Safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in hepatitis C virus/human immunodeficiency virus co-infected patients

Table 1 Demographic characteristics of the patients at baseline n (%)

Characteristic	Ledipasvir/sofosbuvir for 12 wk (n = 40)
Median age (IQR) - yr	53 (51-57)
Male sex	25 (62.5)
Race1
White	13 (32.5)
Black	22 (55.0)
Asian	1 (2.5)
Other or unknown	4 (10.0)
Mean body-mass index (IQR)2	26.2 (22.7-28.7)
Smoking	13 (32.5)
HCV genotype
1a	34 (85.0)
1b	5 (12.5)
3a	1 (2.5)
Baseline HCV RNA (IQR), log10 IU/mL	6.3 (6.0-6.6)
HCV RNA > 6 million IU/mL	5 (12.5)
Cirrhosis	10 (25.0)
Baseline creatinine, mean (range), mg/dL	0.95 (0.56-1.48)
Baseline eGFR, mean (range), mL/min	90.0 (52-134)
CD4, cells/mm3
< 200	1 (2.5)
200-350	7 (17.5)
> 350	32 (80)
Mean CD4+ cell count (IQR), cells/μL	638 (366-857)
Antiviral regimen	40 (100)
HCV treatment history
No previous treatment	31 (77.5)
Previous treatment	9 (22.5)

¹Self-reported;

²Calculated as weight in kilograms divided by height in meters squared. BMI: Body mass index; eGFR: Estimated glomerular filtration rate; HCV: Hepatitis C virus; IQR: Interquartile range.

Table 2 Antiviral regimen

Antiviral regimen	n (%)
Efavirenz-emtricitabine-tenofovir DF	1 (2.5)
Tivicay-emtricitabine-tenofovir DF	1 (2.5)
Rilpivirine-emtricitabine-tenofovir DF	5 (12.5)
Raltegravir- Rilpivirine-emtricitabine-tenofovir DF	2 (5)
Raltegravir-emtricitabine-tenofovir DF	6 (15)
Ritonavir- Raltegravir-emtricitabine-tenofovir DF	1 (2.5)
Dolutegravir-emtricitabine-tenofovir DF	1 (2.5)
Raltegravir-telaprevir	4 (10)
Abacavir-dolutegravir-lamivudine	8 (20)
Abacavir-etravirine-lamivudine	1 (2.5)
Darunavir-ritonavir-etravirine-raltegravir	3 (7.5)
Abacavir-lamivudine-darunavir-ritonavir	3 (7.5)
Abacavir-lamivudine-darunavir-ritonavir-etravirine-raltegravir	1 (2.5)
Elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide	3 (7.5)

DF: Disoproxil fumarate.

Table 3 Response during and after therapy

Response	Ledipasvir-Sofosbuvir for 12 wk (n = 40), n (%)
HCV RNA < LLOQ1
During therapy period
At wk 4	34 (78.2)
At wk 12	40 (100)
After end of therapy
At wk 4	40 (100)
At wk 122	39 (97.5)
HCV viral breakthrough	0 (0)
HCV viral relapse	1 (2.5)
HIV viral breakthrough	7 (17.5)
HIV virologic rebound	2 (5)

¹LLOQ denotes lower limit of quantification (HCV RNA in serum, < 15 copies per milliliter HIV RNA in serum, < 40 copies per milliliter).

²A sustained virologic response 12 wk after the end of therapy was the primary end point. SVR: Sustained viral response.