DIRECT-ACTING ANTIVIRALS FOR HEPATITIS C DO NOT AFFECT THE RISK OF DEVELOPMENT OR THE OUTCOME OF HEPATOCELLULAR CARCINOMA.

HCV infection and its complications, especially hepatocellular carcinoma, is a substantial public health burden. In 2015 "Nationwide hepatitis C elimination program" was launched in Georgia. According to the protocol, patients with HCC also receive DAA antiviral treatment. We study the effect of the different DAA therapy regiments on the incidence or recurrence of HCC and its prognosis. Overall, 408 patients were recruited in Georgian-French Joint Hepatology Clinic HEPA between April 2015-March 2016. The selection criteria were as follows: 1 - age 50-65 years; 2. Liver fibrosis level F3-F4 or cirrhosis at least 15 years of disease history; 3. HCV positive diagnosed by PCR method, whatever the level of viral load and genotype; 4. absence of previous complications of cirrhosis (ascites, gastrointestinal bleeding or HCC; 5. Child-Pugh class A or B; and 6. absence of severe extrahepatic disease. Essential clinical and biological parameters were recorded. Clinical monitoring and management of adverse events were performed on a regular base. HCV All patients included in the study received anti-HCV treatment with direct-acting antivirals (DAAs) within the national hepatitis C elimination program in accordance with national protocols. During April 2015-March 2016 treatment was provided with sofosbuvir (SOF) in combination with ribavirin (RBV), with or without pegylated interferon (IFN). Since March 2016, ledipasvir/sofosbuvir (LDV/SOF) was prescribed to all patients with or without RBV depending on the HCV genotype, level of fibrosis, and previous treatment experience. In conclusion, we find that neither different DAA regimens nor different treatment duration affects HCC risk after antiviral treatment. Moreover, there are no significant changes in mortality rate due to HCC in these groups. Therefore, it can be concluded, that HCC status is not a contraindication for DAA treatment, especially at the early stages of cancer, when a tumor is curative.

Treatment outcomes of integrase inhibitors, boosted protease inhibitors and nonnucleoside reverse transcriptase inhibitors in antiretroviral-naïve persons starting treatment.

OBJECTIVES: Although outcomes of antiretroviral therapy (ART) have been evaluated in randomized controlled trials, experiences from subpopulations defined by age, CD4 count or viral load (VL) in heterogeneous real-world settings are limited. METHODS: The study design was an international multicohort collaboration. Logistic regression was used to compare virological and immunological outcomes at 12 ± 3 months after starting ART with an integrase strand transfer inhibitor (INSTI), contemporary nonnucleoside reverse transcriptase inhibitor (NNRTI) or boosted protease inhibitor (PI/b) with two nucleos(t)ides after 1 January 2012. The composite treatment outcome (cTO) defined success as VL < 200 HIV-1 RNA copies/mL with no regimen change and no AIDS/death events. Immunological success was defined as a CD4 count > 750 cells/µL or a 33% increase where the baseline CD4 count was ≥ 500 cells/µL. Poisson regression compared clinical failures (AIDS/death ≥ 14 days after starting ART). Interactions between ART class and age, CD4 count, and VL were determined for each endpoint. RESULTS: Of 5198 ART-naïve persons in the International Cohort Consortium of Infectious Diseases (RESPOND), 45.4% started INSTIs, 26.0% PI/b and 28.7% NNRTIs; 880 (17.4%) were aged > 50 years, 2539 (49.4%) had CD4 counts < 350 cells/µL and 1891 (36.8%) had VL > 100 000 copies/mL. Differences in virological and immunological success and clinical failure among ART classes were similar across age groups (≤ 40, 40-50 and > 50 years), CD4 count categories (≤ 350 vs. > 350 cells/µL) and VL categories at ART initiation (≤ 100 000 vs. > 100 000 copies/mL), with all investigated interactions being nonsignificant (P > 0.05). CONCLUSIONS: Differences among ART classes in virological, immunological and clinical outcomes in ART-naïve participants were consistent irrespective of age, immune suppression or VL at ART initiation. While confounding by indication cannot be excluded, this provides reassuring evidence that such subpopulations will equally benefit from contemporary ART.

HIV care in times of the COVID-19 crisis - Where are we now in Central and Eastern Europe?

INTRODUCTION: The SARS-CoV-2 pandemic has hit the European region disproportionately. Many HIV clinics share staff and logistics with infectious disease facilities, which are now on the frontline in tackling COVID-19. Therefore, this study investigated the impact of the current pandemic situation on HIV care and continuity of antiretroviral treatment (ART) supplies in CEE countries. METHODS: The Euroguidelines in Central and Eastern Europe (ECEE) Network Group was established in February 2016 to review standards of care for HIV in the region. The group consists of professionals actively involved in HIV care. On March 19, 2020 we decided to review the status of HIV care sustainability in the face of the emerging SARS-CoV-2 pandemic in Europe. For this purpose, we constructed an online survey consisting of 23 questions. Respondents were recruited from ECEE members in 22 countries, based on their involvement in HIV care, and contacted via email. RESULTS: In total, 19 countries responded: Albania, Armenia, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Greece, Hungary, Lithuania, Macedonia, Poland, Republic of Moldova, Russia, Serbia, Turkey, and Ukraine. Most of the respondents were infectious disease physicians directly involved in HIV care (17/19). No country reported HIV clinic closures. HIV clinics were operating normally in only six countries (31.6%). In 11 countries (57.9%) physicians were sharing HIV and COVID-19 care duties. None of the countries expected shortage of ART in the following 2 weeks; however, five physicians expressed uncertainty about the following 2 months. At the time of providing responses, ten countries (52.6%) had HIV-positive persons under quarantine. CONCLUSIONS: A shortage of resources is evident, with an impact on HIV care inevitable. We need to prepare to operate with minimal medical resources, with the aim of securing constant supplies of ART. Non-governmental organizations should re-evaluate their earlier objectives and support efforts to ensure continuity of ART delivery.

The EuroSIDA study: 25 years of scientific achievements.

The EuroSIDA study was initiated in 1994 and follows adult people living with HIV (PLHIV) in 100 collaborating clinics across 35 countries covering all European regions, Israel and Argentina. The study aims to study the long-term virological, immunological and clinical outcomes of PLHIV and to monitor temporal changes and regional differences in outcomes across Europe. Annually collected data include basic demographic characteristics, information on AIDS- and non-AIDS-related clinical events, and details about antiretroviral therapy (ART), hepatitis C treatment and other medications, in addition to a range of laboratory values. The summer 2016 data set held data from a total of 23 071 individuals contributing 174 481 person-years of follow-up, while EuroSIDA's unique plasma repository held over 160 000 samples. Over the past 25 years, close to 300 articles have been published in peer-reviewed journals (h-index 52), covering a range of scientific focus areas, including monitoring of clinical and virological outcomes, ART uptake, efficacy and adverse events, the influence of hepatitis virus coinfection, variation in the quality of HIV care and management across settings and regions, and biomarker research. Recognizing that there remain unresolved issues in the clinical care and management of PLHIV in Europe, EuroSIDA was one of the cohorts to found The International Cohort Consortium of Infectious Disease (RESPOND) cohort consortium on infectious diseases in 2017. In celebration of the EuroSIDA study's 25th anniversary, this article aims to summarize key scientific findings and outline current and future scientific focus areas.

INCIDENCE OF TUBERCULOSIS AMONG HIV/HCV CO-INFECTED PATIENTS RECEIVING HEPATITIS C TREATMENT WITH PEGYLATED INTERFERON AND RIBAVIRIN IN GEORGIA.

Treatment of hepatitis C is necessary for ensuring higher life expectancy among HIV/HCV co-infected patients. However antiviral treatment for chronic HCV infection with Pegylated interferon (PEG-IFN) and Ribavirin (RBV) is associated with a variety of side effects. In Georgia up to 22% of HIV-infected patients were found to have active Tuberculosis (TB) and 22.4 to 32.6% had latent TB. The objective of this study was to describe the characteristics and clinical outcomes of tuberculosis in HIV/HCV co-infected patients receiving hepatitis C treatment with pegylated interferon and ribavirin and calculate incidence rate of TB. A retrospective study was conducted among HIV/HCV co-infected patients receiving antiviral treatment for chronic HCV infection at the Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia from December 2011 to May, 2015. A total of 420 HIV/HCV co-infected patients received HCV therapy with PEG-IFN and RBV during study period. Six of 420 patients developed TB while receiving PEG IFN + RBV therapy. These patients were on Antiretroviral treatment. Baseline HIV RNA load was <34 copies/ml and CD4+ cell counts >350 cells/mm3. No opportunistic infections were observed in all cases. Three of 6 patients had a previous positive tuberculin skin test (TST) result and had completed isoniazid chemoprophylaxis several years before TB diagnosis. In 2 patients TST was not performed. Only one patient had experienced a previous episode of TB and had completed the anti-TB therapy 1 year before hepatitis C treatment. In all patients TB was diagnosed during the PEG IFN + RBV therapy. Hepatitis C treatment was immediately stopped in all patients. The incidence rate of TB was 1.4 cases per 100 person-years (95% CI=0.58-2.97). Our study emphasizes the necessity of screening for latent TB prior to the initiation of chronic hepatitis C treatment with PEG IFN and RBV.

MOLECULAR TRACING OF HETEROSEXUAL HIV-1 TRANSMISSION IN GEORGIA.

HIV epidemic in Georgia has entered a new phase with number of heterosexually acquired infections rising each year. Epidemiological data indicates that this switch in epidemic trends is largely due to HIV positive male IDUs transmitting the virus to their female sexual partners. However, no genetic studies confirming linkage between IDUs and their sex partners were done in Georgia before. The objective of our study was to investigate molecular epidemiology of HIV-1 transmission events between heterosexual couples. Viral genotypes were obtained from plasma specimens of 36 heterosexual HIV-1 positive antiretroviral treatment (ART) naive persons representing 18 epidemiologically linked transmission events were genotyped and phylogenetic analyses were done on HIV pol sequences. HIV infection among all women was attributed to heterosexual transmission from their partners. None of 18 women had history of IDU. Fourteen pairs had subtype A virus, three - subtype B and one - subtype G viruses. Phylogenetic analysis confirmed the existing epidemiological link in 16 pairs with bootstrap values ranging from 88% to 100%. Of these 16 events, viruses from 14 pairs had genetic distance less than 0.015.Mutation A62V was seen in samples from 5 pairs, of them samples from 4 pairs additionally had V77I mutation. All 5 pairs were infected with the subtype Avirus. Women, who are sexual partners of IDUs or other men with high risk heterosexual behaviors, are at increased risk of HIV acquisition. HIV epidemic in Georgia has not spread to general population and remains concentrated around key populations at risk. Our work confirms that female sexual partners can serve as a bridge between key affected populations and general community, such as heterosexually active adults. Therefore, prevention efforts targeting key populations at risk and their sexual partners need to be expanded to avoid the spread of the infection within specific communities and beyond.

Distinct drug resistance profile of HIV-1 subtype A strain circulating in Georgia.

Emergence of HIV-1 drug resistance limits effectiveness of antiretroviral therapy (ART). Since 2004 Georgia provides free ART to all patients in need. We aimed to evaluate drug resistance patterns of Georgian HIV-1 variants among patients with virologic failure. Study included adult HIV-1 patients, who experienced virologic failure and were found to carry drug resistant strains based on genotypic resistance testing in 2005-2013. HIV-1 pol gene sequences were examined for the presence of resistance-associated mutations. Stanford HIV Sequence Database was used for interpretation of resistance data. A total 193 patients were included in the study. Among them majority (86.5%) carried subtype A virus and nearly 80% were on Efavirenz-based regimen. The most common nucleoside reverse transcriptase inhibitor (NRTI) mutation was M184V - 86.0% (n=166). The most frequent non-nucleoside reverse transcriptase inhibitor (NNRTI) mutation was G190S, found in 105 (54.4%) of samples. Other significant NNRTI mutations included K101E (31.6%, n=61), K103N (30.1%, n=58) and Y181CI (26.9%, n=52). The prevalence of G190S was 62.3% in subtype A viruses compared to 3.8% in non-A variants (p<0.0001). Frequency of K101E was also significantly higher in subtype A (36.5% vs. 0%, p<0.0001). ). In 69 samples G190S co-occurred with either K101E or Y181C or with both: 39 genotypes G190S/K101E; 10 genotypes G190S/Y181CI and 20 genotypes G190S/K101E/Y181CI. High prevalence of G190S and K101 mutations suggests subtype A specific response to currently approved first-line NNRTIs. Frequent co-occurrence of G190S with Y181C and K101E may limit the use of novel generation NNRTIs in subtype A infected patients with previous exposure to this drug class.

The cascade of care in the Eastern European country of Georgia.

OBJECTIVES: Individual and public health benefits of antiretroviral therapy (ART) rely on successful engagement of HIV-infected patients in care. We aimed to evaluate the HIV care continuum in the Eastern European country of Georgia. METHODS: The analysis included all adult (age ≥ 18 years) HIV-infected patients diagnosed in Georgia from January 1989 until June 2012. Data were extracted from the national HIV/AIDS database as of 1 October 2012. The following stages of the HIV care continuum were quantified: HIV infected, HIV diagnosed, linked to care, retained in care, eligible for ART and virologically suppressed. RESULTS: Of 3295 cumulative cases of adult HIV infection reported in Georgia, 2545 HIV-infected patients were known to be alive as of 1 October 2012, which is 52% of the estimated 4900 persons living with HIV in the country. Of the 2545 persons diagnosed with HIV infection, 2135 (84%) were linked to care and 1847 (73%) were retained in care. Of 1446 patients eligible for ART, 1273 (88%) were on treatment and 985 (77%) of them had a viral load <400 HIV-1 RNA copies/mL. Overall, 39% of those diagnosed and 20% of those infected had a suppressed viral load. CONCLUSIONS: The findings of our analysis demonstrate that the majority of patients diagnosed with HIV infection are retained in care. Loss of patients occurs at each step of the HIV care continuum, but the major gap is at the stage of HIV diagnosis. Reducing the number of persons living with undiagnosed HIV infection and simultaneously enhancing engagement in continuous care will be critical to achieve maximum individual and public health benefits of ART.

High seroprevalence of Chlamydia trachomatis in newly diagnosed human immunodeficiency virus patients in georgia.

Due to the shared routes of transmission, co-infection with Human Immunodeficiency Virus (HIV) and other sexually transmitted infections (STIs) is common. There is strong evidence of bidirectional interactions between HIV and ulcerative STIs. Recent studies have also shown importance of non-ulcerative inflammatory STIs in the acquisition of HIV. The incidence of HIV and Chlamydia in Georgia has risen every year. We explored the extent of the problem of co-infection with C. trachomatis in HIV patients in the country. Study included 234 consecutive patients diagnosed with HIV from September 2008 through May 2009. Of them, approximately two-thirds were male 162 (69.23%), up to 44% (102) of patients had more than one lifetime sexual partner and one fifth of patients reported prior history of STIs. The seroprevalence of C. trachomatis in our study was 23.93% (95% CI: 18.61%-29.92%). In multivariate analysis the strongest predictors of C. trachomatis infection were history of STI (PR 1.94, 95% CI: 1.22-3.07) and female gender (PR 1.79, 95% CI: 1.11-2.87), while younger age and not being in marriage showed borderline significance. Findings of our study have important public health and clinical implications. Data suggest that STIs may play important role in increasing heterosexual transmission of HIV in Georgia. Efforts should be made to expand HIV screening programs. Further research is needed to better understand the role of inflammatory STIs in spreading HIV.

HLA-B*5701 genetic screening prior to abacavir prescription in Georgia.

A hypersensitivity reaction to abacavir develops in approximately 2-8% of HIV patients receiving this drug and is strongly associated with presence of the human leukocyte antigen (HLA)-B*5701. Screening for HLA-B*5701 reduces the risk of developing an abacavir hypersensitivity reaction. The carriage rate of HLA-B*5701 has not been studied in Georgia before 2009. Objective of the study was to determine HLA-B*5701 prevalence in HIV-infected patients in Georgia. One hundred and sixty HIV positive patients attending Georgian Infectious Diseases, AIDS and Clinical Immunology Research Center in 2009 were recruited for the study. None of the patients had previously been treated with abacavir. Blood samples were collected and screened for HLA-B*5701 prior to abacavir prescription. Of 160 patients recruited 9 tested HLA B*5701 positive - 5.6% (95% CI: 2.6-10.4%). Of these nine patients 7 were males (male prevalence: 6.5%, 95% CI: 2.6-12.9 %) and 2 females (female prevalence: 4.8%, 95% CI: 0.6-16.2%). The first prospective study of HLA-B*5701 prevalence in Georgia show similar results to the results of other studies. Abacavir still remains one of the key drugs of antiretroviral regimens in Georgia and other countries. Therefore, prospective HLA-B*5701 screening should be implemented in all settings where abacavir is widely used to guide selection of ART regimens and to reduce the risk of potentially life threatening hypersensitivity reaction.

Re-treatment of patients with hepatitis C who failed to respond (nonresponders) to previous treatment.

The aim of four-year follow up study was evaluation of re-treatment efficacy of antiviral therapy in patients with hepatitis C who failed to respond (non responders) to previous therapy. Study enrolled 29 patients, aged 21-59 with HCV infection (15 had HCV genotype 1, and 14 had HCV non-genotype1), who previously were treated with unmodified interferon alfa (conventional interferon) 2a or 2b 5 MIU TIW plus ribavirin (1000-1200 mg/day) and who failed under this therapy. Study subjects were randomized into two groups: in group I were included 17 patients--relapsers (patient in whom HCV RNA becomes undetectable on treatment and is undetectable at the end of therapy, but is detected again after discontinuation of treatment). Group II was composed of 12 patients: 4 were non responders (patient in whom HCV RNA levels remain stable on treatment), 4--partial responders (HCV RNA levels decline by >2 logs, but never become undetectable during treatment) and 4--breakthrough non responders (HCV RNA become undetectable during treatment, but before-treatment termination again become detectable). The diagnosis of HCV infection was made based on detection of HCV antibodies by ELISA and confirmed by RIBA. Detection of HCV RNA (qualitative) and HCV RNA Viral load--by Real time PCR technique (COBAS TaqMan Test). HCV genotypes were detected by INNO-Lipa method. In group I--rapid virological response (RVR) was observed in 10 (58%) patients, early viral response (EVR) in 12 patients (70%). Among them 9 (52%) patients remained HCV RNA undetectable by the end of treatment. After 6 months sustained viral response (SVR) was received in 7 (41%) patients from group I. In group II--RVR was observed in 5 (41%), EVR in 6 (50%) patients. Among them 5 (41%) patients remained HCV RNA undetectable by the end of treatment. After 6 months Sustained Viral Response was received in 3 (25%) patients. Re-treatment with pegylated interferon and ribavirin in patients with hepatitis C who failed to responds to previous treatment was effective in relapsers. Re-treatment in non responders, partial responders and breakthrough non responders was less effective (especially in non responders). Re-treatment effectiveness was higher in HCV genotype non 1 patients in comparison with HCV genotype 1. Thus re-treatment will be considered for relapsers. For making decision on re-treatment for other nonresponders, severity of disease (advance disease) should be considered.

Morphological changes and manganese content in the brains of rat pups subjected to subchronic poisoning with manganese chloride.

Morphological changes in neurons and the distributions of nerve and glial cells were studied, the glial index was calculated, and manganese (Mn) contents were determined in the caudate nucleus, the nucleus accumbens, the dorsal and ventral septal nuclei, and the frontoparietal areas of the cerebral cortex in the 40-day-old offspring of rats given different doses (10 and 20 mg/kg) of manganese chloride (MnCl2.4H2O) 15-20 days before pregnancy, during pregnancy, and for one month after parturition with the first portion of food. Mn poisoning increased Mn contents in the brains of rat pups, damaged a small proportion of neurons, and produced marked gliosis. These changes are believed to underlie previously described impairments to learning processes and emotional state in rat pups.

[Morphological changes and manganese level in the brain of rat pups subjected to subchronic manganese chloride intoxication].

The morphological alterations in the neurons together with the distribution of the neural and glial cells were studied, the glial index was calculated, and manganese level was determined in n. caudatus, n. accumbens septalis, n. dorsalis and ventralis septalis, and in the fronto-parietal region of the brain cortex in the 40-day old offspring of the rats, which were given a various daily dose (0, 10, and 20 mg/kg) of manganese chloride (MnCl2 x 4H2O) with the first portion of their food 15-20 days prior to pregnancy, during the pregnancy and for one month after the parturition. Manganese intoxication induced elevation of the manganese level in the brain of the pups with the injury of a small portions of the neurons and a pronounced gliosis. We believe that these changes underlie the previously reported disorders in learning processes and emotional state of the pups.

Successful application of laboratory tools for the detection of HIV drug resistance in routine clinical care in Georgia.

Since 2004, Georgia the first among Eastern European countries ensured universal access to highly active antiretroviral therapy (HAART). Laboratory monitoring of HAART using CD4 count, viral load (VL) and HIV genotypic resistance testing was carried out in according with National HIV/AIDS Treatment Guidelines. Georgia the first among former Soviet Union countries implemented HIV genotypic resistance testing in HIV clinical care. The present paper reports on successful application of laboratory tools in routine clinical care for the early detection of HIV drug resistance. For genotypic resistance testing the TruGene HIV-1 Genotyping Kit (Bayer HealthCare LLC, Tarrytown, NY) was used according to manufacturer's instructions. Analysis included 45 patients with virologic failure. Of them 34 (75.5%) had at least one resistant mutation. Dual-class drug resistance was found in 30 (66.7%) patients. One (2.2%) patient carried triple-class resistance mutations. Median number of resistant mutations was 2. Most commonly detected NRTI mutation was M184/V/I (68.9%). G190S/A was the most frequent NNRTI mutation (42.2%), followed by K103N (28.9%). All patients with drug resistance mutations were switched to a second line regimens. Analysis of virologic and immunological outcomes among 23 patients who had at least two follow-up measurements of CD4 and VL after resistance test, showed statistically significant decrease in VL by 2.5 log(10) and mean gain of 181 cells/mm(3) in CD4 count by the last available measurement. Routine monitoring of VL and subsequent use of HIV drug resistance testing allowed for early identification of HIV drug resistance, reducing the opportunity for mutations to accumulate. Routine use of sophisticated laboratory methods for HAART monitoring has beneficial impact on clinical outcomes and should be used as part of the strategy to combat resistance.

Prevalence of hepatitis B and C among HIV positive patients in Georgia and its associated risk factors.

The aim of the study was to determine the prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) co-infection among HIV positive patients, to identify most relevant risk factors of co-infection and develop preventive interventions. Study participants were voluntary individuals 18 years of age or older recruited from AIDS Center VCT unit in Tbilisi, Georgia. Eligibility criteria of participants were: HIV positive result confirmed by western blot; age; and voluntary participation. Total 175 patients undergo interview with specially designed questionnaires. Most of the participants were male (71.4%), age range of HIV positives varied from 20 to 77 years old. Prevalence of HCV among HIV positive patients is high. Almost half (48.57%) HIV positive patients are co-infected with HCV. Men were more likely than women co-infected with HCV (60.80% and 18% accordingly). Major risk factor of male co-infection was related to drug use, needle and injection equipment sharing. Prevalence of HCV among injecting drug users was (73.40%). Drug users had 3.25 times more risk (PR 3.25; 95%CI; CL--1.89-5.26; p<0.01) to be infected with HCV compare non IDUs. Prevalence of being infected with HBV (Anti-HBc) among HIV positives was 43.42% (76/175) and the prevalence of Chronic HBV (HBsAg positive) was 6.86% (12/175). Prevalence rate of HBsAg among IDUs was 8.51% and among non IDU participants 5.26%. Triple infection (HIV, Hepatitis C and chronic form of Hepatitis B--HBsAg) was among 9 patients (5.14%). Infections were associated with injection drug use (88.88%) and mostly were related to share of needles/syringes and other injecting medical equipment. Transmission of HBV and HCV by sexual contact was not observed among those 9 participants. High risk behavior among HIV positive participants mostly related to drug use and unprotected sex with non regular partners. Other risk factors for Hepatitis transmission were associated with invasive medical manipulations, blood transfusion, surgery, abortions and etc. None of cases of HIV, or Hepatitis (B, C) transmission through medical manipulations can be documentary proved based on those research data.

Expansion of CD3/CD16/CD56 positive NKT cells in HIV/AIDS: the pilot study.

UNLABELLED: NKT cells are a subset of lymphocytes possessing features of NK cells and T cells; they play a key role in the formation of innate immune response. Upon stimulation, rapid production of large quantities of both T(h1) and T(h2) type cytokines permits them to bridge the innate and adaptive immune responses by activating NK cells, T cells, B cells and dendritic cells. Scientific knowledge has been collecting up to date toward the definition of the role of NKT lymphocytes in HIV/AIDS setting. This direction in HIV/AIDS immunopathogenesis is relatively new and quite concerning. The objective of this study was to investigate CD3+/CD16+/CD56+ NKT cell expansion in HIV/AIDS patients and explore its association with virologic and immunologic markers of HIV infection. Retrospective analysis of 30 HIV infected patients data, taken from the database of the laboratory of clinical immunology at the Infectious Diseases, AIDS and Clinical Immunology Research Center, was conducted. RESULTS: there was slightly increased risk of higher plasma viral load related to lower NKT cell expansion. With regard to immunologic status, borderline significance between expansion of CD3/CD16/CD56 positive NKT cells and lower CD4 positive cell count was shown. However, study did not show strong associations of NKT cell expansion with either virologic or immunologic status, interestingly, all HIV/TB co infected patients where NKT cell positive, which underlines the possible role of TB in CD3+/CD16+/CD56+ NKT cell expansion phenomena in HIV infected individuals. We think these new findings may serve as prerequisite for future, larger scale research in this direction.