Tetiana Kyrychenko MD. Poltava Regional HIV/AIDS Prevention and Control Center. 4TH CEE MEETING ON VIRAL HEPATITIS AND HIV October 2018, Prague

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1 Tetiana Kyrychenko MD Poltava Regional HIV/AIDS Prevention and Control Center 4TH CEE MEETING ON VIRAL HEPATITIS AND HIV October 2018, Prague

2 Disclosures No relevant conflicts of interest to declare in relation to this presentation

3 HCV epidemic in Ukraine: overview and trends Ukraine belongs to countries with an average prevalence of hepatitis C. Each year, about 6,000 people are diagnosed with hepatitis C. There are 24,786 patients who expect to be cured from hepatitis C in the near future. It is expected ledipasvir/sofosbuvir and sofosbuvir + daclatasvir to be purchased by government for HCV treatment in Official Data on HIV * as of HIV epidemic in Ukraine Number of registered people living with HIV Number of reported new cases of HIV infection Number of people on ART b89c010ac74b207d3dccec512c2c.pdf Number of reported deaths due to AIDS-related diseases 3364

4 Background Ukraine s HCV distribution epidemic is seen to be fueled by people who injected drugs (PWID) with limited access to the integrated services, which contribute to poor retention in care of HIV/HCV coinfected patients. Data about efficacy and tolerability of new directly antiviral agents (DAAs) among PWID in Ukraine are limited.

5 The aim of this study to assess real-life effectiveness of Ledipasvir/Sofosbuvir(LDV/SOF) based regimen, to analyze factors associated with retention in care during the treatment among HIV/HCV co-infected PWID in Ukraine.

6 Materials & Methods: An observational retrospective study includes 75 HIV/HCV co-infected patients with history of injection drug use, who started LDV/SOF based regimen between April 1, 2017 and November 30, 2017 and who were assessed for sustained virologic response (SVR) by May 31, Key Inclusion Criteria: PWID (active intravenous drug users or receiving opioid substitution therapy or people are being injected in the past and don t do it anymore); 1 HCV genotype; Patients who were taking all prescribed doses of drug LDV/SOF during 12 weeks of treatment period; Key Exclusion Criteria: Pregnant or nursing female or male with pregnant female partner. Hepatocellular carcinoma (HCC) or other malignancy. Patients who missed two or more HIV clinic appointments (doctor s physical examinations or prescribed analysis) were considered to be unengaged people in care. SVR was defined as undetectable HCV RNA at least 12 weeks after completing treatment. Liver fibrosis was evaluated by indirect methods (real time elastography and biochemical markers). Bivariate comparisons were tested using Pearsons s chi-square or Fisher s exact tests. Potential risk factors associated with dropout during treatment have been identified by using multivariate logistic regression models. SPSS version 22.0 was used for statistical analysis.

7 Results: Characteristics HIV/HCV-coinfected patients n=75 Age (yrs, mean) (IQR) 41 (26-60) Gender (male, %) (female, %) Opioid substitution therapy (OST) 51 (68,0) 24 (32,0) 35 (46,7) Duration of HCV-infection (yrs, mean) 8,7+0,13 HIV clinical stage (n, %): I 6 (8) II 3 (4) III 39 (52) IV 27 (36) Average CD4 count 619 ±16,2 before HCV treatment, cells/ul ± standard deviation HCV treatment naïve patients (n, %) 71 (96,4) Mean HCV RNA, IU/L HCV viral load >600,000 IU/L (n, %) 30 (40) Fibrosis stage by METAVIR (n, %) 0 13 (17,3) (56,0) 20 (26,7) 3-4

8 History of opportunistic infections in 75 HIV/HCV-co-infected patients Candidiasis 28% Hairy leukoplakia, oral Bacterial pneumonia 20% 20% Tuberculosis 28% Herpes zoster 20% Toxoplasmosis of brain 8% Cytomegalovirus disease Kaposi sarcoma 1% 3% 0% 5% 10% 15% 20% 25% 30%

9 Antiretroviral therapy regimens in 75 HIV/HCV-co-infected patients 12% 3% 3% TDF/FTC/EFV 16% 42% AZT/3TC + EFV TDF/FTC + LPV/r AZT/3TC + LPV/r ABC/3TC + EFV Duration of ART 24% ABC/3TC + LPV/r 28% 8% 64% < 1 year 2-5 years more than 5 years

10 Prevalence of Symptoms in persons with HIV/HCV co-infection Variable No. (%) of patients Physical tiredness 30 (40,0) Mental tiredness 45 (60,0) Poor concentration 28 (37,3) Irritability 25 (33,3) Sleep problems 20 (26,6) Abdominal pain 17 (22,6) Nausea 15 (20,0) Poor appetite 13 (17,3) AST and ALT >N 35 (46,6)

11 SVR of Chronic Hepatitis C therapy in HIV/HCV co-infected persons 100% 92% 94,3% 91,1% 90% 80% 70% 60% 50% 40% 30% 20% 10% SVR Patients being on OST Never receiving OST

12 LDV/SOF adverse effects in patients depending on receiving OST Variable Receiving OST (n=35) Never receiving OST (n= 45) P<0.05 Fatigue 20% 4,5% 0.05 Nausea 17,1% 2,2% 0.02 Headache 14,2% 5,0% 0.1 Diarrhea 8,5% 4,4% 0.5 Insomnia 11,4% 6,6% 0.7

13 Factors of best predicted retention in care Variable OR 95% CI during HCV treatment Attending clinic of integrated services with access to OST Social support Evidence of previous TB treatment Our multidisciplinary team - doctor, social worker and nurse, Poltava Regional HIV/AIDS Prevention and Control Center

14 Conclusions LDV/SOF-based regimen used in our real-life cohort, consisted of people with history of drug use, achieved high overall SVR rate. The study has shown that treatment outcome is similar to patients being on OST with other patients with history of drug use. Significant prevalence of LDV/SOF adverse effects has been revealed among patients receiving OST. Retention in care during HCV treatment of HIVinfected PWID in Ukraine has been associated with good access to OST, social support, and evidence of previous TB treatment.

15 Thank you for your attention! Welcome to Ukraine! Kiev Swallow s Nest Castle, Yalta Synevir Lake Lviv