Efavirenz Regimens Research Articles

The effect of efavirenz versus nevirapine-containing regimens in the HIV-CAUSAL Collaboration

The effect of efavirenz versus nevirapine-containing regimens in the HIV-CAUSAL Collaboration

Systematic Review of Antiretroviral-Associated Lipodystrophy: Lipoatrophy, but Not Central Fat Gain, Is an Antiretroviral Adverse Drug Reaction

BackgroundLipoatrophy and/or central fat gain are observed frequently in patients on antiretroviral therapy (ART). Both are assumed to be antiretroviral adverse drug reactions.MethodsWe conducted a systematic review to determine whether fat loss or gain was more common in HIV-infected patients on ART than in uninfected controls; was associated with specific antiretrovirals; and would reverse after switching antiretrovirals.ResultsTwenty-seven studies met our inclusion criteria. One cohort study reported more lipoatrophy, less subcutaneous fat gain, but no difference in central fat gain in HIV-infected patients on ART than in controls. Randomised controlled trials (RCTs) showed more limb fat loss (or less fat gain) with the following regimens: stavudine (versus other nucleoside reverse transcriptase inhibitors (NRTIs)); efavirenz (versus protease inhibitors (PIs)); and NRTI-containing (versus NRTI-sparing). RCTs showed increased subcutaneous fat after switching to NRTI-sparing regimens or from stavudine/zidovudine to abacavir/tenofovir. There were no significant between-group differences in trunk and/or visceral fat gain in RCTs of various regimens, but results from efavirenz versus PI regimens were inconsistent. There was no significant between-group differences in central fat gain in RCTs switched to NRTI-sparing regimens, or from PI-containing regimens.ConclusionsThere is clear evidence of a causal relationship between NRTIs (especially thymidine analogues) and lipoatrophy, with concomitant PIs possibly having an ameliorating effect or efavirenz causing additive toxicity. By contrast, central fat gain appears to be a consequence of treating HIV infection, because it is not different from controls, is not linked to any antiretroviral class, and doesn't improve on switching.

Generic Antiretrovirals and the Uncertain Future of HIV Care in the United States

Editorials15 January 2013Generic Antiretrovirals and the Uncertain Future of HIV Care in the United StatesRenslow Sherer, MDRenslow Sherer, MDFrom University of Chicago, Chicago, Illinois.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-158-2-201301150-00010 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Generic antiretroviral drugs have contributed to remarkable achievements in the global HIV epidemic. Mortality has decreased by 24% since 2005, new HIV infections have decreased by 20% since 2001, and 8 million persons are receiving treatment (1). In the United States, 10 available generic antiretrovirals have been used infrequently because of greater toxicity and inferior efficacy. However, when generic efavirenz becomes available in 2013, a regimen of generic efavirenz and lamivudine with branded tenofovir will become a credible alternative to branded regimens.In this issue, Walensky and colleagues (2) mathematically model the effect of the substitution of generic efavirenz and ...

Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria

Aim:This study evaluated the suspected adverse drug reactions (ADR) reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV) positive patients receiving antiretroviral therapy (ART) in NigeriaMaterials and Methods:This descriptive study analyzed individual case safety reports (ICSRs) in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval.Results:From 1237 ICSRs collated, only 1119 (90.5%) were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1–35.5) years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD) of 1.5 (± 0.8) ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0%) peripheral neuropathy, (11.4%) skin rash, (10.1%) pruritus and (6.5%) dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05) unlike gender. Anaemia was associated with Zidovudine (AZT)/ Lamivudine (3TC) /Nevirapine (NEV) regimen [Odds ratio, OR = 6.4 (3.0–13.8); P < 0.0001], and peripheral neuropathy with Stavudine (d4T)/3TC/NEV regimen [OR = 8.7 (5.8–30.0), P < 0.0001] and Tenofovir (TDF)/Emtricitabine (FTC)/Efavirenz (EFV) regimen [OR = 2.1 (1.0–4.1), P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3–6.6), P = 0.0056] and 45–59years [OR = 1.9 (1.3–2.7), P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9–349.6), P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS) [OR = 50.2 (0.9–562.1), P = 0.0040] respectively.Conclusion:ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to zidovudine-based regimens. Peripheral neuropathy was also found to be associated with tenofovir-based regimen. This may require further studies and evaluation.

Efavirenz regimens superior to nevirapine for children with HIV

Efavirenz regimens superior to nevirapine for children with HIV

Self‐reported adherence supports patient preference for the single tablet regimen (STR) in the current cART era

ObjectiveTo analyze self-reported adherence to antiretroviral regimens containing ritonavir-boosted protease inhibitors, non-nucleoside reverse transcriptase inhibitors (NNRTI), raltegravir, and maraviroc.MethodsOverall, 372 consecutive subjects attending a reference center for HIV treatment in Florence, Italy, were enrolled in the study, from December 2010 to January 2012 (mean age 48 years). A self-report questionnaire was filled in. Patients were defined as “non-adherent” if reporting one of the following criteria:<90% of pills taken in the last month, ≥1 missed dose in the last week, spontaneous treatment interruptions reported, or refill problems in the last 3 months. Gender, age, CD4, HIV-RNA, years of therapy, and type of antiretroviral regimen were analyzed with respect to adherence.ResultsAt the time of the questionnaire, 89.8% of patients had <50 copies/mL HIV-RNA and 14.2% were on their first combined antiretroviral therapy. 57% of patients were prescribed a regimen containing ritonavir boosted protease inhibitors (boosted PI), 41.7% NNRTI, 17.2% raltegravir, and 4.8% maraviroc; 49.5% of the subjects were on bis-in-die regimens, while 50.5% were on once-daily regimens, with 23.1% of these on the single tablet regimen (STR): tenofovir/emtricitabine/efavirenz. The non-adherence proportion was lower in NNRTI than in boosted-PI treatments (19.4% vs 30.2%), and even lower in STR patients (17.4%). In multivariable logistic regression, patients with the NNRTI regimen (OR: 0.56, 95% CI: 0.34–0.94) and the STR (OR: 0.45, 95% CI: 0.22–0.92) reported lower non-adherence. Efavirenz regimens were also associated with lower non-adherence (OR: 0.42, 95% CI: 0.21–0.83), while atazanavir/ritonavir regimens were associated with higher non-adherence. No other relation to specific antiretroviral drugs was found. A higher CD4 count, lower HIV-RNA, and older age were also found to be associated with lower non-adherence, while a longer time on combined antiretroviral therapy was related to higher non-adherence.ConclusionIn conclusion, older age, higher CD4 cell counts, lower HIV-RNA viral loads, and the use of STR are all related to lower non-adherence. In particular, the use of STR maintains an advantage in improving adherence with respect to other cARTs, even with the availability of new, well-tolerated antiretroviral drugs and drug classes in recent years.

Impact of pharmacogenetic markers of CYP2B6 and clinical factors on plasma efavirenz level in HIV/tuberculosis co‐infected Thai patients

Purpose of studyPolymorphisms of CYP2B6 are associated with altered activity of cytochrome P450 2B6 which has an effect on plasma efavirenz level. The data of these polymorphisms and their effect, particularly in HIV/TB co‐infected patients, is still limited.MethodsA total of 150 HIV‐infected Thai adults with active tuberculosis (TB) and receiving rifampicin‐containing anti‐TB regimen were prospectively enrolled to receive a once‐daily regimen of efavirenz 600 mg/tenofovir/lamivudine. Nine single nucleotide polymorphisms (SNPs) within CYP2B6 were genotyped using real‐time PCR‐based allelic discrimination. At 12 weeks after ART, plasma efavirenz levels at 12 hours after dosing were measured by HPLC assay.Summary of resultsOf all, the median (IQR) CD4 count was 44 (17–113) cells/mm3 and median (IQR) plasma HIV‐1 RNA was 5.8 (5.4–6.3) log copies/mL. Eight (5.3%) patients discontinued efavirenz due to adverse events prior to measuring efavirenz level. Of 142 patients, the frequencies of wild type, heterozygous mutant, and homozygous mutant of each SNP were 64C&gt;T (89%, 10%, 1%), 499C&gt;G (99%, 1%, 0%), 516G&gt;T (45%, 47%, 8%), 785A&gt;G (36%, 54%, 10%), 1375A&gt;G (100%, 0%, 0%), 1459C&gt;T (97%, 3%, 0%), 3003C&gt;T (29%, 44%, 27%), 18492T&gt;C (55, 39%, 6%), and 21563C&gt;T (38%, 57%, 5%). Median (IQR) plasma efavirenz level of 102 patients who were concurrently receiving efavirenz and rifampicin was 2.08 (1.33–3.51) mg/dL and those of 40 patients who did not received rifampicin was 2.72 (1.80–5.21) mg/dL. Of 102 patients, heterozygous/homozygous mutant vs. wild type of 5 SNPs associated with high mean efavirenz level were 516G&gt;T (3.6 vs. 1.9 mg/dL, P&lt;0.001), 785A&gt;G (3.2 vs. 2.0 mg/dL, P=0.001), 3003C&gt;T (4.0 vs. 2.4 mg/dL, P=0.012), 18492T&gt;C (3.5 vs. 2.0, P&lt;0.001), 21563C;&gt;T (3.4 vs. 1.9 mg/dL, P&lt;0.001). Three of 9 haplotypes identified, including *6/*6, *1/*6, and *4/*6, were associated with high efavirenz level. By multivariate analysis, factors associated with high efavirenz level included specific haplotype (P&lt;0.001), low body weight (P=0.003), and receiving rifampicin (P=0.058).ConclusionsParticular SNPs and haplotype of CYP2B6, especially *6/*6, has the greatest impact on efavirenz level in HIV/TB co‐infected Thai patients whereas low body weight and concurrent receiving rifampicin have lesser effects.

The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study

To compare regimens consisting of either efavirenz or nevirapine and two or more nucleoside reverse transcriptase inhibitors (NRTIs) among HIV-infected, antiretroviral-naive, and AIDS-free individuals with respect to clinical, immunologic, and virologic outcomes. Prospective studies of HIV-infected individuals in Europe and the US included in the HIV-CAUSAL Collaboration. Antiretroviral therapy-naive and AIDS-free individuals were followed from the time they started an NRTI, efavirenz or nevirapine, classified as following one or both types of regimens at baseline, and censored when they started an ineligible drug or at 6 months if their regimen was not yet complete. We estimated the 'intention-to-treat' effect for nevirapine versus efavirenz regimens on clinical, immunologic, and virologic outcomes. Our models included baseline covariates and adjusted for potential bias introduced by censoring via inverse probability weighting. A total of 15 336 individuals initiated an efavirenz regimen (274 deaths, 774 AIDS-defining illnesses) and 8129 individuals initiated a nevirapine regimen (203 deaths, 441 AIDS-defining illnesses). The intention-to-treat hazard ratios [95% confidence interval (CI)] for nevirapine versus efavirenz regimens were 1.59 (1.27, 1.98) for death and 1.28 (1.09, 1.50) for AIDS-defining illness. Individuals on nevirapine regimens experienced a smaller 12-month increase in CD4 cell count by 11.49 cells/μl and were 52% more likely to have virologic failure at 12 months as those on efavirenz regimens. Our intention-to-treat estimates are consistent with a lower mortality, a lower incidence of AIDS-defining illness, a larger 12-month increase in CD4 cell count, and a smaller risk of virologic failure at 12 months for efavirenz compared with nevirapine.

5.0 What to start

5.0 What to start

Safety and effectiveness of efavirenz versus nevirapine-based regimens in resource-limited settings

639–641Keywords: efavirenz, effectiveness, modelling, nevirapine, safety,sub-Saharan AfricaCombination antiretroviral therapy (ART) with eitherefavirenz (EFV) or nevirapine (NVP), both nonnucleo-side reverse transcriptase inhibitors (NNRTIs), and twonucleoside reverse transcriptase inhibitors (NRTI) isrecommended by the WHO as first-line therapy inresource-limited countries [1]. Compared with NVP,EFV is easier to monitor, is relatively well tolerated, hasless frequent and less severe rash and hepatic toxicity thanNVP, and can be administered once daily. Whereas NVPandEFVhavegenerallycomparableclinicalandvirologicefficacy [2–5], because of lower drug–drug interactions,EFV-based ART is associated with superior virologicoutcome compared with NVP-based ART in individualswith tuberculosis (TB) receiving anti-TB therapycontaining rifampicin. Therefore, efavirenz is theNNRTI antiretroviral drug of choice of TB-coinfectedindividuals [6–9]. However, there have been concernsregarding potential for central nervous system birthdefects with first-trimester exposure to EFV based onstudiesinpregnantrhesusmacaquesandretrospectivecasereportsinhumansthathavelimitedEFVuseinwomenofchildbearing age. This is a problem in many resource-limitedsettings,wherewomenconstitute50%or moreofHIV-infected individuals and TB is endemic, but there islimited access to contraception or women may wish tobecome pregnant.In this issue, Ouattara and colleagues use a computersimulation model to evaluate the risks and benefits ofusing EFV and NVP in women of childbearing age inresource-limited countries [10]. Using the previouslyvalidated Cost-Effectiveness of Preventing AIDS Com-plications (CEPAC) International model, the authorssimulated the trade-off between potential excess birthdefects and potential long-term clinical benefits forwomen starting EFV-based versus NVP-based ART inCote d’Ivoire. In a ‘hypothetical’ cohort of 100000women starting ARTwith EFV, the authors found that adrug with lower toxicity and requiring less regimenswitching led to approximately 911 more women aliveafter 10 years compared with those starting with NVP, animprovement in survival of approximately 1%. However,over thesameperiod,therewere59morebirthdefectsinwomen initiating EFV-based ART than those startingwith NVP. The authors concluded that in Cote d’Ivoire,initiating ART with EFV instead of NVP is likely to

HIV and Reproduction: Fertility, Contraception, and Preconception Issues and Interventions

HIV and Reproduction: Fertility, Contraception, and Preconception Issues and Interventions

Efavirenz Conceptions and Regimen Management in a Prospective Cohort of Women on Antiretroviral Therapy

Use of the antiretroviral drug efavirenz (EFV) is not recommended by the WHO or South African HIV treatment guidelines during the first trimester of pregnancy due to potential fetal teratogenicity; there is little evidence of how clinicians manage EFV-related fertility concerns. Women on antiretroviral therapy (ART) were enrolled into a prospective cohort in four public clinics in Johannesburg, South Africa. Fertility intentions, ART regimens, and pregnancy testing were routinely assessed during visits. Women reporting that they were trying to conceive while on EFV were referred for regimen changes. Kaplan-Meier estimators were used to assess incidence across ART regimens. From the 822 women with followup visits between August 2009–March 2011, 170 pregnancies were detected during study followup, including 56 EFV conceptions. Pregnancy incidence rates were comparable across EFV, nevirapine, and lopinavir/ritonavir person-years (95% 100/users (P = 0.25)); incidence rates on EFV were 18.6 Confidence Interval: 14.2–24.2). Treatment substitution from EFV was made for 57 women, due to pregnancy intentions or actual pregnancy; however, regimen changes were not systematically applied across women. High rates of pregnancy on EFV and inconsistencies in treatment management suggest that clearer guidelines are needed regarding how to manage fertility-related issues in. women on EFV-based regimens.

Opportunistic infections in relation to antiretroviral status among AIDS patients from south India

Background: There is a need to generate data from India on relative frequencies of specific opportunistic infections (OIs) in different regions and their relation to the choice of commonly used generic highly active anti-retroviral therapy (HAART) regimens. Objectives: To document the prevailing prevalence pattern of OIs both before and after HAART, to look for reduction in OIs following HAART, to assess the risk of developing new OIs within 6 months of HAART initiation and to see if there is any difference in the risk of developing a new OI within 6 months of HAART initiation, for those on Efavirenz (EFV)-based regimens and Nevirapine (NVP)-based regimens. Materials and Methods: In a prospective observational cohort study conducted in South India involving 108 ART-naive AIDS patients, different pathogens were isolated and identified using standard laboratory techniques. Data analysis was done using SPSS software (version 16.0). Risk of developing an OI after HAART initiation was assessed using the likelihood ratio test from Cox regression models. Results: Tuberculosis (53.4%), oral Candidiasis (27.2%) and Herpes Zoster (14.7%) were the common infections seen. There was a drastic reduction of 96.59% in OI events after 6 months of HAART. The risk of developing an OI within 6 months of HAART initiation was 5.56%. Time to development of an OI in the first 6 months of HAART was shorter for the NVP-based regimens than with EFV-based regimens, but this difference was not statistically significant (HR=0.891, 95% CI: 0.179–4.429; P=0.888). Conclusion: Tuberculosis is the most important OI before initiation of HAART. Both EFV and NVP-based regimens are equally efficacious in controlling OIs.

Comparative Effectiveness of Efavirenz, Protease Inhibitors, and Raltegravir-Based Regimens as First-Line Treatment for HIV-Infected Adults: A Mixed Treatment Comparison

Objective: Compare the efficacy of 2 NRTIs combined with raltegravir (RAL), efavirenz (EFV), or protease inhibitors (PI) in the management of antiretroviral-naïve HIV adult patients. Methods: By means of a systematic literature view, 7 randomized controlled trials were identified: 2 RAL vs EFV trials; 1 ritonavir-boosted lopinavir (LPV/RTV) vs EFV trial; 1 ritonavir-boosted atazanavir (ATV/RTV) vs LPV/RTV trial; 1 ritonavir-boosted darunavir (DRV/RTV) vs LPV/RTV trial; 1 ritonavir-boosted fosamprenavir (FPV/RTV) vs LPV/RTV trial; and 1 FPV/RTV vs ATV/RTV trial. Endpoints concerned virological suppression and immunologic efficacy. Trials were analyzed with Bayesian mixed treatment comparison meta-analysis. Results: For up to 24 weeks of treatment, a PI-based regimen resulted in a lower proportion of patients with virological response than an EFV-based regimen, whereas RAL seems more efficacious than EFV up to at least 12 weeks. After 48 weeks, the odds ratio (OR) of virological suppression with RAL relative to EFV was 1.34 (95% credible interval [CrI], 0.87–2.07). ORs for PIs relative to EFV varied from 0.68 (0.41–1.07) with LPV/RTV to 0.99 (0.52–1.84) with DRV/RTV. RAL demonstrated a greater improvement in CD4+ T cell counts than EFV at 48 weeks. The PI regimens showed all similar improvements relative to EFV. Conclusion: Based on available RCTs, the fastest virological suppression is expected with RAL followed by EFV and PIs. Over time, RAL appears to be at least as good as PI and EFV regimens. CD4+ cell recovery seems the greatest with LPV/RTV, DRV/RTV, and RAL. Given the limited number of RCTs, additional studies are recommended.

O2-1.3 Evaluation of HIV treatment outcomes in Southwestern Nigeria

IntroductionThe recently published 2010 United Nations (UNGASS) report shows that 70% of adults and children with HIV are alive 12 months after initiation of antiretroviral therapy in Nigeria. This study...

Long‐term effectiveness and safety of didanosine combined with lamivudine and efavirenz or nevirapine in antiretroviral‐naive patients: a 9‐year cohort study in Senegal

The use of didanosine (ddI) in first-line antiretroviral therapy has been recently promoted for resource-limited settings. We therefore compared the long-term effectiveness and safety of the regimen combining ddI, lamivudine, and efavirenz or nevirapine with that of the WHO-recommended regimen of zidovudine (ZDV), lamivudine, and efavirenz or nevirapine in antiretroviral-naïve patients in Senegal. Observational cohort study of patients enrolled between January 2000 and April 2002 in the Senegalese antiretroviral drug access initiative. Multivariate analyses were performed to compare, between the ddI and ZDV groups, the proportion of patients with a viral load <500 copies/ml during follow-up; the increase in the CD4 cell count; survival; treatment changes and severe adverse events. Of 151 patients, 71 received the ddI-based treatment and 80 received the ZDV-based treatment. Throughout follow-up, 80-95% of patients had a viral load below 500 copies/ml in both the ddI and ZDV groups (P = 0.5). The CD4 cell count increased after treatment initiation from 176 to 497 cells/mm(3) in the ddI group and from 176 to 567 cells/mm(3) in the ZDV group (P > 0.3). The rate of death tended to be higher in the ddI group (P = 0.06). ddI was less commonly discontinued than ZDV (P = 0.03). The combination of ddI, lamivudine, and efavirenz or nevirapine resulted in sustained viral suppression and immunological recovery.

Virological outcomes in ARV‐naïve patients switching or not from a first successful boosted PI‐regimen to efavirenz, nevirapine or abacavir regimens

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

5‐year safety and efficacy of the once‐daily antiretroviral regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial)

once-daily combinations of efavirenz and two nucleoside analogues are recommended for the treatment of HIV infection. Long-term efficacy and safety data are scarce for the combination of efavirenz, emtricitabine and didanosine. the ALIZE ANRS 099 trial enrolled 355 adults with plasma HIV RNA levels of <400 copies/mL under a protease inhibitor-based regimen, who were randomized to remain on this regimen or to switch to a once-daily regimen of emtricitabine, didanosine and efavirenz for 48 weeks. An extended 4 year follow-up was available for the 178 patients who switched to the efavirenz-containing regimen, and assessed plasma HIV RNA levels, CD4 cell counts, safety and tolerability. after a median follow-up of 42 months, 121 patients (68%) remained on an efavirenz-based regimen, and 62% and 57% had plasma HIV RNA levels of <400 and <50 copies/mL, respectively, in an intent-to-continue analysis with missing data and treatment discontinuation considered as failure. There was a significant increase in CD4 cell count of 41 cells/mm(3). Drug-related adverse events were the main reason for treatment discontinuation in 26 patients (15%), and 15 were reported during the first year of therapy (58%). There was no emergence of clinically defined lipodystrophy, and lipid and glucose profiles were favourable with a significant increase from baseline of high-density lipoprotein cholesterol levels (median increase 12 mg/dL, P < 10(-4)). a once-daily regimen of emtricitabine, didanosine and efavirenz provided a durable antiretroviral response and was well tolerated through 4 years of therapy.

Effects of Maraviroc and Efavirenz on Markers of Immune Activation and Inflammation and Associations with CD4+ Cell Rises in HIV-Infected Patients

BackgroundMaraviroc treatment for HIV-1 infected patients results in larger CD4+ T cell rises than are attributable to its antiviral activity alone. We investigated whether this is due to modulation of T cell activation and inflammation.Methods and FindingsThirty maraviroc-treated patients from the Maraviroc versus Efavirenz Regimens as Initial Therapy (MERIT) study were randomly selected from among those who had CCR5-tropic (R5) HIV on screening and achieved undetectable HIV RNA (<50 copies/mL) by Week 48. Efavirenz-treated controls were matched for baseline characteristics to the maraviroc-treated patients selected for this substudy. Changes in immune activation and inflammation markers were examined for associations with CD4+ T cell changes. Maraviroc treatment tended to result in more rapid decreases in CD38 expression on CD4+ T cells and in plasma D-dimer concentrations than did treatment with efavirenz. The proportion of patients with high-sensitivity C-reactive protein >2 µg/mL increased from 45% to 66% in the efavirenz arm, but remained constant in the maraviroc arm (P = 0.033). Decreases in CD38 expression on CD8+ T cells were correlated with CD4+ T cell rises for maraviroc treatment (r = −0.4, P = 0.048), but not for treatment with efavirenz.ConclusionsMaraviroc-treated patients had earlier, modest decreases in certain markers of immune activation and inflammation, although in this small study, many of the differences were not statistically significant. Levels of high-sensitivity C-reactive protein remained constant in the maraviroc arm and increased in the efavirenz arm. Decreases in immune activation correlated with increased CD4+ T cell gains.Trial RegistrationClinicalTrials.gov NCT00098293