P4. One year treatment outcomes among all HIV-1 infected patients in Sweden on Eviplera

Amanda Häggblom1, Catharina Maijgren Steffensson1,2, Göran Skoglund2, Veronica Svedhem Johansson1,3

Affiliates: 1Unit of Infectious Diseases, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden, 2Gilead Sciences Sweden, Solna, Sweden, 3Department of Infectious Diseases, Karolinska University Hospital

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Background
Eviplera (EVP) is a single tablet regimen (STR) containing tenofovir disoproxil fumarate, emtricitabine and rilpivirine to be taken once daily in adults infected with human immunodeficiency virus-1 (HIV-1). In June 2015 there were 6457 HIV-1 infected patients on treatment in Sweden, out of those 568 were on treatment with EVP. A cohort with 368 patients has been followed for more than 1 year and is included in this report.

Methods
The 368 patients in the cohort were started on EVP in Sweden prior to the 30th of November 2013. Among the 368 patients, 73% (269) were treatment experienced and 27% (99) were treatment naïve at initiation. 71% (263) were male. About half of the patients were MSM. 44% were born in Sweden and 67% had a subtype other than subtype B.
The data is collected retrospectively from the National Quality Register InfCareHIV, which includes all patients diagnosed with HIV-1 in Sweden.

Results
EVP in treatment naïve patients
In the naïve patients, the median baseline viral load was 8617.5 copies /ml (2212Q25- 30300Q75) at initiation of EVP treatment. The median age for the naïve patients who started EVP was 39 (33 Q25-46 Q75) and the median CD4 T-cell count at start was 400 (300 Q25-520 Q75)
After one year of follow up of the 99 naïve patients 86 (87%) patients were still suppressed on EVP. Of the 13 (13%) patients who discontinued EVP, 2(2%) had developed a virologic failure (VF) and 11 (11%) discontinued of other reasons. Most of the discontinuations happened early in the course of treatment ( 1 year). The main reasons for 1 year were switches to DTG+KVX. The two patients who developed VF did not have any resistance associated mutations to EVP.
EVP in treatment experienced patients
Of the 269 experienced patients, 28 patients switched to EVP because of treatment failure with the previous regimen and 226 switched due to side effects. The majority of the patients who switched to EVP because of side effects were previously on treatment with an efavirenz based regimen. There is no data regarding switch reasons for the remaining 16 patients. Previous treatment before switch to EVP included NNRTIs + NRTIs in 53%, PIs + NRTIs in 36%, INIs + NRTIs in 4% and other combinations in 7% of the patients. Regarding the NRTIs, TDF + FTC were used in 66% and ABC + 3TC in 22%, 3TC + ZDV in 5% and in 7% of the patients other combinations were used. The median age for the experienced
patients who started EVP was 47 (38 Q25-53 Q75) and the median CD4 T-cell count at EVP start was 510 (390 Q25-670 Q75).
Of the experienced patients who switched to EVP, 80% (215/269) were still suppressed on EVP after one year. Of the 20% (53/269) who had discontinued EVP, 3% (9) had developed a VF and 16% (44) discontinued for other reasons. Most of the discontinuations happened after >1 year on EVP. Of the 9 patients who developed a VF, two had resistance associated mutations to EVP. One developed Y181C and M184I during the EVP treatment and one E138Q. Y181C and E138Q are associated with rilpivirine resistance and M184I with FTC resistance.

Conclusions
EVP was associated with high rates of virologic suppression 87% and 80% in treatment naïve and experienced patients, respectively, after one year follow up. VF occurred in 2 and 3% of the patients, respectively.