HIV Drug Resistance Pattern Due to Migration in Poland

Possible Changes in HIV Drug Resistance Pattern Due to Migration of People From the Eastern Europe to Poland

According to the Polish governmental statistics migration of people from Ukraine to Poland is growing and only in year 2020 have come to Poland about a quarter of a million of Ukrainian migrants. As well, more than 40% of those diagnosed with HIV infection in the European Union (EU)/European Economic Area (EEA) in 2018 were also migrants, originating from countries with generalized HIV epidemics, such as Ukraine. Antiretroviral treatment should be started, based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; HIV-1-infection; Resistant Infection
• Intervention / Treatment: Diagnostic test: HIV drug resistance testing

Detailed Description

BACKGROUND:

According to the Polish governmental statistics during the year 2020 have come to Poland about 240 thousand of ukarinian migrants, and it is estimated that nowadays in Poland live and work about 1.2 million of people from Ukraine. In recent years substantial increases in diagnosis of HIV infected people have been reported in some countries, including Poland. At the same time 42% of those diagnosed in the EU/EEA in 2018 were migrants, defined as originating from outside of the country in which they were diagnosed. More than one-third (40%) of newly diagnosed cases due to heterosexual transmission were among migrants originating from countries with generalized HIV epidemics, such as Ukraine. Overall in the EU/ EEA, and even in some settings with decrease in newly diagnosed HIV infections in men having sex with others men (MSM), new HIV diagnoses in migrant MSM have not declined at the same rate as those who are not foreign-born. Antiretroviral treatment should be started immediately in all HIV-positive patients, regardless of origin, race, gender or sexual preferences. The choose of first-line antiretroviral regimen is based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.

AIM OF THE STUDY:

Due to changes in epidemiological pattern in newly diagnosed patients with HIV infection in Poland and increase in number of HIV positive patients from Ukraine we aimed to asses whether the presence of drug resistance mutations in the population of Ukrainian patients differs from the pattern of resistance of not foreign born patients with newly diagnosed HIV infection in Poland. The potential differences may have further implications on antiretroviral regimens in drug naive HIV positive patients.

MATERIAL AND METHODS:

We have designed observational, prospective study which will be performed in several clinical centers in Poland. As a part of the study we will collect epidemiological (age, gender, origin, migration data, sexual preferences) and clinical data (HIV viral load, CD4+ cells count, presence of AIDS-defining diseases, proposed combined antiretrovirat therapy (cART) regimen and the response to the treatment, Hepatitis B (HBV) and C (HCV) co-infections).

In all patients, before starting antiretroviral treatment, presence of drug resistance mutations of HIV will be assessed. The molecular diagnostics will cover mutations to the nucleotide and non-nucleotide reverse transcriptase inhibitors (NRTI and NNRTI), protease inhibitors (PI) and as well integrase inhibitors (InSTI).

Statistical evaluation will be performed in subgroups of migrants and in patients born in Poland. The distribution of continuous variables will be analysed by the Shapiro-Wilk test. The data will be expressed as the median and interquartile range (IQR). Quantitative data will be analysed using the Mann-Whitney U test or Kruskal-Wallis ANOVA when appropriate. Qualitative data will be compared using the χ² test or the Fisher exact test. A P value of <0.05 will be considered statistically significant.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Andrzej Zaleski, PhD; Phone Number: 048600982185; Email: andrzejzaleski84@wp.pl

Study Locations

• Poland
  • Mazowia
    • Warsaw, Mazowia, Poland, 01-201
      • Department of Infectious Diseases, Tropical Diseases and Hepatology, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People diagnosed with HIV infection in Poland, originating from Poland and other countries

Description

Inclusion Criteria:

• recent diagnosis with HIV infection (<6 months)
• no history of antiretrovirals intake (PrEP, PEP)
• age 18 years or olde

Exclusion Criteria:

- failure to meet any of the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV POLISH (PL); HIV infected people with polish nationality, who most probably acquired infection in Poland	Diagnostic test: HIV drug resistance testing; HIV drug resistance testing in people newly diagnosed in HIV in Poland
HIV MIGRANTS (M); HIV infected people, originating from outside of Poland, where they were diagnosed with HIV infection	Diagnostic test: HIV drug resistance testing; HIV drug resistance testing in people newly diagnosed in HIV in Poland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in HIV drug resistance pattern	Differences between people originating from Poland and from Eastern Europe	2 years

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Chair: Alicja Wiercińska-Drapało, PhD, Department of Infectious Diseases,Tropical Diseases and Hepatology, Medical University of Warsaw

Publications and helpful links

General Publications

• Wensing AM, Calvez V, Ceccherini-Silberstein F, Charpentier C, Gunthard HF, Paredes R, Shafer RW, Richman DD. 2019 update of the drug resistance mutations in HIV-1. Top Antivir Med. 2019 Sep;27(3):111-121.
• Shafer RW, Rhee SY, Pillay D, Miller V, Sandstrom P, Schapiro JM, Kuritzkes DR, Bennett D. HIV-1 protease and reverse transcriptase mutations for drug resistance surveillance. AIDS. 2007 Jan 11;21(2):215-23. doi: 10.1097/QAD.0b013e328011e691.

Helpful Links

• Hiv surveillance report
• Migration report in Poland
• Migration report in Poland
• Hiv resistance pattern
• HIV/AIDS European guidelines on diagnostics and treatment

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: AIDS; HIV-infection; cART; migration; drug-resistance
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; HIV Infections; Infections; Communicable Diseases
• Other Study ID Numbers: HIVresistancePL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan to share the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No