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Sustained Virologic Response (SVR) in HIV-HCV Co-infected Patients with HCV Genotype 1(G1) Infection who have a Rapid Virological Response (RVR) at Week 4 of Treatment with Peginterferon Alfa-2a (40KD) (PEG IFNa-2a, PEGASYS®) Plus Ribavirin (RBV, COPEGUS®): AIDS PEGASYS Ribavirin International Co-infection Trial (APRICOT)
Douglas Dieterich*1, F Duff2, M Sulkowski3, F Torriani4, E Lissen5, N Brau6, and M Rodriguez-Torres7
1Mt Sinai Sch of Med, New York, NY, US; 2Roche, Nutley, NJ, US; 3Johns Hopkins Univ, Baltimore, MD, US; 4Univ of California, San Diego, US; 5Virgen del Rocío Univ Hosp, Seville, Spain; 6VAMC, Bronx, NY, US; and 7Fndn de Investigacion de Diego, Santurce, PR, US
Background: SVR rates were significantly
higher with PEG IFNa-2a
(40KD) (PEGASYS) + RBV (COPEGUS) than PEG IFNa-2a (40KD) + PL or IFN/RBV in APRICOT (40% vs
20% and 12%, p<0.0001). In G1 pts, the overall SVR rates were 29%, 14% and
7%, respectively. However, PEG IFNa-2a
(40KD) + RBV produced an SVR in 61% of G1 pts with a low viral load (LVL),
which was similar to that in G2/3 pts with an LVL (61%) or high viral load
(63%)
In HCV monoinfection,
G1 pts have very high SVR rates if they achieve a rapid virological response
(RVR) at wk 4, regardless of baseline VL. We studied the effect of an RVR on
the probability of an SVR in G1 pts who received PEG IFNa-2a (40KD) + RBV in APRICOT.
Methods: Eligible pts had quantifiable serum HCV RNA (>600 IU/mL), elevated ALT, compensated liver disease and HIV
co-infection. Pts were randomized to 48 wks of treatment with PEG IFNa-2a (40KD) 180µg/wk + either RBV 800mg/d or PL, or IFN+RBV. LVL =
HCV RNA <800 000 IU/mL. In this analysis virologic
responses (ITT) in pts treated with PEG IFNa-2a (40KD) + RBV are described with descriptive statistics. RVR =
HCV RNA <50 IU/mL at wk 4. SVR = HCV RNA
<50IU/mL after 24 wks of untreated follow-up (wk72).
Results: (Table) In total, 22 /289 G1 pts (13%) had
an RVR and 18 (82%) had an SVR (15/18 with an LVL and 3/4 with an HVL). 176/289
pts randomized to PEG IFNa-2a
(40KD) + RBV had G1, 46 of whom had an LVL.
Conclusion: RVR at wk 4 indicates a high probability of SVR in G1 pts (~80%)
regardless of baseline viral load. PEG IFNa-2a (40KD) + RBV produced an SVR rate of 61% in G1 pts with an LVL,
similar to that in G2/3 pts with an LVL (61%) or a high viral load (63%).
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Virologic response in 176 G1 pts
treated with PEG IFNa-2a
(40KD) 180µg/wk + RBV 800 mg/d in APRICOT (ITT population)
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|
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N
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SVR (%)
|
|
RVR (HCV RNA <50 IU/mL at wk 4)
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22
|
18 (82)
|
|
LVL
(HCV RNA ≤800,000 IU/mL)
|
18
|
15 (83)
|
|
HVL
(HCV RNA >800,000 IU/mL)
|
4
|
3 (75)
|
|
HCV GT-1 (all pts)
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176
|
51 (29)
|
|
LVL
(HCV RNA ≤800,000 IU/mL)
|
46
|
28 (61)
|
|
HVL
(HCV RNA >800,000 IU/mL)
|
130
|
23 (18)
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