantified factors associated with virologic failure (VF) (VL ≥ 1000 copies/mL) using Wilcoxon Rank Sum, chi-square, and Fisher's Exact Tests. We enrolled 503 participants; 75.9% were female, the median age was 45 years, and the median duration of time on ART was 6.8 years (IQR = 6.0–7.6 years). Sixty-nine percent of participants were receiving nevirapine, lamivudine, and zidovudine regimens; 22.5% were receiving efavirenz, lamivudine, and zidovudine; and 8.6% were receiving other regimens. Of the 479 with complete follow-up data, 12 (2.5%) had VL ≥ 1000 copies/mL. VF was inversely associated with reporting never missing pills (41.7% of VFs vs 72.8% non-VFs, P = .034). There were differences in distribution of the previous ART regimens ( P = .005), but no clear associations with specific regimens. There was no association between having a VL of 50 to 999 copies/mL at enrollment and later VF ( P = .160). Incidence of VF among individuals receiving ART for nearly 7 years was very low in the subsequent 3 years. NNRTI-based regimens appear to be very durable among those with good initial adherence.

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Virological failure and treatment switch after ART initiation among people living with HIV with and without routine viral load monitoring in Asia

et al. 2022

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Introduction Viral load (VL) testing is still challenging to monitor treatment responses of antiretroviral therapy (ART) for HIV treatment programme in Asia. We assessed the association between routine VL testing and virological failure (VF) and determine factors associated with switching to second‐line regimen. Methods Among 21 sites from the TREAT Asia HIV Observational Database (TAHOD), people living with HIV (PLHIV) aged ≥18 years initiating ART from 2003 to 2021 were included. We calculated the average number of VL tests per patient per year between the date of ART initiation and the most recent visit. If the median average number of VL tests was ≥ 0.80 per patient per year, the site was classified as a routine VL site. A site with a median < 0.80 was classified into the non‐routine VL sites. VF was defined as VL ≥1000 copies/ml during first‐line therapy. Factors associated with VF were analysed using generalized estimating equations with Poisson distribution. Results Of 6277 PLHIV starting ART after 2003, 3030 (48%) were from 11 routine VL testing sites and 3247 (52%) were from 10 non‐routine VL testing sites. The median follow‐up was 9 years (IQR 5–13). The median age was 35 (30–42) years; 68% were male and 5729 (91%) started non‐nucleoside reverse‐transcriptase inhibitor‐based regimen. The median pre‐ART CD4 count in PLHIV from routine VL sites was lower compared to non‐routine VL sites (144 vs. 156 cells/mm 3 , p <0.001). Overall, 1021 subsequent VF at a rate of 2.15 (95% CI 2.02–2.29) per 100 person‐years (PY). VF was more frequent at non‐routine VL sites (adjusted incidence rate ratio 2.85 [95% CI 2.27–3.59]) compared to routine VL sites. Other factors associated with an increased rate of VF were age <50 years and CD4 count <350 cells/mm 3 . A total of 817 (13%) patients switched to second‐line regimen at a rate of 1.44 (95% CI 1.35–1.54) per 100 PY. PLHIV at routine VL monitoring sites were at higher risk of switching than those at non‐routine VL sites (adjusted sub‐hazard ratio 1.78 95% CI [1.17–2.71]). Conclusions PLHIV from non‐routine VL sites had a higher incidence of persistent VF and a low switching regimen rate, reflecting possible under‐utilized VL testing.

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No differences in clinical outcomes with the addition of viral load testing to CD4 cell count monitoring among HIV infected participants receiving ART in rural Uganda: Long-term results from the Home Based AIDS Care Project

Cited by 4 publications

References 26 publications

Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

Durability of non-nucleotide reverse transcriptase inhibitor-based first-line ART regimens after 7 years of treatment in rural Uganda

Virological failure and treatment switch after ART initiation among people living with HIV with and without routine viral load monitoring in Asia

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