scholarly journals Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring

2018 ◽  
Vol 69 (3) ◽  
pp. 523-529 ◽  
Author(s):  
Sharon A Riddler ◽  
Jennifer E Balkus ◽  
Urvi M Parikh ◽  
John W Mellors ◽  
Carolyne Akello ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Disease Progression ◽  
Virologic Failure ◽  
Vaginal Ring ◽  
Phase Iii ◽  
Virologic Suppression ◽  
Cell Counts ◽  
The Impact ◽  
Hiv 1

Abstract Background A vaginal ring containing dapivirine, a non-nucleoside human immunodeficiency virus (HIV)-1 reverse transcriptase inhibitor (NNRTI), was safe and effective in preventing HIV-1 infection in African women. We examined the impact of dapivirine ring use at the time of HIV-1 acquisition on subsequent HIV-1 disease progression and responses to NNRTI-containing antiretroviral therapy (ART). Methods HIV-1 disease progression and virologic failure following initiation of ART were assessed among women who acquired HIV-1 while participating in Microbicide Trials Network–020, a randomized, placebo-controlled trial of a monthly, dapivirine vaginal ring. Results Among the 158 participants who acquired HIV-1 (65 dapivirine, 93 placebo), no differences between dapivirine and placebo participants were observed in CD4+ cell counts or plasma HIV-1 RNA over the first year after infection (prior to ART). During follow-up, 100/158 (63%) participants initiated NNRTI-containing ART (dapivirine: 39/65; placebo: 61/93); the median time to HIV-1 RNA <200 copies/ml was approximately 90 days for both dapivirine and placebo ring recipients (log-rank P = .40). Among the 81 participants with at least 6 months of post-ART follow-up, 19 (24%) experienced virologic failure (dapivirine: 6/32, 19%; placebo: 13/39, 27%; P = .42). Conclusions The acquisition of HIV-1 infection during dapivirine or placebo treatment in ASPIRE did not lead to differences in HIV-1 disease progression. After the initiation of NNRTI-containing ART, dapivirine and placebo participants had similar times to virologic suppression and risks of virologic failure. These results provide reassurance that NNRTI-based ART regimens are effective among women who acquired HIV-1 while receiving the dapivirine vaginal ring. Clinical Trials Registration NCT016170096 and NCT00514098.

scholarly journals Racial Disparities in Virologic Failure and Tolerability During Firstline HIV Antiretroviral Therapy

2019 ◽  
Vol 6 (2) ◽  
Author(s):  
Priya Bhagwat ◽  
Shashi N Kapadia ◽  
Heather J Ribaudo ◽  
Roy M Gulick ◽  
Judith S Currier
Keyword(s):  
Antiretroviral Therapy ◽  
Adverse Events ◽  
Socioeconomic Factors ◽  
Ethnic Groups ◽  
Virologic Failure ◽  
Virologic Suppression ◽  
Factors Associated ◽  
Race Ethnicity ◽  
The Impact ◽  
Racial Ethnic

Abstract Background Racial/ethnic disparities in HIV outcomes have persisted despite effective antiretroviral therapy. In a study of initial regimens, we found viral suppression varied by race/ethnicity. In this exploratory analysis, we use clinical and socioeconomic data to assess factors associated with virologic failure and adverse events within racial/ethnic groups. Methods Data were from AIDS Clinical Trial Group A5257, a randomized trial of initial regimens with either atazanavir/ritonavir, darunavir/ritonavir, or raltegravir (each combined with tenofovir DF and emtricitabine). We grouped participants by race/ethnicity and then used Cox-proportional hazards regression to examine the impact of demographic, clinical, and socioeconomic factors on the time to virologic suppression and time to adverse event reporting within each racial/ethnic group. Results We analyzed data from 1762 participants: 757 self-reported as non-Hispanic black (NHB), 615 as non-Hispanic white (NHW), and 390 as Hispanic. The proportion with virologic failure was higher for NHB (22%) and Hispanic (17%) participants compared with NHWs (9%). Factors associated with virologic failure were poor adherence and higher baseline HIV RNA level. Prior clinical AIDS diagnosis was associated with virologic failure for NHBs only, and unstable housing and illicit drug use for NHWs only. Factors associated with adverse events were female sex in all groups and concurrent use of medications for comorbidities in NHB and Hispanic participants only. Conclusions Clinical and socioeconomic factors that are associated with virologic failure and tolerability of antiretroviral therapy vary between and within racial and ethnic groups. Further research may shed light into mechanisms leading to disparities and targeted strategies to eliminate those disparities.

scholarly journals 1024. Impact of Treatment Adherence on Efficacy of DTG/3TC and DTG + TDF/FTC: Pooled Analysis of the GEMINI 1 and 2 Clinical Trials

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S541-S542
Author(s):  
Mounir Ait-Khaled ◽  
Choy Man ◽  
Jorg Sievers ◽  
Richard Grove ◽  
Brian Wynne ◽  
...  
Keyword(s):  
Treatment Adherence ◽  
Panel Member ◽  
Phase Iii ◽  
Research Support ◽  
Review Panel ◽  
Cell Counts ◽  
The Impact ◽  
Hiv 1 ◽  
Adherence Group ◽  
Lower Adherence

Abstract Background GEMINI 1 & 2 are global double-blind, multi-center phase III non-inferiority studies evaluating efficacy and safety of dolutegravir (DTG) + lamivudine (3TC) once daily in treatment-naive HIV-1-infected adults with Screening HIV-1 RNA ≤ 500,000 c/mL (ClinicalTrials.gov: NCT02831673/NCT02831764). Participants were randomized 1:1 to treatment with DTG+3TC or DTG + tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). The primary endpoint was the proportion of participants with plasma HIV-1 RNA &lt; 50 c/mL at Week 48 (Snapshot algorithm). DTG+3TC was non-inferior to DTG+TDF/FTC at Weeks 48 and 96. Here we evaluate the impact of treatment adherence on Week 48 virologic response (VR) within the GEMINI trials as a post-hoc analysis. Methods Adherence was estimated using pill counts data and categorized as follows: ≥ 90% vs &lt; 90%. Week 48 VR was measured as % of participants with HIV-1 RNA &lt; 50 c/mL by Food and Drug Administration Snapshot and by last on treatment viral load (VL) for the intention to treat–exposed population for which adherence could be derived. VR and differences between treatment arms within each adherence category were calculated along with exact unadjusted 95% confidence intervals. Results 5% of participants had &lt; 90% adherence in both treatment arms. Baseline VL and CD4+ cell counts were similar across adherence categories. VR was lower in the &lt; 90% adherence group than the ≥ 90% group, but not different between the 2 treatment arms within the same adherence category: In the low adherence group, DTG+3TC VR was 69% compared to 65% in DTG+TDF/FTC arm by Snapshot and 91% and 85% respectively by last on treatment VL analysis (Table). Table. Conclusion In the GEMINI studies, a lower Week 48 VR was observed in participants with &lt; 90% adherence, but the impact of lower adherence on VR was similar in the DTG+3TC compared with DTG+TDF/FTC arms. One limitation of the analysis is the small number of participants in the lower adherence subgroup. However, the results add further information about the robustness of DTG+3TC compared to 3-drug DTG-containing regimens and may suggest similar regimen forgiveness. Disclosures Mounir Ait-Khaled, PhD, ViiV Healthcare (Employee, Shareholder) Choy Man, BSc, ViiV Healthcare (Employee, Shareholder) Jorg Sievers, DPhil, ViiV Healthcare (Employee) Richard Grove, MSc, GSK/ViiV (Employee, Shareholder) Brian Wynne, MD, ViiV Healthcare (Employee) Rimgaile Urbaityte, MSc, GlaxoSmithKline (Employee, Shareholder) Jean A. van Wyk, MB,ChB, ViiV Healthcare (Employee, Shareholder) Debbie Hagins, MD, Gilead Sciences Inc. (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)Janssen (Grant/Research Support)Merck (Consultant, Grant/Research Support, Advisor or Review Panel member)Viiv Healthcare (Consultant, Grant/Research Support, Advisor or Review Panel member) Andrew Zolopa, MD, ViiV Healthcare (Employee)

scholarly journals Safety and Effectiveness of Switching to Abacavir/Lamivudine Plus Rilpivirine for Maintenance Therapy in Virologically Suppressed HIV-1 Patients in Singapore (SEALS)

2020 ◽  
Author(s):  
Alvin ZC Lim ◽  
Grace SR ◽  
Junhao Ang ◽  
Christine BC Teng ◽  
Li Wei Ang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Maintenance Therapy ◽  
Primary Outcome ◽  
Virologic Failure ◽  
Resistance Testing ◽  
Virologic Suppression ◽  
International Studies ◽  
Resistance Mutations ◽  
Hiv 1

Abstract BackgroundThe efficacy and tolerability of an antiretroviral regimen are important considerations for selection of HIV-1 infection maintenance therapy. Abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV) has been shown in international studies to be effective and well-tolerated in virologically suppressed patients. This study evaluated the effectiveness and safety of switching to ABC/3TC+RPV as maintenance therapy in virologically suppressed HIV-1 infected patients in Singapore.MethodsIn this retrospective, single-centre study, we included patients who were prescribed ABC/3TC+RPV, had HIV-1 RNA <50 copies/ml immediately pre-switch, and had no documented history of resistance mutations or virologic failure to any of the components. Patients were followed up for 48+12 weeks. The primary outcome was the proportion of patients who maintained virologic suppression of HIV-1 RNA <50 copies/ml at the end of follow-up period based on on-treatment analysis. The secondary outcomes were the resistance profiles associated with virologic failure, changes in immunologic and metabolic parameters, and the safety profile of ABC/3TC+RPV.ResultsA total of 222 patients were included in the study. The primary outcome was achieved in 197 patients [88.8%, 95% confidence interval: 83.7%-92.4%]. There were 21 patients (9.5%) who discontinued treatment for non-virologic reasons. The remaining 4 patients experienced virologic failure, of whom, 3 of these patients had developed emergent antiretroviral resistance and had HIV-1 RNA >500 copies/ml at the end of the 48+12 weeks follow-up period. The remaining patient experienced sustained low level viremia and subsequently achieved viral suppression without undergoing resistance testing. A total of 49 adverse events were observed in 31 out of 222 patients (14.0%), which led to 13 patients discontinuing therapy. Neuropsychiatric adverse events were most commonly observed (57.1%). A statistically significant increase in CD4 was observed (p<0.01), with a median absolute change of 31 cells/uL (interquartile range: -31.50 to 140.75). No significant changes in lipid profiles were detected. ConclusionABC/3TC+RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 patients with in Singapore.

scholarly journals Impact of Integrase Sequences From HIV-1 Subtypes A6/A1 on the In Vitro Potency of Cabotegravir or Rilpivirine

2022 ◽  
Author(s):  
Jerry L. Jeffrey ◽  
Marty St. Clair ◽  
Ping Wang ◽  
Chunfu Wang ◽  
Zhufang Li ◽  
...  
Keyword(s):  
Virologic Failure ◽  
Fold Change ◽  
Effective Capacity ◽  
Virologic Suppression ◽  
Subtype B ◽  
Long Acting ◽  
Breakthrough Experiments ◽  
The Impact ◽  
Hiv 1

The FLAIR study demonstrated noninferiority of monthly long-acting cabotegravir + rilpivirine vs daily oral dolutegravir/abacavir/lamivudine for maintaining virologic suppression. Three participants who received long-acting therapy had confirmed virologic failure (CVF) at Week 48, and all had HIV-1 that was originally classified as subtype A1 and contained the baseline integrase polymorphism L74I; updated classification algorithms reclassified all 3 as HIV-1 subtype A6. Retrospectively, the impact of L74I on in vitro sensitivity and durability of response to cabotegravir in HIV-1 subtype B and A6 backgrounds was studied. Site-directed L74I and mutations observed in participants with CVF were generated in HIV-1 subtype B and a consensus integrase derived from 3 subtype A6 CVF baseline sequences. Rilpivirine susceptibility was assessed in HIV-1 subtype B and A1 containing reverse transcriptase mutations observed in participants with CVF. HIV-1 subtype B L74I and L74I/G140R mutants and HIV-1 subtype A6 I74L and I74/G140R mutants remained susceptible to cabotegravir; L74I/Q148R double mutants exhibited reduced susceptibility in HIV-1 subtypes B and A6 (half maximal effective capacity fold change, 4.4 and 4.1, respectively). Reduced rilpivirine susceptibility was observed across HIV-1 subtypes B and A1 with resistance-associated mutations K101E or E138K (half maximal effective capacity fold change, 2.21 to 3.09). In cabotegravir breakthrough experiments, time to breakthrough was similar between L74 and I74 viruses across HIV-1 subtypes B and A6; Q148R was selected at low cabotegravir concentrations. Therefore, the L74I integrase polymorphism did not differentially impact in vitro sensitivity to cabotegravir across HIV-1 subtype B and A6 integrase genes (ClinicalTrials.gov identifier: NCT02938520).

scholarly journals Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS)

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Z. C. Lim ◽  
G. S. Hoo ◽  
J. H. Ang ◽  
C. B. Teng ◽  
L. W. Ang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Maintenance Therapy ◽  
Primary Outcome ◽  
Virologic Failure ◽  
Resistance Testing ◽  
Virologic Suppression ◽  
International Studies ◽  
Resistance Mutations ◽  
Hiv 1

Abstract Background The efficacy and tolerability of an antiretroviral regimen are important considerations for selection of HIV-1 infection maintenance therapy. Abacavir/lamivudine plus rilpivirine (ABC/3TC + RPV) has been shown in international studies to be effective and well-tolerated in virologically suppressed individuals. This study evaluated the effectiveness and safety of switching to ABC/3TC + RPV as maintenance therapy in virologically suppressed HIV-1 infected individuals in Singapore. Methods In this retrospective, single-centre study, we included individuals who were prescribed ABC/3TC + RPV, had HIV-1 viral load (VL) < 50 copies/ml immediately pre-switch, and had no documented history of resistance mutations or virologic failure to any of the components. The follow-up period was 48 ± 12 weeks. The primary outcome was the proportion of individuals who maintained virologic suppression of HIV-1 VL < 50 copies/ml at the end of follow-up period based on on-treatment analysis. The secondary outcomes were the resistance profiles associated with virologic failure, changes in immunologic and metabolic parameters, and the safety profile of ABC/3TC + RPV. Results A total of 222 individuals were included in the study. The primary outcome was achieved in 197 individuals [88.8%, 95% confidence interval: 83.7–92.4%]. There were 21 individuals (9.5%) who discontinued treatment for non-virologic reasons. The remaining 4 individuals experienced virologic failure, of whom, 3 of these individuals had developed emergent antiretroviral resistance and had HIV-1 VL > 500 copies/ml at the end of the 48 ± 12 weeks follow-up period. The remaining individual experienced sustained low level viremia and subsequently achieved viral suppression without undergoing resistance testing. A total of 49 adverse events were observed in 31 out of 222 individuals (14.0%), which led to 13 individuals discontinuing therapy. Neuropsychiatric adverse events were most commonly observed (53.1%). A statistically significant increase in CD4 was observed (p < 0.01), with a median absolute change of 31 cells/uL (interquartile range: − 31.50 to 140.75). No significant changes in lipid profiles were detected. Conclusion ABC/3TC + RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 individuals with in Singapore.

scholarly journals Safety of monitoring antiretroviral therapy response in HIV-1 infection using CD4+ T cell count at long-term intervals

2018 ◽  
Vol 34 (10) ◽  
Author(s):  
Ingridt Hildegard Vogler ◽  
Daniela Frizon Alfieri ◽  
Heloisa Damazio Bruna Gianjacomo ◽  
Elaine Regina Delicato de Almeida ◽  
Edna Maria Vissoci Reiche
Keyword(s):  
Viral Load ◽  
T Cell ◽  
Antiretroviral Therapy ◽  
Sustained Virologic Response ◽  
Virologic Response ◽  
Cd4 T Cell ◽  
Cell Counts ◽  
Hiv 1 ◽  
Cd4 T Cell Count

Abstract: The latest Brazilian guideline recommended the reduction of routine CD4+ T cell counts for the monitoring of patients with human immunodeficiency virus type 1 (HIV-1) under combination antiretroviral therapy (cART). The aim of this study was to evaluate the safety of monitoring response to cART in HIV-1 infection using routine viral load at shorter intervals and CD4+ T cell count at longer intervals. CD4+ T cell counts and HIV-1 viral load were evaluated in 1,906 HIV-1-infected patients under cART during a three-year follow-up. Patients were stratified as sustained, non-sustained and non-responders. The proportion of patients who showed a CD4+ T > 350cells/µL at study entry among those with sustained, non-sustained and non-responders to cART and who remained with values above this threshold during follow-up was 94.1%, 81.8% and 71.9%, respectively. HIV-1-infected patients who are sustained virologic responders and have initial CD4+ T cell counts > 350cells/µL showed a higher chance of maintaining the counts of these cells above this threshold during follow-up than those presenting CD4+ T ≤ 350cells/µL (OR = 39.9; 95%CI: 26.5-60.2; p < 0.001). This study showed that HIV-1-infected patients who had sustained virologic response and initial CD4+ T > 350cells/µL were more likely to maintain CD4+ T cell counts above this threshold during the next three-year follow-up. This result underscores that the evaluation of CD4+ T cell counts in longer intervals does not impair the safety of monitoring cART response when routine viral load assessment is performed in HIV-1-infected patients with sustained virologic response.

scholarly journals Real-World Experience with Dolutegravir-Based Two-Drug Regimens

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Douglas Ward ◽  
Moti Ramgopal ◽  
David J. Riedel ◽  
Cindy Garris ◽  
Shelly Dhir ◽  
...  
Keyword(s):  
Virologic Failure ◽  
Retrospective Chart Review ◽  
Virologic Suppression ◽  
Prior Art ◽  
The Us ◽  
Drug Regimens ◽  
Hiv 1 ◽  
Treatment Simplification

Background. Dolutegravir-based 2-drug regimens (DTG 2DRs) are now accepted as alternatives to 3-drug regimens for HIV antiretroviral treatment (ART); however, literature on physician drivers for prescribing DTG 2DR is sparse. This study evaluated treatment patterns of DTG 2DR components in clinical practice in the US. Methods. This was a retrospective chart review in adult patients in care in the US with HIV-1 who received DTG 2DR prior to July 31, 2017, with follow-up until January 30, 2018. Primary objectives of the study were to determine reasons for patients initiating DTG 2DR and to describe the demographics and clinical characteristics. All analyses were descriptive. Results. Overall, 278 patients received DTG 2DR (male: 70%; mean age: 56 years). Most patients were treatment experienced (98%), with a mean 13.5 years of prior ART. DTG was most commonly paired with darunavir (55%) or rilpivirine (27%). The most common physician-reported reasons for initiating DTG 2DR were treatment simplification/streamlining (30%) and avoidance of potential long-term toxicities (20%). Before starting DTG 2DR, 42% of patients were virologically suppressed; of those, 95% maintained suppression while on DTG 2DR. Of the 50% of patients with detectable viral load before DTG 2DR, 79% achieved and maintained virologic suppression on DTG 2DR during follow-up. There were no virologic data for 8% of patients prior to starting DTG 2DR. Only 15 patients discontinued DTG 2DR, of whom 4 (27%) discontinued due to virologic failure. Conclusions. Prior to commercial availability of the single-tablet 2DRs, DTG 2DR components were primarily used in treatment-experienced patients for treatment simplification and avoidance of long-term toxicities. Many of these patients achieved and maintained virologic suppression, with low discontinuation rates.

scholarly journals Virologic suppression in response to antiretroviral therapy despite extensive resistance within HIV-1 reverse transcriptase after the first virologic failure

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Marta Iglis Oliveira ◽  
Valter Romão de Souza Junior ◽  
Claudia Fernanda de Lacerda Vidal ◽  
Paulo Sérgio Ramos de Araújo
Keyword(s):  
Antiretroviral Therapy ◽  
Reverse Transcriptase ◽  
Virologic Failure ◽  
Virologic Suppression ◽  
Hiv 1

scholarly journals 1029. Long-Term Patient Adherence and Management of Treatment Interruptions With Long-Acting Injectable Cabotegravir + Rilpivirine for Maintenance Therapy in Phase IIb/III Studies

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S544-S544
Author(s):  
Paula Teichner ◽  
Sterling Wu ◽  
Feifan Zhang ◽  
David Dorey ◽  
Ronald D’Amico ◽  
...  
Keyword(s):  
Patient Adherence ◽  
Treatment Interruption ◽  
Phase Iii ◽  
Virologic Suppression ◽  
Pivotal Phase ◽  
Treatment Interruptions ◽  
Long Acting ◽  
Hiv 1

Abstract Background Cabotegravir (CAB) and rilpivirine (RPV) are under development as a novel long-acting (LA) regimen for maintenance of HIV virologic suppression. Pooled data from pivotal phase III trials demonstrated noninferiority of CAB + RPV LA given as gluteal intramuscular injections vs current antiretroviral regimen (CAR) on the primary endpoint of HIV-1 ribonucleic acid (RNA) ≥50c/mL at Week 48, with high levels of adherence. Long-term adherence to dosing visits and outcomes after use of oral CAB+RPV to cover planned missed injections in FLAIR through Week 96 and in LATTE-2 through Week 256 is reported here. Methods Virologically suppressed participants (HIV-1 RNA &lt; 50c/mL) were randomized to switch to CAB+RPV LA or to continue CAR. On-time injections occurred every 4 weeks or every 8 weeks (LATTE-2 only) within a ±7-day dosing window of the projected dosing date. Adherence to LA therapy was calculated as the number of on-time injection visits divided by the number of expected dosing visits through the period of follow up. Injection visits outside the prespecified window and missed injection visits with or without use of oral dosing were characterized. Results Of 6005 expected injection visits through Week 96 in FLAIR, 97% of injections were given within the allowed ±7-day dosing window, with 43% on the projected dosing date. 45 (&lt; 1%) injection visits were early and 107 (2%) were late. Adherence to 9803 expected injection visits in LATTE-2, through Week 256, was similarly high, with 96% of injections given within the allowed ±7-day dosing window and 39% on the projected dosing date. For 31 missed injection visits in 18 participants across both trials, 30 were covered with oral CAB+RPV, with all participants maintaining HIV-1 RNA &lt; 50c/mL through the last study visit. In those participants who used oral CAB + RPV for planned treatment interruptions, 3 had repeat use on ≥2 separate occasions. Conclusion Participants maintained high levels of long-term adherence to CAB+RPV LA, through 2-5 years of follow up, with 97% of injections given within the ±7-day dosing window in the FLAIR and LATTE-2 clinical trials. Oral CAB+RPV to cover planned missed visits provides an effective strategy to maintain virologic suppression during short periods of LA treatment interruption. Disclosures Paula Teichner, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sterling Wu, PhD, GlaxoSmithKline (Employee, Shareholder) David Dorey, MMATH, GlaxoSmithKline Inc. (Employee, Shareholder) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Kenneth Sutton, MA, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Cynthia C. McCoig, MD, ViiV Healthcare (Employee) Joseph Polli, PhD, FAAPS, ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Rodica Van Solingen-Ristea, MD, Janssen R&D (Employee) Kati Vandermeulen, M.SC., Janssen Pharmaceutica (Employee, Shareholder) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) Parul Patel, PharmD, ViiV Healthcare (Employee)

scholarly journals Emergence of Drug Resistance in Human Immunodeficiency Virus Type 1 Infected Patients from Pune, India, at the End of 12 Months of First Line Antiretroviral Therapy Initiation

ISRN AIDS ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Rajesh T. Patil ◽  
Rajiv M. Gupta ◽  
Sourav Sen ◽  
Srikanth P. Tripathy ◽  
Devidas N. Chaturbhuj ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Antiretroviral Therapy ◽  
Virologic Failure ◽  
First Line ◽  
Nnrti Resistance ◽  
Art Initiation ◽  
Cell Counts ◽  
Immunodeficiency Virus ◽  
Hiv 1

Introduction. In India, 4,86,173 HIV infected patients are on first line antiretroviral therapy (ART) as of January 2012. HIV drug resistance (HIVDR) is drug and regimen-specific and should be balanced against the benefits of providing a given ART regimen. Material & Methods. The emergence of HIVDR mutations in a cohort of 100 consecutive HIV-1 infected individuals attending ART centre, on first line ART for 12 months, was studied. CD4+ T-cell counts and plasma HIV-1 RNA level were determined. Result. Out of the 100 HIV-1 infected individuals, 81 showed HIVDR prevention (HIV-1 RNA level < 1000/mL), while the remaining 19 had HIV-1 viral RNA level > 1000/mL. HIVDR genotyping was carried out for individuals with evidence of virologic failure (HIV-1 RNA level > 1000/mL). The most frequent NRTI-associated mutation observed was M184V, while K103N/S was the commonest mutation at NNRTI resistance position. Conclusion. Our study has revealed the emergence of HIVDR in HIV-1 infected patients at the end of 12 months of first line ART initiation. For NRTIs, the prevalence of HIVDR mutations was 9% and 10% for NNRTIs. Our findings will contribute information in evidence-based decision making with reference to first and second line ART delivery and prevention of HIVDR emergence.

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