Effect of Reminder Tools on Drug Adherence among Patients on Anti-retroviral Drug in Specialist Hospital Yola, Adamawa State: A Randomized Field Trial

A Minimum Of 95% Drug Adherence Is Necessary To Achieve Immunological And Virological Success In Antiretroviral Therapy, And To Attain This Level; Patients Need To Be Assisted. The Study Therefore Aimed At Comparing The Effect Of Reminder Tools On Antiretroviral Drug Adherence Among People Living With Human Immunodeficiency Virus. The Study Was A Randomised Field Trial. Questionnaire And Adherence Assessment Forms Were Administered To Two Hundred, And Twenty-Five Patients, And Information Was Elicited On Socio-Demographic History, Antiretroviral Drug Usage, And Adherence Behaviour. Alarm Clocks And Counselling Were Given To One Group, Stickers, Reminder Cards, And Counselling To The Second Group, While Counselling Alone Was Given To The Third Group As Interventions. Three Months Later, Data Were Collected From The Same Patients In Order To Compare The Effect Reminder Tools Had On Antiretroviral Drug Adherence Among The Patients. Data Were Entered Into Epi Info Version 3.5.1 2008 Statistical Software And Analyzed. The Optimum Adherence Levels Were 78.7%, 80.0%, And 84.0% At Pre-Intervention Among Groups That Had Alarm Clock With Counselling, Sticker, Reminder Card With Counselling, And Those That Had Counselling Alone Respectively. The Drug Side Effect Was Negatively Associated With Adherence Level (P< 0.05), While Pill Count Was Not Associated With Adherence Level (P>0.05). At Post-Intervention, The Adherence Levels Increased By 18.5%, 6.8%, And 1.9%, Respectively, Among Groups That Had Alarm Clock With Counselling (P<0.05), Sticker, Reminder Card With Counselling (P>0.05), And Those That Had Counselling Alone (P>0.05). The Alarm Clock Was More Effective Than Stickers And Hand-Held Cards In Improving Adherence.

Intermittent two-drug antiretroviral therapies maintain long-term viral suppression in real life in highly experienced HIV-infected patients

Objectives To assess in real life whether two-drug regimens (2-DRs) given 4–5 days a week in virally suppressed patients can maintain viral suppression over 48 and 96 weeks. Methods This observational single-centre study enrolled all patients who initiated an intermittent 2-DR between 01/01/2016 and 30/06/2019. The primary outcome was the rate of virological failure (VF), defined as confirmed plasma viral load (pVL) ≥50 copies/mL or single pVL ≥50 copies/mL followed by ART change at week 48 (W48) and W96. Secondary outcomes were the 2-DR intermittent strategy success rate (pVL &lt;50 copies/mL with no ART change), change in CD4 count, CD4/CD8 ratio and rate of residual viraemia. Results Eighty-five patients were included; 67/85 (79%) were men, median age = 57 years (IQR = 50–63), CD4 nadir = 233 cells/mm3 (110–327), ART duration = 21 years (13–24), duration of virological suppression = 6.5 years (3.7–10.8) and CD4 count = 658 cells/mm3 (519–867). Intermittent 2-DRs consisted of integrase strand transfer inhibitor (INSTI)/NNRTI (58%), INSTI/NRTI (13%), two NRTIs (11%), PI/NRTI (7%) and other combinations (11%). The median follow-up was 90 weeks (IQR = 64–111). Overall, four VFs occurred, leading to a virological success rate of 98.8% (95% CI = 93.6–100) at W48 and 95.3% (95% CI = 88.4–98.7) at W96. Resuming the same 2-DR 7 days a week led to viral resuppression in three patients, whereas the M184V mutation emerged in one patient, leading to ART modification. There was no significant change in the CD4 count or residual viraemia rate, but a small increase in the CD4/CD8 ratio (P = 0.009) occurred over the study period. Conclusions This observational study shows the potential for intermittent 2-DRs to maintain a high virological success rate, which should be assessed in larger prospective randomized studies.

Use of rilpivirine in HIV-1-infected individuals in routine clinical practice from 2012 to 2017 in France

Objectives We assessed virological outcomes of rilpivirine use in France from 2012 to 2017, in three groups of people living with HIV (PLHIV): (i) antiretroviral (ARV)-naive PLHIV; (ii) ARV-experienced PLHIV switching to rilpivirine while failing therapy; and (iii) ARV-experienced PLHIV switching to rilpivirine while virologically controlled. Methods Virological success (VS) was defined as a plasma HIV-1 viral load (VL) &lt;50 copies/mL and virological failure (VF) as two consecutive VL &gt;50 copies/mL or one VL &gt;50 copies/mL followed by a treatment switch prior to the next VL measurement. The cumulative incidence of VS was assessed considering rilpivirine discontinuation, loss to follow-up and death as competing risks, while estimates of cumulative incidence of VF accounted for loss to follow-up and death. Results Among the 2166 ARV-naive PLHIV initiating rilpivirine, the 4 year cumulative incidence of VS was 91.0% and was associated with baseline VL. Among the 2125 ARV-experienced PLHIV switching to rilpivirine while failing therapy, the 4 year cumulative incidence of VS was 82.5% and was associated with lower VL, higher CD4 and less than three prior ARVs. Among the 11 828 ARV-experienced PLHIV switching to rilpivirine while virologically controlled, the 4 year cumulative incidence of VF was 9.6%. The risk of VF was lower among MSM, for PLHIV with CD4 ≥ 500 cell/mm3, without a prior AIDS event, or with a longer VL suppression at baseline. Conclusions Rilpivirine-containing regimens yielded high rates of viral suppression in most participants, while it was ineffective when used outside the marketing authorization in naive participants.

Impact of archived M184V/I mutation on the effectiveness of switch to co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide among virally suppressed people living with HIV

Objectives Real-world experience regarding the effectiveness of co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (EVG/C/FTC/TAF) as a switch regimen is sparse among people living with HIV (PLWH) harbouring the M184V/I mutation with or without thymidine analogue-associated mutations (TAMs). Methods In this retrospective multicentre study, PLWH who were switched to EVG/C/FTC/TAF after having achieved viral suppression (plasma HIV RNA &lt;200 copies/mL) for 6 months or longer were included. Patients with archived M184V/I mutation (case patients) were matched to controls without M184V/I mutation at a 1:4 ratio. Patients with a history of virological failure or resistance to elvitegravir were excluded. The primary endpoint was virological non-success (plasma HIV RNA ≥50 copies/mL) at Week 48 of switch using a modified FDA snapshot analysis. Results Overall, 100 case patients with the M184V/I mutation were identified, including 6 (6.0%) with K65R and 13 (13.0%) with at least one TAM, and were matched to 400 controls in terms of gender, age (mean = 40.3 versus 39.7 years) and cumulative exposure duration to tenofovir disoproxil fumarate (median = 146 versus 143 weeks). At Week 48, the rate of virological non-success for the case patients and controls was 5.0% (5/100) and 3.3% (13/400), respectively (difference = 1.7%; 95% CI = −2.9%–6.3%), while the rate of virological success was 88.0% and 89.5% for the case patients and controls, respectively. The presence of the K65R mutation or TAMs was not associated with virological non-response. Conclusions Among virally suppressed PLWH, EVG/C/FTC/TAF is effective in maintaining viral suppression at Week 48 despite archived M184V/I mutation with or without TAMs.

HIV MDR is still a relevant issue despite its dramatic drop over the years

Objectives To evaluate the prevalence and therapeutic relevance of drug resistance among isolates from ART-experienced HIV-1-infected patients over the past two decades in Italy. Methods Dynamics of resistance to one, two and three or more antiretroviral classes were evaluated from 1999–2018. Virological success (VS) after the latest therapy switch was evaluated according to cumulative class resistance and cumulative genotypic susceptibility score (Stanford HIV_DB algorithm). Results Among 13 663 isolates (from 6739 patients), resistance to at least one drug class decreased sharply from 1999 to 2010 (≤2001, 84.6%; 2010, 43.6%; P &lt; 0.001), then remained relatively constant at ∼40% during 2010–18, with the proportion of resistance to three or more classes also stable (∼5%). After 2008, integrase inhibitor resistance slightly increased from 5.6% to 9.7% in 2018 and contributed to resistance, particularly in isolates with resistance to three or more classes (one class, 8.4%; two classes, 15.3%; three or more classes, 34.7%, P &lt; 0.001). Among 1827 failing patients with an available follow-up, by 1 year after genotype-guided therapy start the probability of VS was 87.6%. Patients with cumulative resistance to three or more classes and receiving a poorly active regimen showed the lowest probability (62.6%) of VS (P &lt; 0.001) compared with all other patients (≥81.8%). By Cox regression analysis, cumulative MDR and receiving poorly active antiretroviral regimens were associated with a lower hazard of VS compared with those without resistance. Conclusions A dramatic drop of HIV-1 drug resistance at failure has been achieved over the last two decades in Italy; resistance to three or more classes is low but present among currently failing patients. Its management still requires a rational and careful diagnostic and therapeutic approach.

Efficacy of intermittent short cycles of integrase inhibitor-based maintenance ART in virologically suppressed HIV patients

Background Several studies have shown that NNRTI/PI-based triple therapy could be safely administered as a 4 days (4D) or 5 days (5D) a week maintenance strategy. We report here our experience of using an integrase inhibitor (INSTI)-based 4D/5D regimen in virologically suppressed HIV patients. Methods This cohort study enrolled adult patients on ART with viral load (VL) &lt;50 copies/mL for &gt;1 year, who switched to an INSTI-based triple regimen given 4D/5D a week. The primary endpoint was the virological efficacy rate at Week (W) 48, with virological failure defined as confirmed VL ≥50 copies/mL. Results A total of 73 patients were included (n = 28 for 4D, n = 45 for 5D): 54 men (74%), median (IQR) age 51 (45–57) years, ART duration 10 (6–18) years and duration of viral suppression 5 (2–9) years at baseline. As of 25 March 2019, the median follow-up was 21 (14–35) months, with a total of 161 patient-years of follow-up; all patients had reached the W24 visit, 66 (90%) W48 and 34 (47%) W96. Four patients discontinued the strategy: virological failure (n = 2) at W60 and W67, respectively, switch for renal toxicity (n = 1) at W28 and switch to rilpivirine/dolutegravir (n = 1) at W65. Overall the rate of virological success (95% CI) was 100% (94%–100%) at W24 and W48 and 93.7% (79.8%–98.2%) at W96. Conclusions While waiting for the final results of the large randomized QUATUOR ANRS-170 study, our real-life results suggest that the use of an intermittent maintenance triple-drug regimen given as a weekend (2 or 3 days) off is as effective with an INSTI-based regimen as with a PI or an NNRTI.

Factors Affecting Virological Outcome When First-Line Antiretroviral Therapy Is Reintroduced After Unplanned Interruption

There is no guideline concerning choice of antiretroviral therapy (ART) for HIV-infected patients after unplanned interruption. We conducted a retrospective cohort study of HIV-infected patients reintroduced to first-line ART after having unplanned interruption for at least 1 month. Viral load was evaluated at 6 to 18 months after the reintroduction. There were 100 patients included in our study, and 55 of them achieved virological success. History of single interruption (adjusted odds ratio [aOR] 5.51%, 95% confidence interval [CI] 1.82-16.68, P = .003) and CD4 count ≥200 cell/mm3 at the time of reintroduction (aOR 4.33, 95% CI 1.14-16.39, P = .031) increased likelihood to achieve virological success.

Efficacy and safety of pegylated-interferon alpha therapy in patients with chronic hepatitis B in recource-limited settings- Serbian single-center experience

Background/Aim. In Serbia, pegylated interferon (PEGIFN) alpha-2a has been registered since 2013 for the treatment of patients with chronic hepatitis B (CHB). Numerous advantages, new experiences during the past five years and lack of any published data in our specific population, have initiated this study, with the aim to examine efficacy and safety of PEG-IFN in patients in a Serbian referral center. Methods. This prospective study included 36 patients with CHB who were treated in the Hepatology Department of the Clinic for Infectious and Tropical Diseases, Clinical Center of Serbia in Belgrade, during 2012?2017. Patients had a standard 48-week treatment protocol with PEG-IFN, with measurements of liver enzymes, serology and viraemia before, during, at the end of the treatment and follow-up 6 months afterwards. Treatment outcome was determined using serology (clearance of HBeAg), biochemical [normalization of alanine aminotransferase (ALT)] and virological response [hepatitis B virus (HBV) DNA < 2,000 IU/mL]. Results. Virological success in patients with HBeAg positive CHB was achieved in 50% of patients, HBeAg clearance in 62.5%, and normalization of ALT in 37.5% of patients. In patients with HBeAg negative CHB, 38% of the patients achieved virologic success, biochemical success was obtained in 47.6% of the patients and only one (4.7%) patient had HBsAg clearance. Conclusion. PEG-IFN is important for treatment of patients with CHB in well-defined situations, and in our population success rates are similar to other published studies. Although safety and tolerability are satisfactory, there is a possibility of more serious side-effects so it is necessary to monitor patients regularly during the treatment.