Initiation Of Raltegravir Research Articles

Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.

Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) ≥200 copies/mL at 24 weeks or as a single determination of VL ≥1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/μL were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available.

Optimising neonatal antiretroviral therapy using raltegravir: a qualitative analysis of healthcare workers’ and caregivers’ perspectives

BackgroundIn 2020, Zimbabwe adopted the WHO’s recommendation to use raltegravir (RAL) granule-based regimens for treatment of neonates identified with HIV at the time of birth testing. This study explores the...

Raltegravir Inclusion Decreases CD4 T-Cells Intra-Cellular Viral Load and Increases CD4 and CD28 Positive T-Cells in Selected HIV Patients.

Raltegravir (RLT) prevents the integration of HIV DNA in the nucleus, but published studies remain controversial, suggesting that it does not decrease proviral DNA. However, there are only a few studies focused on virus-targeted cells. We aimed our study on the impact of RLT inclusion on total intra-cellular viral DNA (TID) in cellular subsets and immune effects in patients with newly acquired undetectable plasmatic viral load (UVL). Six patients having UVL using an antiretroviral combination for 6 months and CD4 T-cells > 350/mL and <500/mL were selected to receive RLT for 3 months from M0 to M3. Patients had 7 sequential viro-immunological determinations from M-1 to M5. Immune phenotypes were determined by flow cytometry and TID quantification was performed using PCR assay on purified cells. TID (median values) at the initiation of RLT in CD4 T-cells was 117 copies/millions of cells, decreased to 27.5 on M3, and remained thereafter permanently under the cut-off (<10 copies/millions of cells) in 4 out of 6 patients. This was associated with an increase of CD4 and CD4 + CD28+ T-cells and a decrease of HLA-DR expression and apoptosis of CD4 T-cells. RLT inclusion led to decreases in the viral load along with positive immune reconstitution, mainly for CD4 T-cells in HIV patients.

Virologic suppression and CD4+ cell count recovery after initiation of raltegravir or efavirenz-containing HIV treatment regimens.

To explore the effectiveness of raltegravir-based antiretroviral therapy (ART) on treatment response among ART-naive patients seeking routine clinical care. Cohort study of adults enrolled in HIV care in the United States. We compared virologic suppression and CD4 cell count recovery over a 2.5 year period after initiation of an ART regimen containing raltegravir or efavirenz using observational data from a US clinical cohort, generalized to the US population of people with diagnosed HIV. We accounted for nonrandom treatment assignment, informative censoring, and nonrandom selection from the US target population using inverse probability weights. Of the 2843 patients included in the study, 2476 initiated the efavirenz-containing regimen and 367 initiated the raltegravir-containing regimen. In the weighted intent-to-treat analysis, patients spent an average of 74 (95% confidence interval: 41, 106) additional days alive with a suppressed viral load on the raltegravir regimen than on the efavirenz regimen over the 2.5-year study period. CD4 cell count recovery was also superior under the raltegravir regimen. Patients receiving raltegravir spent more time alive and suppressed than patients receiving efavirenz, but the probability of viral suppression by 2.5 years after treatment was similar between groups. Optimizing the amount of time spent in a state of viral suppression is important to improve survival among people living with HIV and to reduce onward transmission.

Antiretroviral Therapy Containing Raltegravir to Prevent Mother-to-Child Transmission of HIV in Infected Pregnant Women.

We conducted a retrospective study in a general hospital in Buenos Aires, Argentina (2009-2015) aimed at evaluating outcomes in HIV-infected pregnant women (HIPW), who were prescribed raltegravir (RAL)-containing antiretroviral therapy (ART). A total of 239 HIPW were enrolled in our study; among them 31 received RAL (12.9%) at different clinical stages: i) intensification (INS): addition of RAL to current ART because of detectable antepartum viral load, 13 (41.9%); ii) late presenter (LP): standard ART + RAL as fourth drug, 15 (48.4%); iii) treatment of resistant-HIV: 3 (9.7%). Median gestational age at RAL initiation was 34 weeks and median exposure was 30 days. In INS-group, median viral load (VL) decrease was 1.48 log10. In LP-group, median VL decline was 2.15 log10. No clinical adverse events or maternal intolerance attributable to RAL were observed. Elective cesarean section was done in 51.7%; mild elevation of transaminases was observed in 35% of neonates. No vertical transmission was documented.

Changes in Insulin Resistance After Initiation of Raltegravir or Protease Inhibitors With Tenofovir-Emtricitabine: AIDS Clinical Trials Group A5260s.

Background. Antiretroviral therapy (ART) can alter glucose metabolism, but little data exist on the association of raltegravir (RAL) with insulin resistance. Methods. A5260s was a substudy of A5257, a prospective open-label randomized trial in which human immunodeficiency virus (HIV)-infected treatment-naive participants were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or RAL over 96 weeks. Baseline and changes in insulin resistance as estimated by the homeostatic model assessment of insulin resistance (HOMA-IR) were assessed. Wilcoxon rank-sum tests were used to assess shifts in the distribution of fold increase from baseline between treatment arms, and Spearman correlation was used to assess associations between HOMA-IR and measures of inflammation and body composition. Results. Three hundred twenty-eight participants were randomized; 90% were male, baseline median age was 36, HIV ribonucleic acid copies were 4.55 log10 copies/mL, and CD4 cell count was 349/mm3. Overall, HOMA-IR increased significantly after 4 weeks (1.9-fold change; 95% confidence interval, 1.73-2.05) then plateaued over the remainder of the study. Changes in HOMA-IR were not different between the arms (P ≥ .23). Changes in HOMA-IR were associated with changes in body mass index at weeks 48 and 96 (r = 0.12-0.22; P ≤ .04). There was a trend with increases in HOMA-IR and increases in visceral abdominal fat at week 96 (r = 0.12; P = .06). At 48 and 96 weeks, HOMA-IR correlated with interleukin-6, high-sensitivity C-reactive protein, and soluble CD163 (r = 0.16-0.27; P ≤ .003). Conclusions. Insulin resistance increased rapidly and then plateaued in treatment-naive participants initiating ART with TDF/FTC, and no differences were found with RAL when compared with ATV/r or DRV/r.

Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s.

Fat gain after antiretroviral therapy (ART) occurs, and its association with protease inhibitors (PIs) is unclear. Peripheral and central fat depots and lean mass were measured using standardized and centrally read abdominal CT scans and whole-body dual-energy absorptiometry scans over a 96-week period in human immunodeficiency virus (HIV)-infected treatment-naive participants. The patients were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or raltegravir (RAL) in ACTG A5260s, a substudy of A5257. Within arm changes were assessed with signed-rank tests. The 96-week percentage changes in fat and lean mass in the 2 PI arms were not different, thus the PI arms were combined and compared to the RAL arm. Associations between baseline biomarkers and changes in body composition were assessed. All analyses used linear regression models. 328 patients were randomized (90% male, 44% white non-Hispanic). The median age was 36 years, HIV-1 RNA 4.6 log10 copies/mL, and CD4 349 cells/μL. Overall, at week 96, increases in limb fat (13.4%), subcutaneous (19.9%) and visceral abdominal fat (25.8%), trunk fat (18%), and lean mass (1.8%) were apparent (P < .001 for changes within each arm). Changes for all fat and lean outcomes were not different between the PI arms or between the RAL and the combined PI arms. Higher baseline HIV-1 RNA levels were associated with greater gains in peripheral and central fat. In treatment-naive participants initiating ART with TDF/FTC, no differences in lean mass and regional fat were found with RAL when compared with ATV/r or DRV/r over 96 weeks. NCT00811954 and NCT00851799.

Effects of raltegravir combined with tenofovir/emtricitabine on body shape, bone density, and lipids in African-Americans initiating HIV therapy

Background:Raltegravir (RAL) plus tenofovir/emtricitabine (TDF/FTC) is a recommended initial antiretroviral regimen. A substantial proportion of persons diagnosed with HIV infection and starting antiretrovirals in the U.S. are African-American (AA); however, the effects of this regimen on metabolic parameters have largely been studied in white patients.Methods:Single-arm, open-label study of untreated AA HIV-infected patients administered RAL with TDF/FTC for 104 weeks. Changes in fasting lipids, insulin resistance, visceral adipose tissue (VAT), abdominal subcutaneous adipose tissue (SAT), limb and trunk fat, and bone mineral density (BMD) were assessed at weeks 56 and 104.Results:Thirty (85% men) participants were included. Median entry characteristics included age of 38 years, CD4 323 cells/mm3, HIV RNA level 29 245 copies/ml, and body mass index 28.1 kg/m2. At 56 and 104 weeks, significant increases in VAT, trunk fat, limb fat, and overall fat were observed. Bone mineral density decreased by 1.5% by week 104.There were no significant changes in non-HDL-cholesterol, fasting triglycerides, or insulin resistance. A median CD4 cell count increase of 318 cells/mm3 (IQR 179, 403; full range 40, 749) (P < 0.001) was observed. Assuming missing = failure, 78 and 70% had HIV RNA levels < 40 copies/ml at weeks 56 and 104, respectively. There were no treatment-related discontinuations and no new antiretroviral resistance mutations were detected.Conclusions:In this cohort of AAs, initiation of RAL with TDF/FTC was associated with significant general increases in fat. Significant changes in lipids or insulin resistance were not observed and there was a small decline in BMD. Therapy was well tolerated and effective. These results are consistent with findings of studies of initial antiretroviral therapy in racially diverse cohorts and inform treatment selection for AA patients starting therapy for HIV infection.

A case series of third-trimester raltegravir initiation: Impact on maternal HIV-1 viral load and obstetrical outcomes.

To describe the impact of initiating raltegravir (RAL)-containing combination antiretroviral therapy (cART) regimens on HIV viral load (VL) in pregnant women who have high or suboptimal VL suppression late in pregnancy. HIV-infected pregnant women who started RAL-containing cART after 28 weeks' gestation from 2007 to 2013 were identified in two university hospital centres. Eleven HIV-infected women started RAL at a median gestational age of 35.7 weeks (range 31.1 to 38.0 weeks). Indications for RAL initiation were late presentation in pregnancy (n=4) and suboptimal VL suppression secondary to poor adherence or viral resistance (n=7). Mean VL at the time of RAL initiation was 73,959 copies/mL (range <40 to 523,975 copies/mL). Patients received RAL for a median of 20 days (range one to 71 days). The mean decline in VL from the time of RAL initiation to delivery was 1.93 log, excluding one patient who received only one RAL dose and one patient with undetectable VL at the time of RAL initiation. After eight days on RAL, 50% of the women achieved a VL <1000 copies/mL (the threshold for recommended Caesarean section to reduce the risk for perinatal transmission). There were no cases of perinatal HIV transmission. The present study provides preliminary data to support the use of RAL-containing cART to expedite HIV-1 VL reduction in women who have a high VL or suboptimal VL suppression late in pregnancy, and to decrease the risk of HIV perinatal transmission while avoiding Caesarean section. Further assessment of RAL safety during pregnancy is warranted.

Raltegravir-based therapy in a cohort of HIV/HCV co-infected individuals

The relationship between hepatic tolerance and hepatitis C virus (HCV) co-infection has not been extensively studied in clinical practice. We assessed the efficacy and safety of raltegravir-based therapy in an Italian cohort of HIV/HCV co-infected patients. One hundred and forty patients with HIV/HCV co-infection initiating raltegravir from SCOLTA project (Surveillance Cohort Long-Term Toxicity Antiretrovirals) were examined. Of them, 43 were women, with mean age of 45.4±6.4years; 65 (46%) had undetectable HIV-RNA<50copies/mL and 75 (54%) HIV-RNA≥50copies/mL. According to CDC classification, 49 (35%) were in stage C. Based on Fib4 score at the time of starting raltegravir, patients were classified in class I in 41 cases, class II in 68 and in class III in 31 cases. Globally, the Fib4 score slightly decreased during 24months follow-up, from 2.2 to a value of 1.8. Hepatic adverse events of any grade were observed in 67 patients, of which only 2 cases (3%) had severe liver toxicity (grade 3–4). Only one patient had to discontinue the therapy because of adverse events. According to univariate analysis, being in CDC stage C represented a risk for the development of liver toxicity, with a hazard ratio (HR) of 2.27 (95% CI 1.06–4.84, P=0.033). None of the other variables considered (age, sex, years since detection of HIV and HCV-RNA detectable, years of previous HIV therapy, concomitant therapy with PI or NRTI, CD4+ cell count, Fib4, and transaminases level at baseline) resulted statistically correlated to the outcome. In conclusion, raltegravir-based regimens can be safely used in HCV infected patients; in this study, the hepatic toxicity has been found to be more frequent in patients with an advanced HIV disease (CDC stage C), independently of HIV-RNA suppression at raltegravir initiation.

Short communication: Use of raltegravir in late-presenting HIV-infected pregnant women.

The risk of HIV-1 mother-to-child transmission (MTCT) is clearly correlated with the maternal HIV cell-free viral load (VL) at delivery. Preventing MTCT in late-presenting (after 28 weeks) HIV-infected pregnant women remains a clinical challenge, and ensuring a rapid decrease of maternal VL is an important preventive strategy. Raltegravir (RGV) has a higher first and second phase viral decay rate, has a high placental transfer, with a potential preloading effect for neonate, and demonstrates effective accumulation in cervicovaginal secretions. We report 14 cases in which RGV was used late in pregnancy for HIV-1 MTCT prophylaxis. All women were RGV naive and the prophylaxis regimens included RGV plus at least two other antiretroviral agents. At RGV initiation, the median gestational age was 36 weeks (range 34-38) and the median maternal plasma HIV-1 RNA viral load was 35,364 copies/ml (range 636-391,535). At delivery, the median gestational age was 38 weeks (range 37-40). The median exposure time to RGV was 17 days (range 7-32), with a mean maternal VL decay of 2.6 log. At delivery, seven women had undetectable (<50 copies/ml) VL, four had between 64 and 457 copies/ml, and in three VL was not available. All but one infant's HIV-RNA tests were negative at 1 and 3 months (one case of in utero MTCT). Raltegravir-containing antiretroviral regimens induced a rapid HIV-RNA decline in maternal VL at delivery, and were safe and effective in preventing MTCT for late-presenting, HIV-infected women.

Three Distinct Phases of HIV-1 RNA Decay in Treatment-Naive Patients Receiving Raltegravir-Based Antiretroviral Therapy: ACTG A5248

The goal of this study was to define viral kinetics after initiation of raltegravir (RAL)-based antiretroviral therapy (ART). ART-naive patients received RAL, tenofovir disoproxil fumarate, and emtricitabine for 72 weeks. Human immunodeficiency virus type 1 (HIV-1) RNA were measured by ultrasensitive and single-copy assays, and first (d1)-, second (d2)-, and, third (d3)-phase decay rates were estimated by mixed-effects models. Decay data were compared to historical estimates for efavirenz (EFV)- and ritonavir/lopinavir (LPV/r)-based regimens. Bi- and tri-exponential models for ultrasensitive assay (n = 38) and single-copy assay (n = 8) data, respectively, provided the best fits over 8 and 72 weeks. The median d1 with ultrasensitive data was 0.563/day (interquartile range [IQR], 0.501-0.610/day), significantly slower than d1 for EFV-based regimens [P < .001]). The median duration of d1 was 15.1 days, transitioning to d2 at an HIV-1 RNA of 91 copies/mL, indicating a longer duration of d1 and a d2 transition at lower viremia levels than with EFV. Median patient-specific decay estimates with the single-copy assay were 0.607/day (IQR, 0.582-0.653) for d1, 0.070/day (IQR, 0.042-0.079) for d2, and 0.0016/day (IQR, 0.0005-0.0022) for d3; the median d1 duration was 16.1 days, transitioning to d2 at 69 copies/mL. d3 transition occurred at 110 days, at 2.6 copies/mL, similar to values for LPV/r-based regimens. Models using single-copy assay data revealed 3 phases of decay with RAL-containing ART, with a longer duration of first-phase decay consistent with RAL-mediated blockade of productive infection from preintegration complexes.

Rapid Reduction in HIV Viral Load in Late Pregnancy with Raltegravir

The use of raltegravir (RAL) is not preferred to prevent perinatal transmission in pregnancy due to lack of safety and pharmacokinetic data in this population. Data have been limited to few case reports of patients who present for treatment late in pregnancy, have multidrug resistance, or have poor adherence, requiring an additional class such as an integrase inhibitor to further lower viral load. This case report describes and supports the initiation of RAL in very late pregnancy (week 33) to rapidly decrease viral load and successfully prevent perinatal transmission. By increasing the efficacy and safety data of RAL use in pregnancy, we believe this report can help provide some guidance on the management of complex cases.

A Case of Possible Darunavir/Ritonavir-Induced Peripheral Neuropathy

A 65-year-old man, M.S.M., known as being HIV infected for 20 years, presented with muscle ache and progressive weakness 3 months after initiation of darunavir as a part of his antiretroviral therapy (ART). The patient's treatment included darunavir/ritonavir 600/100 mg twice daily, plus a backbone of didanosine and abacavir which were the backbone in his previous regimen for several years according to his drug resistance profile. Three months after initiation of darunavir/ritonavir the patient exhibited clinical symptoms of severe pain and progressive weakness of his lower limbs; he was unable to walk and was totally wheelchair-bound. Severe sensory peripheral polyneuropathy was revealed on electromyogram (EMG). All medications, including ART, were stopped. Within two months, concomitantly with initiation of raltegravir, etravirine and emcitricabine/tenofovir, the patient recovered, gained weight, resumed walking and his CD4 counts rose from 270 to 450 cells/mm(3). A second EMG study 3 months after initiation of his new ART regimen showed compete recovery of the previously diagnosed peripheral neuropathy. In this report, we present a case of severe HIV-1-related acute demyelinating polyneuropathy which initiated after new generation PI darunavir/ritonavir was given and resolved after cessation of the drug without the use of immune-based therapies. The variety of HIV-related polyneuropathies will be discussed.

Raltegravir-Induced Rash in a Patient Receiving Rifampin

Objective: To present what we believe to be the first report of a possible case of raltegravir-induced rash in a patient receiving concurrent rifampin treatment. Case Summary: A 38-year-old man with newly diagnosed HIV and miliary tuberculosis (TB) was started on 4-drug TB treatment in combination with highly active antiretroviral therapy (HAART) including efavirenz, emtricitabine, and tenofovir. Eleven days later, the patient developed a rash and HAART was discontinued. Eight days later, HAART was reinitiated with raltegravir 400 mg twice daily and standard dose tenofovir/emtricitabine 300 mg/200 mg. After 14 weeks on this HAART regimen, the patient achieved an undetectable viral load with immune reconstitution. Twenty-two weeks after raltegravir initiation, the dosage was increased to 800 mg twice daily with continuation of emtricitabine/tenofovir. Sixteen days later, the patient developed a maculopapular rash leading to HAART discontinuation. The rash resolved in 2 weeks, and raltegravir rechallenge was not attempted. Discussion: Raltegravir-associated rash may occur in approximately 6–7.6% of patients with HIV, with onset between 2 and 5 weeks and a usual duration of 2 weeks. Rifampin significantly decreases the raltegravir minimum concentration (Cmin), and doubling the raltegravir dosage is recommended. This results in a slightly improved raltegravir Cmin, with a significant 2.6-fold increase in the maximum concentration. Little is known about the risk factors for raltegravir-associated rash. A concentration-dependent effect may enhance the occurrence of this cutaneous adverse reaction. An objective causality assessment revealed that the adverse drug event was possible, as the patient tolerated raltegravir for 5 months and then presented with a rash after dose escalation. Conclusions: Rifampin significantly alters the raltegravir pharmacokinetic profile. Additional safety and efficacy data are necessary to determine the optimal dosing strategy for raltegravir administered with rifampin.

Similar Efficacy of Raltegravir When Used With or Without a Protease Inhibitor in Treatment-Experienced Patients

Background: Patients with multiclass-resistant HIV-1 have limited treatment options. Raltegravir, an inhibitor of integrase, has shown excellent efficacy when used with protease inhibitors (Pis) in patients with drug-resistant HIV-1. Limited data are available however about the outcomes when using raltegravir without Pis in this population. Methods: Medical records of subjects who received raltegravir as part of the Merck EAP study 0518 were reviewed and abstracted at participating sites. Eligibility criteria included HIV positivity, age ≥16 years, limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens, detectable viremia on current treatment regimen, and documented resistance to at least one drug in each antiretroviral class (PI, NNRTI, and nucleoside analogue). Demographic, clinical, and laboratory data were collected locally using a standardized collection form. Genotypic susceptibility scores (GSS) were determined from the most recent genotypic resistance test available prior to the initiation of raltegravir. The main objective was to compare virologic results in patients who received raltegravir with a PI versus those who received raltegravir without a PI. Results: Four hundred forty-two subjects were evaluated from the respective sites in the EAP trial, of whom 340 were evaluable. The baseline mean HIV RNA was 4.6 log copies/ mL, and the mean CD4 cell count was 159 cells/μL. The median number of total and new antiretroviral agents in the background regimen was 4 and 2, respectively. Among the 254 patients who received a PI, the most common PI used was darunavir (89%). Etra-virine was commonly used in both groups: 39% of the PI group and 67% of the non-PI group. At week 12, 67% of PI patients and 64% of non-PI patients achieved HIV RNA <75 copies/mL and 85% and 86%, respectively, achieved HIV RNA <400 copies/mL GSS, which was similar in both groups at baseline, predicted achieving an HIV RNA of <400 and 75 copies/mL at week 12 (P < .05). Conclusions: In treatment-experienced patients, the combination of raltegravir with a regimen not containing a PI (used with etravirine in two-thirds of patients) had similar virologic activity when compared to more standard regimens using raltegravir with a PI. The main determinant of efficacy was the number of active drugs as measured by GSS. These data expand the potential utility of raltegravir in patients with multidrug-resistant HIV.

Severe insomnia related to high concentrations of raltegravir

Severe insomnia related to high concentrations of raltegravir

Clinical, virological and immunological responses in Danish HIV patients receiving raltegravir as part of a salvage regimen.

Raltegravir is the first integrase inhibitor approved for treatment of HIV-infected patients harboring multiresistant viruses. From a Danish population-based nationwide cohort of HIV patients we identified the individuals who initiated a salvage regimen including raltegravir and a matched cohort of HIV-infected patients initiating HAART for the first time. We compared these two cohorts for virological suppression, gain in CD4 count, and time to first change of initial regimen. We identified 32 raltegravir patients and 64 HIV patients who initiated HAART for the first time in the period 1 January 2006 to 1 July 2009. The virological and immunological responses in the raltegravir patients were comparable to those seen in the control cohort. No patients in the two cohorts died and no patients terminated raltegravir treatment in the observation period. Time to first change of initial regimen was considerably shorter for HAART-naïve patients. We conclude that salvage regimens including raltegravir have high effectiveness in the everyday clinical setting. The effectiveness of the regimens is comparable to that observed for patients initiating HAART for the first time. The risk of change in the salvage regimens after initiation of raltegravir is low.

Acute Onset Insomnia Associated with the Initiation of Raltegravir: A Report of Two Cases and Literature Review

AIDS Patient Care and STDsVol. 23, No. 9 Letter to the EditorAcute Onset Insomnia Associated with the Initiation of Raltegravir: A Report of Two Cases and Literature ReviewJacob Gray and Benjamin YoungJacob GrayInternal Medicine Residency Program, University of Colorado Denver, Aurora, Colorado.Search for more papers by this author and Benjamin YoungDenver Infectious Disease Consultants, Denver, Colorado.Division of General Internal Medicine, University of Colorado Denver, Aurora, Colorado.Search for more papers by this authorPublished Online:9 Sep 2009https://doi.org/10.1089/apc.2009.0012AboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Acute Onset Insomnia Associated with the Initiation of Raltegravir: A Report of Two Cases and Literature Review." , 23(9), pp. 689–690FiguresReferencesRelatedDetailsCited ByClass-Based Antiretroviral Exposure and Cognition Among Women Living with HIV Amanda Blair Spence, Chenglong Liu, Leah Rubin, Bradley Aouizerat, David Eugene Vance, Hector Bolivar, Cecile Delille Lahiri, Adaora A. Adimora, Kathleen Weber, Deborah Gustafson, Oluwakemi Sosanya, Raymond Scott Turner, and Seble Kassaye11 July 2022 | AIDS Research and Human Retroviruses, Vol. 38, No. 7Crossroads of Drug Abuse and HIV Infection: Neurotoxicity and CNS Reservoir27 January 2022 | Vaccines, Vol. 10, No. 2HIV Post Exposure Prophylaxis and Risk of Relapse in Adolescent With Bipolar Illness and Psychopharmacologic ChallengesCureus, Vol. 72Evaluating Neurodevelopmental Consequences of Perinatal Exposure to Antiretroviral Drugs: Current Challenges and New Approaches11 September 2019 | Journal of Neuroimmune Pharmacology, Vol. 16, No. 1CNS Neurotoxicity of Antiretrovirals10 December 2019 | Journal of Neuroimmune Pharmacology, Vol. 16, No. 1Altered neuropsychological performance and reduced brain volumetrics in people living with HIV on integrase strand transfer inhibitorsAIDS, Vol. 33, No. 9Adverse Neuropsychiatric Events and Recreational Use of Efavirenz and Other HIV-1 Antiretroviral Drugs26 June 2018 | Pharmacological Reviews, Vol. 70, No. 3HIV-associated Neurocognitive Disorders and Antiretroviral Therapy: Current Concepts and Controversies28 April 2015 | Current Infectious Disease Reports, Vol. 17, No. 6Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice: Results from the SCOLTA project long-term surveillanceInternational Journal of Antimicrobial Agents, Vol. 45, No. 3Quality of Sleep in an HIV Population on Antiretroviral Therapy at an Urban Tertiary Centre in Lagos, NigeriaNeurology Research International, Vol. 2014Raltegravir central nervous system tolerability in clinical practiceAIDS, Vol. 26, No. 18Medication-Induced Sleep Disturbances31 May 2011 | The Consultant Pharmacist, Vol. 26, No. 6Severe insomnia related to high concentrations of raltegravirAIDS, Vol. 25, No. 5Antiviral drugsA Pilot Study of Abacavir/Lamivudine and Raltegravir in Antiretroviral-Naïve HIV-1–Infected Patients: 48-Week Results of the SHIELD Trial6 January 2015 | HIV Clinical Trials, Vol. 11, No. 5 Volume 23Issue 9Sep 2009 InformationCopyright 2009, Mary Ann Liebert, Inc.To cite this article:Jacob Gray and Benjamin Young.Acute Onset Insomnia Associated with the Initiation of Raltegravir: A Report of Two Cases and Literature Review.AIDS Patient Care and STDs.Sep 2009.689-690.http://doi.org/10.1089/apc.2009.0012Published in Volume: 23 Issue 9: September 9, 2009Online Ahead of Print:August 10, 2009PDF download

Immune Reconstitution Inflammatory Syndrome (IRIS) Manifesting as Anogenital HSV-2 Infection in a HIV-1-Infected Patient After Initiation of Raltegravir

Objective: To report a case of immune reconstitution inflammatory syndrome (IRIS), manifesting as anogenital HSV-2 infection after initiation of raltegravir-based antiretroviral (ARV) therapy. Case Summary: We report a case of a 30-year-old HIV-1-infected woman, who presented to an outpatient clinic to reinitiate HAART. Her CD4+ T cell count and HIV-1 RNA level were 100,000 copies/ml, respectively. Due to patient's previous inability to tolerate multiple HAART combinations, she was initiated on raltegravir and emtricitabine/tenofovir. The patient presented after one month of therapy with anogenital lesions that were subsequently diagnosed as HSV-2 infection based on culture results. Her CD4+ T-cell count at that time increased to 229 cells/mm (35%) and HIV-1 RNA level declined to 2,860 copies/ml. Discussion: Immune reconstitution inflammatory syndrome (IRIS) is a complication of highly active antiretroviral therapy (HAART) initiation, especially in patients with extremely low CD4+ T-cell counts and high HIV-1 RNA levels. It is suspected that this patient experienced IRIS, manifested by anogenital HSV-2 infection. This case represents the first published descriptive report of IRIS associated with raltegravir-based HAART. Conclusions: The strong temporal relationship that was seen in this case suggests the possibility of an association between the initiation of raltegravir and IRIS. Health care providers treating HIV-infected patients should consider this potential adverse reaction after initiation of raltegravir.