Insights on treatment of a Portuguese cohort of HCV/HIV coinfected patients.

Filed under: Methadone Treatment

J Int AIDS Soc. 2012; 15(6): 18428
Silva C, Doroana M, Afonso C, Fernandes J, Antunes F

Purpose of the study: This study intends to characterize a Portuguese patient population with chronic HCV and HIV coinfection, followed at our Research Unit, underline the importance of early treatment and incorporate the importance of DDA for retreatment of HCV infection. Methods: Retrospective, observational analysis of medical records of 348 HCV/HIV coinfected patients from 2001 to 2011. Demographic, epidemiological, clinical and laboratory data and virologic response were collected. Summary of results: Review of 348 HCV/HIV coinfected patients, 121 of those (34.7%) under treatment, predominantly male (77.0%) and Caucasians (94.8%) with a median age of 44 yrs old (min 25; max 77 yrs). Intravenous drug use was the main route of HCV infection, in 71.3% of patients, and 8.3% were related with MSM. Frequent morbidities were alcohol abuse (46.8%), illicit drug use (70.1%), methadone (25.6%) and mental disturbances (12.3%) of patients. Regarding HIV infection, six were HIV-2 and 342 HIV-1; 36.1% were stage A and 29.6% were stage C (CDC Atlanta), 94.8% on antiretroviral treatment and only 21.9% of them with more than 350 TCD4 cell count. Genotype 1 was the most prevalent (58.1%-117 genotype 1a, 26 genotype 1b); 1.6% were genotype 2, 22.8% genotype 3 and 17.5% genotype 4. Previous to treatment initiation, HCV ARN was above 600.000 IU/mL in 56.9% patients. Fibrosis was evaluated by fibroelastography in 41.1% and hepatic biopsy in 26.3% of patients; in those, 44.0% had a score above F2 (METAVIR) and ALT was elevated 2 times the limit in 38.0%, with an average value of 94 UI/L. IL 28B testing was performed in only 35 patients at the time, with 45.7% CC and 17.1% CT genotype. Treatment was started in 34.8% of patients, with 1.7 treatments per individual, and regimen was based on peguilated interferon with ribavirin in 93.6% of cases (72.1% with peginterferon alfa 2a). The SVR rate was 51.2%, with 28.9% non responders, 3 relapsers and 9 treatment interruptions due to major toxicities. Conclusions: Our data presents a low HCV treatment initiation, illustrated by 65.2% patients who did not begin any treatment. The majority completed treatment and the SVR rate was similar to literature. Individualized approach is essential to determine the optimal time to initiate HCV treatment, to assess patient adherence and adverse events management, in order to optimize treatment and reserve DDA drugs to experienced patients with worse predictive factors.
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Comprehensive care with antiretroviral therapy for injecting-drug users associates to low community viral load and restriction of HIV outbreak.

Filed under: Methadone Treatment

J Int AIDS Soc. 2012; 15(6): 18394
Kivelä P, Liitsola K, Aho I, Simola S, Tuomola P, Salminen M, Ristola M

An outbreak of HIV was detected amongst Finnish injecting-drug users (IDUs) in 1998. The outbreak was caused by CRF01-AE virus [1]. A comprehensive care programme including infectious diseases, addiction medicine, low threshold methadone program, needle exchange, accommodation and other social services started in December 2000. Funding was provided by municipalities. We have described earlier how the outbreak became geographically and socially restricted [2]. The data of newly diagnosed HIV infections in the hospital district of Helsinki and Uusimaa (Helsinki region) amongst IDUs and HIV-1 subtypes were obtained from the Finnish national HIV registry. The Helsinki University Central Hospital (HUCH) registry was used to obtain the number of IDUs in HIV care, on antiretroviral therapy (ART), and plasma HIV-1 RNA (VL) amongst IDUs. The HUCH registry also includes IDUs diagnosed with HIV infection in other Finnish regions, but currently living in Helsinki region. The highest number (n=65) of newly diagnosed HIV infections among IDUs in Helsinki region was observed in 1999 (Figure 1). Between 1998 and 2011, 249 IDUs were diagnosed with HIV infection. From 1998 to 2004 the subtype was CRF01-AE in 187 (92%) cases, other subtypes in 5 (2%) cases and not subtyped in 11 (5%) cases. From 2005 to 2011 the subtype was CRF01-AE in 25 (54%) cases, other subtypes in 15 (33%) cases and not subtyped in 6 (13%) cases. In 2011 there were 4 IDUs diagnosed with HIV, one of them with CRF01-AE. In the Helsinki region out of 183 HIV-infected IDUs in 2005, 100 (55%) had VL<50 copies/ml and out of 167 HIV-infected IDUs in 2011, 133 (80%) had VL<50 copies/ml in 2011. We propose that from 2005 the low HIV-1 RNA in plasma of IDUs has contributed to the low incidence of HIV among IDUs in Helsinki region. However, the incidence of HIV started to decline before the decline of VL in the cohort (Figure 1 ). This suggests that other factors besides ART may have decreased the risk of HIV infection among IDUs before ART coverage of the cohort became considerable. Other subtypes of HIV circulated among IDUs in the Helsinki region during the observation period, which emphasises the necessity of health promoting services (e.g. needle exchange) to be available to all IDUs. HubMed – Methadone Treatment

Budget impact analysis of introducing the new single-tablet regimen rilpivirine/emtricitabine/tenofovir for the treatment of HIV in Portugal.

Filed under: Methadone Treatment

J Int AIDS Soc. 2012; 15(6): 18375
Gouveia M, Costa J, Teófilo E, Borges M

Purpose of the study: Rilpivirine/emtricitabine/tenofovir (RPV/FTC/TDF) is a new single-tablet regimen (STR) approved for the initial treatment of HIV-1 infection. The aim of this study was to estimate the impact on the State Budget of this new STR introduction in the Portuguese Health System (PHS) using secondary data from official statistics and observational studies. Methods: The analysis considers a time frame of three years, does not include mortality, assumes a constant flow of new patients, and deals only with antiretroviral therapy (ART) costs. Values are not discounted. The stock and flow data of total HIV-1 patients comes from official statistics from the National Committee for HIV/AIDS. The model starts with recent historical data on the percentage of different ART drugs used for the treatment of naïve patients. Estimates from an observational study also provide 1) the probability that a patient in a given regimen switches to another therapy and 2) the probability distribution for the new therapy choices given that the patient has switched. The penetration of the new STR is also linked with the prevalence of adverse effects of other ART, in particular teratogenic effects, central nervous systems effects and possible interactions with methadone. The distribution of patients according to ART drug, together with price information, allow us to estimate average costs of treatment per year and per patient for each class of ART. Estimates of patients’ numbers for the second and third years assume the same inflow as in the first year, a given annual percentage of non-switchers from RPV/FTC/TDF and additional flows from patients switching to non-nucleoside reverse transcriptase inhibitors from other third-agent classes. Summary of results: The model predicts a flow of 245 new naïve patients on RPV/FTC/TDF per year, with 209 and 194 of these patients staying with RPV/FTC/TDF in the second and third years, respectively. Given that the average cost of treatment is lower in the scenarios with RPV/FTC/TDF (because the percentage of patients on the more expensive PI class are lower), the overall budget impact consists in savings of about €2.3 million. Conclusions: The introduction of the new STR RPV/FTC/TDF in the PHS will lead to cost savings in the resources spent on the anti-retroviral therapy of HIV-1.
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